WASHINGTON—In a dispute with the FTC that could have broad implications for the dietary supplement industry, Bayer Corporation last week said its claims regarding a probiotic supplement satisfy a standard that has existed for more than 13 years.
The FTC contends the multinational company violated a 2007 consent decree that it entered with the government because Bayer failed to conduct human clinical trials to substantiate its claims regarding a probiotic supplement. Phillips Colon Health, the supplement at issue in the litigation, is marketed to defend against gas, bloating, constipation and diarrhea.
In an Oct. 3 brief filed in federal district court, Bayer said the consent decree does not require human clinical trials on the specific product. Bayer also argued the government is seeking to hold the company to a standard that conflicts with the FTC’s own guidance and is incompatible with the relevant federal statute
“This is not and has never been the standard for dietary supplement claims such as those at issue," Bayer declared at the outset of the 23-page brief filed with a federal district court in New Jersey. “It is a brand new multi-part test the government invented for this litigation—relying on a single physician who was not even disclosed until the government moved for contempt."
The 20-year-old statute governing dietary supplements (Dietary Supplement Health and Education Act of 1994 or DSHEA) requires that claims must be “truthful and not misleading." And for the last 13 years, Bayer noted, the industry has relied on guidance issued by the FTC, which has stated claims must be backed by “competent and reliable scientific evidence."
While FTC guidance noted human clinical trials are the most reliable type of evidence, it also specified animal and in vitro studies will be considered “particularly where they are widely considered to be acceptable substitutes for human research or where human research is infeasible," Bayer pointed out, quoting the guidance. The FTC guidance does not require human clinical trials, and FDA also has recognized in guidance “that randomized, controlled clinical trials for dietary supplements may not be 'possible, practical, or ethical,'" Bayer added.
Bayer said its probiotic claims are backed by several clinical trials on the species of bacteria in the product, in vitro and animal studies on the bacteria strains, and genomic tests that confirm the strains help protect against constipation, gas, bloating and diarrhea. The company also referenced a consensus report from probiotic experts, which concluded “certain effects can be ascribed to probiotics as a general class" including digestive benefits.
“Nowhere in the [2007 consent] decree is there any provision requiring randomized, controlled clinical trials," Bayer declared in the brief.
Last month, the Justice Department filed a motion requesting an order to show why Bayer should not be held in contempt for violating the decree. The government asked the court to hold Bayer in contempt and assess a fine of USD $25,000 per day to coerce compliance with it.
Relying on the expert opinion of a board-certified gastroenterologist and professor at Yale University School of Medicine, government lawyers said Bayer needed to conduct human clinical trials to substantiate its probiotic claims.
The expert, Loren Laine, also said Bayer needed to conduct the trials on the specific bacteria strains in the product and couldn’t rely on studies using a different combination of bacteria strains. Bayer indicated Laine’s position is contradicted by FTC’s guidance, which states it may be “appropriate to extrapolate from the research to the claimed effect" notwithstanding “significant discrepancies between the research conditions and the real life use being promoted."
In a separate brief filed Oct. 3, the Council for Responsible Nutrition (CRN) expressed concern that the government is attempting to require that claims regarding dietary supplements meet drug standards.
The “government seeks to impose a standard that more closely resembles the evidentiary standard for the marketing of new drugs than what has been required of dietary supplements in the past," CRN stated. “Such a drug-like standard, if applied broadly to the industry, would be largely infeasible for most dietary supplement research, as has been recognized by the FTC, FDA, and Congress."
But the Justice Department contends Bayer’s product impliedly claims that it “prevents, cures, or treats constipation, diarrhea, and gas and bloating." Although dietary supplements can be marketed in the United States without preapproval from FDA, they cannot make so-called drug or disease claims that they prevent, mitigate or treat a disease. Disease claims, if made by Bayer, would need to be substantiated by human clinical trials.
In reliance on an FDA rule, Bayer said it made no such disease claims. For instance, the company noted the FDA rule authorizes a so-called structure/function claim that a product “alleviates bloating" or helps with “occasional constipation." Bayer also said its advertisements make no disease claims and expressly state that its “product is not intended to diagnose, treat, cure or prevent any disease."
The Justice Department is expected to file a reply brief in the coming days to Bayer’s response.
The case, which dates back to a 2011 investigation by the FTC, is before U.S. District Judge Jose L. Linares in the U.S. District Court for the District of New Jersey, 2:07-cv-00001.