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Jennifer Grebow is editor-in-chief of Nutritional Outlook.
Bayer’s FTC legal battle triumph underscores the rightful difference between dietary supplements and drugs.
Bayer Corp. celebrated a landmark victory in late September when a U.S. district court judge ruled in the company’s favor in a Federal Trade Commission case seeking to hold the company in contempt for its probiotic-supplement health claims. In his written opinion, New Jersey federal district court judge Jose Linares ultimately affirmed that dietary supplement structure-function claims must have “competent and reliable scientific evidence,” but that the evidence does not necessarily require randomized controlled trials.
Back in September 2014, the U.S. Department of Justice, on behalf of the FTC, filed a motion of contempt against Bayer alleging that Bayer violated the terms of a 2007 FTC-issued consent order over Bayer’s One-A-Day WeightSmart vitamin. That 2007 consent order prohibited Bayer from making any future weight-loss or disease claims without supporting “competent and reliable scientific evidence”-the FTC’s requirement for claims substantiation. The motion of contempt filed in 2014 accused Bayer of again making unsubstantiated structure-function claims, this time for its Phillips’ Colon Health probiotic supplement.
According to the FTC, the company did not possess adequate evidence to support its advertising claims that the product “helps defend against occasional constipation, diarrhea, gas, and bloating.” These are implied claims to prevent, treat, or cure constipation, diarrhea, gas, and bloating, the FTC suggested.
For its expert witness, the agency enlisted gastroenterologist Loren Laine, MD, a professor at Yale University School of Medicine. Laine asserted that in order to support the claims, Bayer should have conducted two randomized, double-blind human clinical trials (RCTs) in the target population on a product comprising the same combination of bacterial strains in the Phillips’ Colon Health product.
Bayer did not have two randomized, double-blind human clinical trials, but the company did point to more than 100 scientific articles in the public domain that it used to support the structure-function claims for its probiotic species. At this point, one should note that these types of probiotic claims are not unique to Bayer; other probiotic supplement companies have long made similar claims in the past.
Bayer presented its own experts in the case-M. Brian Fennerty, MD, an expert in gastroenterology and clinical trial design, and Daniel J. Merenstein, MD, an expert in medicine, clinical trial design, and probiotics. Both testified that the experts in their field would not require gold-standard RCTs to serve as necessary evidence to substantiate Bayer’s claims.
Supplements Are Not Drugs
This September, Judge Linares ultimately ruled for Bayer, finding that the company’s evidence was “competent and reliable” to support its structure-function claims. The judge’s opinion strongly upholds the right of structure-function claims to rely on the totality of evidence. He also definitively affirmed that the law governing supplements, the Dietary Supplement Health and Education Act (DSHEA) of 1994 amendment to the Federal Food, Drug, and Cosmetic Act, permits dietary supplements to make structure-function claims and that there is a distinct line between the substantiation required for drug claims and the “lower substantiation” requirement for supplement claims.
“Recognizing the health benefits of dietary supplements,” he wrote, “Congress enacted DSHEA to ensure that supplements can be marketed and sold without following the stringent requirements imposed on drugs. Although new drugs must be preapproved by the Food and Drug Administration…and traditionally must be supported by randomized, placebo-controlled, double-blind clinical trials…dietary supplements need not.”
Here are some key takeaways from Judge Linares’s opinion:
Totality of Evidence
“For dietary supplements, the only substantiation requirement is that claims be ‘truthful and not misleading,’” Linares wrote. As long as a supplement does not make drug-type “diagnose, mitigate, treat, cure, or prevent” claims, “it is not regulated like a drug,” he said.
Linares confirmed that DSHEA does not specify what types of studies or evidence are needed to support a non-drug structure-function claim; moreover, he underlined, the FTC’s own advertising guidance for dietary supplements only states that supplement claims must hold “competent and reliable scientific evidence,” which the agency defines as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have 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 short, Linares wrote, structure-function claims do not require the type of RCTs required for drug claims. “[T]he FTC Guidance makes clear that this standard is not the drug standard,” he wrote. FTC’s own guidance states that there is “no fixed formula” for the types and number of studies required. The agency’s guidance states that while RCTs are “the most reliable form of evidence,” they are not required, and other types of evidence should also be considered, including animal studies, in vitro studies, and epidemiological studies.
Linares also pointed out that experts in the field confirmed that the 100-plus scientific articles Bayer used to substantiate its claims were adequate; moreover, he said, the company did not need to possess physical copies of those studies, which the company accessed through subscriptions to scientific journal databases. His opinion went into great detail describing Bayer’s process of reviewing the science in the public domain, which included reading new studies weekly to make sure its claims were substantiated, on an ongoing basis.
Other takeaways from the opinion: A company is not required to perform studies on its exact product formulation or target population, Linares said, pointing out that FTC’s guidance states that companies can use tests done on a “similar formulation” and to “extrapolate” between populations.
