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Persuasive Essay On Non Animal Testing
The Food and Drug Administration (FDA) defines cosmetics as objects intended to be applied to the
human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without
affecting the body's structure or functions. Examples of cosmetics include skin cream, perfume,
lipstick, makeup, shampoo, and hair color. Any ingredient used in a cosmetic also falls under the
definition of a cosmetic. Products normally labeled as cosmetics are classified as drugs when a
medical claim is made. For example, toothpaste is sometimes considered a cosmetic, but if it
advertises cavity protection, then it is a drug.
A lot of these products are often tested on animals to ensure safety. Companies have the option of
using existing non–animal tests or investing developing alternative non–animal tests for new
ingredients. These modern alternatives can offer results that are more relevant to people, more ...
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They consider animals simpler to apply to tests but still similar enough to apply to human beings.
Consequently, results from animal tests may not be relevant to humans. The results may either under
or overestimate real world situations in relation to people. The FDA reports that 9 out of 10 products
that pass animal testing fail human testing, and vice versa. Unreliable and ineffective animal tests
mean consumer safety cannot truly be guaranteed. Regardless of which, Cosmetics companies are
not required to test their products on animals. The Federal Food, Drug, and Cosmetic Act prohibit
the sale of mislabeled and adulterated cosmetics. This Act does not require that animal tests be the
source of testing, just so long as it is tested. Therefore, animal testing does not need to be continued
as long as previously test ingredients are used in
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The Essure Medical Device Analysis
Originally, the company Conceptus manufactured the Essure Permanent Birth Control System,
which was first approved for use by the U.S. Food and Drug Administration (FDA) on Nov. 4, 2002.
In 2013, Bayer purchased Conceptus and the companies merged. According to Bayer, more than
750,000 women use this birth control system to prevent pregnancy, with approximately 70 percent
of these women residing within the U.S.
The Essure Medical Device
The Essure Medical Device consists of flexible coils that are non–surgically placed within the
Fallopian tubes. This device is a permanent form of birth control.
Essure's flexible coils are inserted through the vagina, past the cervix and into the Fallopian tubes.
Once inserted, the device causes a build–up of the tissue within the Fallopian tubes. Over a period
of approximately three months, this tissue blocks the Fallopian tubes; thus, preventing the sperm
from traveling through them to fertilize an egg.
Three months following insertion, a radiologist checks to make sure that the Fallopian tubes are
blocked. Directly before the x–ray is taken, a contrast dye is injected through the patient's cervix to
ensure that there is no leakage of dye past the Essure Medical Device.
According to ... Show more content on Helpwriting.net ...
Art Sedrakyan is a professor at Weill Cornell Medicine in New York. He is also leading the Science
and Infrastructure Center of the FDA's Medical Device Epidemiology Network ((MDEpiNet).
Sedrakyan and a group of colleagues evaluated data from more than 8,000 women who received
Essure implants. This data was compared to data from 44,278 women who underwent the standard
surgery to block (tie) their Fallopian tubes. According to the Safety and efficacy of hysteroscopic
sterilization compared with laparoscopic sterilization: an observational cohort study, women who
opted for Essure frequently had to have surgery regardless and their risk of needing a second
procedure was substantially higher than it was for women who underwent
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Argumentative Essay On Fda
The Food and Drug Administration is the oldest consumer protection agency in United States (FDA
2). From recalls on food products to the monitoring of the safety of our medicine sources, the Food
and Drug Administration (FDA) ensures that they are both safe and wholesome (FDA 1). The Food
and Drug Administration also ensures that the cosmetics we use won't harm consumers, and that
radiation–emitting product such as microwaves are secure and effective (FDA 1).
The FDA is authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and many
other public health laws (FDA1). The agency monitors import, export, manufacture, storage, and
sale of up to one trillion worth of goods yearly, at an average cost to taxpayers of about three dollars
per person (FDA1). Before FDA was created, the power to regulate was given to the individual
states (fda 1). The federal government did little to nothing, while ... Show more content on
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The FDA was first under the control of The Depart of Agriculture then shifted to Federal Security
Agency and later the Department of Health, Education and Welfare (2). Today the FDA is currently
under the control of the Department of Public Health Services (2).
Although the FDA was not known by this title until 1930, the FDA's regulatory functions first began
with the passage of the 1906 Pure Food and Drugs Act, prohibiting interstate commerce in
adulterated and incorrect labels on food and drugs (FDA 2). The bill gave the FDA its power to
adjust over a wide subject matter (fda 2). This law was the merging of 100 bills over a half of
century that was aimed towards abuses in the consumer product marketplace (FDA 2). The meat
inspection act was also passed on the same day which set rules for cleanliness and sanitation of meat
processing and slaughterhouses
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Drug And Cosmetic Act Of Chipotle
Put down your carnitas burrito and give a side–eye to your soda. Chipotle has been has sneaking
GMOs into its "non–GMO" menu offerings. At least that's what a recent class action lawsuit is
claiming.
Back in late April, Chipotle announced it was "G–M–Over it," rolling out a marketing campaign
that claimed it was only going to use "non–GMO ingredients."
"When it comes to our food, genetically modified ingredients don 't make the cut," read
advertisements for the fast–casual chain. (You'll probably recall that the media reacted quite
critically and wasted no time lambasting the company.)
Apparently consumers in California were just as dubious. In her class action lawsuit filed last week
in federal court in San Francisco, lead plaintiff Colleen Gallagher of Piedmont, Calif., said that
Chipotle deceived customers into paying more for their food and violated the Federal Food, Drug
and Cosmetic Act with its false and misleading food labeling.
The lawsuit, filed on behalf of California consumers who bought food from Chipotle after April 27,
2015, says that the advertising campaign is deceptive and misleading because many menu items do
contain GMOs and that the plaintiff was injured "by purchasing (or overpaying for) Chipotle's Food
Products" (page 18). and that "[p]laintiff would not have purchased Chipotle's Food Products (or
paid as much for it) had she known the truth" (page 19).
It is a bit strange that Chipotle, a restaurant chain that has done the most work to align itself
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The US Food And Drug Administration (USFDA)
The U.S Food and Drug Administration (USFDA) is the government agency responsible for
ensuring the safety and efficacy of drugs and medical devices in the USA. The two legislative acts
that are the main source of the FDA's authority are: 1. The United States Federal Food, Drug, and
Cosmetic Act, which is a set of laws passed by Congress in 1938 in reaction to the growing public
safety demands, significantly expanding federal regulatory authority to oversee the safety of food,
drugs, cosmetics and medical devices. The act gave authority to FDA to mandate pre–market
approval of all new drugs. It was for the first time that manufacturers were required to prove to FDA
that a drug was safe before it could be marketed. 2. The 1962 Kefauver–Harris
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Ensuring Consumer Safety: Toward Redefining the U.S. Food...
Kayla Shelton Professor Lodge UNIV 200 14 April 2011 Ensuring Consumer Safety: Toward
Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) is an
agency of the United States Department of Health and Human Services. The FDA is responsible for
protecting and promoting public health through the regulation and supervision of foods, medical
devices, and prescription and over–the–counter pharmaceutical drugs (medications). The FDA
regulates and supervises medical devices and drugs throughout their development, manufacturing,
process of approval, marketing, and post marketing stages. When a drug or medical device is
granted approval by the FDA, it will shortly become marketed in the United States and ... Show
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The third and final phase of drug trials involves a large number of volunteers in well–controlled
settings. A variety of ways can be used to test the drug; however, placebo is the standard comparator
for the drug (Wing et al.). After the completion of clinical trials, the data from the trials is submitted
among other safety and efficacy reports in the NDA process. When the FDA receives the completed
NDA, they begin their review process, which they are legally allowed ten months to review the
application and submit their decision of approval (FDA). The label content is decided next, then the
drug can be granted approval by the FDA. A drug approved by the FDA is said to be "safe and
effective when used as directed on the label" (Wing et al.). Unlike prescription drugs, the FDA has
two different regulatory standards for reviewing medical devices: premarket approval (PMA) and
510(k) clearance. The FDA classifies medical devices, according to their risk, through which they
can be identified. There are Class I , Class II, and Class III medical devices. The PMA process is the
FDA process of reviewing Class III medical devices. According to the FDA, "Class III devices are
those that support or sustain human life, are of substantial importance in preventing impairment of
human health, or which present a potential, unreasonable risk of illness or injury" (FDA). The PMA
process is the most stringent type of
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Advantages Of Animal Testing In Cosmetics
Animal Testing in Cosmetics: A Reflection on the Advantages and Disadvantages and the Impact of
Technology of Animal Testing
Over the last decades, animal testing in cosmetics has become popular and a routine for many
cosmetics manufacturing companies. The act of testing animals for cosmetics, however, remains to
be a heated debate with some sides condemning it while others see nothing wrong with it.
Consequently, to some people or organizations, animal testing is and has for long been a life–saving
technique for the cosmetics' consumers. Even with a life–saving advantage towards the consumers,
animal testing in cosmetics is not as good as some view it. Millions of innocent animals often
rabbits, mice, and rats among others are killed or caged to support the testing. For this reason, this
essay will critically examine the pros and cons of animal testing in cosmetics. The focus will lean on
the cons and some of the alternatives that advanced technology provides for this subject.
On the aspect of life–saving, animal testing in cosmetics is a technique that improves and protects
human health. By supporting animal testing in cosmetics, individuals attribute the use of animals to
determine the safety of products before they are used by humans. The argument in this light is that,
the end–user of animal–tested cosmetics products, which are undoubtedly increasing day–to–day
across the world, is less exposed to toxic chemicals. Less exposure to toxic chemicals is due to the
fact that
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Cosmetics Testing On Animals Is Inhumane?
Cosmetic/Household Product Testing The act of testing cosmetic and household products on animals
is inhumane. Animals have rights also, and for humans to test products on them for their benefit is
heartbreaking. The use of rabbits being used to test shampoo and mascara in their eyes blinds them.
The European Union and Israel have banned cosmetic and cosmetic ingredients being tested on
animals in their country. Those countries have also banned imports with cosmetics tested on other
animals from other countries. China is slowly making the decision to ban animal testing for
cosmetics as well. India has temporarily banned the testing of cosmetics and household products on
animals, and is permanently in effect in November 2014. According to Peta, "Unfortunately, things
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This reluctance to change is especially unforgivable considering the current wide availability of
superior non–animal tests. Instead of measuring how long it takes a chemical to burn away the
cornea of a rabbit's eye, manufacturers can now drop that chemical onto donated human corneas.
Human skin cultures can be grown and ordered for irritancy testing. These and dozens more tests
now in use today are cheaper, faster, and more accurate at predicting human reactions to a product
than the old animal tests ever were." With other alternatives available to test for irritation and
chemical exposure, there is no explanation for the United States to still be using live animals for
cosmetic testing. With some countries banning the use of cosmetic testing on animals, there is hope
that other countries will begin to as well. The countries who still use animal testing as a way of
testing products might recognize why the countries have banned such an act. When the cruelty of
animal testing is recognized, countries who still testing with
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Gmp Iq7 Regulations Paper
I. Introduction:
Before any biopharmaceutical company can begin to manufacture a desired product, the company is
required by law to establish an adequate facility to support a safe and efficient manufacturing
process. The US Food and Drug Administration (FDA) department under the authority of the
Federal Food, Drug, and Cosmetic Act determines whether or not a specific manufacturing facility
is approved. Furthermore, companies must adhere to the Good Manufacturing Practice Regulations
(GMP) specifically those described in ICH Q7 in order to effectively fulfill FDA requirements. The
fundamental purpose of the regulations beforehand is to accomplish a system that ensures products
are consistently produced and controlled to the highest standards and thus prevent human safety
risks that may not be reduced through testing the final ... Show more content on Helpwriting.net ...
In the long run, these practices will ensure that consumers purchase an effective product that is not
dangerous, otherwise, companies may face very serious consequences including recall, seizure,
fines, jail time and of course, lost of profit. When the manufacturer believes they are equipped for
an inspection, a highly specialized FDA staff examines the pharmaceutical manufacturing facilities
and ensures that it is compliant with current Good Manufacturing Practice (cGMP) regulations.
