The document discusses the regulatory structure for cosmetics in the United States. The FDA is responsible for enforcing the Federal Food, Drug, and Cosmetic Act and other laws governing cosmetic marketing. Cosmetics are not subject to pre-market approval, but cannot be adulterated or misbranded. They must include ingredient labels and warnings as needed. The FDA can take enforcement actions like seizures or injunctions for violations.
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
TSE/BSE is a type of disease affected to the animals which may transmit to the humans if any products obtained by the disease caused animal may affect to humans also
The many biologic products are expracted from the animal source so before the extraction the animal should be tested for TSE/BSE organism in their source/Body
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Labeling/Advertising and Promotion, Import/Export, and Enforcement ActionsMichael Swit
Presentation to the Regulatory Affairs Certification (RAC) Review Course, sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group, on August 2, 2014, in Irvine, CA. See slides 4-58 for Labeling/Advertising Discussion; slide 59 to 72 for Imports/Exports, and 73 to end for Enforcement Actions
TSE/BSE is a type of disease affected to the animals which may transmit to the humans if any products obtained by the disease caused animal may affect to humans also
The many biologic products are expracted from the animal source so before the extraction the animal should be tested for TSE/BSE organism in their source/Body
Combination Products, Orphan Drugs and OTC DrugsMichael Swit
Presentation to the 2016 Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network (SDRAN) in July 2017, with a focus on:
A Brief History of Combination Product Regulation
Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
The Request for Designation (RFD) Process
GMPs
Post-Market Safety Reporting
How Many Applications to File?
User Fees
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
Brazil Cosmetics Regulations by ArtixioAndyThomas119
Cosmetics in Brazil are classified as Class I and Class II products based on the risk involved. In the Brazilian Market there are two ways of product authorization - registration and prior notification of a product exempted of registration.
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
As part of my Executive MBA program at St Mary's College of California, I worked on a Capstone project in which I helped Indonesian Cosmetic manufacturer to help export their Purbasari body scrub product into the North American Market. This presentation is a draft outline to my export strategy plan for PT Gloria Origita Cosmetic.
If you have any questions or comments for improvements please feel free to reach out to me or comment below.
Combination Products, Orphan Drugs and OTC DrugsMichael Swit
Presentation to the 2016 Regulatory Affairs Certification (RAC) Test Review Course sponsored by the San Diego Regulatory Affairs Network (SDRAN) in July 2017, with a focus on:
A Brief History of Combination Product Regulation
Primary Mode of Action (PMOA) –The Key Lynchpin to FDA’s Regulatory Regime for Combination Products
The Request for Designation (RFD) Process
GMPs
Post-Market Safety Reporting
How Many Applications to File?
User Fees
labelling of drugs and cosmetics in European UnionBindu Kshtriya
labelling of pharmaceutical drug products and cosmetics, with special emphasis on font size, type, and other recommendations such as particulars to be mentioned and legal framework for labelling
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
MARKETING AUTHORISATION, LICENSING AND QUALITY ASSESSMENT OF VACCINES IN INDI...Swapnil Fernandes
- European pharmaceutical legislation provides a comprehensive framework for the marketing authorisation of vaccines.
- In contrast to the European scenario, the Indian scenario for vaccines is relatively less regulated and follows the same process of approval as other biologics in spite of having a National Handbook for Vaccine Policy.
- Vaccine authorisation in the US, as is the case in EU, is a more straightforward process than in most other markets as the USFDA has provided vaccines with a distinct set of regulations in concerned areas of safety and quality.
REGULATORY ASPECTS OF FOOD & NUTRACEUTICALS A GLOBALKapilKumar198
This presentation contains detailed information about the regulatory aspects of food and nutraceuticals a global prospective, which includes WHO guidelines on nutrition and NSF International.
NSF certification, Standard for dietary supplementAtul Bhombe
Manufacturers, regulators and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF is a global, independent organization, our standards team facilitates development of public health standards, and our service teams test, audit and certify products and services
Brazil Cosmetics Regulations by ArtixioAndyThomas119
Cosmetics in Brazil are classified as Class I and Class II products based on the risk involved. In the Brazilian Market there are two ways of product authorization - registration and prior notification of a product exempted of registration.
