Members of the natural products industry have submitted an open letter to the Federal Trade Commission (FTC) to express concerns about FTC's Randomized Clinical Trial (RCT) requirement for all “health-related” claims. The letter, which was submitted by the trade organization Alliance for Natural Health USA, along with Alkemist Labs, NOW Foods, Precision Patient Outcomes, Inc., RidgeCrest Herbals, and Xlear Inc, contends that the current RCT policy protects pharmaceuticals, and not consumers. 

Michael Ames-Sikora, Managing Editor & Policy Analyst for Alliance for Natural Health USA, outlined the issue for WholeFoods Magazine readers. He explained, "The crux of the issue is that the FTC, in conjunction with the FDA, is trying to impose drug standards on supplements, requiring expensive clinical trials in order for supplement companies to make most health claims."


FTC's call for “competent and reliable” scientific evidence

As WholeFoods has reported, in December 2022, the FTC updated its Health Products Compliance guidance, advising companies that they must have “competent and reliable” scientific evidence in support of health claims in advertising. "Previously, this could include all kinds of studies, such as animal, in vitro, or epidemiological studies—though clinical trials were considered 'best,'" Ames-Sikora explained. "The revised guidance states that, substantiation of health-related benefits will need to be in the form of randomized, controlled human clinical testing (RCTs) 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," 

FTC's next action on this front came on April 13, 2023. As WholeFoods reported at the time, FTC put approximately 670 advertisers (including many prominent industry companies; see the list here) on notice that they should "avoid deceiving consumers with advertisements that make product claims that cannot be backed up or substantiated." Hundreds of companies were sent notifications from the agency, which said it "will not hesitate to use its authority to target violators with large civil penalties." 

"The intention of this policy is to prevent companies from being able to communicate the benefits of natural health products to consumers," Ames-Sikora told WholeFoods Magazine. "The FTC’s new policy can be traced to the lawsuit brought by the FTC against Pom Wonderful, the pomegranate juice company, in 2014. The FTC went after Pom Wonderful for advertising the health benefits of its products—even though the company spent $35 million on studies to back up its claims.This is a major issue because this requirement is a backdoor ban on most claims. Not only are clinical trials often inappropriate for studying nutrients, they are not economically feasible. Clinical trials are incredibly expensive. Drug companies can afford them because drugs are patentable and the costs can be recouped when the drug is approved and sold for exorbitant prices. Nutrients generally cannot be strongly patented, so the costs of clinical trials cannot be recouped."

Putting the issue into perspective for brands, Matt Warnock, J.D., owner of RidgeCrest Herbals, told WholeFoods Magazine, "FTC's actions in imposing the RCT standard are significant because they were taken by policy and by litigation, rather than by rule-making. Bypassing public input, they have imposed broad and significant evidentiary and financial burdens on companies that, under the FTC Act, have done nothing wrong. This is part of a larger concerted action by FTC against our industry. Last March they sent a letter to 670 members of our industry, making an unsubstantiated warning of possible unsubstantiated claims, and putting them on notice that they might be liable for penalties of over $50,000 per day. This idea of shifting the burden of proof from government to individual defendants (guilty until proven innocent) has become common with Federal agencies, but shouldn't be tolerated. The FTC should go after untruthful claims, but they should have to show that they are in fact untruthful or misleading. If not, FTC has no business imposing additional administrative burdens."

From a policy perspective, Warnock added, "The fear that companies will make unjustified claims (some always will) has carried us to a place where the only people NOT allowed to engage in scientific dialog are those with an actual stake in the product or ingredient—precisely those who are likely to be best informed and have the best incentive to put forth a possible innovative solution to a problem. If we wait for 'significant scientific agreement' on a subject, innovations aren't likely to ever see the light of day. We don't do this in other areas, such as high tech, aerospace, or finance. Placing artificial constraints on speech is something that rubs most Americans the wrong way. If free speech is fraudulent, misleading, or otherwise wrongful, we have better ways of addressing it than prior restraint (or government approval) of entire categories of subject matter.


