While the FTC appears to have backtracked slightly on its draconian campaign to censor supplement health claims, it is really a classic example of doublespeak. Action Alert!
The FTC is working to conceal the remarkable truth about the healing and disease-preventing powers of foods and nutrients. This is only good if you’re a drug company looking to sell more expensive drugs for preventable chronic illnesses that often do not work. This censorship keeps you from learning that magnesium can help lower blood pressure, for example, or that chromium can lower blood sugar, or any of the other innumerable benefits that come from natural vitamins, minerals, herbs, and amino acids.
The FTC has been censoring natural product health claims for years, but the latest threat is the December 2022 revision to the agency’s Health Products Compliance guidance coupled with the hundreds of warning letters sent in April this year to producers of supplements, homeopathic medicines, and functional foods. These letters warned companies that if they make claims without proper scientific substantiation (that is, evidence from more than one randomized controlled trial, or RCT), they will face large civil penalties. You can reference our earlier coverage for the details.
At a recent event, the FTC reportedly “clarified” its position on the need for RCTs for supplement claims. The natural products industry came to the same conclusion that we did: the FTC updated its policy to require RCTs for supplement health claims. Yet FTC spokespeople tried to walk that position back, telling the trade journal NutraIngredients: “There may be other types of health-related claims…that might not require RCTs, although of course it depends on the express and implied claims at issue and the opinion of experts in the relevant field.”
The agency is talking out of both sides of its mouth. On the one hand, it says quite clearly in its updated guidance (see below) that most supplement claims will require substantiation by RCTs, and other kinds of evidence will not be sufficient. On the other hand, it’s saying there “may” be some exceptions, but it depends on what experts in the field say. But we know good and well that the “experts” the government consults with are often on the take from Big Pharma or are otherwise critics of the use of natural products as the mainstay in health. Just look at what’s happening with another natural medicine in the government’s crosshairs, compounded bioidentical hormone replacement therapy (cBHRT). The FDA asked an “independent” panel of “experts” at the National Academies of Sciences, Engineering, and Medicine to review the clinical utility of cBHRT, and lo and behold, they concluded that there wasn’t any evidence to support cBHRT because there weren’t RCTs supporting safety and efficacy.
In our view, this “clarification” about possible exceptions to the RCT standard is all a smokescreen from the FTC, perhaps to lure companies into thinking they don’t need RCTs to support a health claim so the agency can bring the hammer down on them later.
We explained the issues at play in previous coverage, but the crux of the matter is that the FTC is trying to apply a drug standard to supplement health claims, requiring RCTs in order for supplements to carry most health claims. The updated guidance states:
As a general matter, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing to meet the competent and reliable scientific standard… Animal and in vitro studies may provide useful supporting or background information, but, without confirmation by human RCTs, they aren’t sufficient to substantiate health-related claims.
There is not much ambiguity here. If you plan on making a health claim for a supplement, you will need at least one RCT to back up the claim, perhaps even more. The guidance continues:
Although there is no requirement for a specific number of RCTs, the replication of research in an independently conducted study adds to the weight of the evidence [because it] reduces the chance that the results of a single RCT may be influenced by unanticipated, undetected, systematic biases that may occur despite the best intentions of sponsors and investigators.
Note that the FDA requires two RCTs to support drug approval. Of course, with FDA approval comes market exclusivity and the ability to make a claim that the drug can treat or prevent a disease. The FTC is trying to require the same level of evidence for supplements, even though supplement cannot make claims to treat or prevent disease. How does this make any sense?
ANH-USA supports light-touch regulation that would still allow the free flow of plausible information about supplements by allowing companies to cite peer-reviewed studies demonstrating health benefits. Help us push back against the government’s censorship campaign and support free speech!
Action Alert! Write to Congress to pass legislation to permit food and supplements to share and promote peer reviewed scientific studies about supplement benefits. Please send your message immediately.