Also of note: In discussing some of the studies presented, Linares pointed out that even if one of the studies Bayer referenced did not include enough subjects to generate a statistically significant benefit, “the study does not undercut Bayer’s substantiation of [Phillips’ Colon Health] because many successful products, including FDA-approved drugs, have neutral studies.”
The judge also repeatedly mentioned Bayer’s use of the industry-standard disclaimer, “This product is not intended to diagnose, treat, cure, or prevent any disease.” He pointed out that the Phillips’ Colon Health packaging and advertisements all carry this disclaimer, which would contradict any suggestions that the company was making explicit or implicit drug claims. Additionally, he pointed out that the company’s ads depict only healthy people, not sick people.
Judge Linares heavily questioned the expertise of the FTC witness, Dr. Laine. On the stand, Laine admitted that he had never written any articles or books on probiotics, had never conducted a probiotics study, and had no knowledge of the regulations governing dietary supplements and how the requirements for structure-function claims differ from those for drug claims. In fact, Laine said, he wasn’t aware of any dietary supplements with evidence meeting his prescribed study design, which he said in itself does not distinguish at all between supplements and drugs.
Judge Linares contrasted Laine’s lack of pertinent expertise in the case with that of Bayer’s own medical witnesses, who did have expertise in the field, and pointed out that both witnesses testified that a majority of their colleagues would disagree with Laine’s argument that RCTs are required to substantiate probiotic claims like Bayer’s.
Constipation, Diarrhea, Gas, and Bloating Are Not Disease Claims
Bayer’s probiotic claims are not disease claims, Judge Linares stated. But he went further than that.
“Even if Bayer made implied claims regarding prevention, treatment, or cure, they are not disease claims,” he wrote. “Although the words ‘prevent, treat, and cure’ often signal a disease claim, the Government has not proven that Bayer advertised [Phillips’ Colon Health] to prevent, treat, or cure any disease. Instead, the government asserts that Bayer advertised [Phillips Colon Health] to prevent, treat, or cure constipation, diarrhea, gas, and bloating. These are not diseases, but rather variations of the normal state of health.”
Claims of supporting or promoting digestive health are structure-function claims, he said, and claims of alleviating symptoms like gas and bloating are structure-function in nature because they do not characterize a specific disease.
Bayer’s probiotic claims, he noted, are quite common within the industry. “The Government has not pointed to any instance when it has asserted that these claims are disease claims,” he wrote. “If these claims were disease claims, then many of the most popular probiotic supplements on the market would be in violation of the law, and subject to seizure by the FDA.”
No Rewriting History
Most importantly, Judge Linares pointed out that the agency cannot, at this later date, reinterpret its own 2007 consent orders by instructing that “competent and reliable scientific evidence” must now take the form of two RCTs. “The Government’s position that Laine-level RCTs are required is found nowhere within the four corners of the consent decree,” he wrote. “The consent decree that Bayer agreed to in January of 2007 speaks only of ‘competent and reliable scientific evidence.’”
As a result, Linares said, “the Government cannot try to reinvent this standard through expert testimony”-namely, the sole opinion of Dr. Laine-especially when what the FTC now asserts is necessary runs counter to what supplement laws and the agency’s own guidance state are required for supplement claims.
The dietary supplement industry cheered the denial of contempt at industry events this fall.
“I think we should just take a moment and say thank you,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN; Washington, DC), at a SupplySide West trade show roundtable in October. While he noted that the FTC has 60 days to appeal the decision, “it is a great moment for the industry because it does set the FTC back on their heels once again and tells them that you cannot superimpose the RCT standard over supplements making structure-function claims that, by guidance and of long history, have been allowed to have a variety of evidence in place.”
It’s also a win for probiotics, pointed out Ray Matulka, PhD, director of toxicology at Burdock Group (Orlando, FL), during his SupplySide West presentation on probiotic regulations. “This claim of helping to defend against occasional constipation and other issues is typically considered a structure-function clam in that it is about how the probiotic is helping change your body by the structure or function of the body. [This case] was a very good thing for probiotics in general because it is really helping to set the stage that the FTC cannot extend a drug-type terminology to probiotics when the claim itself is of a structure-function nature.”
Natural Products Association (NPA; Washington, DC) CEO and executive director Dan Fabricant, PhD, who was also part of the SupplySide West roundtable, said via press release, “This case is evidence that the FTC is willing to try and expand their authority through enforcement decisions, even with a bad case which they had from the start, and this remains one of the biggest, if not the biggest, concern for the industry…NPA felt the FTC would have set a dangerous precedent had the overbearing standards it was seeking become affirmed.”
Supplement leaders also encouraged industry members to read the judge’s opinion. “The decision discusses what Bayer does-really endorsed it-and is a roadmap for both methods and content that the substantiation allows,” said attorney Marc Ullman of Rivkin Radler LLP during the SupplySide West roundtable. “So if any of you are involved in making claims, I really do urge you to read that opinion.”
Nutritional Outlook magazine