Celebrations are shadowed by suspicions that some are treading on the law.
October 25th marked the 20th year since President Clinton signed the Dietary Supplement Health and Education Act (DSHEA) into law. DSHEA defined the category of dietary supplements in the United States and, by so doing, gave consumers free market access to the health benefits that supplements provide. But even as today’s industry stakeholders pay tribute to the two decades of DSHEA’s governance, those celebrations are shadowed by strong suspicions that some-namely, the FTC, through recent regulatory actions-are treading on the law as written.
According to industry leaders, the latest indication of FTC overstepping was when the FTC filed a legal motion for order of contempt against Bayer Corp. this fall, calling the company’s Phillips’ Colon Health probiotic structure/function claims unsupported. Bayer says the product “defend[s] against occasional constipation, diarrhea, gas, and bloating. When taken on a daily basis, it can help replenish the good bacteria in your colon and support digestive health and immune health.”
According to the FTC and its own gastroenterology expert, Bayer would need randomized, placebo-controlled human clinical trials (RCTs) to substantiate such claims. But industry leaders argue that RCTs are required for drug treatment claims, not supplement structure/function claims, and that both law (DSHEA) and formal FDA and FTC guidance specifically state that dietary supplements are not to be regulated as drugs.
While structure/function claims must be supported by “competent and reliable scientific evidence,” RCTs are not required. There are a number of reasons for this, relating to the fact that supplement studies-studies proving that a product shores up general good health over time rather than curing an acute disease-are more complicated than the typical single-API drug study. Supplement studies are also complicated by such factors as subjects’ overall nutrient intake and the fact that performing studies in healthy populations requires a very long (and expensive) trial. As such, supplement firms are allowed to refer to a number of study types to support structure/function claims, including, explains the Council for Responsible Nutrition (CRN; Washington, DC), randomized clinical studies on a specific population whose results are extrapolated to the general population, epidemiological evidence, in vitro studies, animal studies, and observational studies. FTC guidance even makes clear that there is “no fixed formula for the number or type of studies required,” CRN points out, and FDA does not require that studies must be done on the finished product being sold.
Industry leaders say the Bayer case is just the latest example of FTC overstepping DSHEA’s authority, as it has in consent orders past. And the slope towards unofficially rewriting supplement regulations, they say, is slippery. As the Natural Products Association (NPA; Washington, DC) said, if the Bayer case is allowed to stand, “the distinction between dietary supplements and drugs will effectively evaporate.”
This is why CRN and NPA are now objecting legally in the Bayer case. In October, both associations filed amicus briefs (“friend of the court” insights that challenge the FTC’s legal actions in the Bayer case) “to try to inform the judge as to what we believe the correct standard is, because we believe the FTC is using the wrong standard in this case,” says Steve Mister, CRN’s president and CEO. Because, he points out, Bayer is not making drug claims that would require RCTs. “In this case, you’re not talking about treating an acute symptom. The product is not suggesting that when you have gas, you go out and buy the product and it cures the gas in 30 minutes. That’s not what the product says. In this case, what we see is a straight structure/function claim: defends against occasional gas, bloating, constipation, and diarrhea. Those are recognized for years in both the FTC guidance and the FDA guidance on structure/function.”
At this stage in the legal game for Bayer, there is still a chance that the court could take these associations’ objections into consideration. “We’re waiting to hear now whether the FTC would oppose that,” Mister says. If it does, “then we’d have to go have a hearing with the judge to argue why we have the right to intervene in this case and become an amicus in the case.”
If the dietary supplements industry aims to celebrate another 20 years of DSHEA, then it needs to defend the law. “I think everything about this case is a wake-up call to the industry that we need to pursue this,” says Mister.
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