Here, the ICHQ7 guidelines, staff responsibilities and training will be discussed followed by how to
manage a 483 and close out meeting. I. GMP ICHQ7 Guidelines:
The ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API),
outlines the standards for the facility, utilities and equipment necessary to support a good
manufacturing operation. This guide describes aspects related to all operations of receipt of
materials, production, packaging, repackaging, labeling, relabeling, quality control, release,
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Food Drug And Cosmetic Act 1938
The 1938 Food, Drug, and Cosmetic Act mandated that manufacturers of drugs had to provide
labels on their drugs. These labels provided the consumer with information about what certain drugs
contained and specific directions about how to take them. This action prevented false claims about
drugs and allowed consumers to know that certain drugs were safe. As a result, the scrutiny of drugs
ensured the selling of safe drugs in the United States. Food became upheld to a standard after
passing the 1938 Food, Drug, and Cosmetic Act. The manufacturers of various foods were required
to list the ingredients contained in their products. Only certain ingredients that were deemed
nutritious and safe became allowed to be included in food production. This
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Cosmetic Products Have Been Integrated Into Our Society
Cosmetic products have been integrated into our society for centuries, and women have put their
trust in the companies that provide them. These products are used confidently, sometimes without
the thought of possible harm to health crossing the mind of the consumer because the cosmetic
products purpose is for protection, cleaning, and beautification. As people are becoming more aware
of the hazards in their everyday lives, questions have arisen about the ingredients, particularly the
chemicals, that are being used to create women's cosmetics. In recent studies, cosmetics have been
found to contain chemicals that can be harmful to a woman's reproductive health, including
miscarriages and birth defects, and have links to breast cancer. ... Show more content on
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It is advised to use caution when using products that contain phthalates. Petrochemicals are a
petroleum based substance that, when used in topical or oral application, can result in anemia,
kidney regeneration and damage to nerves in the brain or spinal cord. Petrochemicals are seen as
synthetic colors used within cosmetic products such as lipsticks and eyeshadows. Exposure to these
chemicals has been linked to a rise in cancer, as well as other lifelong diseases (Nohynek, 2010).
Recently, the importance of testing and monitoring the harmful effects of cosmetic products has
increased because they have also been found with compounds of different metals, which is can be
extremely dangerous when in frequent contact with the skin. Although humans are likely to be
exposed by naturally occurring metals released into the environment, cosmetic products can lead to
routes of toxic metal entry into the body (Kalicanin, 2015). The theory is that the low, but constant
exposure to the harmful chemicals in personal care products, increases the risk for women to
experience reproductive problems, miscarriages, infant mortality and birth defects. Although these
are only a few examples of the vast amount of harmful chemicals that are used to cosmetic products,
it is safe to say that there should be more of a concern when it comes to the products that women are
using on their bodies multiple times on a day to day basis. Current regulations on cosmetic products
have
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Microbial Regulation oin the Food Industry
Microbiology Topic Paper:
Microbial Regulation in the Food Industry
Microorganisms have been involved I the development of food items throughout history. Although
at first it may have not been intentional over time humans have study and experimented with
culturing microbes to prolong the shelf life of foods, inadvertently changing the taste and textures of
the food item as well. As safety concerns spread in the 1900s regulations were formed to ensure the
safety and well–being of humans. In the United States, the U.S. Food and Drug Admiration is the
organization that determines the overall safeness of a food element.
When Microbes are used in food they tend to fall under two types of categories in the FDA
regulatory classifications. The first category would be the generally recognized as safe category or
GRAS published as a proposed rule in 1997. Microbes considered GRAS fall under multiple
definitions. If a microbe was utilized prior to 1958 as an additive with no apparent side effects and
proven to be safe over time, it will fall under GRAS via being grandfathered in. Another way in
which a microbe additive will be considered GRAS is through common knowledge. Common
knowledge is the assumed awareness that experts have in knowing that a microbe is naturally in the
development in the food process. For example if a microbe is naturally present in yogurt, such as S.
thermophiles, then supplementary amounts of the same microbes being added to the yogurt
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The Drug And Cosmetic Act 1938
FDA POSITION: LEGAL ARGUMENT 1) FOOD DRUG AND COSMETIC ACT 1938, (FD&C
ACT) according to this act it is illegal to import prescription drugs which are not FDA approved into
USA by individuals or groups. We (FDA) are a federal regulatory body of United States responsible
for regulating the use of the unapproved drugs in United States. The FDA has a ban for importing
the unapproved drugs from other countries. The United States Federal Food, Drug, and Cosmetic
Act (Act) (21 U.S.C. section 331) prohibit the shipment of unapproved drugs, which includes the
importing drugs from other countries. The importer can be liable for prosecution by the FDA. 2)
Kefauver Harris Amendement or "Drug Efficacy Amendment" is a 1962 amendment according to
this drug cannot be brought into united states without proving its efficacy and safety. This act says
that manufacturers need to prove the effectiveness of drug products before they go on the market,
and report any serious side effects to us (FDA). It also requires that evidence of effectiveness of the
unapproved drug be based on adequate and well–controlled clinical studies conducted by qualified
experts and all this information to be documented in the appropriate form according to ICH
guidelines and submitted for approval. The drug is allowed for marketing after the FDA approves
the NDA when all the information is reviewed and is considered safe and appropriate. FDA Social
Argument: 1) We are a drug–regulated body and completely responsible
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The Ethics Of Cosmetic Surgery
The Ethics of Cosmetic Surgery
Cosmetic surgery, a type of elective surgery undertaken to alter a person's appearance for reasons
beyond injury, illness, or disease, has become increasingly pervasive in society in the past few
decades despite sparking controversial debates. (Coleman, 171) While reconstructive surgery is
condoned, cosmetic surgery occupies a gray area where physicians "dedicated to saving lives,
healing, and promoting health" perform "invasive surgical operations on healthy bodies for the sake
of improving appearance." (Miller, 353) Nevertheless, demand for it is higher than ever with people
looking to surgery as an easy method for changing their appearances. This essay will argue that
cosmetic surgery is indeed ethical for physicians to perform by examining it through the perspective
of the four basic principles of medical ethics: autonomy, beneficence, non–maleficence, and justice.
Respecting autonomy is when a physician respects a patient's wish when the patient makes a fully
informed decision. (Rhodes, 77) Patients are expected to participate in their health care by
understanding the risks and benefits of the procedures they agree to, and the physician are expected
to provide necessary information and allow independent choice. Miller, in his essay "Cosmetic
Surgery and the Internal Morality of Medicine", argues that cosmetic surgery does not allow for true
autonomy as deceptive advertising fails to properly inform patients of plastic surgery risks:
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Medical Products Liability Lawsuit Case
Medical Products Liability Claims in the Wake of Coleman v. Medtronic
The California Court of Appeals' decision in Coleman v. Medtronic has made it easier for plaintiffs
to pursue medical products liability claims. In the landmark 2014 decision, the court held that the
state law tort claims asserted by the plaintiff were not federally preempted. The decision is part of a
growing body of medical products liability law regarding the circumstances under which a state law
claim can impose "parallel" requirements to those under the Food, Drug & Cosmetics Act (FDCA)
and, therefore, avoid federal preemption.
The Facts of the Case
John Coleman filed a product liability lawsuit against Medtronic, Inc., and Medtronic Sofamor
Danek USA, Inc. (collectively, Medtronic), alleging that he suffered painful complications after a
spinal surgery in which Infuse, Medtronic 's federally–approved bone fusion medical device, was
used in an "off–label" manner.
The Federal Drug Administration (FDA) granted Infuse premarket approval for use in certain types
of spinal fusion surgeries, including Anterior Lumbar Interbody Fusion (Anterior Fusion). The type
of surgery Coleman underwent – Posterior Fusion – was promoted by Medtronic but not approved
by the FDA. As detailed in court documents, studies funded by Medtronic found that the medical
device could cause bone growth in the spinal canal, but the company did not report the adverse
events to the FDA. Medtronic was also aware that adverse
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Pros And Cons Of The FDA
Should the FDA be able to control what manufacturers put into cosmetic products? I believe that the
FDA and the FDCA should be able to determine what ingredients are being put into cosmetic
products. I believe this because it can become very dangerous in the future if the FDA doesn't
control what is being put into these products. Over the years, makeup and cosmetic brands have
been putting more and more synthetic and dangerous chemicals in their products to make them
better quality. This can become an overall bigger problem if it is not addressed and changed. In a
statement from the FDA, they claimed that the FDA is not allowed to change the ingredients that are
put into the products. They are only allowed to request that the ingredient is taken away. There are
many chemicals that have been proven to be dangerous to the human body, but are still not being
take away from the product by the FDA. There has also been proof that manufactures put these
chemicals to make the products smell and last longer, but don't help the consumers skin or body in
any way. I believe that the FDA should be allowed to remove chemicals from certain products if
they are proven to be dangerous. If the FDA doesn't do something about the problem then something
else needs to be done to stop these ... Show more content on Helpwriting.net ...
In a statement from the FDA, they state that, "In general, cosmetic manufacturers may use any
ingredient they choose." This means that they have little to no say in the ingredients that are being
put into different cosmetic products. In conclusion, the FDA should pay more attention to these
ingredients, and do something to change to rules about cosmetics. If the FDA isn't able to dot that,
then they should bring more attention to the consumers of the cosmetics and add a warning because
no a lot of people who use these products know the potential
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History Of The Food And Drug Administration
The Food and Drug Administration was founded on June 30, 1906 by then US president Theodore
Roosevelt and Harvey Washington Wiley. It was formed as a response to serious abuses that were
taking place at the time. In the government structure the FDA is a federal independent executive
agency so that means that it is like a cabinet but it doesn't have the statues that some other agencies
would have. And now I will go over why the FDA is necessary and what they do in it. A job of the
FDA is ensuring the safety of the nations food and drug products. One way they do it with food is
by having manufactures send a report of the process that it takes to make the food so they can see if
the process is a healthy or unhealthy one. The FDA do the same
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Perspective Analysis Sample
Retrospective Analysis Introduction Section: This retrospective analysis is on a class III medical
device called the Micra Transcatheter Pacing System (TPS). The device is created by Medtronic
Incorporated which is a company that focuses primarily on devices for cardio and vascular,
restorative therapies, diabetes, and minimally invasive therapies. The target customers are those who
have slow or irregular heartbeats that need to be monitored. This pacemaker is useful for patients
who could have difficulties with the placement of traditional pacemakers, or would be better off
with a single chamber pacemaker. The underlying technology used is a 1in long pacemaker that is
placed directly into the right ventricle through the femoral artery using ... Show more content on
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The response letter highlighted some of the restrictions placed on the device which include the
following: 21 CFR 801.109 and 515(d)(1)(B)(ii) (sale and distribution), 515(d)(1)(B)(ii) (label
devices for experience needed to operate), and 502(q) and (r) (requirements for a restricted device.
The letter also informed that an Annual Report was necessary within section 21 CFR 814.84 for the
PMA approval to stay in place. This Annual Report should have the following parts: number of
devices distributed during the regulation period, the number of the devices implanted in people, the
amount of deaths and explants, and a survival table. It is important to note that the deaths should be
broken down into related to the pacemaker and not related. The explants should be broken down
into those that no longer had battery, complications that could not be solved with programming, and
other safety and efficacy problems. Other than the Annual Report the company should also perform
a post approval study (PAS). The ending of the letter warns against the repercussions if some of
these requirements are not met. It also informs the company of what steps need to be taken if the
product was changed or if any safety and efficacy problems arose that made the product necessary
for
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Harvey Washington Sinclair's Book 'The Jungle'
New agencies were established as a role of the government's responsibility to its citizens and one of
those agencies was the Food and Drug Association. The Food and Drug Association origins could be
traced back to the creation of the Agricultural Division in the Patent Office in 1848. The FDA
federal consumer protection agency began when the 1906 Pure Food and Drug Act was passed. This
law was aimed to end serious abuses in the consumer product marketplace. This agency was
strongly advocated by Harvey Washington Wiley and the act was passed because of his efforts and
Upton Sinclair's book "The Jungle". FDA's organization consists of the Office of the Commisioners
and four directorates overseeing the core functions of the agency: Medical Products
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Should The Fda Ban Cosmetics
Society would assume that when there is a problem, the government intervenes for the safety of the
public. But, when it comes to makeup there is no open case between the Federal Drug
Administration and cosmetic regulations. For the past years the FDA has worked to eliminate
chemicals that have been inconvenient to consumers. These products include "methanol, methylene
chloride, mercury compounds [etc.]" (U.S). These additives used to be sold at any over the counter
stores but, after its consumption the FDA realized that the product increased death rates more as it
increases its consumption. For example, "finger nail extenders containing methyl methacrylate
monomer [was banned due] to number of complaints of personal injuries" (U.S). Although first the
product appeared to be beneficial to the consumer, its' daily use increased the magnitude to have
negative impacts on the human body. ... Show more content on Helpwriting.net ...
