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BIO4360_Sept. 19th, 2011
 

BIO4360_Sept. 19th, 2011

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  • -MIND organizes the 200+ oral pathologies into categories based on etiology Metabolic – diabetes, Vit B 12 , HIV/AIDS Inflammatory – cheek biting,
  • -Plasma cell gingivitis due to flavouring agents (cinnamon) in tooth pastes, gums etc….. Diffusely edematous and fiery red gingiva
  • -papillary hyperplasia below a denture…papillary hyperplasia due to suction effect of CUD, - pyogenic granuloma assoc. with a rough tooth, -epulis fissuaraum adjacent to a denture flange…..often in situations where denture reline would be beneficial
  • -if long standing, pt. may not be aware -usually from one location so ask pt. if only one or multiple locations -multiple location decreases likelihood of neoplasm -95% of oral cancers associated with these 2 risk factors -pic of squamous cell carcinoma
  • -Basal cell Nevus (mole) and macule (focal melanosis) are both genetic conditions
  • -William Osler…..famous Canadian Physician in 1800s -first physician-in-chief of John Hopkins Hospital -one of the first people to do ‘rounds’ with med students…… "He who studies medicine without books sails an uncharted sea, but he who studies medicine without patients does not go to sea at all." -that applies equally well to this program!!
  • -doesn’t necessarily change what is on your diff. diagnosis but could change the ranking of those possibilities. -can also help arrive at definitive Dx. How Long? -often people will not even be aware that there is a lesion there (ex: tori) -could still be metabolic if went off meds recently (ex: diabetes) -apthous ulcers…..etiology not full known….speculation that it is caused by hypersensitivity rxn, autoimmune response, etc. >6wks could also be chronic inflammation
  • 3)-location…attached ging. Secondary Herpes….unattached apthous ulcer
  • 4)-pain increases likelihood of inflammation and decreases but does not eliminate other possibilities -offering pt. descriptive options prejudices the patient’s comments and accurate information can be lost -if patient can’t describe then may have to give options, but be aware that info may not be accurate anymore -sharp, throbbing, burning -could still be neoplastic based on description
  • 5) Assumes pt. is even aware of it -compiling of responses can help order your diff. diagnosis
  • 6) -if lesion resolved after stopping use of a specific product likely due to hypersentivity -if improves with salt water and worsens with acidic juices really doesn’t help with etiology other than to say it’s likely an ulcer or erosion -erosion can be difficult to distinguish
  • 7)-changes over short period of time often more related to traumatic origins -fluctulant lesion that is larger around dinner time and smaller between meals could be saliva cyst
  • 8) sometimes trauma in an area draws your attention to that spot where coincidentally there is some other pathology going on, so trauma may not actually be associated (ex: tori, maybe chronic abscess, etc)
  • 9) if lesions elsewhere on body more likely to be of immunologic origin (sub-category of inflammation) -pemphigoid, pemphigus, erythema multiformi may have intraoral and dermatologic manifestations -developmental conditions like café au lait spots assoc. with neurofibromatosis
  • -lichen planus is an oral AND cutaneous disorder…most often noted intraorally but 5-45% have both oral and cutaneous lesions at some point -Scleroderma…immune disfunction disease affecting connective tissue. -combines rheumatoid arthritis, Sjogrens, Raynaud’s phenomena, skin lesions -may not be a mouth problem, but a problem that expresses itself in the mouth
  • 10) familial relationship may also be coincidental….ex: lichen planus…frequent enough occurrence that other family members may have also but is still and immunologic problem
  • 11) will already have an idea based on health history -if is still possible that pt. has an undetected metabolic disease but usually sub-clinical disorders don’t cause oral mucosal symptoms without causing other systemic symptoms ex: malaise, fever, etc. -studies show that 75% of people with serious life threatening conditions when asked how you rate your overall health will say “pretty good”
  • 12) some people will say they’re health is good and neglect to mention that they are using corticosteriod inhaler for asthma (causing local immuniosuppresion and candiasis) -maybe recently took amox. For sinusitis and indirectly caused the fungal infection…..anti-hypertensives causing swollen and tender ging. -some meds may cause allergic reactions and manifest as oral ulcerations. …..ex: NSAIDs
  • -oral exam only provides SOME of the info needed to arrive at a diagnosis -ex: many lesions present as an ulceration…..observing it clinically helps little with developing a Dx -your not just a recording secretary, you’re a health care professional -sometimes Dx based on success of tmt. Ex: sore tooth could be root exposure, occlusion related, cracked tooth, necrotic pulp -may start with duraflur first and see if that helps
