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"Don't subject our dietary supplement
rights to WTO - CODEX controls,
instead,
Harmonize the rest of the world to
American
freedoms protected under DSHEA."
Ralph Fucetola JD on the Gary Null Show,
06/11/03.
Vitamin Lawyer Report on the Proposed Current Good Manufacturing Practices (CGMPs) for Dietary Supplements -- how the new rules will impact small marketers with their own labeled products - 05/16/03
NEW FDA "Science Based Initiative" -
FDA Press
Release
- 07/10/03
"FDA's Task Force on Consumer Health Information for Better Nutrition
unveiled a process for FDA to review... health claims. This process will rely on
expertise from the Agency... coupled with enhanced consumer studies, to review
health claims before they appear in food labeling. In addition to the report,
FDA is announcing enhanced enforcement activity against dietary supplement
manufacturers and others who make misleading claims about health benefits that
are not based on science."
Task Force Report
FDA Issues Statement on Increased Enforcement -
FDA Statement - 06/30/03
"[FDA] is committed to pursuing Federal Food, Drug, and Cosmetic
Act violations. Enforcement activities include warning and untitled letters,
injunctions, recalls, arrests, and convictions. Overall, these point to
dramatically increased enforcement, particularly in areas related to the most
serious threats to public health, such as arrests and convictions on criminal
charges involving potentially dangerous activities and actions against
manufacturers making misleading claims about product risks and benefits."
CGMPs are Coming to the Vitamin
Industry!
Proposed Current Good Manufacturing Practices
Is Your Company Ready?!? Click below to learn more -
Vitamin Lawyer
Report
The Right of the Public to Know the Truth
FDA Structure and Function Claims Notice Requirements
Sharry Edwards with 19 Tips to Protect IP from Computer Criminals, Here - 06/07/03
Traditional Uses of Dietary Supplements as Substantiation for Advertising Claims, Click Here - 06/15/03
US Supreme Court Considers Commercial
Speech Issues -
http://news.findlaw.com/news/s/20030423/courtnikedc.html
Will the Court continue recent trend supporting freedom of speech in
commercial communications? -04/23/03
FDA announces new initiatives involving dietary supplement
ingredient Standards - 03/07/03
"...as part of the agency's ongoing effort to
help Americans take more control over their own health..."
FTC slams Slim Down for false claims - click Here - 01/24/03
FTC planning new actions - 11/15/02 -Updated, Red Flag List
The Vitamin Lawyer protects SUNNIE
® trademark in decision against Kellogg Co. -- SUNNIEtm.html 7/31/02 - updated 6/23/03, Trade Mark Registration 2,726,137 issued.The Right of the Public to Know
Your web site needs a proper SUS
- Site Use Statement -
Disclosure - Privacy Disclaimer Page -
The Vitamin Lawyer has the right form for
you,
www. Disclaimers for Sale.com
The Vitamin Lawyer's On Line Seminar - FREE! - vitonlinesem.html
Sharry Edwards with 19 Tips to Protect IP from Computer Criminals, Here - 06/07/03
Express Your Opinion to the FDA about Ephedra - Here -- Deadline, April 7, 2003.
National Center for Complementary and Alternative Medicine (NCCAM)
Pressroom -
http://nccam.nci.nih.gov/pressroom/
An example of an FDA May 2002 Cyber Warning Letter
Commercial Free Speech - 04/29/02
The High Court addresses Claims and Disclaimers, emphasizing the proper use of such statements.
The Vitamin Lawyer on Labeling and Advertising,
fdaftcspeech.html.The Institute for Health Research has established a 9/11 Aftermath Message Board.
Email rumors got you? Check them first at www.breakthechain.org.
Information on Vaccine Issues, News & Links -
vacinfo.htmlHuman BioAcoustics Sharry Edwards Recent Awards -
2002 O Spurgeon English
Humanitarian Award
2001 IANS "SCIENTIST OF THE YEAR"
FDA allows "Diabetiks" as brand name
08/21/01Note: "WTO" is the World Trade Organization. CODEX is the international Food Code, US laws may be subject to its jurisdiction.
