Victory for Supplements—and Free Speech—in Bayer Case

A federal district court has ruled in favor of Bayer in a case where the government tried to regulate supplements as drugs. Here’s what it means for you.
Pharmaceutical giant Bayer AG has won a lawsuit brought by the FTC that accused the company of making unsubstantiated claims about a probiotic colon supplement.
The court ruled, in essence, that Bayer’s claims about its supplement were sufficiently substantiated by the hundreds of studies it supplied to back up its claims—without the double-blind randomized clinical trials (RCTs) that the FTC tried to demand.
In her decision, the judge wrote, “As two other courts have held, competent and reliable scientific evidence does not require drug-level clinical trials, and the Government cannot try to reinvent this standard.”
In our previous coverage of the Bayer case, we noted that the FTC is completely outside of its jurisdiction in trying to demand RCTs for food and supplement claims—a process that is under the authority of the FDA. The FTC was also acting illegally in attempting to change existing law without going through a formal rulemaking procedure.
This isn’t the first time the FTC has tried to do this. We’ve increasingly suspected that the FTC is working at the behest of the FDA, which knows it couldn’t get away with such a requirement and is asking the FTC to do its dirty work.
Other recent court cases have ruled against government efforts to gag free speech. A district court ruled late this summer that the FDA could not stop Amarin, an Irish pharmaceutical company, from showing doctors the medical studies supporting off-label uses of its fish-oil-derived drug. The FDA’s longstanding position has been that it is unlawful to market a drug for a purpose not approved by the agency, no matter what the science says.
Why does this matter? Consumers are looking for reliable information backed by legitimate scientific research to assist in making informed choices. Access to this information is essential to knowing which foods and food supplements really are healthy and helpful for good health. When government agencies prevent companies from making health claims backed by good science, consumers are denied crucial information.
It should also be noted that there are significant problems with demanding RCTs for food and supplements. First, RCTs are often inappropriate for studying food and nutrients. A new-to-nature drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, D, and magnesium (especially the K2), but isolating it for an RCT would miss that.
RCTs are also incredibly expensive—on average $600 million each and often much more. Pharmaceutical companies can afford to pay this because their drugs have been patented, but this is not the case for natural supplement companies since natural molecules generally cannot be patented and their investment could never be recouped. Supplement companies would likely go out of business if RCTs were required in order to make health claims. This is part of the Catch-22 that we so often refer to.
And what are the statements that Bayer made that are so objectionable? They claimed that their probiotic supplement “helps defend against” the occasional constipation, loose bowels, and gas and bloating—structure/function claims that are protected by DSHEA (the Dietary Supplement Health and Education Act of 1994) and that should not, by law, require an RCT.
(Note: Structure/function claims are statements that describe the role of a nutrient or ingredient as it affects normal structure or function in humans—statements like “calcium builds strong bones” or “vitamin D boosts immune system function.”)
Will these decisions put a stop to further efforts to gag free speech? Probably not, but these court cases provide important precedents to defend against future attacks.