  • -pain secondary to bruxism may be a result of nervousness and anxiety issues -phobias may cause pt. to worry about ‘lesions’ that are really normal anatomy (lingual tonsils, sublingual varicosities, fordyce’s granules, etc.) -excessive cleaning for ex: -Dx of psychological cause is made after all other possible etiologies have been eliminated. -pic of fingernail damage
  • How many of you take some sort of supplements or natural or herbal products? -have you ever purchased them either in the US or online? -this can often be a divisive topic with strong feelings on both sides -information hopefully benefit from both a professional and a personal perspective
  • -supplements and herbal are available everywhere…..esp. thanks to the internet -along with all kinds of other medications
  • -vitamins, mineral supplements, amino acids, antioxidants, vegetable subsititutes, etc
  • -this disclaimer is buried pretty deep in the site -Try to find out where this site is based……can’t. -the assumption based on shipping info is that they’re out of the States, but who really knows -that is very IMPORTANT because different countries have different regulations governing the sale of these products
  • -what are ‘natural health products’…..pretty nebulous term that means different things to different people - ‘biologics’ typically refers to ‘probiotics’….ie: good bacteria
  • -study released last week in the British Medical Journal indicating that Chondroitin and glucosamine have little or know effect
  • -#2 on list is the internet......now THAT is scary -#4 on the list with only 14% is the family Doc. -when surveyed about who they see if they have an adverse reaction to a supplement who is #1?? -THE FAMILY DOC!!!
  • -this is interesting because it gives some insight into people's perceptions of the difference between 'natural' and 'man made' -# 5 is ‘chemical free/toxin free’…….chemicals are not just man made substances……how do you know it’s toxin free if you don’t know all that’s in it……..think pet food and melamine!!! -# 10 on the list is ‘recommended by medical doctor’…and only 1/3 the number that were ‘recommended by family member or friend’ -what are things that ads typically say? ‘Better for you than chemical products/drugs’, ‘concerned about your health’, ‘maintain and promote health’, ‘chemical free’, ‘build immune system’, ‘no side-effects’, …… who says marketing doesn’t work??
  • -from the Archives of Family Medicine in 1998 -if something can affect your health then it has to be acting biologically within the body….same as pharmaceuticals -chemistry is often considered to be something that is ‘man made’ and was once accepted to be the saviour……then it turned into the enemy Dupont chemicals used as their slogan " Better Living Through Chemistry " from 1935-82 Then when the environmental movement started to take off thru the ’70s in 1982 they dropped the chemical reference
  • -since 1998 the slogan has been "The miracles of science"…..so ‘science’ is good, but ‘chemicals’ are still bad
  • Mark Plotkin – ethnobotanist - Amazon Conservation Team works in partnership with indigenous people to save the forest This was a talk he gave to Google employees in Apr/07
  • Paracelsus was a Swiss chemist and physician Father of modern toxicology
  • -if something can affect your health then it has to be acting biologically within the body….same as pharmaceuticals -’Natural’ does NOT equal ‘safe’ -herbal drugs are important because many ‘modern’ drugs are synthesized versions of ones found originally in nature
  • -if something can affect your health then it has to be acting biologically within the body….same as pharmaceuticals -’Natural’ does NOT equal ‘safe’ -herbal drugs are important because many ‘modern’ drugs are synthesized versions of ones found originally in nature
  • -US Pharmacopeia was the equivalent of the current CPS -Quinine used to treat malaria -reasons for manufactured pharmaceuticals 1) active ingredient in herbal product can be isolated (ex: active portion without hallucinogenic effects 2) Can develop different strengths of product 3) can make ‘standardized’ product (potency of herbs can vary based on climate and soil conditions they were grown in) 4) plant may not be available in sufficient quantities……or at all anymore due to other environmental issues
  • -ethnobotanists are on the front lines of trying to put a stop to deforestation of the Amazon and other undeveloped areas of the world -they’re concerned about the disappearance of undiscovered and unique plants as well as the disappearance of indigenous cultures -It’s like burning all the libraries before you’ve had a chance to read the books -I’ve posted link to entire video (~1hr long
  • -in developed countries, most people use herbals for preventative medicine then health maintanence -enormous challenges and costs to drug companies to conduct R&D in areas of preventative medicine