NSF International and its role in Dietary supplements & Nutraceutical industr...SyedArshiya4
This presentation will allow the reader to know about NSF international its history, mission, NSF Mark, role in Dietary supplements and Nutraceutical industries. It also give information on testing, inspection, certification of products.
As part of my Executive MBA program at St Mary's College of California, I worked on a Capstone project in which I helped Indonesian Cosmetic manufacturer to help export their Purbasari body scrub product into the North American Market. This presentation is a draft outline to my export strategy plan for PT Gloria Origita Cosmetic.
If you have any questions or comments for improvements please feel free to reach out to me or comment below.
This project was the final project for the Marketing Management 2 course at McGill university. We represented team MAC, and "battled" against team Make Up Forever, a competing cosmetics brand. This project resulted in our team winning the battle, as well as top marks in the class.
Cosmetics & Beauty Product Litigation - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
This presentation will give General overview about Indian Regulatory Requirements for cosmetics.
This ppt contains information about latest cosmetics rules 2020 and D& C Act 1940
Brazilian Blowout - A Case Study in Failed Cosmetics Regulation v2zq
Brazilian Blowout - A Case Study in Failed Cosmetics Regulation - Resources for Healthy Children www.scribd.com/doc/254613619 - For more information, Please see Organic Edible Schoolyards & Gardening with Children www.scribd.com/doc/254613963 - Gardening with Volcanic Rock Dust www.scribd.com/doc/254613846 - Double Food Production from your School Garden with Organic Tech www.scribd.com/doc/254613765 - Free School Gardening Art Posters www.scribd.com/doc/254613694 - Increase Food Production with Companion Planting in your School Garden www.scribd.com/doc/254609890 - Healthy Foods Dramatically Improves Student Academic Success www.scribd.com/doc/254613619 - City Chickens for your Organic School Garden www.scribd.com/doc/254613553 - Huerto Ecológico, Tecnologías Sostenibles, Agricultura Organica www.scribd.com/doc/254613494 - Simple Square Foot Gardening for Schools - Teacher Guide www.scribd.com/doc/254613410 - Free Organic Gardening Publications www.scribd.com/doc/254609890 ~
In this presentation I have mentioned whatever the possible relevant content required for the title.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
The term “cosmeceutical” has become popular in recent years to describe a cosmetic product that claims medicinal benefits. While those in the cosmetic industry use the term to advertise the ingredients and benefits of their products, the FDA does not legally recognize the term...
REGULATORY PROVISION RELATING TO MANUFACTURING OF COSMETICSourav Mohanto
REGULATORY PROVISION RELATING TO MANUFACTURING OF COSMETIC.
Minimum requirement of space, equipment and machinery for manufacturing of cosmetic have been prescribed under M II to the Drugs and Cosmetics Rule,1945
Ensuring Compliance with U.S. FDA Cosmetics RegulationsRegistrar Corp
For more than a decade, Registrar Corp has offered businesses its dedicated assistance in complying with U.S. Food and Drug Administration (FDA) regulations. Spanning 16 offices across the globe, Hampton, Virginia-based Registrar Corp has extensive experience in the food and beverage, drug, medical device, and cosmetics sectors. Registrar Corp employees consist of a number of scientists and other regulatory specialists who have formerly worked for the FDA.
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
263778731218 Abortion Clinic /Pills In Harare ,ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group ABORTION WOMEN’S CLINIC +27730423979 IN women clinic we believe that every woman should be able to make choices in her pregnancy. Our job is to provide compassionate care, safety,affordable and confidential services. That’s why we have won the trust from all generations of women all over the world. we use non surgical method(Abortion pills) to terminate…Dr.LISA +27730423979women Clinic is committed to providing the highest quality of obstetrical and gynecological care to women of all ages. Our dedicated staff aim to treat each patient and her health concerns with compassion and respect.Our dedicated group of receptionists, nurses, and physicians have worked together as a teamof receptionists, nurses, and physicians have worked together as a team wwww.lisywomensclinic.co.za/
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Dehradun #ℂall #gIRLS Oyo Hotel 9719300533 #ℂall #gIRL in Dehradun
REGULATORY REQUIREMENTS FOR MARKETING OF COSMETICS BY ROOMA KHALID
1. Presented by
Rooma Khalid
M.Phil Pharmaceutics
(2014-2016)
ISLAMIA UNIVERSITY
BAHAWALPUR
2. Cosmetic regulatory bodies.
Basic U.S regulatory structure for cosmetics.