"Harmonize" is a term used to describe the process whereby international agencies cajole nations into subjecting their laws to international standards. In the case of Dietary Supplements, these "standards" are more restrictive than US policy as determined by Congress and demanded by vitamin users.
"DSHEA" is the 1994 Dietary Supplement Health and Education Act that codified the right of Americans to truthful and not misleading information about dietary supplements in a open marketplace.
Health Freedom supporters throughout the US are demanding that our DSHEA rights be preserved and that our trading partners harmonize their restrictive vitamin regimes to our free market.
Back to Breaking News.
The FTC has joined the Organization for Economic Co-Operation and Development (OECD) in supporting the new Guidelines for Protecting Consumers from Fraudulent and Deceptive Commercial Practices Across Borders -- "For the purposes of these Guidelines, "fraudulent and deceptive commercial practices" refers to those fraudulent and deceptive commercial practices that cause actual harm to consumers, or that pose an imminent threat of such harm if not prevented, such as: 1. A practice of making misrepresentations of material fact, including implied factual misrepresentations, that cause significant detriment to the economic interests of misled consumers. 2. A practice of failing to deliver products or provide services to consumers after the consumers have been charged. 3. A practice of charging or debiting consumers’ financial, telephone or other accounts without authorisation... For the purposes of these Guidelines, "consumer protection policy agency" means any national public body, as determined by each Member country, that is specifically responsible for formulating policies to protect consumers from fraudulent, misleading, or unfair commercial practices."
Link to the Guidelines
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2001 FDA Nutrient Claims Filing Requirements
FDA increasing enforcement (06/30/01)
FTC Announces "Operation Cure-All" on June 19, 2001
11/15/02 -- FTC announces new initiative on
Nutrient Claims.The Vitamin Lawyer's services and fees,
vitservices.html
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Top, Back to IndexWhen the FDA isn't throwing a left jab, the FTC is telegraphing a right hook...
This information was received by the Vitamin Lawyer on 11/15/02 -- Updated, Red Flag List
FTC Considering Formal Set of Guidelines For Marketing Dietary Supplements
Claiming Weight-Loss Benefits
The Federal Trade Commission, as recently reported, is considering development
of a formal set of guidelines specifically for the marketing of dietary
supplements claiming weight-loss benefits.
The Commission "will search for consensus that certain claims are false,
regardless of the product being promoted....It shouldn't be hard to come up
with a simple set of guidelines condemning claims about extreme, rapid weight
loss, or claims that you can eat all you want and still lose weight".
The Commission might also consider drafting guidelines for mainstream media
channels, such as TV, radio and newspaper, to discourage them from accepting
fraudulent weight-loss ads.
It is expected that the commission as a part of this effort will engage
participation from a broad range of stakeholders, including "scientists,
regulators, law enforcers, marketers, publishers, broadcasters...in finding
new and creative solutions to the weight-loss fraud epidemic".
There are currently more than 40 active FTC investigations involving
supplement advertising, which is more than any other advertising program.
On November 19, 2002, the FTC hosted a workshop on dietary supplement weight loss claims. At the workshop, a 10-member science panel discussed various claims that appear in weight-loss ads and voted that each of these claims was not supported by science. They included:
* Claims that a product will work
for all people.
* Claims of permanent weight loss.
* Claims that users can eat all that they want and still lose weight.
* Claims that weight loss can be targeted to specific areas of the body.
* Claims related to fat absorption or fat blockers.
* Claims related to transdermal or "patch" products.
* Claims of easy weight loss with no effort.
* Claims of safety for weight loss exceeding three pounds per week.
The science panel also expressed its opinion that weight loss is only possible by increasing exercise and/or decreasing calorie consumption.
The panel consisted of representatives from Harvard Medical School, the National Institutes of Health (NIH), the American Society of Bariatric Physicians, Columbia University, the University of Pennsylvania, Slim Fast Foods Co., ImagiNutrition, the University of California-Davis, the University of Pennsylvania and Health Management Resources.