[However] the FDA bans only nine of [those]substances" (Report). This shows the lack of
regulation that exists between the chemicals and the Federal Drug Administration. Since the FDA
has only banned a few chemicals rather than restricting the epidemic it has promoted the increase of
tumors, allergic reactions, and death. The main reason why only a few chemicals in cosmetics are
banned is because "neither the law nor FDA regulations require specific tests to demonstrate the
safety of ingredients" (U.S). In other words, the manufactures have complete control to use any
chemical toxic or non toxic without government regulation. Since the manufactures are not required
to register ingredients they could continue hurting the consumer until the damage is
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Cosmetic History And Facts About The Cosmetic Industry
The cosmetic industry has become such an integral part of the human culture that it often goes on
without notice. In the vast and various cultures across our planet cosmetics are used for multitudes
of reasons from religious expression, camouflage for soldiers in combat, Hollywood sets, to getting
ready for a date. In our culture the use of makeup is almost a rite of passage into young adulthood
for young girls and their mothers. The one question that almost no one ask when they open the
make–up container is "What harm will this bring me?" Our assumption is that what we buy in a
store is safe to use and is normal. But do we wonder how the cosmetic industry came to the
conclusion about their product to support our assumption? According to the website, History of
Cosmetics, article: "Cosmetic History and Facts," the use of cosmetics dates back some twelve
thousand years to the ancient Egyptians when they discovered the properties of healing oils. Soon
the use of cosmetics grew throughout their entire population as a way of expression and to honor
their gods. Soon almost everyone wore eyeliner and used scented oils the allure of cosmetics didn't
stop even when some of the ingredients proved to be fatal. The cosmetic industry pushed past the
boundaries of Egypt into other parts of the world in some parts of the world like Rome and Greece it
was met with some resistance. The resistance proved to be only a minor damper to the movement of
the cosmetic industry
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Funny Face And Novelty Now Case Analysis
Although, it was done by the direction of Chris, and there is no evidence on the statement that says
that Matt and Ian were aware of this, under corporate criminal liability they are all responsible for
being corporate officials who are responsible for enforcing the law. "Neither the law nor FDA
regulations require specific tests to demonstrate the safety of individual products or ingredients. The
law also does not require cosmetic companies to share their safety information with FDA." (FDA
Authority Over Cosmetics, n.d). "The FD&C Act defines cosmetics by their intended use, as
"articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body". (Cosmetics Defined by Law, n.d). Novelty Now, responsible for the
manufacturing of the product, ... Show more content on Helpwriting.net ...
Whom does this decision affect? Although substituting PFY in the formula increased sales revenue,
Funny Face and Novelty Now failed to consider that because of lack of test and FDA approval of
this product, consumers health could and in fact resulted to be at risk of side effects. Purpose– Both
companies failed to take efficiency into consideration. Although substituting the ingredient, seemed
like a profitable market idea, would the aftershave be as efficient as it was originally formulated?
How– As owners of cosmetic companies, corporate officials need to take into consideration how
public disclosure would affect the business if customers knew about the substitution of an ingredient
for something inferior and not FDA approved. By developing reasoning towards the WPH
framework we can conclude that although it seemed like a "smart" market/profit move to substitute
PYR, in ethical terms, it meant a violation of consumer trust and safety. Moreover, the damage to
the public speaking career that the aftershave caused to Mr. Margolin, could never be ethically
... Get more on HelpWriting.net ...
History Of Animal Testing
Beginning of Animal Testing
Historically animals have been used in scientific experimentation to satisfy the curiosity and the
pursuit of knowledge. For example, one of the first, known scientists to conduct experiments on
living animals, practiced in the 2nd century. Galen of Pergamum was a renowned Greek physician,
surgeon and philosopher in the Roman Empire. In his book De Anatomicis Administrationibus (On
Anatomical Procedures) he detailed precise experimental methods and instruments to perform
specific procedures and dissections on animals. Since the first successful use of anesthesia wasn't
until 1846, Galen, and other scientists he inspired, preformed elaborate and thorough procedures
without pain relief. Since then animal testing has been responsible for numerous medical
breakthroughs.
Beginning of Cosmetic Animal Testing
Predating the 20th century alone, animal testing led to the creation of the Small Pox Vaccine, Rabbis
Vaccine, Anthrax Vaccine, Cholera and Plague Vaccines, and treatment for Beriberi. Between the
1900's and 1930's blood transfusions, modern anesthesia, Tetanus Vaccine, and Diphtheria Vaccine
relied on animal research. It wasn't until 1933 when a woman used the brand Lash Lure Mascara ...
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The European Union is planning to ban animal testing for cosmetics to be by 2009. In the United
States, Revlon and Avon were two of the first large companies to halt all cosmetics testing on
animals. Some, on the other hand, have debated that the main ingredients in cosmetics have
previously been tested on animals. Therefore, their safety is well established, which means that it's
'easier' for companies to find alternatives to test product formulations because most active
ingredients have already been approved. As time, technology and technology progress, it is likely
that cosmetic animal testing will either decrease or end all
... Get more on HelpWriting.net ...
Regulations Of The Fda On Cosmetics Essay
Limited regulations of The FDA on cosmetics Frequently, consumers like you and I buy items
everyday not knowing chemicals or harsh byproducts that they are made with. We trust that
cosmetic products we buy everyday will be safe, but there are ingredients in our daily products that
could or has caused some health or skin conditions. In 1820, the U.S gathered physicians to create,
The FDA and regulations on drugs in the United States. The general purpose of The Food and Drug
Act was to have a standard on the specific food and drugs that were being imported into the United
States. It was not until 1848 the Drug Importation Act was passed by Congress. It required U.S.
Customs Service Inspection to stop entry of adulterated drugs from outside our border. In the middle
of 1906, fifty–eight years later the food and drugs act was passed. The original Food and Drugs Act
was passed by Congress on the 30th of June and signed by President Theodore Roosevelt. The Food
and Drug Act prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs
(FDA). The Food and Drug establishes standards and regulations ensuring that general public is safe
from harmful domestically and internationally produced products. Since 1906, there has been
thousands of bills passed placing restrictions, instituting regulations and setting standard on drugs.
According to the FDA the daily products, such as mouthwash is considered a drug. In 1937, a new
and updated billed was passed
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Fda And Obtain Clearance Of Their Safety And Effectiveness...
In order to be legally marketed in the US, many medical devices must be reviewed by the FDA and
obtain clearance of their safety and effectiveness to enter the market. The regulations can affect the
cost, quality, and availability of medical devices. Pre–Market Approval and 510(k) Clearance There
are two FDA processes for different medical devices: Premarket Notification 510(k), and Premarket
Approval (PMA). A PMA is required of new Class III high–risk devices. Companies need to submit
evidence that provides reasonable assurance that the device is safe and effective. The PMA can take
more than 450 days and the clinical data required can cost millions to collect. Most Class I and
Class II devices (low– to moderate–risk devices) only need to receive 510(k) clearance before being
marketed. The companies only need to demonstrate that the device is "substantially equivalent" to a
device already on the market (a predicate device) that does not require a PMA. The 510(k) clearance
tends to take around 200 days and costs much less than PMA. Access to the US market FDA
approval enables medical device companies to access the US market, 43% of the global medical
device market. According to National Health Expenditures in 2012, the $140 billion medical device
market has grown at a rate of 6% annually in the US. Coverage under Medicare Getting FDA–
approval is the first step to enter the healthcare system. Centers for Medicare & Medicaid Services
requires devices to be FDA–approved
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Cosmetic History And Facts About The Cosmetic Industry
The cosmetic industry has become such an integral part of the human culture that it often goes on
without notice. In the vast and various cultures across our planet cosmetics are used for multitudes
of reasons from religious expression, camouflage for soldiers in combat, Hollywood sets, to getting
ready for a date. In our culture the use of makeup is almost a rite of passage into young adulthood
for young girls and their mothers. The one question that almost no one ask when they open the
make–up container is "What harm will this bring me?" Our assumption is that what we buy in a
store is safe to use and is normal. But do we wonder how the cosmetic industry came to the
conclusion about their product to support our assumption? According to the website, History of
Cosmetics, article: "Cosmetic History and Facts," the use of cosmetics dates back some twelve
thousand years to the ancient Egyptians when they discovered the properties of healing oils. Soon
the use of cosmetics grew throughout their entire population as a way of expression and to honor
their gods. Soon almost everyone wore eyeliner and used scented oils the allure of cosmetics didn't
stop even when some of the ingredients proved to be fatal. The cosmetic industry pushed past the
boundaries of Egypt into other parts of the world in some parts of the world like Rome and Greece it
was met with some resistance. The resistance proved to be only a minor damper to the movement of
the cosmetic industry
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Pure Food And Drug Act Of 1906 Analysis
Pure Food and Drug Act of 1906 On June 30, 1906, President Theodore Roosevelt signed the Pure
Food and Drug Act. He began to enforce this act by also passing the Meat Inspection Act of 1906.
The person responsible for introducing the act is Sen. Weldon Heyburn. The act is sure to benefit the
health of Americans in the present and future. In the first place, children from Camden and St. Louis
died from tainted vaccines in 1901. The purpose of the act is to prevent misbranding and
adulteration of products to prevent more health problems and death. It bans the manufacture, selling,
and transportation of medicines that are poisonous or without scientific support. It also applies to
goods shipped in interstate or foreign commerce. The Department
... Get more on HelpWriting.net ...
Federal Food Drug, and Cosmetic Act of 1938
Federal Food, Drug, and Cosmetic Act of 1938
According to, http://www.toxicology.org/gp/fda.asp, the Society of Toxicology website, in 1937 the
Massengill pharmaceutical company dispersed Elixir Sulfanilamide. This drug was prescribed
generally to anyone who had symptoms of strep throat. Elixir Sulfanilamide contains diethylene
glycol, which is a chemical equivalent of antifreeze. There were 107 documented deaths, involving
many children, because of the lack in regulations. The Pure Food and Drug Act was deemed to
insufficient to protect the public. This tragedy was the critical motivation for the creation of the
Federal Food, Drug, and Cosmetic Act.
The Federal Food, Drug, and Cosmetic Act (FFDC) can be found in chapter 9 of title 21 in ... Show
more content on Helpwriting.net ...
Since the amendment the technology that is capable of finding such small particles of substance has
caused some reconsideration of the "at any level," concept. The flavor industry requested for a "de
minimis," which refers to a level of risk that is too small to raise concern. The Senate has
propositioned bills that would improve the meaning of the Delaney Clause but nothing has passed
yet (http://cnie.org/NLE/CRSreports/Pesticides/pest–1.cfm).
1996 Food Quality Protection Act In 1996 both houses of congress passed the quality protection act
(FQPA) unanimously. This amendment particularly reformed regulations of pesticides. Eliminating
the Delaney Clause from being applied to pesticide residues. The U.S. Environmental Protection
Agency (EPA) website indicates that this new law sets a single health–based standard instead of the
previous multiple standards. The general safety standard is considered to be, "a reasonable certainty
of no harm." When the EPA sets the standards it will have to take in consideration all sources, which
include water, and other pesticides with a common "mechanism of toxicity"
(http://www.epa.gov/pesticides/regulating/laws/fqpa/backgrnd.htm ). The website also mentions a
special provision considering babies and children, where there is to be a clear determination that
proves tolerance levels are in fact safe for children. Three Food Standards
... Get more on HelpWriting.net ...
Injection Eye Drug Research Paper
CPT 67028 – Injection eye drug (Intravitreal injection of a pharmacological agent (separate
procedure) – injection on one antibiotic. CPT 67028 – Injection eye drug (Intravitreal injection of a
pharmacological agent (separate procedure) – injection of a different antibiotic. The payment was
denied because the provider of service (Dr. V. C., MD) did not sign the medical record. The
procedure billed was included as part of an evaluation and management encounter signed by a
different physician (Dr. R.T.D.). Per the QIC's letter, "Medicare requires that services
provided/ordered be authenticated by the author to indicate the service has been reviewed and
authenticated by the provider. The method used shall be a handwritten or electronic signature.
Stamped ... Show more content on Helpwriting.net ...
She was evaluated for the vision loss and changes in the appearance of her right eye; she was treated
with injections of 2 different antibiotic medications in the right
... Get more on HelpWriting.net ...
How Did The Food And Drugs Act Of 1906
The Food & Drug Administration became a possibility because of the Pure Food and Drugs Act of
1906. Harvey Washington Wiley was the driving force behind this law and headed its enforcement,
which provided basic elements of protection that consumers had never had before (FDA's Origin).
The FDA is an agency that works within the US Department of Health and Human Services of the
executive branch of government (About FDA). The Food and Drug Administration is responsible
for protecting the public health of all Americans by ensuring the safety, efficacy, and security of a
large range of products from drugs to cosmetics (What We Do).
The FDA is a very structured, governmental agency. The Office of the Commissioner and four
directors overseeing
... Get more on HelpWriting.net ...