Health-related statements

"A 'health-related' statement (which is not defined by law, and could be very, very broad) can be entirely truthful, and not misleading, yet when FTC goes beyond that standard to require expensive RCTs on the product, not the ingredients, they drive the cost and time to develop new products up dramatically," Warnock said. "DSHEA was very clear in finding that the Federal Government (not just the FDA) 'should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers' (DSHEA findings, section 2(13).) No one wants dietary supplements and medicinal herbs to be as expensive as pharmaceuticals are now. When government becomes the gatekeeper and arbiter of what is safe and accurate, rather than going after those who hurt or defraud others, it quickly becomes oppressive."


Sharing an in-depth look at what can happen when FTC takes action against a company, Nathan Jones, CEO of Xlear, recently submitted this open letter to the natural products industry "to share Xlear’s experiences with the Federal Trade Commission (FTC) and the Department of Justice (DOJ) and to offer some cautionary advice." In that letter, Jones cautions, "Simply put, if you haven’t already been the subject of an FTC enforcement action or been sued by the FTC/DOJ, you probably will. Now is the time to take basic steps to prepare for this eventuality." Read his warnings for the natural products industry—and his advice—here.


Narrowing Information Available to Consumers

"This is nothing new," Ames-Sikora said of FTC's latest action on RCT requirement. "The agency has a proven track record in narrowing, rather than widening, the information available to consumers about supplement benefits. The FDA attacked cherry and walnut growers for listing the health benefits of those foods on their websites. The FDA has restricted many structure/function claims because they are 'implied disease claims'—an FDA fabrication that isn’t in the law. There was a massive, coordinated censorship campaign launched during COVID by the FDA and the FTC threatening doctors and clinics that told us about the benefits of natural products like vitamin D and zinc for COVID treatment and prevention."

Call to Action for Industry

"We're asking that industry and consumers alike stand up and object to this policy," said Warnock, who initially wrote the open letter after several discussions while at Natural Products Expo West in March. "Rather than advancing consumer interests, it imposes drug-type standards of proof and costs on products that, according to Congress, neither need nor deserve this kind of administrative burden."
The hope, Warnock added, is that others in the industry will find the policy troubling, and will join in signing on to this letter. "We hope to have signers from all 50 states, and more than 100 companies and organizations in total. FTC has already been kind enough to prime some 670 of us to the importance of the issue, so it shouldn't be hard to gather signatures. We hope to raise this issue with Congress at the upcoming NPA fly-in on May 22."
Warnock added that a new website is being created to address this and other important issues of health freedom: FreeMyHealth.org. "Watch this space! But for right now, people can join on with this letter just by emailing me personally at matt@rcherbals.com," he added. "Please put 'Open Letter to FTC' in the subject line."

Ames-Sikora added, "This is a fight ANH-USA has been engaged in since its inception. In fact, ANH-USA was part of the lawsuit that created qualified health claims for dietary supplements. For companies looking to learn more about this issue and how to get involved, they can visit our website at anh-usa.org; that contains many articles discussing this and other issues related to improving supplement access. They can also contact Jo Twombly, ANH-USA’s Deputy Director, at jo@anh-usa.org."

Also taking action, in 2023 the Council for Responsible Nutrition (CRN) filed a petition with the Federal Trade Commission (FTC). CRN is requesting FTC clarify certain aspects of its new new Health Products Compliance Guidance. Get the details here.

About Natural Products Fly-In Day 

As Warnock stated, industry members are aiming to raise this issue with Congress at the upcoming NPA fly-in on May 22. Fly-in day starts with training and education from NPA's experts about what it means to be an advocate and to lobby up at the Capitol. Attendees will discuss legislative priorities for 2024 and learn how to speak to their legislators about these issues. Then, attendees go to the Capitol to advocate, followed by networking with industry members and members of congress. There is no registration cost to attend, and NPA arranges all meetings. Interested parties can reserve their spot and make hotel reservations online here. For questions, please contact Kyle Turk at kturk@npanational.org. 

Related: A Label Claim Risk Assessment

CRN to FTC: Randomized Clinical Trials Not Required for Most Supplements

Natural Products Guidance Letter