Statutory control on cosmetics.
Law enforcement of FD&C Act violations.
Regulatory control on cosmetics.
Cosmetic ingredients label declarations.
Cosmetic label warnings.
References.
3.
4. The FDA is the principal regulatory agency
charged with the enforcement of the
governing the marketing of cosmetics in the
United states.
For cosmetics , the agency is given the
mandate for enforcing the statutory
requirements of the 1938 Federal Food Drug and
Cosmetics Act (FD& C act, also referred to as the
ACT), the 1960 color amendments to the Act, and
the 1966 Federal Fair Packaging and Labeling
Act (FPLA).
5. Federal regulation of cosmetics involve oversight
of print, radio, television and multimedia
advertising as well as of the product package
labeling.
The jurisdiction of the FTC (Federal Trade
Commission) to regulate the advertising of
cosmetic and “over the counter” (OTC) cosmetic-drug
products overlaps that of FDA.
FDA has signed a memorandum of understanding
(MOU) with the FTC establishing the parameters
of relationship.
6. The FDA also shares its regulatory responsibilities
for the regulation of cosmetics and topical personal
care products with other federal agencies.
The U.S Consumer Product Safety Commission
(CPSC) also is delegated the authority under the
1970 poison prevention packaging act (PPPA) for
promulgating “child resistant” packaging
regulations for cosmetic products and soap
products.
7. In recent years , final rules have been promulgated
, requiring CR packaging for nail care products
containing 5% methacrylic acid and household
glue removers containing acetonitrile.
CR packaging would also be required for fluid
cosmetic products formulated with 10% of low
viscosity hydrocarbons.
8. Environmental protection agency (EPA) is a fourth
federal agency that has become a significant
presence in the regulation of multifunctional
personal care products, such as the OTC screen
products/insect repellent/lotions.
10. The use of the term “cosmetics” refers not only to
finished cosmetic products marketed to consumers
but also to constituent ingredients and other
components of such finished products (e.g.,
packaging).
Under current legal standards , topical products
functioning as cosmetics may cleanse, beautify,
promote attractiveness, or alter the appearance
without altering body’s structure and functions.
11. Soap products are generally exempt from the
cosmetic provisions of the FD&C Act, and, indeed
from the definition of cosmetics given in the
statute.
Liquid and solid product formulations consisting
of synthetic detergents intended not only for
cleansing but also for claiming other cosmetic
product performance attributes (e.g., beauty bars)
must comply with regulatory requirements
applicable to cosmetics.
12. The act explicitly prohibits the adulteration and
misbranding of cosmetics.
The delivery of an adulterated or misbranded
cosmetic for pay or otherwise is also a “prohibited
act” (FD&C Act, Sec. 301).
13. ADULTERATED COSMETICS:
A cosmetic is adulterated according to
the FD&C Act, Sec.601(a)-(e) if:
• It bears or contain any poisonous or deleterious
substance, which may render it injurious to users
under the conditions of use prescribed in the
labeling or under “customary or usual” uses.
• It consists wholly or in part of any filthy, putrid, or
decomposed sustance.
14. It has been prepared, packed, or held under
insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have
been rendered injurious to health.
Its container is composed, wholly or in part, of any
poisonous or deleterious substance which may
render the contents injurious to health.
15. COAL TAR HAIR DYE EXEMPTION:
The FD&C Act exempts so called
“coal tar” hair dyes from the adulteration provision
at section 601 (a), the coal tar hair dye exemption
named for the synthetic organic colors originally
derived from the coal tar derivative, aniline, to
which the exemption was initially applied, but it
does not include eyelash and eyebrow dyes.
16. SOURCES OF ADULTERATION:
Cosmetic adulteration may be associated
with unintentional trace level contaminants (e.g.,
N-Nitrosamines, 1,4-Dioxane) of the ingredients
(also referred to as the raw materials) employed in
finished cosmetic products.
17. MISBRANDED COSMETICS:
A cosmetic is “misbranded”
according to the FD&C Act,sec. 602 (a)-(f) if:
Its labeling is false or misleading in a particular
way
Its container is made, formed, or filled in a manner
likely to be misleading.