The Fda's Global Unique Device Identification Analysis
The FDA has established a unique device identification (UDI) database to enhance the identification
of medical devices from point of manufacture through delivery to the end user. This guideline
covers medical devices Classes I, II, and III (FDA 2014), where Class I poses the lowest risk to
patient and Class III carries the highest risk. When fully implemented, the label for the majority of
medical devices will contain a unique device identifier (UDI) in a human and machine–readable
(barcode) form (FDA 2017). Medical device companies operating under FDA guidelines will be
required to submit certain information about each device to the FDA's Global Unique Device
Identification Database (GUDID) (FDA 2014). In order to allow organizations ... Show more
content on Helpwriting.net ...
Problem Statement
Many companies have set forth action plans for UDI compliance, however, when they purchase the
Prisym ID solution, their personnel, from entry level through C–level have not had exposure or
training on the PRISYM 360 software application and do not have sufficient knowledge of the
application as required to perform their job. They may have understanding of the guideline
requirements, but they do not yet know how to translate it into creating the actual label for market
medical devices.
Problem Background and Causes
The FDA developed UDI in order to better track medical devices manufactured in the United States.
It was signed into law on Septebmer 27, 2007 as a part of the U.S. Food and Drug Administration
Amendments of 2007 (FDA, 2007). The law is recognized as a significant addition to overall FDA
authority, and as a result medical devices companies must implement the guidance to maintain
compliance with U.S. FDA, or be ordered to cease all operations. The organizations must prepare
and train personnel relative to the production labeling process in order to ensure product being sold
is in compliance. Because the employees are not yet trained on the proper usage is a concern to the
company if they are to meet the deadline for total compliance. The deadline as set forth by the FDA
is a phased in schedule between 2014–2020. The PRISYM 360 solution is UDI compliant, and the
instruction will allow the organizations' employees to
... Get more on HelpWriting.net ...
Examples Of 20th Century False Advertising
20th Century False Advertising and Regulation
The 20th century was a time of conflict between false advertising and regulations. With the passage
of The Pure Food and Drug Act in 1906 there was finally regulation that helped protect the health
and safety of consumers. The passage of this act was also the birth of the Food and Drug
Administration (FDA). An article published in the Journal of Public Health explains the reasoning
behind this act: "an unprecedented convergence of consumer, scientific, and industrial support in
1906 prompted such action" (Barkan 18). As technology and medicine became more prevalent, it
became more necessary for products to pass certain tests and follow stricter regulations.
After the passage of The Pure Food and ... Show more content on Helpwriting.net ...
Spam is said to have caused America a loss of $10 billion due to spam preventative measures and
productivity loss (Stock 1). Spam was a large problem and needed to be addressed. In 2003, the
Controlling the Assault of Non–Solicited Pornography and Marketing Act, or CAN–SPAM Act, was
introduced to combat the growing levels of false advertising manifesting itself on the internet.
Before this act, people or businesses were able to send unsolicited emails without any punishment
from the government. This act "imposes a series of new requirements on the use of commercial
electronic mail ('email') messages. In addition, the Act gives federal civil and criminal enforcement
authorities new tools to combat unsolicited commercial email ('UCE' or 'spam')" ("Definitions,
Implementation, and Reporting" 50092). While this Act had the hope of increasing punishment for
people who do not follow these rules, the CAN–SPAM Act was not as successful as the FTC hoped.
One large issue with this Act is how it defines spam. According to an article published in the
Berkeley Technology Law Journal, this act is essentially giving spammers information on what they
cannot do, allowing them to spam legally as long as they follow the FTC's rules (Zhang 301). This
may allow people to spam more if they understand the limitations and instead "legally spam" email
users. Also, this act
... Get more on HelpWriting.net ...
CLIA Test Complexity
CLIA Test Complexity and Requirements Nicole Cersovsky INRODUCTION In 1988, the
Department of Health and Human Services (DHHS) created regulations that were passed by
Congress [2]. These became known as the Clinical Laboratory Improvement Amendments (CLIA)
of 1988 [2,3]. The standards set were designed to improve the quality of testing on human
specimens run in almost every laboratory in the United States [2,4]. The Food and Drug
Administration (FDA) has three categories that test complexities fall under: waived, moderate and
high complexity [2,3,4]. WAIVED Currently there are eight tests that meet the criteria to fall under
waived testing. These criteria indicate that the method of testing is so easy that the chance of getting
a wrong ... Show more content on Helpwriting.net ...
Laboratories with only this CW are not required to have routine inspections, but they must follow
the manufacturer's instructions for testing. They must also allow random inspections for compliance
and/or investigations into complaints [2,4]. MODERATE AND HIGH COMPLEXITY Provider–
performed microscopy (PPM) procedures are a part of moderately complex testing in which a
microscope is used as the main instrument for testing [4]. PPM is performed by a physician, mid–
level provider, or a dentist and is performed during the patients' exam [3,4]. Examples of PPM
testing include KOH preparations, wet mounts, post–vasectomy specimens, and urine sedimentation
exams [4]. There are currently close to 10,000 tests that fall under the criteria that classifies
moderate and high complexity testing [2]. These seven criteria are as follows: the expertise to run a
test, the training and experience needed for testing, how complex reagent and quality control
preparation is, the required training to operate the instrument, quality control, proficiency testing
and calibration requirements, troubleshooting and maintenance requirements for the instrument, and
the ability of the testing personnel for interpretation of results
... Get more on HelpWriting.net ...
Food And Drug Administration Case Study
Introduction
"Is it FDA approved?" Today, we hear more of this question and would check for the "FDA
approved" stamp on the product before purchasing it. This behavior signifies the accountability of
the agency, on how it has impacted the choices made by the people. This may not always be the
case, however, for there are people who do not find the label necessary or would be applicable to
their lifestyle. Nevertheless, this agency has made its mark in history to watch over the products
being purchased by the consumers. Food and Drug Administration (FDA) is an agency under the
Department of Health and Human Services. Its main responsibility is to protect the public health by
assuring safety, efficacy and security. FDA assures safety by allowing ... Show more content on
Helpwriting.net ...
With this act, there are written practices that can be submitted by the public and the final rules are
published in the Code of Federal Regulations (Milakovich and Gordon). Although with a deadline to
issue comments, the involvement of the public gives emphasis on the value of citizens' input and
affirms that the public has a say on the rules and regulations that will be soon applicable, if not, is
necessary to benefit them. Moreover, one of the procedures required by the APA for the agencies to
comply to, is formal adjudication. If authority making must be delegated, then a trial type hearing
where cross–examination and witnesses must construe, hence, the traditional "formal rulemaking"
comes into play. The concern regarding formal rulemaking retaliates to cause abandonment of
regulatory programs, for the factors of cost and delays come into place, that it was almost
denounced by federal agency proceedings (Gellhorn and Levin 326). There was an existing struggle
within using formal adjudication or formal rulemaking for the agency to use, to make the process
and procedure fair to both agency and accused. Hence, the creation of the informal rulemaking that
consists involvement of the public– a hybrid rulemaking option, but was effectively halted by the
Supreme Court. The court has, however, formed a compromise to allow hybrid
... Get more on HelpWriting.net ...
Animal Testing Kills Animals
Don't kill you're living friend.
As Anthony Douglas William, author, researcher, and consultant, once said "When I look into the
eyes of an animal I do not see an animal. I see a living being. I see a friend. I feel a soul." As
defined by Merriam–Webster Dictionary a living being is a state of existing, a living thing, or a
living organism. While the Federal Food, Drug, and Cosmetic Act law states that animal testing is
not required, it does not prohibit the act to conduct animal experimentation. With several other
methods existing out there, testing of new ingredients by cosmetic companies is normally an
expensive and unethical choice. The only effective way to save the innocent lives of these animals is
by creating a law that forbids the sale and manufacture of cosmetic companies who use living
beings as test subjects.
Animal testing for cosmetic ingredients was introduced a few years ago due to the fact that women
were wearing cosmetics, which included ingredients that were unsafe to human flesh and eyes, ...
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For example, in Europe, the world's largest cosmetic company, it is illegal to sale or import any
animal tested beauty products. Also, in other countries like Israel and India also apply this type of
law. (dosomething.org) Other countries either have restrictions towards how they must handle their
test subjects and even some countries are close to banning the act of animal testing in full. All of the
American based companies who export to the foreign countries have to comply by the laws that are
already in place, so most of the cosmetic companies already obey produce products that are not
animal tested to be able to sell them in the distinct markets. Because these U.S. based companies
who export internationally are already expected to comply by testing bans, more than 1.7 billion
people can already buy cosmetics products that are not tested on animals.
... Get more on HelpWriting.net ...
Should Animal Testing Be Banned In The United States
"We know that animals can experience pain and distress in experiments and that this can be severe.
The way that animals are bred, transported, housed and handled may also cause suffering."(RSPCA)
Animal testing is an issue that has existed since the early 1900s. Some countries have passed laws to
ban the use of animals in cosmetic testing, but the United States has not. This is important because
over 100 million animals are tested on each year across the world. "Europe, the world's largest
cosmetic market, Israel and India have already banned animal testing for cosmetics, and the sale or
import of newly animal–tested beauty products."(dosomething.org) Animal testing needs to be
banned from the United States. It is not right to use animals ... Show more content on
Helpwriting.net ...
The U.S. is one of only two countries whose government openly allows it. "Europe, the world's
largest cosmetic market, Israel and India have already banned animal testing for cosmetics, and the
sale or import of newly animal–tested beauty products." (dosomething.org) So, some countries can
see that animal testing is wrong. Those countries have found ways to test products without using
animals. they just use existing information when creating new products. The consequences of not
stopping animal testing are obvious. Animals will continue to be in pain and suffering until it is all
over. "There are already many alternatives to animals which have been developed. Particularly in
the areas of toxicity testing and teaching."(Animals Australia) If animal testing was banned,
scientists could just use the alternatives or they just use existing information when creating new
products. The Animal Welfare Act is not doing anything to help animals. Yes, it gives those few
species some protection, but it doesn't protect them from being tested on. Therefore, laws banning
animal testing from the United States need to be laid down. Us as humans can continue to protest or
write to the government. ASPCA and PETA will also continue to do what they are doing and they
won't stop until the rights are returned to the
... Get more on HelpWriting.net ...
The Breast Implants Produced By Poly Implant
PIP Implant Scandal
1.0 Background
The breast implants produced by Poly Implant Prothese (PIP) French company were banned in the
year of 2010. PIP which was founded in year 1991 and was once the world's third largest supplier of
silicone gel breast implants was eventually shut down within the same year. This company had
illegally produced and marketed the implants using unauthorized industrial grade silicone gel that
meant for use in mattresses instead of approved and mandated medical grade silicone gel since year
2001. The implants were widely used across Europe, Britain and South America and estimated
about 400, 000 patients in 45 countries around the world with PIP Implants. The scandal was
surfaced in year 2009 due to medical device reports from surgeons on the abnormally high rupture
rates of the PIP implants than other approved implants. France's drug and medical safety agency
(AFSSAPS) recalled the PIP implants and advised 30,000 women to have their implants removed
due to this scandal in subsequent year of 2010.
2.0 Issues with PIP implants
A full recall of PIP implants by French Ministry of Health has sparked a worldwide fear and alert.
The implants with cheap and unapproved industrial grade silicone as filler are believed to have
higher rupturing rates, though the exact figure varies with each health authority. According to
SCENIHR , this filler could weaken the shell of PIP implants with increased risk of gel–leakage and
rupture. The silicone gel filing can
... Get more on HelpWriting.net ...
Cosmetic Testing with Animals is Cruel Essay
The Cruelty of Cosmetic Testing on Animals
Each year, thousands of animals are brutally tortured in laboratories, in the name of cosmetic
research. A movement to ban animal testing for cosmetic purposes has been gaining popularity, with
many companies hopping on the bandwagon against this research. New alternatives have been
developed to eliminate the necessity to test on animals. This is only a small beginning of what is
necessary to end these immoral acts. Animal testing in cosmetics is useless and cruel, and can be
accomplished by other methods of research to end the suffering of animals.
One of the many painful tests administered on animals in laboratories is the Draize Test. This
experiment, introduced forty–five years ... Show more content on Helpwriting.net ...
The Gallup Organization published a poll taken showed that 60% of adults are against animal
experimentation (Public, 97). All of these results show both how many animals are killed, and the
view of the general population. If this is the reaction regarding these cruel acts, then why does the
suffering of animals continue?
The testing that occurs in animal laboratories appeals to our emotion because of the cruelty that is
involved. This is not the only reason for concern. The current conditions of the treatment and
facilities are not acceptable. This is a violation of the Animal Welfare Act of 1996 (97). This law
was established to protect animals from inhumane treatment of research animals 97). Inhumane
treatment is the torture that occurs everyday, as animals for forced into tests that determine the
safety of cosmetic products.
A major part of the argument against animal testing revolves around the moral issues of the issue.