FDA Structure and Function Notice Requirements
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At a press conference on 01/24/03, the FTC announced:
"The Federal Trade Commission today charged Slim Down Solution, LLC, Maderia
Management, Inc., and several related companies and individuals with using
false and unsubstantiated claims in the marketing and advertising of "Slim
Down Solution" - a purported weight-loss product. The advertising claimed that
the product's key ingredient, D-glucosamine, absorbs up to 20 grams of dietary
fat and causes significant weight loss without diet or exercise. According to
the FTC complaint, these claims are false."
Another company, Mederia Management, was also named, as the manufacturer of
various D-glucosamine products.
The official government position is now:
"It's no secret that claims promoting significant weight loss without diet or
exercise are false," said Howard Beales, Director of the FTC's Bureau of
Consumer Protection. "The scientific community knows it, the law enforcement
community knows it, and the media know it. Law enforcement has been
significant and aggressive on the issue. But it's clear we need the media's
help to keep these bogus claims from reaching consumers. Although hope for
quick and easy weight loss springs eternal, the only real solutions require
eating less and exercising more."
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New Dietary Supplement Ingredient Standards
Update here: Report (05/13/03)
"FDA Proposes Manufacturing and Labeling Standards for all Dietary Supplements
"March 7, 2003 -- TODAY'S ACTION:
"The Food and Drug Administration (FDA) today took
action to help Americans get accurately labeled and properly manufactured
dietary
supplements, through its Proposed Rule for Dietary Supplement Current Good
Manufacturing Practices (CGMPs). FDA is submitting this proposed
rule as part of the agency's ongoing effort to help Americans take more control
over their own health.
"FDA's Proposed Rule for Dietary Supplement Labeling and Manufacturing Standards
"This proposed rule would establish the standards
necessary to ensure that dietary supplements and dietary ingredients are not
adulterated
with contaminants or impurities and are labeled to accurately reflect the active
ingredients and other ingredients in the product.
Specifically this proposal would:
* Require the use of new industry-wide standards in
the manufacturing, packing, and holding of dietary supplements, thus reducing
risks associated with dietary supplements that are contaminated with harmful or
undesirable substances such as pesticides, heavy metals, or other impurities or
are not properly labeled to accurately describe what they contain.
* Ensure that the identity, purity, quality, strength, and composition of
dietary supplements are accurately reflected on the product label, which would
be a significant step in assuring consumers they are purchasing the type and
amount of ingredients declared.
"Science-Based Consumer Protection.
"Previously, dietary supplements have not been subject to mandatory standards for manufacturing or labeling. Congress gave FDA the authority to develop and implement CGMPs as part of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
"The proposed rule addresses the quality of manufacturing processes for dietary supplements, and the accurate listing of supplement ingredients. It does not limit consumers' access to dietary supplements, or address the safety of their ingredients, or their effects on health when proper manufacturing techniques are used. Rather, the proposed rule creates a level playing field for the industry by ensuring that every firm uses high-quality manufacturing procedures and uses the same rules for describing their ingredients. ***
"Under DSHEA, dietary supplement manufacturers have an essential responsibility to substantiate the safety of the dietary ingredients they use in manufacturing a product. Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading." ***
FDA Increasing Enforcement -- from the Vitamin Mavin, 04/25/01
"The US Food and Drug Administration said its Center for Drug Evaluation and Research and its Center for Food Safety and Applied Nutrition will divide the DSHEA enforcement responsibilities. Each group will enforce the Act depending on how products are marketed with CDER responsible for hormones and OTC products and CFSAN responsible for supplements with disease claims. One industry insider said the decision indicates the FDA is stepping up its enforcement action."
June 19, 2001 FTC Announces "Operation Cure-All" Actions against Internet Marketers,
http://www.ftc.gov/opa/2001/06/cureall.htm -- for the Vitamin Lawyer's views, mummarkt.html.And this sent to us (05/08/01) -
"NEWPORT BEACH, CA (www.thehealthchannel.com) - The Inspector General's office of the Department of Health and Human Services has just issued a draft report calling for tougher regulations on the sale and use of dietary supplements."The report said that current federal regulations do a poor job of protecting the public from risks associated with dietary supplement use. Approximately 60 percent of Americans have used such supplements, the report notes.