  • Dietary Supplement Health and Education Act -tobacco is the #1 herbal product that is used today -dietary ingredients (including vitamins, minerals, herbs, amino acids, and certain other substances) -taken by mouth (tablet, capsule, powder, softgel, gelcap, or liquid) -no wonder people have different definitions of what a dietary supplement is
  • Dietary Supplement Health and Education Act Botanicals A plant or part of a plant used for its flavor, scent, or potential therapeutic properties. Includes flowers, leaves, bark, fruit, seeds, stems, and roots -may be listed to build immunity and have herb added, but for flavoring only
  • -US regulations still important to know given the availability of products on the internet and the exposure to US media…..it’s important to understand how the reg’ns differ from ours -in ’94, US wanted to bring in stricter reg’ns (at that time the supplement industry was not very big) -aggressive lobbying from industry and public ended up with current compromise regulations -**Must remember that all government regulations are usually the result of compromise and often heavily affected by industry lobbying**
  • -pre-94 manufacturers had to prove that herbal product was safe and effective -post-94, the FDA must prove that it’s unsafe -2006 – had to start reporting adverse drug effects -2007-10 – phasing in of requirements to test for purity, ensure no contaminants, verify contents match labelling info -IF YOU ARE BUYING ONLINE – you may be purchasing product that does not meet the current requirements…dumping old stock? Or product that failed testing? -what is the country of origin for the website….what regulations are they under? -counterfeit products…..dollar store products, etc.
  • -Dietary Supplement Health and Education Act
  • Driving in to the College listening to the sports station and heard an ad for one of the many supplement stores and they were pushing this…
  • -whether info is false or misleading is up to FDA to prove
  • Lipton Green Tea 100% Natural Naturally Decaffeinated -warning letting from FDA in Aug/10 concerning claims made by Lipton -8 CUPS PER DAY???? Maybe cholesterol went down because they were spending so much time peeing that they didn’t have time to eat!!
  • Canada Dry Sparkling Green Tea Ginger Ale -warning letting from FDA in Aug/10 concerning claims made by Lipton -also listed other issues with information on website referring to antioxidants -these are the sorts of statements that we see all the time on products, but in reality they are not allowed.
  • -separation of information…..hard to see an advantage of this part of the act other than maybe to get the bill passed in the first place due to industry lobby efforts?? -Remember……all gov’t legislation is a compromise!!!! Especially regulatory type legislation is a balance between industry interests and public interests. - ‘stakeholders’ are always asked to make presentations on how the proposed legislation may or may not affect them.
  • -in Canada regulations evolved after extensive public consultations -pre-2004 fell under either the ‘drugs’ or the ‘foods’ requirements in the -if as ‘drugs’ had to follow the more rigorous drug review process re: safety, efficacy, clinical trials, etc. -if as ‘food’ could only make limited health claims and only had to carry limited safety info on labels
  • -claims/evidence of effectiveness require different levels based on classifications -ex: toothpastes are considered cosmetic agents….not drug (now do have an NPN on them) -so…..manufacturers are held to different levels of proof for claims made….ex: whitening, tarter reduction, etc. -don’t assume that because a product is covered by a ‘regulation’ that it is held to the same level as drugs -the changes introduced in the 2004 legislation were also to be phased in with the last of them being completed by the end of 2010
  • -in Canada regulations evolved after extensive public consultations -pre-2004 fell under either the ‘drugs’ or the ‘foods’ requirements in the -if as ‘drugs’ had to follow the more rigorous drug review process re: safety, efficacy, clinical trials, etc. -if as ‘food’ could only make limited health claims and only had to carry limited safety info on labels -claims/evidence of effectiveness require different levels based on classifications -ex: toothpastes are considered cosmetic agents….not drug (now do have an NPN on them) -so…..manufacturers are held to different levels of proof for claims made….ex: whitening, tarter reduction, etc. -don’t assume that because a product is covered by a ‘regulation’ that it is held to the same level as drugs -the changes introduced in the 2004 legislation were also to be phased in with the last of them being completed by the end of 2010
  • -Homeopathic medicines are treated differently under the NHP Regulations in that they can contain or be manufactured from substances ( Schedule F or Schedule D substances) that are not otherwise regulated under the Natural Health Products Regulations .