"Should we be allowed to cause suffering to animals to gain something for ourselves" (Dufva, 1,
97). The answer to this question is no. These animals are tortured to test the safety of makeup and
other cosmetics; these creatures are sacrificed so humans can alter their physical appearance. This
act is not only unethical, but violates the basic teachings of Godís word. As quoted in Matthew 7:12,
"Do unto
... Get more on HelpWriting.net ...

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Persuasive Essay On Non Animal Testing

  • 1. Persuasive Essay On Non Animal Testing The Food and Drug Administration (FDA) defines cosmetics as objects intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Examples of cosmetics include skin cream, perfume, lipstick, makeup, shampoo, and hair color. Any ingredient used in a cosmetic also falls under the definition of a cosmetic. Products normally labeled as cosmetics are classified as drugs when a medical claim is made. For example, toothpaste is sometimes considered a cosmetic, but if it advertises cavity protection, then it is a drug. A lot of these products are often tested on animals to ensure safety. Companies have the option of using existing non–animal tests or investing developing alternative non–animal tests for new ingredients. These modern alternatives can offer results that are more relevant to people, more ... Show more content on Helpwriting.net ... They consider animals simpler to apply to tests but still similar enough to apply to human beings. Consequently, results from animal tests may not be relevant to humans. The results may either under or overestimate real world situations in relation to people. The FDA reports that 9 out of 10 products that pass animal testing fail human testing, and vice versa. Unreliable and ineffective animal tests mean consumer safety cannot truly be guaranteed. Regardless of which, Cosmetics companies are not required to test their products on animals. The Federal Food, Drug, and Cosmetic Act prohibit the sale of mislabeled and adulterated cosmetics. This Act does not require that animal tests be the source of testing, just so long as it is tested. Therefore, animal testing does not need to be continued as long as previously test ingredients are used in ... Get more on HelpWriting.net ...
  • 2. The Essure Medical Device Analysis Originally, the company Conceptus manufactured the Essure Permanent Birth Control System, which was first approved for use by the U.S. Food and Drug Administration (FDA) on Nov. 4, 2002. In 2013, Bayer purchased Conceptus and the companies merged. According to Bayer, more than 750,000 women use this birth control system to prevent pregnancy, with approximately 70 percent of these women residing within the U.S. The Essure Medical Device The Essure Medical Device consists of flexible coils that are non–surgically placed within the Fallopian tubes. This device is a permanent form of birth control. Essure's flexible coils are inserted through the vagina, past the cervix and into the Fallopian tubes. Once inserted, the device causes a build–up of the tissue within the Fallopian tubes. Over a period of approximately three months, this tissue blocks the Fallopian tubes; thus, preventing the sperm from traveling through them to fertilize an egg. Three months following insertion, a radiologist checks to make sure that the Fallopian tubes are blocked. Directly before the x–ray is taken, a contrast dye is injected through the patient's cervix to ensure that there is no leakage of dye past the Essure Medical Device. According to ... Show more content on Helpwriting.net ... Art Sedrakyan is a professor at Weill Cornell Medicine in New York. He is also leading the Science and Infrastructure Center of the FDA's Medical Device Epidemiology Network ((MDEpiNet). Sedrakyan and a group of colleagues evaluated data from more than 8,000 women who received Essure implants. This data was compared to data from 44,278 women who underwent the standard surgery to block (tie) their Fallopian tubes. According to the Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study, women who opted for Essure frequently had to have surgery regardless and their risk of needing a second procedure was substantially higher than it was for women who underwent ... Get more on HelpWriting.net ...
  • 3. Argumentative Essay On Fda The Food and Drug Administration is the oldest consumer protection agency in United States (FDA 2). From recalls on food products to the monitoring of the safety of our medicine sources, the Food and Drug Administration (FDA) ensures that they are both safe and wholesome (FDA 1). The Food and Drug Administration also ensures that the cosmetics we use won't harm consumers, and that radiation–emitting product such as microwaves are secure and effective (FDA 1). The FDA is authorized by Congress to enforce the Federal Food, Drug, and Cosmetic Act and many other public health laws (FDA1). The agency monitors import, export, manufacture, storage, and sale of up to one trillion worth of goods yearly, at an average cost to taxpayers of about three dollars per person (FDA1). Before FDA was created, the power to regulate was given to the individual states (fda 1). The federal government did little to nothing, while ... Show more content on Helpwriting.net ... The FDA was first under the control of The Depart of Agriculture then shifted to Federal Security Agency and later the Department of Health, Education and Welfare (2). Today the FDA is currently under the control of the Department of Public Health Services (2). Although the FDA was not known by this title until 1930, the FDA's regulatory functions first began with the passage of the 1906 Pure Food and Drugs Act, prohibiting interstate commerce in adulterated and incorrect labels on food and drugs (FDA 2). The bill gave the FDA its power to adjust over a wide subject matter (fda 2). This law was the merging of 100 bills over a half of century that was aimed towards abuses in the consumer product marketplace (FDA 2). The meat inspection act was also passed on the same day which set rules for cleanliness and sanitation of meat processing and slaughterhouses ... Get more on HelpWriting.net ...
  • 4. Drug And Cosmetic Act Of Chipotle Put down your carnitas burrito and give a side–eye to your soda. Chipotle has been has sneaking GMOs into its "non–GMO" menu offerings. At least that's what a recent class action lawsuit is claiming. Back in late April, Chipotle announced it was "G–M–Over it," rolling out a marketing campaign that claimed it was only going to use "non–GMO ingredients." "When it comes to our food, genetically modified ingredients don 't make the cut," read advertisements for the fast–casual chain. (You'll probably recall that the media reacted quite critically and wasted no time lambasting the company.) Apparently consumers in California were just as dubious. In her class action lawsuit filed last week in federal court in San Francisco, lead plaintiff Colleen Gallagher of Piedmont, Calif., said that Chipotle deceived customers into paying more for their food and violated the Federal Food, Drug and Cosmetic Act with its false and misleading food labeling. The lawsuit, filed on behalf of California consumers who bought food from Chipotle after April 27, 2015, says that the advertising campaign is deceptive and misleading because many menu items do contain GMOs and that the plaintiff was injured "by purchasing (or overpaying for) Chipotle's Food Products" (page 18). and that "[p]laintiff would not have purchased Chipotle's Food Products (or paid as much for it) had she known the truth" (page 19). It is a bit strange that Chipotle, a restaurant chain that has done the most work to align itself ... Get more on HelpWriting.net ...
  • 5. The US Food And Drug Administration (USFDA) The U.S Food and Drug Administration (USFDA) is the government agency responsible for ensuring the safety and efficacy of drugs and medical devices in the USA. The two legislative acts that are the main source of the FDA's authority are: 1. The United States Federal Food, Drug, and Cosmetic Act, which is a set of laws passed by Congress in 1938 in reaction to the growing public safety demands, significantly expanding federal regulatory authority to oversee the safety of food, drugs, cosmetics and medical devices. The act gave authority to FDA to mandate pre–market approval of all new drugs. It was for the first time that manufacturers were required to prove to FDA that a drug was safe before it could be marketed. 2. The 1962 Kefauver–Harris ... Get more on HelpWriting.net ...
  • 6. Ensuring Consumer Safety: Toward Redefining the U.S. Food... Kayla Shelton Professor Lodge UNIV 200 14 April 2011 Ensuring Consumer Safety: Toward Redefining the U.S. Food and Drug Administration The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the regulation and supervision of foods, medical devices, and prescription and over–the–counter pharmaceutical drugs (medications). The FDA regulates and supervises medical devices and drugs throughout their development, manufacturing, process of approval, marketing, and post marketing stages. When a drug or medical device is granted approval by the FDA, it will shortly become marketed in the United States and ... Show more content on Helpwriting.net ... The third and final phase of drug trials involves a large number of volunteers in well–controlled settings. A variety of ways can be used to test the drug; however, placebo is the standard comparator for the drug (Wing et al.). After the completion of clinical trials, the data from the trials is submitted among other safety and efficacy reports in the NDA process. When the FDA receives the completed NDA, they begin their review process, which they are legally allowed ten months to review the application and submit their decision of approval (FDA). The label content is decided next, then the drug can be granted approval by the FDA. A drug approved by the FDA is said to be "safe and effective when used as directed on the label" (Wing et al.). Unlike prescription drugs, the FDA has two different regulatory standards for reviewing medical devices: premarket approval (PMA) and 510(k) clearance. The FDA classifies medical devices, according to their risk, through which they can be identified. There are Class I , Class II, and Class III medical devices. The PMA process is the FDA process of reviewing Class III medical devices. According to the FDA, "Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury" (FDA). The PMA process is the most stringent type of ... Get more on HelpWriting.net ...
  • 7. Advantages Of Animal Testing In Cosmetics Animal Testing in Cosmetics: A Reflection on the Advantages and Disadvantages and the Impact of Technology of Animal Testing Over the last decades, animal testing in cosmetics has become popular and a routine for many cosmetics manufacturing companies. The act of testing animals for cosmetics, however, remains to be a heated debate with some sides condemning it while others see nothing wrong with it. Consequently, to some people or organizations, animal testing is and has for long been a life–saving technique for the cosmetics' consumers. Even with a life–saving advantage towards the consumers, animal testing in cosmetics is not as good as some view it. Millions of innocent animals often rabbits, mice, and rats among others are killed or caged to support the testing. For this reason, this essay will critically examine the pros and cons of animal testing in cosmetics. The focus will lean on the cons and some of the alternatives that advanced technology provides for this subject. On the aspect of life–saving, animal testing in cosmetics is a technique that improves and protects human health. By supporting animal testing in cosmetics, individuals attribute the use of animals to determine the safety of products before they are used by humans. The argument in this light is that, the end–user of animal–tested cosmetics products, which are undoubtedly increasing day–to–day across the world, is less exposed to toxic chemicals. Less exposure to toxic chemicals is due to the fact that ... Get more on HelpWriting.net ...
  • 8. Cosmetics Testing On Animals Is Inhumane? Cosmetic/Household Product Testing The act of testing cosmetic and household products on animals is inhumane. Animals have rights also, and for humans to test products on them for their benefit is heartbreaking. The use of rabbits being used to test shampoo and mascara in their eyes blinds them. The European Union and Israel have banned cosmetic and cosmetic ingredients being tested on animals in their country. Those countries have also banned imports with cosmetics tested on other animals from other countries. China is slowly making the decision to ban animal testing for cosmetics as well. India has temporarily banned the testing of cosmetics and household products on animals, and is permanently in effect in November 2014. According to Peta, "Unfortunately, things ... Show more content on Helpwriting.net ... This reluctance to change is especially unforgivable considering the current wide availability of superior non–animal tests. Instead of measuring how long it takes a chemical to burn away the cornea of a rabbit's eye, manufacturers can now drop that chemical onto donated human corneas. Human skin cultures can be grown and ordered for irritancy testing. These and dozens more tests now in use today are cheaper, faster, and more accurate at predicting human reactions to a product than the old animal tests ever were." With other alternatives available to test for irritation and chemical exposure, there is no explanation for the United States to still be using live animals for cosmetic testing. With some countries banning the use of cosmetic testing on animals, there is hope that other countries will begin to as well. The countries who still use animal testing as a way of testing products might recognize why the countries have banned such an act. When the cruelty of animal testing is recognized, countries who still testing with ... Get more on HelpWriting.net ...
  • 9. Gmp Iq7 Regulations Paper I. Introduction: Before any biopharmaceutical company can begin to manufacture a desired product, the company is required by law to establish an adequate facility to support a safe and efficient manufacturing process. The US Food and Drug Administration (FDA) department under the authority of the Federal Food, Drug, and Cosmetic Act determines whether or not a specific manufacturing facility is approved. Furthermore, companies must adhere to the Good Manufacturing Practice Regulations (GMP) specifically those described in ICH Q7 in order to effectively fulfill FDA requirements. The fundamental purpose of the regulations beforehand is to accomplish a system that ensures products are consistently produced and controlled to the highest standards and thus prevent human safety risks that may not be reduced through testing the final ... Show more content on Helpwriting.net ... In the long run, these practices will ensure that consumers purchase an effective product that is not dangerous, otherwise, companies may face very serious consequences including recall, seizure, fines, jail time and of course, lost of profit. When the manufacturer believes they are equipped for an inspection, a highly specialized FDA staff examines the pharmaceutical manufacturing facilities and ensures that it is compliant with current Good Manufacturing Practice (cGMP) regulations. Here, the ICHQ7 guidelines, staff responsibilities and training will be discussed followed by how to manage a 483 and close out meeting. I. GMP ICHQ7 Guidelines: The ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (API), outlines the standards for the facility, utilities and equipment necessary to support a good manufacturing operation. This guide describes aspects related to all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, ... Get more on HelpWriting.net ...
