FTC Issues Civil Penalty Notice to 700 Companies Challenging Substantiation For Product Claims

The FTC stated that the notices for each company outline specific unlawful acts and practices, which generally include allegations of:

1. Failing to have competent and reliable evidence for product claims;
2. Failing to have competent and reliable scientific evidence to support health or safety claims;
3. Failing to have at least one well-controlled human clinical trial to support claims that a product is effective in curing, mitigating, or treating a serious disease;
4. Misrepresenting the level or type of substantiation for a claim; and
5. Misrepresenting that a product claim has been scientifically or clinically proven.

Although the FTC Act prohibits deceptive acts and practices, the statute itself does not require any particular type of evidence for health or other claims. For decades, dietary supplement and food manufacturers have relied on the Dietary Supplement Health and Education Act (DSHEA) as well as long-standing FTC and FDA guidance to make dietary supplement claims without drug-level clinical trials. Instead, DSHEA, FTC guidance, and FDA guidance all made clear that dietary supplement companies were permitted to rely on other types of scientific evidence, not drug-level trials, including observational, open-label, animal, and laboratory studies. Therefore, most supplements and foods on the market today do not make drug-level claims.

For the past 15 years, and despite its long-standing guidance, the FTC has tried to increase the level of substantiation required for dietary supplement claims. When challenged in court, the FTC has not prevailed. For example, in United States v. Bayer, the court granted judgment to Bayer, holding that the government’s demand for drug-level randomized controlled trials was “inconsistent” with both the DSHEA and the FTC’s own guidance, which “specifically refute[d] the standard the Government [was] seeking to impose.” 2015 WL 5822595, at *14 (D.N.J. Sept. 24, 2015).

Nearly seven years after the Bayer decision, the FTC issued new guidance suggesting that the Bayer decision was incorrect and suggesting that randomized controlled clinical trials were required for certain dietary supplement claims. The warning letters issued today are a strong indication that the FTC may continue to try to push the substantiation standard even further. While there are serious due process and other procedural concerns with mass notices like these, companies making health claims for their products should take this moment to update their internal substantiation policies and files. If and when the FTC attempts to enforce these notices and this new policy on substantiation, the FTC’s enforcement action will be subject to serious attack. Just as in the Bayer case, courts should be persuaded to follow the long-standing and accepted standard, based on previous FDA guidance, particularly for dietary supplement and food claims.