  • -probiotics - A microorganism introduced into the body for its beneficial qualities -typically beneficial bacteria used to re-establish healthy intestinal flora in the human body
  • -Canadian regs much better defined than US -also more rigorous hence the availability of some products in the US that are not available in Canada
  • -prescription drugs have a DIN (drug infromation number) -natural health products have an NPN -my tube of Crest toothpaste has an NPN # on it -homeopathic products have a DIN-HM number
  • -taurine is an amino acid required for normal function of skeletal muscle and is touted to allow quicker recovery when exercising -zero evidence that it has any effect on repair, energy, etc -many ‘energy’ drinks also combine herbal ingredients
  • -taurine is an amino acid required for normal function of skeletal muscle and is touted to allow quicker recovery when exercising -zero evidence that it has any effect on repair, energy, etc -many ‘energy’ drinks also combine herbal ingredients
  • -studies show that people drinking AmED drinks will drink more, but not feel as intoxicated as they really are. -“have a cup of coffee to sober you up”…….doesn’t work - ‘sobering up’ is based on the rate of metabolism of the alcohol -will changes be made??? I won’t hold my breath given the strength of lobby groups for the beverage industry Jägermeister’s ingredients include 56 herbs, fruits, roots and spices including citrus peel, liquorice , anise , poppy seeds , saffron , ginger , juniper berries and ginseng

BIO4360_Sept. 19th, 2011 BIO4360_Sept. 19th, 2011 Presentation Transcript

  • BIO4360 Oral Medicine Etiology of Pathologies II Monday, Sept. 19 th , 2011
  • Metabolic Inflammatory Neoplasms Developmental Metabolic a) Hormonal b) Nutritional c) Compromised Organ Systems Inflammatory a) Trauma b) Infection – viral, fungal, bacterial c)Immunologic - autoimmune ‘ MIND’ Algorithm
  • Inflammatory – c) immunologic i) immune response to body’s own antigens (autoimmune) -pemphigus, pemphigoid ii) allergic reaction to external antigen - cinnamon, toothpaste, medications, etc. ‘ MIND’ Algorithm
  • Inflammatory – c) immunologic i) immune response to body’s own antigens (autoimmune) -pemphigus, pemphigoid ii) allergic reaction to external antigen - cinnamon, toothpaste, medications, etc. Inflammatory – d) reactive -body’s response to chronic, physical irritation -papillary hyperplasia, pyogenic granuloma, epulis fissuratum ‘ MIND’ Algorithm
  • ‘ MIND’ Algorithm
    • Neoplasms – benign, premalignant, malignant
      • -usually some change in surface colour &/or texture
      • - +or- swelling &/or pain
      • -usually one location and enlarges from that point
      • -risk factors (tobacco &/or alcohol)
  • ‘ MIND’ Algorithm
    • Neoplasms – benign, premalignant, malignant
      • -usually some change in surface colour &/or texture
      • - +or- swelling &/or pain
      • -usually one location and enlarges from that point
      • -risk factors (tobacco &/or alcohol)
    • Developmental
      • -genetic – Basal Cell Nevus (mole), Macule
      • -acquired – cleft palate
      • -other – geog. tongue, leukodema
  • 12 Questions to Ask “ Listen to your patient and the patient will give you the diagnosis” Sir William Osler
  • 12 Questions to Ask
    • 1) How long has the problem been present?
      • -if <2-3 weeks more likely inflammatory etiology
      • -less likely developmental, neoplasm, metabolic
        • -if > 5-6 wks poss. of neoplasm
    • 2) Has it happened previously, and, if so, did it go away
    • completely?