"The report specifically mentioned that dietary supplement manufacturers do not have to undergo stringent FDA testing procedures before being marketed, and manufacturers do not have to report adverse health effects experienced by consumers of their products. Instead, the FDA relies on voluntary information provided by the manufacturers themselves.
"The report referenced a previous FDA study that estimated the agency learns of only 1 percent of all "adverse events" involving dietary supplements. More than three-quarters of the products mentioned in adverse event reports do not have adequate labeling, and 71 percent do not specify where the product was manufactured.
"The Inspector General's office said the current regulatory system "cannot serve as an adequate safety valve" for protecting consumers. It called for immediate regulatory action to impose the same manufacturing and marketing standards on dietary supplements as exist on other food and consumer products.
"FDA Warning on Aristolochic Acid
"As a perfect example of this imperfect system, the FDA has just issued a consumer alert regarding aristolochic acid, an herbal extract linked to permanent kidney damage and urinary tract cancers. It is found in many folk medicines and diet aids.
"The FDA recently called on supplement manufacturers to closely monitor any of their products that contain aristolochic acids, and to report any adverse reactions to the agency. But they felt that more aggressive action was warranted.
"As a result, they issued a national consumer alert, which advised anyone who has taken any herbal products containing aristolochic acids to contact their healthcare provider immediately. "Even if these products have not been used recently," it warns, "consumers should still inform their healthcare provider about which product they took, so that an appropriate evaluation may be conducted."
"Lack of Communication
"Problems with dietary supplements can be compounded because patients often do not inform their doctors that they are using them.
"In a study presented at the annual meeting of the American Academy of Family Physicians, Dr. Margaret Planta reported that 60 percent of the patients she interviewed at a low-income county health clinic reported using herbal remedies or dietary supplements. But more than half (53 percent) said they had not informed their physician. Furthermore, nearly 20 percent of the patients who reported using such product said that they had no intention of telling their physician about their use of the products.
"In a related study, Dr. John Metz of the University of Pennsylvania reported at a recent meeting of the American Society of Clinical Oncology that cancer patients tend to divulge their use of alternative therapies only when directly questioned by their physician. After interviewing 196 cancer patients, just 13 (7 percent) said they were using an alternative or unconventional therapy. Yet, more than a third of the patients (34 percent) admitted using vitamins, herbal supplements, shark cartilage, guided imagery or meditation when asked directly about these therapies.
"A Patient's Responsibility
"Even in a best-case scenario, it will be years before a meaningful, industry-wide system is implemented that will guarantee the safety and effectiveness of all dietary supplements on the market. And even then, these supplements will still not undergo the stringent review and approval procedures that the Food and Drug Administration applies to medicinal drugs.
"Therefore, consumers themselves must take the initiative to ensure the quality and safety of what they are purchasing. Talk to your pharmacist, read the labels, and most importantly of all, let your physician know that you are taking such supplements. While most herbal products are safe if taken in the appropriate doses, they can skew the results of certain diagnostic tests and possibly interact with other medicines being taken.
"A growing number of research studies are now underway which are testing the safety and effectiveness of at least the most popular herbal products. For example, four herbal products-aloe vera, ginseng, kava kava, and milk thistle-have been recommended by the National Cancer Institute for substantially increased testing because of their widespread use by the public. NCI also cited indole-3-carbinol, a substance found in cruciferous vegetables such as broccoli, as a compound requiring additional study.
"But many more herbal products must be subjected to similar scrutiny. And definitive results from these and other studies are still years away. Therefore, in the interim, the old adage still applies-buyer beware."
SOURCES:
Office of the Inspector General, U.S. Department of Health and Human Services (
http://www.hhs.gov)Written by Richard A. Zmuda, www.thehealthchannel.com Editorial Team
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http://www.vitaminlawyer.com/October 6, 2000 -- the FDA today announced an Interim Enforcement Strategy
for Dietary Supplement Health Claims.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) allowed, for the first time, truthful claims to be made about dietary supplements. The law contemplates several categories of claims applicable to nutrients (medical, general wellness, structure & function and health claims). Some are permitted, others are not. The FTC and FDA have issued regulations and guidelines regarding the implementation of dietary supplement law.
