Understanding regulatory and FDA compliance with dietary supplements advertising first means understanding that the Food & Drug Administration (the “FDA”) has primary responsibility for claims related to dietary supplements and weight loss products on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale.
The FDA can take action against dietary supplements only after they are proven to be unsafe. This allows manufacturers of supplements and herb based products to make health benefit “structure/function” claims, provided their products are not falsely promoted for cure, mitigation, treatment, or prevention of disease. If they are promoted for such purposes, they are going to be subject to FDA regulation as “drugs.”
Product sellers and promoters should not promote or claim any product as a cure for anything!
The word “cure” is absolutely an FTC and FDA red flag. What lands most advertisers into trouble is failing to understand that results usually will vary. You must disclose that any type of treatment plan, supplement or weight loss product will not work for everyone. Potential users should also be advised to consult with a physician or other licensed healthcare professional.
Dietary supplements are always subject to FDA regulation regarding adulteration and misbranding. They may be deemed to be misbranded if they are characterized as a drug without having undergone the clinical trials to which new drugs are subjected. If you sell products that fall under the regulation of the FDA (including dietary supplements, tobacco products, drugs, vaccines, cosmetics, medical devices, veterinary devices, biopharmaceuticals, blood transfusions and electromagnetic radiation emitting devices) you should consult a qualified attorney to determine what is legally required. Besides product labeling requirements, there may be other notice and disclosure requirements, pre-approval and testing requirements and other requirements you will need to follow to ensure FDA compliance.
The FDA also reviews and regulates prescription drug advertising and promotion directly. The scope of this article does not cover FDA regulations or requirements or in depth DHSEA regulations in this regard. This is an introduction to the perils of advertising dietary and herbal supplement and weight loss type products and making health claims in general online.
The FTC Also Has Oversight
Supplement sellers also need to understand how the Federal Trade Commission (“FTC”) generally views any claims regarding health, since they are scrutinized much more heavily than other claims. FTC advertising laws are not different for dietary supplements and weight loss products as the same materially misleading standard will be used to determine if any claim is deceptive. However, selling dietary supplements or weight loss products will require both strong scientific support and careful presentation for any claims made under existing FTC laws.
The FTC’s approach to food, dietary supplement and weight loss product advertising is contained in its “Enforcement Policy Statement on Food Advertising” (“Food Policy Statement”). Although the Food Policy Statement does not specifically refer to dietary supplements, the principles underlying the FTC’s regulation of health claims in food advertising apply to dietary supplements and weight loss products in general. The FTC has primary responsibility for claims in advertising and has primary jurisdiction over the advertising of foods, nonprescription drugs, cosmetics along with most other goods and services.
In terms of advertising guidelines, the FTC has issued “Dietary Supplements: An Advertising Guide for Industry” (the “Dietary supplement Guide”). These guidelines provide the FTC’s viewpoint on dietary supplements and you should absolutely read it if you intend on selling these types of products. If you advertise these types of products, you should also review the Food Policy Statement. The Dietary Supplement Guide contains numerous examples regarding substantiation of supplement health claims. A disclosure may be necessary under FTC laws if the text or images in the ad lead consumers to believe that the product has “undergone any kind of review for safety and efficacy that the FDA conducts on new drugs and has been found to be beneficial for the treatment of disease.” Otherwise, the ad may be deceptive (FTC Dietary Supplement Guide). But, a disclaimer or disclosure will not cure an otherwise deceptive ad, particularly where the deception concerns claims about the disease benefits of a product.
Substantiating Health & Safety Claims
As stated, the same principles of deception apply to health claims relating to dietary and herbal supplements as do all other types of claims. The caution lies with the substantiation of these claims, given the nature of the product. The FTC approach generally requires that claims be backed by sound, scientific evidence, but the FTC provides flexibility in the precise amount and type of support that is required. Also, the support for any claim must be scientifically sound, adequate in the context of the surrounding body of evidence, and relevant to the specific product and claim advertised. The FTC gives great weight to an FDA determination of whether there is adequate support for a health claim regarding a dietary supplement.
If health and safety claims are made, advertisers should have “competent and reliable scientific evidence” in the form of scientific analysis and clinical trials. Acceptable scientific evidence consists of “tests, analyses, research, studies, or other evidence based upon the expertise of professionals in the relevant area that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. (FTC vs. Brakeguard Products, Inc. (1998)). Sometimes, it is difficult to know exactly what substantiation is needed. However, if you are making specific claims as to performance or give numbers representing performance levels, your company should have scientific tests demonstrating those performance levels. If you do not have tests showing those results, or the tests are not performed by entities the FTC would consider reputable and competent, your business runs the risk of FTC liability.’
Dietary Supplement Health Education Act
If you plan on selling weight loss or diet related products, such as dietary and herbal supplements, you should be familiar with a wide array of laws that govern the sale of these products. Requirements under the Dietary Supplement Health Education Act (“DSHEA”) must be met by sellers. For example, Under the DSHEA, all statements of nutritional support for any dietary supplements must be accompanied by a two-part disclaimer on the product label. The disclaimer must state the supplement has not been evaluated by the FDA and that the product is not intended to “diagnose, treat, cure or prevent any disease.”
Dietary supplements are also specifically regulated by the DSHEA. It defines any product (except tobacco) as a dietary supplement that contains at least one of the following items: (1) a vitamin, (2) a mineral, (3) an herb or botanical, (4) an amino acid, (5) a dietary substance “for use to supplement the diet by increasing total dietary intake,” or (6) any concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients. The DSHEA requires the FDA to regulate dietary supplements as food, not drugs. Therefore, dietary supplements are not subject to safety and efficacy testing and there are no approval requirements.
FTC and FDA compliance with dietary supplements and weight loss products advertising is possible with a cautious approach.