  • 10. Food Drug And Cosmetic Act 1938 The 1938 Food, Drug, and Cosmetic Act mandated that manufacturers of drugs had to provide labels on their drugs. These labels provided the consumer with information about what certain drugs contained and specific directions about how to take them. This action prevented false claims about drugs and allowed consumers to know that certain drugs were safe. As a result, the scrutiny of drugs ensured the selling of safe drugs in the United States. Food became upheld to a standard after passing the 1938 Food, Drug, and Cosmetic Act. The manufacturers of various foods were required to list the ingredients contained in their products. Only certain ingredients that were deemed nutritious and safe became allowed to be included in food production. This ... Get more on HelpWriting.net ...
  • 11. Cosmetic Products Have Been Integrated Into Our Society Cosmetic products have been integrated into our society for centuries, and women have put their trust in the companies that provide them. These products are used confidently, sometimes without the thought of possible harm to health crossing the mind of the consumer because the cosmetic products purpose is for protection, cleaning, and beautification. As people are becoming more aware of the hazards in their everyday lives, questions have arisen about the ingredients, particularly the chemicals, that are being used to create women's cosmetics. In recent studies, cosmetics have been found to contain chemicals that can be harmful to a woman's reproductive health, including miscarriages and birth defects, and have links to breast cancer. ... Show more content on Helpwriting.net ... It is advised to use caution when using products that contain phthalates. Petrochemicals are a petroleum based substance that, when used in topical or oral application, can result in anemia, kidney regeneration and damage to nerves in the brain or spinal cord. Petrochemicals are seen as synthetic colors used within cosmetic products such as lipsticks and eyeshadows. Exposure to these chemicals has been linked to a rise in cancer, as well as other lifelong diseases (Nohynek, 2010). Recently, the importance of testing and monitoring the harmful effects of cosmetic products has increased because they have also been found with compounds of different metals, which is can be extremely dangerous when in frequent contact with the skin. Although humans are likely to be exposed by naturally occurring metals released into the environment, cosmetic products can lead to routes of toxic metal entry into the body (Kalicanin, 2015). The theory is that the low, but constant exposure to the harmful chemicals in personal care products, increases the risk for women to experience reproductive problems, miscarriages, infant mortality and birth defects. Although these are only a few examples of the vast amount of harmful chemicals that are used to cosmetic products, it is safe to say that there should be more of a concern when it comes to the products that women are using on their bodies multiple times on a day to day basis. Current regulations on cosmetic products have ... Get more on HelpWriting.net ...
  • 12. Microbial Regulation oin the Food Industry Microbiology Topic Paper: Microbial Regulation in the Food Industry Microorganisms have been involved I the development of food items throughout history. Although at first it may have not been intentional over time humans have study and experimented with culturing microbes to prolong the shelf life of foods, inadvertently changing the taste and textures of the food item as well. As safety concerns spread in the 1900s regulations were formed to ensure the safety and well–being of humans. In the United States, the U.S. Food and Drug Admiration is the organization that determines the overall safeness of a food element. When Microbes are used in food they tend to fall under two types of categories in the FDA regulatory classifications. The first category would be the generally recognized as safe category or GRAS published as a proposed rule in 1997. Microbes considered GRAS fall under multiple definitions. If a microbe was utilized prior to 1958 as an additive with no apparent side effects and proven to be safe over time, it will fall under GRAS via being grandfathered in. Another way in which a microbe additive will be considered GRAS is through common knowledge. Common knowledge is the assumed awareness that experts have in knowing that a microbe is naturally in the development in the food process. For example if a microbe is naturally present in yogurt, such as S. thermophiles, then supplementary amounts of the same microbes being added to the yogurt ... Get more on HelpWriting.net ...
  • 13. The Drug And Cosmetic Act 1938 FDA POSITION: LEGAL ARGUMENT 1) FOOD DRUG AND COSMETIC ACT 1938, (FD&C ACT) according to this act it is illegal to import prescription drugs which are not FDA approved into USA by individuals or groups. We (FDA) are a federal regulatory body of United States responsible for regulating the use of the unapproved drugs in United States. The FDA has a ban for importing the unapproved drugs from other countries. The United States Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. section 331) prohibit the shipment of unapproved drugs, which includes the importing drugs from other countries. The importer can be liable for prosecution by the FDA. 2) Kefauver Harris Amendement or "Drug Efficacy Amendment" is a 1962 amendment according to this drug cannot be brought into united states without proving its efficacy and safety. This act says that manufacturers need to prove the effectiveness of drug products before they go on the market, and report any serious side effects to us (FDA). It also requires that evidence of effectiveness of the unapproved drug be based on adequate and well–controlled clinical studies conducted by qualified experts and all this information to be documented in the appropriate form according to ICH guidelines and submitted for approval. The drug is allowed for marketing after the FDA approves the NDA when all the information is reviewed and is considered safe and appropriate. FDA Social Argument: 1) We are a drug–regulated body and completely responsible ... Get more on HelpWriting.net ...
  • 14. The Ethics Of Cosmetic Surgery The Ethics of Cosmetic Surgery Cosmetic surgery, a type of elective surgery undertaken to alter a person's appearance for reasons beyond injury, illness, or disease, has become increasingly pervasive in society in the past few decades despite sparking controversial debates. (Coleman, 171) While reconstructive surgery is condoned, cosmetic surgery occupies a gray area where physicians "dedicated to saving lives, healing, and promoting health" perform "invasive surgical operations on healthy bodies for the sake of improving appearance." (Miller, 353) Nevertheless, demand for it is higher than ever with people looking to surgery as an easy method for changing their appearances. This essay will argue that cosmetic surgery is indeed ethical for physicians to perform by examining it through the perspective of the four basic principles of medical ethics: autonomy, beneficence, non–maleficence, and justice. Respecting autonomy is when a physician respects a patient's wish when the patient makes a fully informed decision. (Rhodes, 77) Patients are expected to participate in their health care by understanding the risks and benefits of the procedures they agree to, and the physician are expected to provide necessary information and allow independent choice. Miller, in his essay "Cosmetic Surgery and the Internal Morality of Medicine", argues that cosmetic surgery does not allow for true autonomy as deceptive advertising fails to properly inform patients of plastic surgery risks: ... Get more on HelpWriting.net ...
  • 15. Medical Products Liability Lawsuit Case Medical Products Liability Claims in the Wake of Coleman v. Medtronic The California Court of Appeals' decision in Coleman v. Medtronic has made it easier for plaintiffs to pursue medical products liability claims. In the landmark 2014 decision, the court held that the state law tort claims asserted by the plaintiff were not federally preempted. The decision is part of a growing body of medical products liability law regarding the circumstances under which a state law claim can impose "parallel" requirements to those under the Food, Drug & Cosmetics Act (FDCA) and, therefore, avoid federal preemption. The Facts of the Case John Coleman filed a product liability lawsuit against Medtronic, Inc., and Medtronic Sofamor Danek USA, Inc. (collectively, Medtronic), alleging that he suffered painful complications after a spinal surgery in which Infuse, Medtronic 's federally–approved bone fusion medical device, was used in an "off–label" manner. The Federal Drug Administration (FDA) granted Infuse premarket approval for use in certain types of spinal fusion surgeries, including Anterior Lumbar Interbody Fusion (Anterior Fusion). The type of surgery Coleman underwent – Posterior Fusion – was promoted by Medtronic but not approved by the FDA. As detailed in court documents, studies funded by Medtronic found that the medical device could cause bone growth in the spinal canal, but the company did not report the adverse events to the FDA. Medtronic was also aware that adverse ... Get more on HelpWriting.net ...
  • 16. Pros And Cons Of The FDA Should the FDA be able to control what manufacturers put into cosmetic products? I believe that the FDA and the FDCA should be able to determine what ingredients are being put into cosmetic products. I believe this because it can become very dangerous in the future if the FDA doesn't control what is being put into these products. Over the years, makeup and cosmetic brands have been putting more and more synthetic and dangerous chemicals in their products to make them better quality. This can become an overall bigger problem if it is not addressed and changed. In a statement from the FDA, they claimed that the FDA is not allowed to change the ingredients that are put into the products. They are only allowed to request that the ingredient is taken away. There are many chemicals that have been proven to be dangerous to the human body, but are still not being take away from the product by the FDA. There has also been proof that manufactures put these chemicals to make the products smell and last longer, but don't help the consumers skin or body in any way. I believe that the FDA should be allowed to remove chemicals from certain products if they are proven to be dangerous. If the FDA doesn't do something about the problem then something else needs to be done to stop these ... Show more content on Helpwriting.net ... In a statement from the FDA, they state that, "In general, cosmetic manufacturers may use any ingredient they choose." This means that they have little to no say in the ingredients that are being put into different cosmetic products. In conclusion, the FDA should pay more attention to these ingredients, and do something to change to rules about cosmetics. If the FDA isn't able to dot that, then they should bring more attention to the consumers of the cosmetics and add a warning because no a lot of people who use these products know the potential ... Get more on HelpWriting.net ...
  • 17. History Of The Food And Drug Administration The Food and Drug Administration was founded on June 30, 1906 by then US president Theodore Roosevelt and Harvey Washington Wiley. It was formed as a response to serious abuses that were taking place at the time. In the government structure the FDA is a federal independent executive agency so that means that it is like a cabinet but it doesn't have the statues that some other agencies would have. And now I will go over why the FDA is necessary and what they do in it. A job of the FDA is ensuring the safety of the nations food and drug products. One way they do it with food is by having manufactures send a report of the process that it takes to make the food so they can see if the process is a healthy or unhealthy one. The FDA do the same ... Get more on HelpWriting.net ...
  • 18. Perspective Analysis Sample Retrospective Analysis Introduction Section: This retrospective analysis is on a class III medical device called the Micra Transcatheter Pacing System (TPS). The device is created by Medtronic Incorporated which is a company that focuses primarily on devices for cardio and vascular, restorative therapies, diabetes, and minimally invasive therapies. The target customers are those who have slow or irregular heartbeats that need to be monitored. This pacemaker is useful for patients who could have difficulties with the placement of traditional pacemakers, or would be better off with a single chamber pacemaker. The underlying technology used is a 1in long pacemaker that is placed directly into the right ventricle through the femoral artery using ... Show more content on Helpwriting.net ... The response letter highlighted some of the restrictions placed on the device which include the following: 21 CFR 801.109 and 515(d)(1)(B)(ii) (sale and distribution), 515(d)(1)(B)(ii) (label devices for experience needed to operate), and 502(q) and (r) (requirements for a restricted device. The letter also informed that an Annual Report was necessary within section 21 CFR 814.84 for the PMA approval to stay in place. This Annual Report should have the following parts: number of devices distributed during the regulation period, the number of the devices implanted in people, the amount of deaths and explants, and a survival table. It is important to note that the deaths should be broken down into related to the pacemaker and not related. The explants should be broken down into those that no longer had battery, complications that could not be solved with programming, and other safety and efficacy problems. Other than the Annual Report the company should also perform a post approval study (PAS). The ending of the letter warns against the repercussions if some of these requirements are not met. It also informs the company of what steps need to be taken if the product was changed or if any safety and efficacy problems arose that made the product necessary for ... Get more on HelpWriting.net ...
  • 19. Harvey Washington Sinclair's Book 'The Jungle' New agencies were established as a role of the government's responsibility to its citizens and one of those agencies was the Food and Drug Association. The Food and Drug Association origins could be traced back to the creation of the Agricultural Division in the Patent Office in 1848. The FDA federal consumer protection agency began when the 1906 Pure Food and Drug Act was passed. This law was aimed to end serious abuses in the consumer product marketplace. This agency was strongly advocated by Harvey Washington Wiley and the act was passed because of his efforts and Upton Sinclair's book "The Jungle". FDA's organization consists of the Office of the Commisioners and four directorates overseeing the core functions of the agency: Medical Products ... Get more on HelpWriting.net ...
  • 20. Should The Fda Ban Cosmetics Society would assume that when there is a problem, the government intervenes for the safety of the public. But, when it comes to makeup there is no open case between the Federal Drug Administration and cosmetic regulations. For the past years the FDA has worked to eliminate chemicals that have been inconvenient to consumers. These products include "methanol, methylene chloride, mercury compounds [etc.]" (U.S). These additives used to be sold at any over the counter stores but, after its consumption the FDA realized that the product increased death rates more as it increases its consumption. For example, "finger nail extenders containing methyl methacrylate monomer [was banned due] to number of complaints of personal injuries" (U.S). Although first the product appeared to be beneficial to the consumer, its' daily use increased the magnitude to have negative impacts on the human body. ... Show more content on Helpwriting.net ... [However] the FDA bans only nine of [those]substances" (Report). This shows the lack of regulation that exists between the chemicals and the Federal Drug Administration. Since the FDA has only banned a few chemicals rather than restricting the epidemic it has promoted the increase of tumors, allergic reactions, and death. The main reason why only a few chemicals in cosmetics are banned is because "neither the law nor FDA regulations require specific tests to demonstrate the safety of ingredients" (U.S). In other words, the manufactures have complete control to use any chemical toxic or non toxic without government regulation. Since the manufactures are not required to register ingredients they could continue hurting the consumer until the damage is ... Get more on HelpWriting.net ...