On October 6th the FDA announced its Interim Enforcement Strategy for Health Claims. FDA's previous policies regarding such claims have had to be changed due to the landmark case of Pearson v Shalala. While developing regulations to permit such claims, it will engage in "enforcement discretion" regarding such claims and not expect the high "significant scientific agreement" standard to be met. Essentially this means that such claims, if presented in the correct form, will be allowed during this interim period, with FDA authorized disclaimers.
Health Claims characterize the relationship of a nutrient to a disease or condition for a certain population. They are, in general, in this form, "Nutrient W does X to disease Y for population Z."
Nutrient purveyors are therefore advised to seek competent legal advice regarding 21 C.F.R. Sec. 101.14 (Health Claim) applications. I've prepared a detailed proprietary checklist of requirements to obtain Health Claim approval under the new Interim Strategy for the benefit of my clients.
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Top, Back to IndexNovember 11, 2000 -- New Substantiation Process in the Industry
A powerful new alliance of large corporate interests (like Monsanto) have formed the Research-Based Dietary Ingredients Association (
www.rdia.org) and are having their first conference in DC next week.Update: see:
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August 24, 2000 -- Enforma Natural Products Case
Recently the FTC has been writing to various internet nutrient web sites telling them about the settlement in the Enforma Natural Products case. While the ten million dollar hit Enforma took is high, a quick perusal of the FTC's recent actions web site area shows many quarter million dollar fines.
Enforma made claims about its two products, a chitosan product called Fat Trapper and a pyruvate product named Exercise in a Bottle. The FTC now says that it has never seen any adequate scientific data upon which to base a claim that chitosan or pyruvate will:
"cause weight loss; permit consumers to lose weight without a restricted calorie diet and/or exercise; prevent or reduce the absorption of fat in the human body; increase metabolism, burn sugar or carbohydrates before they turn to fat, or burn off fat already in the human body; or enable consumers to lose weight even if they eat foods high in fat."
The underlying issue here is the distinction between "significant scientific agreement" (the FDA standard which the Court disallowed in Pearson v Shalala) which is the standard the FTC seems to be enforcing against Enforma versus the ordinary FTC advertising standard of "prior substantiation."
This is what the FTC said in its Advertising Guide to Supplement Marketers, November 18, 1998:
"supplement marketers are cautioned that the FTC will require both strong scientific support and careful presentation for... claims. *** Supplement marketers should ensure that anyone involved in promoting products is familiar with basic FTC advertising principles. The FTC has taken action not just against supplement manufacturers, but also, in appropriate circumstances, against ad agencies, distributors, retailers, catalog companies, infomercial producers and others involved in deceptive promotions. Therefore, all parties who participate directly or indirectly in the marketing of dietary supplements have an obligation to make sure that claims are presented truthfully and to check the adequacy of the support behind those claims. "
"The FTC's truth-in-advertising law can be boiled down to two common-sense propositions: 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims. A deceptive ad is one that contains a misrepresentation or omission that is likely to mislead consumers acting reasonably under the circumstances to their detriment. The FTC's substantiation standard is a flexible one that depends on many factors. When evaluating claims about the efficacy and safety of foods, dietary supplements and drugs, the FTC has typically applied a substantiation standard of competent and reliable scientific evidence. To determine whether an ad complies with FTC law, it is first necessary to identify all express and implied claims that the ad conveys to consumers. Once the claims are identified, the scientific evidence is assessed to determine whether there is adequate support for those claims..."
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2001 FDA "Structure & Function"
Nutrient Claims Filing Requirement
FDA's 1999 Structure and Function Rule does not require prior FDA approval of claims about how nutrients nourish the normal structure and function of the body
The Rule does require that the FDA be notified in writing, within 30 days of placing a dietary supplement on the US market, of the structure and function claims being made.