        • -if occurred before and healed completely chance of neoplasm is minimal
        • -inflammatory more likely
          • -infectious (herpes, recurrent fungal infection)
          • -immunologic (apthous ulcer, lichen planus)
  • 12 Questions to Ask
    • 3) Is it happening (has it occurred) in other locations in
    • your mouth
        • -multiple locations almost always rule out neoplasms
        • - likelihood of trauma
        • -location also important ex: attached vs. unattached
  • 12 Questions to Ask
    • 3) Is it happening (has it occurred) in other locations in
    • your mouth
        • -multiple locations almost always rule out neoplasms
        • - likelihood of trauma
        • -location also important ex: attached vs. unattached
    • 4) Does it hurt? And if it does, chose one word to describe
    • the pain.
        • -one of 4 aspects of inflammation
        • -‘burning’ more chance of fungal etiology
        • ***important to let patient chose word***
  • 12 Questions to Ask
    • 5) Has it grown/become worse/spread to other spots?
        • +ve response (along with location) will affect prob. of metabolic etiolology
        • -or neoplasm, esp. malignancy which will grow in size but seldom spread
    Remember ….all questions build on each other Must link info gained from various questions Ex: pain for 4 weeks, several locations, pain is more ‘ burning, seems to be spreading slightly….. Likelihood of fungal infection is fairly high
  • 12 Questions to Ask 6) What can you do/have you done that makes it better or worse? -if stopped using product and it resolved…immunologic -hypersensitivity/allergic rxn -improves with salt water, worsens with orange juice -ulceration/erosion
  • 12 Questions to Ask 6) What can you do/have you done that makes it better or worse? -if stopped using product and it resolved…immunologic -hypersensitivity/allergic rxn -improves with salt water, worsens with orange juice -ulceration/erosion 7) Does it come and go/change during the day? -if rapid change…….trauma related -if stress related…..less in morning, worse later in day -around mealtime?
  • 12 Questions to Ask 8) Do you remember injuring the area of the lesion? -identify trauma or recurrent trauma
  • 12 Questions to Ask 8) Do you remember injuring the area of the lesion? -identify trauma or recurrent trauma 9) Do you have any lesions on other parts of your body? -increased potential for immunologic cause -auto-immune diseases with dermatologic symptoms -some developmental lesions also have skin changes (café au lait spots)
  • 12 Questions to Ask 8) Do you remember injuring the area of the lesion? -identify trauma or recurrent trauma 9) Do you have any lesions on other parts of your body? -increased potential for immunologic cause -auto-immune diseases with dermatologic symptoms -some developmental lesions also have skin changes
  • 12 Questions to Ask 10) Do other people in your family have anything similar? -family Hx points to developmental problem (usually)
  • 12 Questions to Ask 10) Do other people in your family have anything similar? -family Hx points to developmental problem (usually) 11) How is your general health? Other than the oral problem, do you feel medically well? -if ‘yes’ less likely due to metabolic or systemic disease
  • 12 Questions to Ask 10) Do other people in your family have anything similar? -family Hx points to developmental problem (usually) 11) How is your general health? Other than the oral problem, do you feel medically well? -if ‘yes’ less likely due to metabolic or systemic disease 12) Are you taking any medication for any reason currently or were you taking medication recently? -verifies info about general health -oral effects of meds
  • 12 Questions to Ask REMEMBER: -intra-oral exam is NOT all that’s required to arrive at diagnosis -need to combine with info gained from questioning -either confirm Dx or lead to next step in tmt plan -biopsy, drug therapy, or ‘watchful waiting’ depends on suspected etiology
  • 12 Questions to Ask
    • -some conditions have multiple etiologies
      • Ex: AIDS, Leukemia are Metabolic (compromised organ system
      • -but oral problems typically of the Inflammation category (infection)
