The FTC Statement to Congress on Deceptive Marketing of Dietary Supplements is a good place to begin to understand legal compliance issues regarding marketing.In this document, the FTC makes some critical points:
- the FTC has primary authority over the advertising of foods, including dietary supplements; while the FDA has primary responsibility for dietary supplement labeling
- the FTC and FDA staff share access to each others’ databases on dietary supplement marketing
- the FTC and FDA share access to Consumer Sentinel, the FTC’s secure online database for complaints (received over 1 million complaints in 2009)
- the FTC focuses enforcement on:
- national advertising campaigns for products with unproven benefits
- products promoted to treat or cure serious diseases
- products that may present significant safety concerns to consumers
- products that were deceptively marketed to vulnerable populations including children and the elderly
- FDA and FTC monitor the Internet and print advertising for violations
- FTC and FDA look for weight loss products and other fads for possible enforcement triggers
- FTC will open an investigation and issue civil investigative demands to obtain marketing and labeling materials, sales information, and relevant substantiation materials
- Dietary supplement investigations often involve an assessment of the scientific evidence for a claimed health benefit
FTC can issue warning letters or obtain:
- injunction
- consumer redress or disgorgement of ill-gotten gains
- bans (in case of outright fraud or repeated legal violations)
Enforcement examples include:
- false and unsubstantiated claims for Airborne effervescent tablets (NOT clinically proven to prevent colds and flu and protect against exposure to germs on planes)
- false claims by copycat cold remedy products
- false claims by “Supreme Greens”
- claims that dietary supplements could cure cancer, Parkinson’s, heart disease, and autoimmune disease
- claims that an infrared sauna could treat various diseases
- deceptive weight loss claims (including “eat all you want and still lose weight”)
The FTC notes that “marketing scams are particularly cruel by preying on consumers when they are most vulnerable and desperate, offering false hope and even luring them away from more effective treatments.” The FTC has targeted dietary supplements that purport to address anthrax, SARS, avian flu, and H1N1 flu, or that promise “dramatic weight loss, or to treat the common cold, or to make children smarter.” The FTC has also targeted supposed dietary supplement cancer cures, “everything from essiac tea and other herbal blends (some containing highly toxic herbs), to laetrile, shark cartilage, coral calcium, mushroom extract, and black salve.” Many websites were shut down.
If you are bringing a dietary supplement, an herbal product, or another therapy to market, be sure to have your claims (including your website) reviewed by an attorney familiar with FDA and FTC rules applicable to these situations. Contact the Cohen Healthcare Law Group for your dietary supplement legal needs and for FDA and FTC review of your marketing materials.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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