The Federal Trade Commission (FTC) won a $2.2 million judgment against health food marketer Wellness Support Network, Inc. (WSN) in federal court for the “Diabetic Pack” and the “Insulin Resistance Pack.”
The FTC alleged that WSN’s claims that the health packs would prevent or treat diabetes were deceptive because they were not supported by adequate scientific proof and WSN’s claims about the amount of proof it had were false.
FTC cited the use of keywords, metatags, and Google Adwords — such as “diabetic cure,” “remedies diabetes,” and “diabetes treatment.”
What online health and wellness companies don’t realize is that they are subject not only to FDA rules about crafting valid structure/function claims (as opposed to therapeutic, medical, disease claims), but also to FDA and FTC rules about substantiation.
Put simply, you can’t make a disease claim for a dietary supplement, and even if you make a proper structure/function claim, you must have substantiation.
FDA and FTC each have more detailed legal rules and regulations about substantiation for dietary supplements / nutraceuticals and other health and wellness products.
FTC requires that all advertisers have competent and reliable evidence to substantiate their claims.
Marketers of health and wellness products are at particular risk of enforcement action, because they feel they can market more aggressively by mentioning diseases such as cancer, diabetes, or even thyroid conditions, and link these to their products.
As this case shows, FDA and FTC can look to meta-tags, online advertising links, etc. – and marketing companies cannot afford to ignore how the consumer and expert testimonials that appear on their sites (and social media sites) can be construed to make disease claims or, claims that lack substantiation.
In this case, the reviewing court accepted the opinion of the FTC’s expert that WSN’s disease prevention and treatment claims should have been, but were not, supported by consistent results from well-conducted controlled, randomized, and double-blind human clinical studies with statistically significant results. This is in fact the gold standard.
The principals were also held jointly and severally liable for the $2.2 million judgment.
Be sure to contact FDA regulatory counsel to evaluate substantiation for any claims you make for health and wellness products. Ask California FDA lawyer Michael H. Cohen to assess whether your health and wellness products meet FDA and FTC regulatory compliance requirements.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
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