That requirement was delayed until February 2001. The deadline is now past. ALL dietary supplements sold in the US now must have notifications filed with the FDA.
All new supplements have 30 days from first sale to comply with the Notice Rule, by filing the required Notice. Nutritional companies are now part of a "self-regulating" industry in which each seller of dietary supplements is required to file there Structure and Function claims with the FDA.
The Vitamin Lawyer is ready to assist all nutrient purveyors who have products being sold in the US comply with this requirement. We are ready to file the Notice for you.
UNLESS THE NOTICE IS FILED ON TIME THE PRODUCT MAY BE BANNED FROM THE US MARKET.
In this urgent matter, please go to claimnotice.html for details on how to file the required Notice.
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Top, Back to IndexFDA Reports to Congress on the Supplement Market
On March 20, 2001 the FDA official responsible for dietary supplements (Joseph A. Levitt) appeared before a congressional committee. He reported on the current nutrient market -- you may find these statistics interesting:
"The dietary supplement industry has grown exponentially since the> enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Today's multi-billion dollar dietary supplement industry is now one of the world's fastest growing industries. Moreover, in the past, dietary supplements were mainly sold to adults in health food stores. These products are now purchased in supermarkets, retail stores, and even through the Internet, making them available to a much wider range of consumers of all ages. "There are an estimated 1566 establishments that claim to manufacture dietary supplements. Many large pharmaceutical companies have entered the dietary supplement business. Dietary supplement sales are reported to have reached $17.1 billion in 2000. Between 1994 and 2000, consumer spending on dietary supplements nearly doubled, and sales continue to grow at better than 10 percent a year. "Surveys show that over 158 million consumers use dietary supplements. An estimated 115.3 million Americans buy vitamins and mineral for themselves, and 55.8 million purchase them for family members, including children. According to a Prevention Magazine survey published in 2000, consumers use dietary supplements to help them achieve their self-care goals and as a means of ensuring good health. They also use them for "medicinal" purposes such as treating and preventing various illnesses, colds, flu, increasing mental sharpness, and alleviating depression. "The consumer's desire for self-care and the widespread use of dietary supplements raises a number of issues. This includes the possibility of harmful interactions between dietary supplements and prescription or over-the-counter (OTC) pharmaceutical products. Indeed, an estimated 19.6 million consumers use them with a prescription product. Herbals and botanicals constituted 32 percent of the estimated $17.1 billion dietary supplement market in 2000 compared to vitamins that account for 38 percent of the market. Finally, as the overall use of these products increases, so does the potential for adverse effects."
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Top, Back to IndexChinese Recognize Western Medicine -- as an Alternative...
Summary of a report from Sin Hua, China News Agency, April 1, 2001
China Gives Limited Approval to Western Medicine
At the conclusion of a 3-day meeting held in the Great Hall of the People in Beijing, March 28-30, an elite panel of 12 Traditional Chinese Medicine (TCM) practitioners declared, "There is sufficient evidence of Western Medicine's effectiveness to expand its use into TCM and to encourage further studies of its physiology and clinical value".
"In particular", the panel's report stated, "Western Medicine shows promise as adjunctive treatment to TCM. As a stand-alone medicine, however, its efficacy is mainly in the areas of acute and catastrophic care that comprise a relatively minor percentage of total patient complaints."
The consensus report was particularly critical of biomedical research design, since the panel had based their assessments solely on data from randomized controlled trials. Key points of the critique were:
1)Biomedical trials are designed to determine the mean response to treatment. This outcome is of limited value to TCM practitioners who are trained to devise individualized treatment protocols.
2)Biomedical trials test one drug at a time. This approach is bound to reveal unwanted side effects. In contrast, TCM seeks combinations of herbs to balance out adverse effects of individual herbs.
3)Diseases chosen for study in biomedical research are, too often, imprecise collections of symptoms, such as Irritable Bowel Syndrome or Chronic Fatigue Syndrome. These categorizations lump together different conditions that are readily distinguishable by TCM diagnosis.