It is a color additive, unless its packaging and
labeling are in conformity with requirements in
the regulations.
18. Its package fails to contain the name and place of
business of the manufacturer, packer, or
distributor, as well as an accurate statement of the
quantity of the contents in terms of weight,
measure, or numerical count.
19. Violation of the adulteration and misbranding
provision of the act may subject the violator to
various enforcement tools available to the FDA;
these include:
Warning letters: Which are subject to public
disclosure under the freedom of the information
act (FOIA), may be posted on internet FDA
website and are regularly publicized in the trade
press and industry news letters.
20. Targeted establishment inspections and sampling
programs.
“Seizure” and “detention” of cosmetic offered for
entry into U.S interstate commerce that appear to
be in violation of the law e.g. FD&C Act, section
801(a)
“Injuction” against present and future commercial
operations.
21. “Criminal prosecution” of responsible persons
within violator cosmetic firms
“Voluntary recalls.” Recalls of cosmetic products
can either be firm-initiated or be FDA requested.
The FDA has no authority under the FD&C to
order the recall of a possibly harmful consumer
product, although it can request a firm to recall a
product.
22. FDA’s guidelines divide voluntary recalls into 3
categories:
Category 1-products that are clearly dangerous or
defective that pose clear or irreversible hazards to
public health.
Category 2-products that are intermediate in their
potential for adverse public health consequences,
but may cause a temporary or reversible health
problem.
23. Category 3-products that are unlikely to cause any
adverse health reaction but which violate FDA
violations.
24. Cosmetics marketed in United States, whether
manufactured domestically or imported from
abroad, must be in compliance with the provisions
of the FD&C Act and the regulations published
under the authority of these laws.
But the cosmetics are the least regulated category
of articles subjected to the jurisdiction of the
FD&C Act.
25. There is no premarket approval requirement for
cosmetic products or their constituent ingredients
under the law.
Other than color additives and those few
ingredients restricted or prohibited by regulation
from use in cosmetics, no mandatory regulatory
controls exist on the chemistry and structure of
ingredients, conditions of manufacture of the
finished cosmetic products, or safety testing of
ingredients and no premarket test results need to
be submitted to FDA.
26. o Promotion of “gimmick” additives, combined with
more sophisticated cosmetic ingredients.
Lotion contain bovine albumin and the label
claimed it would give a face lift without surgery.
Exaggerated claims of beauty or long lasting
effects.
27. Product claims should be based on skin care
realities, promises banked on achievable
benefits.
In the past, cosmetic manufacturers have
depended upon mysterious gimmick
additives, such as turtle oil to promote skin
rejuvenation or tighten chin muscles, shark
oil, queen bee royal jelly, chick embryo
extract, horse blood serum, and pigskin
extracts.
28. Cosmetic claims, even those considered "puffery,"
are allowed without scientific substantiation.
But if a cosmetic makes a medical claim, such as
removing dandruff, the product is regulated as a
drug for which scientific studies demonstrating
safety and efficacy must be submitted .
29. Cosmetics are not currently subject to the same
FDA safety and effectiveness standards as are
drugs, biologics and medical devices.
The FD&C act does not require that cosmetic
manufacturers or marketers test their products for
safety, nor does the FDA specify particular test
batteries of preclinical and human clinical safety
tests by cosmetic product category that marketers
must use to ensure cosmetic product safety.
30. Manufacturers or marketers of cosmetic products
are not required to submit the results of such safety
tests to the agency on a premarket approval basis.
31. The FD&C act provides no statutory authority for
the premarket approval of cosmetic ingredients.
Only the color additives are subjected to pre
market approval.
The marketers of finished cosmetic product bears
legal responsibility for an adverse reactions
experienced by consumers or public health
consequences that may result from this action.
32. The term color additive is defined in the FD&C act
at section 201(t).
The 1960 color additive amendments to the FD&C
act requires that color additives used in food, drug,
medical devices, and cosmetics be approved by
FDA for their intended use, a process that requires
both chemistry and safety reviews of the color
additive by color chemistry and toxicology staff
experts at the FDA.
33. A cosmetic containing an unlisted color additive is
considered adulterated and subject to the
regulatory action.