  • 21. Cosmetic History And Facts About The Cosmetic Industry The cosmetic industry has become such an integral part of the human culture that it often goes on without notice. In the vast and various cultures across our planet cosmetics are used for multitudes of reasons from religious expression, camouflage for soldiers in combat, Hollywood sets, to getting ready for a date. In our culture the use of makeup is almost a rite of passage into young adulthood for young girls and their mothers. The one question that almost no one ask when they open the make–up container is "What harm will this bring me?" Our assumption is that what we buy in a store is safe to use and is normal. But do we wonder how the cosmetic industry came to the conclusion about their product to support our assumption? According to the website, History of Cosmetics, article: "Cosmetic History and Facts," the use of cosmetics dates back some twelve thousand years to the ancient Egyptians when they discovered the properties of healing oils. Soon the use of cosmetics grew throughout their entire population as a way of expression and to honor their gods. Soon almost everyone wore eyeliner and used scented oils the allure of cosmetics didn't stop even when some of the ingredients proved to be fatal. The cosmetic industry pushed past the boundaries of Egypt into other parts of the world in some parts of the world like Rome and Greece it was met with some resistance. The resistance proved to be only a minor damper to the movement of the cosmetic industry ... Get more on HelpWriting.net ...
  • 22. Funny Face And Novelty Now Case Analysis Although, it was done by the direction of Chris, and there is no evidence on the statement that says that Matt and Ian were aware of this, under corporate criminal liability they are all responsible for being corporate officials who are responsible for enforcing the law. "Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA." (FDA Authority Over Cosmetics, n.d). "The FD&C Act defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body". (Cosmetics Defined by Law, n.d). Novelty Now, responsible for the manufacturing of the product, ... Show more content on Helpwriting.net ... Whom does this decision affect? Although substituting PFY in the formula increased sales revenue, Funny Face and Novelty Now failed to consider that because of lack of test and FDA approval of this product, consumers health could and in fact resulted to be at risk of side effects. Purpose– Both companies failed to take efficiency into consideration. Although substituting the ingredient, seemed like a profitable market idea, would the aftershave be as efficient as it was originally formulated? How– As owners of cosmetic companies, corporate officials need to take into consideration how public disclosure would affect the business if customers knew about the substitution of an ingredient for something inferior and not FDA approved. By developing reasoning towards the WPH framework we can conclude that although it seemed like a "smart" market/profit move to substitute PYR, in ethical terms, it meant a violation of consumer trust and safety. Moreover, the damage to the public speaking career that the aftershave caused to Mr. Margolin, could never be ethically ... Get more on HelpWriting.net ...
  • 23. History Of Animal Testing Beginning of Animal Testing Historically animals have been used in scientific experimentation to satisfy the curiosity and the pursuit of knowledge. For example, one of the first, known scientists to conduct experiments on living animals, practiced in the 2nd century. Galen of Pergamum was a renowned Greek physician, surgeon and philosopher in the Roman Empire. In his book De Anatomicis Administrationibus (On Anatomical Procedures) he detailed precise experimental methods and instruments to perform specific procedures and dissections on animals. Since the first successful use of anesthesia wasn't until 1846, Galen, and other scientists he inspired, preformed elaborate and thorough procedures without pain relief. Since then animal testing has been responsible for numerous medical breakthroughs. Beginning of Cosmetic Animal Testing Predating the 20th century alone, animal testing led to the creation of the Small Pox Vaccine, Rabbis Vaccine, Anthrax Vaccine, Cholera and Plague Vaccines, and treatment for Beriberi. Between the 1900's and 1930's blood transfusions, modern anesthesia, Tetanus Vaccine, and Diphtheria Vaccine relied on animal research. It wasn't until 1933 when a woman used the brand Lash Lure Mascara ... Show more content on Helpwriting.net ... The European Union is planning to ban animal testing for cosmetics to be by 2009. In the United States, Revlon and Avon were two of the first large companies to halt all cosmetics testing on animals. Some, on the other hand, have debated that the main ingredients in cosmetics have previously been tested on animals. Therefore, their safety is well established, which means that it's 'easier' for companies to find alternatives to test product formulations because most active ingredients have already been approved. As time, technology and technology progress, it is likely that cosmetic animal testing will either decrease or end all ... Get more on HelpWriting.net ...
  • 24. Regulations Of The Fda On Cosmetics Essay Limited regulations of The FDA on cosmetics Frequently, consumers like you and I buy items everyday not knowing chemicals or harsh byproducts that they are made with. We trust that cosmetic products we buy everyday will be safe, but there are ingredients in our daily products that could or has caused some health or skin conditions. In 1820, the U.S gathered physicians to create, The FDA and regulations on drugs in the United States. The general purpose of The Food and Drug Act was to have a standard on the specific food and drugs that were being imported into the United States. It was not until 1848 the Drug Importation Act was passed by Congress. It required U.S. Customs Service Inspection to stop entry of adulterated drugs from outside our border. In the middle of 1906, fifty–eight years later the food and drugs act was passed. The original Food and Drugs Act was passed by Congress on the 30th of June and signed by President Theodore Roosevelt. The Food and Drug Act prohibits interstate commerce in misbranded and adulterated foods, drinks and drugs (FDA). The Food and Drug establishes standards and regulations ensuring that general public is safe from harmful domestically and internationally produced products. Since 1906, there has been thousands of bills passed placing restrictions, instituting regulations and setting standard on drugs. According to the FDA the daily products, such as mouthwash is considered a drug. In 1937, a new and updated billed was passed ... Get more on HelpWriting.net ...
  • 25. Fda And Obtain Clearance Of Their Safety And Effectiveness... In order to be legally marketed in the US, many medical devices must be reviewed by the FDA and obtain clearance of their safety and effectiveness to enter the market. The regulations can affect the cost, quality, and availability of medical devices. Pre–Market Approval and 510(k) Clearance There are two FDA processes for different medical devices: Premarket Notification 510(k), and Premarket Approval (PMA). A PMA is required of new Class III high–risk devices. Companies need to submit evidence that provides reasonable assurance that the device is safe and effective. The PMA can take more than 450 days and the clinical data required can cost millions to collect. Most Class I and Class II devices (low– to moderate–risk devices) only need to receive 510(k) clearance before being marketed. The companies only need to demonstrate that the device is "substantially equivalent" to a device already on the market (a predicate device) that does not require a PMA. The 510(k) clearance tends to take around 200 days and costs much less than PMA. Access to the US market FDA approval enables medical device companies to access the US market, 43% of the global medical device market. According to National Health Expenditures in 2012, the $140 billion medical device market has grown at a rate of 6% annually in the US. Coverage under Medicare Getting FDA– approval is the first step to enter the healthcare system. Centers for Medicare & Medicaid Services requires devices to be FDA–approved ... Get more on HelpWriting.net ...
  • 26. Cosmetic History And Facts About The Cosmetic Industry The cosmetic industry has become such an integral part of the human culture that it often goes on without notice. In the vast and various cultures across our planet cosmetics are used for multitudes of reasons from religious expression, camouflage for soldiers in combat, Hollywood sets, to getting ready for a date. In our culture the use of makeup is almost a rite of passage into young adulthood for young girls and their mothers. The one question that almost no one ask when they open the make–up container is "What harm will this bring me?" Our assumption is that what we buy in a store is safe to use and is normal. But do we wonder how the cosmetic industry came to the conclusion about their product to support our assumption? According to the website, History of Cosmetics, article: "Cosmetic History and Facts," the use of cosmetics dates back some twelve thousand years to the ancient Egyptians when they discovered the properties of healing oils. Soon the use of cosmetics grew throughout their entire population as a way of expression and to honor their gods. Soon almost everyone wore eyeliner and used scented oils the allure of cosmetics didn't stop even when some of the ingredients proved to be fatal. The cosmetic industry pushed past the boundaries of Egypt into other parts of the world in some parts of the world like Rome and Greece it was met with some resistance. The resistance proved to be only a minor damper to the movement of the cosmetic industry ... Get more on HelpWriting.net ...
  • 27. Pure Food And Drug Act Of 1906 Analysis Pure Food and Drug Act of 1906 On June 30, 1906, President Theodore Roosevelt signed the Pure Food and Drug Act. He began to enforce this act by also passing the Meat Inspection Act of 1906. The person responsible for introducing the act is Sen. Weldon Heyburn. The act is sure to benefit the health of Americans in the present and future. In the first place, children from Camden and St. Louis died from tainted vaccines in 1901. The purpose of the act is to prevent misbranding and adulteration of products to prevent more health problems and death. It bans the manufacture, selling, and transportation of medicines that are poisonous or without scientific support. It also applies to goods shipped in interstate or foreign commerce. The Department ... Get more on HelpWriting.net ...
  • 28. Federal Food Drug, and Cosmetic Act of 1938 Federal Food, Drug, and Cosmetic Act of 1938 According to, http://www.toxicology.org/gp/fda.asp, the Society of Toxicology website, in 1937 the Massengill pharmaceutical company dispersed Elixir Sulfanilamide. This drug was prescribed generally to anyone who had symptoms of strep throat. Elixir Sulfanilamide contains diethylene glycol, which is a chemical equivalent of antifreeze. There were 107 documented deaths, involving many children, because of the lack in regulations. The Pure Food and Drug Act was deemed to insufficient to protect the public. This tragedy was the critical motivation for the creation of the Federal Food, Drug, and Cosmetic Act. The Federal Food, Drug, and Cosmetic Act (FFDC) can be found in chapter 9 of title 21 in ... Show more content on Helpwriting.net ... Since the amendment the technology that is capable of finding such small particles of substance has caused some reconsideration of the "at any level," concept. The flavor industry requested for a "de minimis," which refers to a level of risk that is too small to raise concern. The Senate has propositioned bills that would improve the meaning of the Delaney Clause but nothing has passed yet (http://cnie.org/NLE/CRSreports/Pesticides/pest–1.cfm). 1996 Food Quality Protection Act In 1996 both houses of congress passed the quality protection act (FQPA) unanimously. This amendment particularly reformed regulations of pesticides. Eliminating the Delaney Clause from being applied to pesticide residues. The U.S. Environmental Protection Agency (EPA) website indicates that this new law sets a single health–based standard instead of the previous multiple standards. The general safety standard is considered to be, "a reasonable certainty of no harm." When the EPA sets the standards it will have to take in consideration all sources, which include water, and other pesticides with a common "mechanism of toxicity" (http://www.epa.gov/pesticides/regulating/laws/fqpa/backgrnd.htm ). The website also mentions a special provision considering babies and children, where there is to be a clear determination that proves tolerance levels are in fact safe for children. Three Food Standards ... Get more on HelpWriting.net ...
  • 29. Injection Eye Drug Research Paper CPT 67028 – Injection eye drug (Intravitreal injection of a pharmacological agent (separate procedure) – injection on one antibiotic. CPT 67028 – Injection eye drug (Intravitreal injection of a pharmacological agent (separate procedure) – injection of a different antibiotic. The payment was denied because the provider of service (Dr. V. C., MD) did not sign the medical record. The procedure billed was included as part of an evaluation and management encounter signed by a different physician (Dr. R.T.D.). Per the QIC's letter, "Medicare requires that services provided/ordered be authenticated by the author to indicate the service has been reviewed and authenticated by the provider. The method used shall be a handwritten or electronic signature. Stamped ... Show more content on Helpwriting.net ... She was evaluated for the vision loss and changes in the appearance of her right eye; she was treated with injections of 2 different antibiotic medications in the right ... Get more on HelpWriting.net ...
  • 30. How Did The Food And Drugs Act Of 1906 The Food & Drug Administration became a possibility because of the Pure Food and Drugs Act of 1906. Harvey Washington Wiley was the driving force behind this law and headed its enforcement, which provided basic elements of protection that consumers had never had before (FDA's Origin). The FDA is an agency that works within the US Department of Health and Human Services of the executive branch of government (About FDA). The Food and Drug Administration is responsible for protecting the public health of all Americans by ensuring the safety, efficacy, and security of a large range of products from drugs to cosmetics (What We Do). The FDA is a very structured, governmental agency. The Office of the Commissioner and four directors overseeing ... Get more on HelpWriting.net ...
