“The FTC is trying to regulate supplements as drugs!” says Bayer. Yes, that’s what we’ve been saying for quite some time now. Action Alert!
Global chemical company Bayer AG has a bone to pick with the Federal Trade Commission (FTC) and the Justice Department. Its pharmaceutical and medical products subgroup, Bayer HealthCare, produces a probiotic colon supplement—but the government, they claim, is trying to hold the supplement to the same evidentiary standard as a drug.
The company has provided hundreds of studies which, it argues, support its structure/function claims for the product. The government insists that claims cannot be made without the kind of double-blind random-controlled trial (RCT) used in the drug approval process.
Two weeks ago, the Consumer Protection Branch of the Justice Department, instigated by the FTC, filed a motion requesting an order to show cause why Bayer should not be held in contempt of court for allegedly violating a 2007 settlement order prohibiting Bayer from making “unsubstantiated claims for any dietary supplement it promotes or sells. The government alleges in today’s motion that Bayer promotes one of its products, Phillips’ Colon Health, using claims about the product’s purported benefits without having evidence to substantiate those claims.
Bayer’s 2007 settlement with the FTC had to do with a different supplement, their WeightSmart line of One-A-Day vitamins. Bayer paid a fine and agreed to refrain from making advertising claims concerning the health benefits of nutritional supplements in general unless—and here’s the point of contention between the drug company and the government—Bayer “possesses and relies upon competent and reliable scientific evidence.” Such evidence was defined as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
In the Phillips’ Colon Health case, the government-hired expert, Dr. Loren Laine, a board-certified gastroenterologist and a professor at the Yale University of Medicine, decided that RCTs are needed to distinguish actual efficacy of the supplement from the placebo effect. This is no surprise. The FTC in various other cases has been trying to require a two RCT standard for any claim.
Bayer claims it satisfied the scientific standard by giving the FTC nearly 100 separate scientific papers and studies to back up its claims for Phillips’ Colon Health. Laine reviewed the literature and wasn’t satisfied that Bayer met the “competent and reliable scientific evidence” standard, according to the Justice Department. We are skeptical that this is just Laine speaking. Given the background, it seems likely to us that the FTC staff is as much or more behind this demand.
We would note that the FTC’s proposed standard is supported neither by law nor by science:
- The Federal Trade Commission Act does not require RCTs. As we noted previously, the RCT standard is used under the Food Drug and Cosmetic Act (FD&C) to establish disease claims for drugs. This process is overseen not by the FTC, but by the FDA. And, importantly, there is no such requirement for structure/function claims for supplements.
- When it comes to supplements, RCTs are not necessarily the “gold standard”—a topic we explored in depth two years ago. In this case, Bayer has already provided mountains of scientific evidence, which the FTC’s paid expert simply dismisses out of hand.
- If the FTC wants to change existing law—to change the agency standard for the amount of scientific evidence required—it should go through a formal rulemaking procedure. The public should have the opportunity to comment on such a huge policy change; it certainly should not be done in a back-door approach, through consent orders. It is noteworthy that Congress earlier stripped the FTC of some of its discretion in matters like this, precisely because the agency was abusing it. This is in effect an attempted end run around Congress.
Why then would the FTC, which regulates advertising claims, be attempting to force supplements to use an evidentiary standard that applies only to pharmaceutical drugs? Could it be that the FDA knew it couldn’t get away with such a requirement, so decided to skirt the law by asking the FTC to do the dirty work for them?
Bayer, fortunately, intends to fight back. This is helpful. Too often matters between federal agencies and giant companies are worked out quietly behind closed doors, leaving consumers (and voters) in the dark. The company is protesting the government’s imposition of a drug standard on dietary supplements, and they say they did indeed provide “competent and reliable scientific evidence” as they agreed to do in their 2007 settlement.
One of the underlying issues is whether Bayer’s claims for its product are indeed structure/function (s/f) claims. S/f claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans—for example, “calcium builds strong bones” or “vitamin D boosts immune system function.” Under FDA rules, one cannot legally cite the science showing that vitamin D prevents and treats the flu. The flu is considered a disease, so this is forbidden. (In this area, science is completely disregarded by the FDA. So is freedom of speech.)
Most of the health claims Bayer makes—a “probiotic supplement” that “helps defend against” the occasional constipation, diarrhea, and gas and bloating—are indeed s/f claims, according to Bayer and according to the plain meaning of the words. Since s/f claims are specifically protected by DSHEA, the landmark federal Dietary Supplement Health and Education Act of 1994, they should not require an RCT. Requiring RCTs for s/f claims is an alarming and dangerous precedent.
Probiotics, of course, present serious competition to pharmaceutical drugs, and have even been targeted by the FDA’s NDI (new supplement) draft guidance. The guidance contains a vague statement that could stymie the future of probiotics: “Not all bacterial microorganisms are dietary ingredients, and a microorganism that is not a dietary ingredient cannot be a NDI.” We hope the new version of the draft guidance, when it is released, will either strike or clarify this provision.
Action Alert: Tell the FTC to Respond to ANH-USA’s Petition! In 2011, ANH-USA filed a Citizen Petition with the FTC alleging that its arbitrary requirements for food and dietary supplement health claims oversteps its jurisdiction, violates the First Amendment, and chills protected speech. Don’t let the FTC continue to ignore citizens asking for change! Please take action immediately!