    • -MIND does not include conditions secondary to psychologic
    • problems
      • -anxiety, phobias, self-inflicted trauma
  • Available Online
  • BIO4360 Oral Medicine Monday, Sept. 19 th , 2011 Herbal Products and Supplements
  • Come One, Come all
  • Come One, Come all
  • Come One, Come all
  • The products and the claims made about specific products on or through this site have not been evaluated by Herbal Remedies or the United States Food and Drug Administration and are not approved to diagnose, treat, cure or prevent disease. The information provided on this site is for informational purposes only and is not intended as a substitute for advice from your physician or other health care professional or any information contained on or in any product label or packaging. You should not use the information on this site for diagnosis or treatment of any health problem or for prescription of any medication or other treatment. You should consult with a health care professional before starting any diet, exercise or supplementation program, before taking any medication, or if you have or suspect you might have a health problem . Disclaimer
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  • Beliefs -Canadian studies have shown herbal medicines being used by 30-35% of people “ Patients often believe that herbs are natural alternatives to prescription medications, and do not recognize that herbs are composed of bio-active chemicals which may be toxic and can interact with other medications” Arch Fam Med 1998;7(6):523-36 &quot; Better Living Through Chemistry &quot;
  • Beliefs -Canadian studies have shown herbal medicines being used by 30-35% of people “ Patients often believe that herbs are natural alternatives to prescription medications, and do not recognize that herbs are composed of bio-active chemicals which may be toxic and can interact with other medications” Arch Fam Med 1998;7(6):523-36 &quot;The miracles of science&quot;
  • Ethnobotany Botany + Anthropology
  • Ethnobotany Botany + Anthropology
  • Ethnobotany Phillippus Aureolus Paracelsus 1493-1541AD “ It’s the dose that makes the poison” Botany + Anthropology
  • Ethnobotany Poisonous plants are medicinal plants & Medicinal plants are poisonous plants Herbal medications are important
  • Ethnobotany Poisonous plants are medicinal plants & Medicinal plants are poisonous plants Herbal medications are important
  • Herbal based Medicines -1900’s – herbal supplements hallmarks of pharmaceutical industry -67% of all medicine listed in US Pharmacopeia were botanicals……now only 2% - >1/2 of “modern” prescription & OTC drugs have botanical origins (aspirin, caffeine, cyclosporine, digoxin, quinine)
  • Herbal based Medicines -1900’s – herbal supplements hallmarks of pharmaceutical industry -67% of all medicine listed in US Pharmacopeia were botanicals……now only 2% - >1/2 of “modern” prescription & OTC drugs have botanical origins (aspirin, caffeine, cyclosporine, digoxin, quinine) -ethnobotany very important - < 0.5% of the world’s vanishing tropical plant species have been investigated for their medicinal qualities
  • Herbal Medicine
    • ~7000 plants have medicinal applications
    • -75% of world’s pop’n rely on plants for health care
    • -in NA most use for prevention and health maintenance
    • -pharmaceuticals target symptomatic/curative medicine
    • -majority of knowledge on plant derived medicine is traditional
    • -Herbals reputation hampered by:
    • -lack of standardization
    • -lack of clinically verifiable safety and efficacy
  • Definitions
    • Dietary Supplement (DSHEA):
    • a product (other than tobacco) that:
      • -Is intended to supplement the diet
      • -Contains one or more dietary ingredients or their
      • constituents
      • -Is intended to be taken by mouth
      • -Is labeled as being a dietary supplement.
  • Definitions Herbal supplements : -are one type of dietary supplement -An herb is a plant or plant part (leaves, flowers, seeds, roots) that is used for its flavor, scent, and/or therapeutic properties -&quot;Botanical&quot; is often used as a synonym for &quot;herb.&quot; -may contain a single herb or mixtures of herbs.
