WASHINGTON—Imposing a requirement on dietary supplement firms to conduct special human clinical studies in order to substantiate their claims would wreak havoc on the industry, leaving shelves bare and eviscerating the distinction between drugs and supplements, according to the Natural Products Association (NPA).
NPA expressed concern in court papers that the federal government’s position in litigation pending against Bayer Corporation “is contrary to federal statutory law and would reduce the availability of cost-effective dietary supplements to American consumers."
NPA, the trade association founded in 1936, recently weighed in with a “friend of the court" or amicus brief filed in the U.S. District Court for the District of New Jersey in ongoing litigation that has pitted the FTC and U.S. Justice Department against Bayer Corporation. NPA also made the U.S. Supreme Court aware of its brief.
The Justice Department contends Bayer should have conducted randomized, double blind human clinical trials to substantiate its claims that a probiotic named Phillips’ Colon Health defends against constipation, diarrhea, gas and bloating. Government lawyers allege Bayer has violated a 2007 consent decree, which barred the multinational company from making unsubstantiated claims for dietary supplements it sells or promotes. Justice Department lawyers have filed a motion requesting an order to show why Bayer should not be held in contempt for violating the decree.
In an Oct. 3 brief, Bayer maintains its claims are backed by “competent and reliable scientific evidence", the standard imposed by FTC to substantiate statements. The company said it didn’t need to conduct human clinical trials.
“NPA is very concerned that the government is using consent orders to effectively rewrite federal law on dietary supplements," said Daniel Fabricant, executive director and CEO of NPA, in a statement. “It’s important to point out that consent orders, which are meant to be case specific, may have unintended consequences for consumers if applied across the industry. Those include not just increased costs, but also the possibility of the reduced quality and quantity of information about products available to consumers."
The government’s motion is premised on the idea that nutritional statements require a randomized double blind clinical trial, but that notion is contrary to the 20-year-old law governing dietary supplements, NPA said in its brief. Although dietary supplement labels may not claim to treat a disease, the Dietary Supplement Health and Education Act of 1994 (DSHEA) authorizes claims that describe “the role of a nutrient or dietary ingredient intended to affect the structure or function in humans," NPA said, quoting the provision of the law governing so-called structure/function claims.
NPA expressed concern that the government is seeking to impose drug standards on the dietary supplement industry by requiring human clinical trials.
“Dietary supplements that are not marketed as drugs were not intended to be subject to the same standards as drugs, which do require substantiation by full clinical trial research," counsel for NPA wrote. “Requiring that standard would drive many responsible supplement companies that make and sell safe and beneficial products out of business."
An expert retained by the government said Bayer needed to conduct human clinical trials to substantiate its probiotic claims. The expert, a board-certified gastroenterologist and professor at Yale University School of Medicine, 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.
While FTC guidance to the dietary supplement industry has 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 in court papers, 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.