Color additives listed at 21 CFR 73 are
predominantly of inorganic or botanical origins
and are considered exempt from FDA’s “batch
certification” requirements.
34. Color additives listed at 21 CFR 74 are largely
synthetic organic dyes and pigments and are
subjected to FDA’s “batch certification”
requirements.
The FDA regulations for cosmetic color additives
may be listed for general use in imparting color to
product formulations, for use in decorative
cosmetics intended for external application to the
hair.
35. Only one color additive, dihydroxyacetone (DHA)
is specifically listed for an intended use in
externally applied cosmetics “to impart color to
human body”.
No color additives are approved for use in inject
able cosmetic tattoos.
36. ‘Labeling’ means actual product package labels as
well as other written, printed, or graphic material
on or accompanying a product (e.g., hand-tags,
package inserts).
Label statements required under the FD&C act
must appear on both the inside as well as an
outside container or wrapper
FPLA requirements need only appear on the label
of outer container or wrapper.
37. Cosmetic products distributed in United States
must comply with labeling regulations published
by the FDA under the authority of the FD&C act
and the FPLA.
The FPLA gives the FDA the authority to require
labeling of products ,that is, products regulated
under the FD&C act.
38. The statute requires that product be honestly and
informatively labeled so that consumers can
conduct “value comparisons” at the point of
purchase.
Cosmetic product package labeling regulations
require that cosmetic labels bear certain fields of
information that provides the consumer with
proper identification and understanding of the
product being purchased.
39. The required fields of information includes the
following:
Statement of identity, (common name) rendered in
bold type on the cosmetic product
Name and address of manufacturer/distributor.
Cosmetic ingredient label declarations.
Warning statements concerning safe use.
40. The FPLA specifically authorizes the FDA to
promulgate regulations requiring the declaration of
all the cosmetic ingredients on product package
labels of cosmetics produced or distributed for
retail sale to consumers for personal care.
Ingredient declarations must be conspicuous and
prominent in placement on any information panel
of the outer container.
41. FPLA labeling requirements specify that cosmetic
ingredients must be declared in qualitative
descending order of predominance.
Soap is exempt from the FPLA requirement for
mandatory label ingredient declarations applicable
to cosmetics.
42. Cosmetics containing sunscreen ingredients for
non therapeutic, non physiological uses, must
qualify the use of term “sunscreen”.
43.
44. Cosmetic that may be hazardous to consumers
when misused must bear appropriate label
warnings and adequate directions for safe use.
Manufacturers and marketers of cosmetics have a
general responsibility to ensure that the labels of
their finished cosmetic products bear a warning
statement whenever necessary to prevent a health
hazard that may be associated with the product.
45. Specific cosmetic product categories requiring such
statements currently include:
Cosmetic products for which adequate
substantiation of safety has not been obtained.
Cosmetics in self-pressurized containers.
Foaming detergent bath products.
“Coal tar” hair-dyes posing a risk of cancer.
46. TAMPER-RESISTANT PACKAGING:
The FDA is given the authority under
sections 601 (a) and (c) and 701(a) of the FD&C
act to issue the package security requirements for
cosmetics. Requirements for tamper-resistant
packaging for liquid oral hygiene products (e.g.,
mouthwashes and breath fresheners) were
promulgated.
47. COSMETIC GOOD MANUFACTURING
PRACTICES GUIDELINES:
The FDA has never published current
good manufacturing practice (cGMP) regulations
for cosmetics, although agency has actively
promoted good manufacturing practices by firms
marketing cosmetics.
48. THE VOLUNTARY COSMETIC REGISTRATION
PROGRAM (VCRP):
The FD&C act does not require
cosmetic firms to register manufacturing
establishments or formulations with the FDA, nor
does it mandate that companies submit product
adverse reaction report data. Nevertheless, the
FDA has encouraged the voluntary registration of
such data as being in the public interest .
49. FDA does not pre-approve cosmetic products or
ingredients, with the important exception of color
additives
Cosmetic firms are responsible for marketing safe,
properly labeled products; using no prohibited
ingredients; and adhering to limits on restricted
ingredients
Considered good practice to follow industry safety
guidelines and recommendations.
50. Must carry warning if safety is not determined but
can still market product.
FDA must “go to court” to remove a cosmetic
from the market.
Puffery is OK.