  • Regulations (USA) -US Dietary Supplement Health and Education Act (1994) -compromise -exempts vitamins, minerals, & botanical products from meaningful FDA regulation
  • Regulations (USA) -US Dietary Supplement Health and Education Act (1994) -compromise -exempts vitamins, minerals, & botanical products from meaningful FDA regulation -burden of proof? -2006 – Changes to Federal food, Drug and Cosmetic Act -require industry to report all serious dietary supplement related adverse drug effects to the FDA -2007-10 – manufacturers must test for purity, -ensure no contaminants -verify contents match labeling information
  • -Labeling according to the DSHEA: -prevents use of therapeutic claim ex: “for treatment of hypertension” -must be labeled as dietary supplement -CAN contain claims of effect on structure or function of body (ex: increases immunity) Regulations (USA)
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  • -Labeling according to the DSHEA: -prevents use of therapeutic claim ex: “for treatment of hypertension” -must be labeled as dietary supplement -CAN contain claims of effect on structure or function of body (ex: increases immunity) -info does not have to be scientific, but cannot be false or misleading (responsibility in hands of FDA) Multiple violations / near violations Regulations (USA)
  • … your webpage …. bears the following claim: &quot;[F]our recent studies in people at risk for coronary disease have shown a significant cholesterol lowering effect from tea or tea flavonoids ... One of these studies, on post-menopausal women, found that total cholesterol was lowered by 8% after drinking 8 cups of green tea daily for 12 weeks ....“ The therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. Regulations (USA)
  • Your Sparkling Green Tea Ginger Ale bears the claim, &quot;ENHANCED WITH 200 mg OF ANTIOXIDANTS FROM GREEN TEA & VITAMIN C**&quot; with the double asterisk referring to the statement, &quot;* *Each 8 oz serving contains 200 mg of antioxidants from Green Tea Flavonoids and Vitamin C&quot; on the principal display panel of the product label. In the context of this label the term &quot;enhanced&quot; is an unauthorized synonym for a &quot;more&quot; nutrient content claim. FDA has defined the nutrient content claim &quot;more&quot; and its authorized synonyms in 21 CFR 101.54(e). Regulations (USA)
  • -Labeling according to the DSHEA: -prevents use of therapeutic claim ex: “for treatment of hypertension” -must be labeled as dietary supplement -CAN contain claims of effect on structure or function of body (ex: increases immunity) -info does not have to be scientific, but cannot be false or misleading (responsibility in hands of FDA) -information can be physically separate from the product (ie: product on one shelf, info in another isle) HUH????? Regulations (USA)
  • Canada: Natural Health Product Regulations (2004) -allowed for sale of products otherwise not allowed under the Food and Drug Regulations -pre-2004 natural health products either drugs, or foods ( Food and Drug Act ) Regulations (Canada)
  • Canada: Natural Health Product Regulations (2004) -allowed for sale of products otherwise not allowed under the Food and Drug Regulations -pre-2004 natural health products either drugs, or foods ( Food and Drug Act ) -different sets of reg’s for cosmetics, foods, drugs, etc. -burden of proof varies Regulations (Canada)
  • Canada: Natural Health Product Regulations (2004) -allowed for sale of products otherwise not allowed under the Food and Drug Regulations -pre-2004 natural health products either drugs, or foods ( Food and Drug Act ) -different sets of reg’s for cosmetics, foods, drugs, etc. -burden of proof varies Regulations (Canada)
  • Canada: Natural Health Product Regulations (2004) Natural health products (NHPs) are defined as: -vitamins and minerals, -herbal remedies (ex: St. John’s Wort), -homeopathic medicines ** -traditional medicines (Traditional Chinese Medicines), -probiotics, Regulations (Canada)
  • Canada: Natural Health Product Regulations (2004) Natural health products (NHPs) are defined as: -vitamins and minerals, -herbal remedies (ex: St. John’s Wort), -homeopathic medicines ** -traditional medicines (Traditional Chinese Medicines), -probiotics, Regulations (Canada)
  • Canada: Natural Health Product Regulations (2004) Natural health products (NHPs) are defined as: -vitamins and minerals, -herbal remedies (ex: St. John’s Wort), -homeopathic medicines ** -traditional medicines (Traditional Chinese Medicines), -probiotics, -other products like amino acids and essential fatty acids. Regulations (Canada)
  • Canadian Database
  • Labeling Requirements (Can)
    • Brand Name
    • Product/Herb Name
    • Structure/Function Claims
    • Disclaimer
    • Number of Product and Net Weight of Each
    • Directions for use
    • Supplement Facts
    • Manufacturer’s or distributor’s name, city, state, zip code
    • Expiration date
  • Energy Drinks -call for Health Canada to get involved with regulating -if considered ‘foods’ only have to list ingredients -talks about natural product not having to label caffeine containing herbal ingredients -if ‘natural health products’ also have to have appropriate warnings packs 505 mg of caffeine and 5000 mg of taurine Beverage…..or drug delivery systems??
  • Energy Drinks -call for Health Canada to get involved with regulating -if considered ‘foods’ only have to list ingredients -talks about natural product not having to label caffeine containing herbal ingredients -if ‘natural health products’ also have to have appropriate warnings packs 505 mg of caffeine and 5000 mg of taurine Beverage…..or drug delivery systems??
  • Energy Drinks
  • Energy Drinks
  • Energy Drinks
  • Alcoholic Energy Drinks
  • Alcoholic Energy Drinks