  • 31. The Fda's Global Unique Device Identification Analysis The FDA has established a unique device identification (UDI) database to enhance the identification of medical devices from point of manufacture through delivery to the end user. This guideline covers medical devices Classes I, II, and III (FDA 2014), where Class I poses the lowest risk to patient and Class III carries the highest risk. When fully implemented, the label for the majority of medical devices will contain a unique device identifier (UDI) in a human and machine–readable (barcode) form (FDA 2017). Medical device companies operating under FDA guidelines will be required to submit certain information about each device to the FDA's Global Unique Device Identification Database (GUDID) (FDA 2014). In order to allow organizations ... Show more content on Helpwriting.net ... Problem Statement Many companies have set forth action plans for UDI compliance, however, when they purchase the Prisym ID solution, their personnel, from entry level through C–level have not had exposure or training on the PRISYM 360 software application and do not have sufficient knowledge of the application as required to perform their job. They may have understanding of the guideline requirements, but they do not yet know how to translate it into creating the actual label for market medical devices. Problem Background and Causes The FDA developed UDI in order to better track medical devices manufactured in the United States. It was signed into law on Septebmer 27, 2007 as a part of the U.S. Food and Drug Administration Amendments of 2007 (FDA, 2007). The law is recognized as a significant addition to overall FDA authority, and as a result medical devices companies must implement the guidance to maintain compliance with U.S. FDA, or be ordered to cease all operations. The organizations must prepare and train personnel relative to the production labeling process in order to ensure product being sold is in compliance. Because the employees are not yet trained on the proper usage is a concern to the company if they are to meet the deadline for total compliance. The deadline as set forth by the FDA is a phased in schedule between 2014–2020. The PRISYM 360 solution is UDI compliant, and the instruction will allow the organizations' employees to ... Get more on HelpWriting.net ...
  • 32. Examples Of 20th Century False Advertising 20th Century False Advertising and Regulation The 20th century was a time of conflict between false advertising and regulations. With the passage of The Pure Food and Drug Act in 1906 there was finally regulation that helped protect the health and safety of consumers. The passage of this act was also the birth of the Food and Drug Administration (FDA). An article published in the Journal of Public Health explains the reasoning behind this act: "an unprecedented convergence of consumer, scientific, and industrial support in 1906 prompted such action" (Barkan 18). As technology and medicine became more prevalent, it became more necessary for products to pass certain tests and follow stricter regulations. After the passage of The Pure Food and ... Show more content on Helpwriting.net ... Spam is said to have caused America a loss of $10 billion due to spam preventative measures and productivity loss (Stock 1). Spam was a large problem and needed to be addressed. In 2003, the Controlling the Assault of Non–Solicited Pornography and Marketing Act, or CAN–SPAM Act, was introduced to combat the growing levels of false advertising manifesting itself on the internet. Before this act, people or businesses were able to send unsolicited emails without any punishment from the government. This act "imposes a series of new requirements on the use of commercial electronic mail ('email') messages. In addition, the Act gives federal civil and criminal enforcement authorities new tools to combat unsolicited commercial email ('UCE' or 'spam')" ("Definitions, Implementation, and Reporting" 50092). While this Act had the hope of increasing punishment for people who do not follow these rules, the CAN–SPAM Act was not as successful as the FTC hoped. One large issue with this Act is how it defines spam. According to an article published in the Berkeley Technology Law Journal, this act is essentially giving spammers information on what they cannot do, allowing them to spam legally as long as they follow the FTC's rules (Zhang 301). This may allow people to spam more if they understand the limitations and instead "legally spam" email users. Also, this act ... Get more on HelpWriting.net ...
  • 33. CLIA Test Complexity CLIA Test Complexity and Requirements Nicole Cersovsky INRODUCTION In 1988, the Department of Health and Human Services (DHHS) created regulations that were passed by Congress [2]. These became known as the Clinical Laboratory Improvement Amendments (CLIA) of 1988 [2,3]. The standards set were designed to improve the quality of testing on human specimens run in almost every laboratory in the United States [2,4]. The Food and Drug Administration (FDA) has three categories that test complexities fall under: waived, moderate and high complexity [2,3,4]. WAIVED Currently there are eight tests that meet the criteria to fall under waived testing. These criteria indicate that the method of testing is so easy that the chance of getting a wrong ... Show more content on Helpwriting.net ... Laboratories with only this CW are not required to have routine inspections, but they must follow the manufacturer's instructions for testing. They must also allow random inspections for compliance and/or investigations into complaints [2,4]. MODERATE AND HIGH COMPLEXITY Provider– performed microscopy (PPM) procedures are a part of moderately complex testing in which a microscope is used as the main instrument for testing [4]. PPM is performed by a physician, mid– level provider, or a dentist and is performed during the patients' exam [3,4]. Examples of PPM testing include KOH preparations, wet mounts, post–vasectomy specimens, and urine sedimentation exams [4]. There are currently close to 10,000 tests that fall under the criteria that classifies moderate and high complexity testing [2]. These seven criteria are as follows: the expertise to run a test, the training and experience needed for testing, how complex reagent and quality control preparation is, the required training to operate the instrument, quality control, proficiency testing and calibration requirements, troubleshooting and maintenance requirements for the instrument, and the ability of the testing personnel for interpretation of results ... Get more on HelpWriting.net ...
  • 34. Food And Drug Administration Case Study Introduction "Is it FDA approved?" Today, we hear more of this question and would check for the "FDA approved" stamp on the product before purchasing it. This behavior signifies the accountability of the agency, on how it has impacted the choices made by the people. This may not always be the case, however, for there are people who do not find the label necessary or would be applicable to their lifestyle. Nevertheless, this agency has made its mark in history to watch over the products being purchased by the consumers. Food and Drug Administration (FDA) is an agency under the Department of Health and Human Services. Its main responsibility is to protect the public health by assuring safety, efficacy and security. FDA assures safety by allowing ... Show more content on Helpwriting.net ... With this act, there are written practices that can be submitted by the public and the final rules are published in the Code of Federal Regulations (Milakovich and Gordon). Although with a deadline to issue comments, the involvement of the public gives emphasis on the value of citizens' input and affirms that the public has a say on the rules and regulations that will be soon applicable, if not, is necessary to benefit them. Moreover, one of the procedures required by the APA for the agencies to comply to, is formal adjudication. If authority making must be delegated, then a trial type hearing where cross–examination and witnesses must construe, hence, the traditional "formal rulemaking" comes into play. The concern regarding formal rulemaking retaliates to cause abandonment of regulatory programs, for the factors of cost and delays come into place, that it was almost denounced by federal agency proceedings (Gellhorn and Levin 326). There was an existing struggle within using formal adjudication or formal rulemaking for the agency to use, to make the process and procedure fair to both agency and accused. Hence, the creation of the informal rulemaking that consists involvement of the public– a hybrid rulemaking option, but was effectively halted by the Supreme Court. The court has, however, formed a compromise to allow hybrid ... Get more on HelpWriting.net ...
  • 35. Animal Testing Kills Animals Don't kill you're living friend. As Anthony Douglas William, author, researcher, and consultant, once said "When I look into the eyes of an animal I do not see an animal. I see a living being. I see a friend. I feel a soul." As defined by Merriam–Webster Dictionary a living being is a state of existing, a living thing, or a living organism. While the Federal Food, Drug, and Cosmetic Act law states that animal testing is not required, it does not prohibit the act to conduct animal experimentation. With several other methods existing out there, testing of new ingredients by cosmetic companies is normally an expensive and unethical choice. The only effective way to save the innocent lives of these animals is by creating a law that forbids the sale and manufacture of cosmetic companies who use living beings as test subjects. Animal testing for cosmetic ingredients was introduced a few years ago due to the fact that women were wearing cosmetics, which included ingredients that were unsafe to human flesh and eyes, ... Show more content on Helpwriting.net ... For example, in Europe, the world's largest cosmetic company, it is illegal to sale or import any animal tested beauty products. Also, in other countries like Israel and India also apply this type of law. (dosomething.org) Other countries either have restrictions towards how they must handle their test subjects and even some countries are close to banning the act of animal testing in full. All of the American based companies who export to the foreign countries have to comply by the laws that are already in place, so most of the cosmetic companies already obey produce products that are not animal tested to be able to sell them in the distinct markets. Because these U.S. based companies who export internationally are already expected to comply by testing bans, more than 1.7 billion people can already buy cosmetics products that are not tested on animals. ... Get more on HelpWriting.net ...
  • 36. Should Animal Testing Be Banned In The United States "We know that animals can experience pain and distress in experiments and that this can be severe. The way that animals are bred, transported, housed and handled may also cause suffering."(RSPCA) Animal testing is an issue that has existed since the early 1900s. Some countries have passed laws to ban the use of animals in cosmetic testing, but the United States has not. This is important because over 100 million animals are tested on each year across the world. "Europe, the world's largest cosmetic market, Israel and India have already banned animal testing for cosmetics, and the sale or import of newly animal–tested beauty products."(dosomething.org) Animal testing needs to be banned from the United States. It is not right to use animals ... Show more content on Helpwriting.net ... The U.S. is one of only two countries whose government openly allows it. "Europe, the world's largest cosmetic market, Israel and India have already banned animal testing for cosmetics, and the sale or import of newly animal–tested beauty products." (dosomething.org) So, some countries can see that animal testing is wrong. Those countries have found ways to test products without using animals. they just use existing information when creating new products. The consequences of not stopping animal testing are obvious. Animals will continue to be in pain and suffering until it is all over. "There are already many alternatives to animals which have been developed. Particularly in the areas of toxicity testing and teaching."(Animals Australia) If animal testing was banned, scientists could just use the alternatives or they just use existing information when creating new products. The Animal Welfare Act is not doing anything to help animals. Yes, it gives those few species some protection, but it doesn't protect them from being tested on. Therefore, laws banning animal testing from the United States need to be laid down. Us as humans can continue to protest or write to the government. ASPCA and PETA will also continue to do what they are doing and they won't stop until the rights are returned to the ... Get more on HelpWriting.net ...
  • 37. The Breast Implants Produced By Poly Implant PIP Implant Scandal 1.0 Background The breast implants produced by Poly Implant Prothese (PIP) French company were banned in the year of 2010. PIP which was founded in year 1991 and was once the world's third largest supplier of silicone gel breast implants was eventually shut down within the same year. This company had illegally produced and marketed the implants using unauthorized industrial grade silicone gel that meant for use in mattresses instead of approved and mandated medical grade silicone gel since year 2001. The implants were widely used across Europe, Britain and South America and estimated about 400, 000 patients in 45 countries around the world with PIP Implants. The scandal was surfaced in year 2009 due to medical device reports from surgeons on the abnormally high rupture rates of the PIP implants than other approved implants. France's drug and medical safety agency (AFSSAPS) recalled the PIP implants and advised 30,000 women to have their implants removed due to this scandal in subsequent year of 2010. 2.0 Issues with PIP implants A full recall of PIP implants by French Ministry of Health has sparked a worldwide fear and alert. The implants with cheap and unapproved industrial grade silicone as filler are believed to have higher rupturing rates, though the exact figure varies with each health authority. According to SCENIHR , this filler could weaken the shell of PIP implants with increased risk of gel–leakage and rupture. The silicone gel filing can ... Get more on HelpWriting.net ...
  • 38. Cosmetic Testing with Animals is Cruel Essay The Cruelty of Cosmetic Testing on Animals Each year, thousands of animals are brutally tortured in laboratories, in the name of cosmetic research. A movement to ban animal testing for cosmetic purposes has been gaining popularity, with many companies hopping on the bandwagon against this research. New alternatives have been developed to eliminate the necessity to test on animals. This is only a small beginning of what is necessary to end these immoral acts. Animal testing in cosmetics is useless and cruel, and can be accomplished by other methods of research to end the suffering of animals. One of the many painful tests administered on animals in laboratories is the Draize Test. This experiment, introduced forty–five years ... Show more content on Helpwriting.net ... The Gallup Organization published a poll taken showed that 60% of adults are against animal experimentation (Public, 97). All of these results show both how many animals are killed, and the view of the general population. If this is the reaction regarding these cruel acts, then why does the suffering of animals continue? The testing that occurs in animal laboratories appeals to our emotion because of the cruelty that is involved. This is not the only reason for concern. The current conditions of the treatment and facilities are not acceptable. This is a violation of the Animal Welfare Act of 1996 (97). This law was established to protect animals from inhumane treatment of research animals 97). Inhumane treatment is the torture that occurs everyday, as animals for forced into tests that determine the safety of cosmetic products. A major part of the argument against animal testing revolves around the moral issues of the issue. "Should we be allowed to cause suffering to animals to gain something for ourselves" (Dufva, 1, 97). The answer to this question is no. These animals are tortured to test the safety of makeup and other cosmetics; these creatures are sacrificed so humans can alter their physical appearance. This act is not only unethical, but violates the basic teachings of Godís word. As quoted in Matthew 7:12, "Do unto ... Get more on HelpWriting.net ...