"It is also our impression", the report continued, "that Western Medicine is based in a belief system that is powerfully reinforced by the large sums of money patients and insurance companies are willing to pay for treatment."
"We strongly recommend", the panel concluded, "that patients should be treated with Western Medicine only on a referral basis from a practitioner of TCM".
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FDA CYBER WARNING LETTER
Example of a May 2002 Letter from FDA to a web site:
“The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The continued marketing of this product with these claims violates the Act and may subject you or the product to regulatory action without further notice…
Furthermore, FDA has no information that your product is generally recognized as safe and effective for the above referenced conditions and therefore, the product may also be a "new drug" under section 201 (p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505 (a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements or as cosmetics if therapeutic claims are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain conditions are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 C.F.R. 101.93(g)).
In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.
Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 CFR) Parts 310 and 330-358, which contain FDA's regulations on over-the-counter drugs.
This letter is not intended to be an all-inclusive review of your web site and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.”
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Massive Multinational Assault on Alternatives...
Australians deliberately denied
access to more than one thousand
products ranging from vitamin pills to multi-mineral supplements
Copyright Joe Vialls, 2 May 2003
"The ever-compliant media immediately started circulating rumors about "that dangerous Travacalm," and hinted at mixing machines not being cleaned properly between blending batches of different products. One former employee was produced on television, to state that he was only allowed one hour to clean his mixing machine between batches instead of three hours, and that was that. The media fix was in, despite a total lack of evidence."
Under cover of the fake "SARS Crisis" currently
saturating the western media, Australia�s Therapeutic Goods Administration has
suddenly moved to outlaw and remove from store shelves about 80% of all vitamin
and other related alternative products. Although less than a week ago customers
were happily buying everything from vitamin A to G, and enthusiastically chewing
every conceivable mineral and trace element, these same customers today face
empty shelves in more than 5,000 health food stores across the nation.
American and European readers who may be wondering "What has this
Australian stuff got to do with me?" are urged to read on a little further.
Australia is well known as a gullible and thus attractive proving ground for
multinational scams, meaning that what happens in Oz this week, might well serve
as a foretaste of what is yet to come in America and Europe next week, or next
month, or even next year.
The extraordinary situation facing Australians today, started at the
beginning of this week, when the Therapeutic Goods Administration [TGA] suddenly
decided to cancel the manufacturing license of Pan Pharmaceuticals, a large
Australian company which not only manufactures its own line of medicines, but
also provides a manufacturing service for 80% of all alternative goods providers
across Australia. Basically then, by shutting down Pan Pharmaceuticals without
just cause, the TGA ensured that alternative health goods purveyors and
customers would be critically disadvantaged across the entire nation.
For further information -- International Advocates for Health Freedom, www.iahf.com
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FTC Seizes Seasilver! - June 19, 2003
"FTC Charges Marketers of Seasilver with Making False and Deceptive Claims; FDA Seizes Seasilver Inventories
"The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) announced coordinated actions against two companies - both charged with promoting the dietary supplement "Seasilver" with unsubstantiated medical claims. The agencies' actions against Seasilver USA, Inc. and Americaloe, Inc. are designed to halt the fraudulent marketing of Seasilver and to seize the available inventory of the product. Today's actions are the latest part of Operation Cure.All, an on-going coordinated effort among the FTC, the FDA, Health Canada, Canada's Competition Bureau, and state Attorneys General to crack down on unscrupulous marketers who prey on consumers with serious illnesses.
"The FTC has charged the two companies, their owners, the principal distributor, and a purported "expert" with making false and unsubstantiated claims about the health benefits and safety of a product they market called "Seasilver"- a purported cure-all liquid supplement. The FTC alleges that the defendants promoted Seasilver as safe and effective to treat or cure 650 diseases, including AIDS and cancers, and to cause substantial and permanent weight loss. The FDA has seized inventories of the product.
"The FTC and the FDA are committed to aggressive action against fraudulent claims in the dietary supplement market," said Timothy J. Muris, Chairman of the FTC." - http://www.ftc.gov/opa/2003/06/seasilver.htm.
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