Last year the US Federal Trade Commission brought a motion against Bayer for claims made in relation to Phillips’ Colon Health. The FTC case focused on two sets of claims – the expressed claims (structure-function claims for dietary supplements) and alleged implied claims. The FTC/DoJ alleged that Bayer violated a 2007 consent decree that prohibited the company making unsubstantiated claims for any dietary supplement it promotes or sells.
US District Court Judge Jose Linares’s decision to rule in favor of Bayer was widely welcomed by the dietary supplements industry.
Steve Mister stopped by our booth at SupplySide West to pick out the key lessons for industry (and why everyone should read the opinion).
“It’s a really good outline of what Bayer did correctly underneath that competent and reliable evidence standard that we’re held to,” Mister told us. “Another company with different facts, if they didn’t have the level of evidence and substantiation that Bayer had, might have had a very different outcome. Companies can read this opinion as an example of what you do need to do.
“This opinion is not a green light for companies to just say whatever they want, but if you substantiate them the right way then this opinion is a reassurance that you won’t be held in contempt.”
There are also lessons for using ingredient studies to substantiate claims in a combination product, he said. “If you look at the FTC guidelines, they have always said that you could use ingredient studies as the basis of your substantiation, even if you are adding ingredients and putting them in combination. In this case, the government tried to argue that Bayer had not done a study using the exact combination of probiotics that are in the product so how did they know for sure that when the probiotics didn’t interact with each other or were not antagonistic. The court said, ‘That’s a valid concern, but when you look at the experts they had actually done some scientific evaluation and they had made a very deliberate determination that the probiotics were not antagonistic.
“I think that’s a caution to the industry: You cannot just mix ingredients together and not do your science, but if you have your scientists look at the combinations and you decide that there is no biologically plausible reason that they would interact – positively or negatively – then you still don’t have to do this additional set of tests on the products, but you’d better know why you have chosen the reason you have to do that.”