UPDATED: NPA calls decision a "win for the industry and consumers"

‘A drug-level randomized controlled clinical trial for a supplement has never been the standard’: Bayer ‘gratified’ with court decision vs FTC

By Stephen Daniells contact

- Last updated on GMT

Image © iStockPhoto
Image © iStockPhoto
The hotly anticipated decision in the dispute between Bayer and the US Federal Trade Commission over claims in support of Phillips’ Colon Health is in, with a judge ruling in favor of the company.

US District Court Judge Jose Linares ruled in favor of Bayer last week, but the order remains sealed until October 8, 2015.

Bayer released the following statement following the Court’s ruling:

“Probiotic bacteria, including the three species used in Phillips’ Colon Health, have substantial science supporting their digestive benefits. Claims about Phillips’ Colon Health are fully substantiated by numerous clinical, animal and genetic studies, among other things, and satisfy all applicable legal standards.

“We are pleased with the US District Court’s decision.  Requiring a drug-level randomized controlled clinical trial for a dietary supplement is not and has never been the standard for dietary supplement claims. We are gratified that the Court agreed with this view.”

History

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.

In its motion, the United States alleged that Bayer expressly claimed Phillips’ Colon Health can “defend against” occasional constipation, diarrhea, and gas and bloating, and impliedly claims that Phillips’ Colon Health prevents, treats and cures constipation, diarrhea, and gas and bloating, even though the company “lacks competent and reliable scientific evidence for those claims”, allegations the company strongly disputed.

Phillips probiotic caps

The FTC/DoJ also alleges that Bayer has violated a 2007 consent decree that prohibited the company making unsubstantiated claims for any dietary supplement it promotes or sells.

Many industry observers warned that success for the government in this case would have wide-ranging implications, requiring structure-function claims to be substantiated by randomized clinical trials. The Council for Responsible Nutrition and the Natural Products Association filed Amicus briefs​ in relation to the case (NPA filed two​). 

Bayer was represented by Sidley Austin LLP. The Sidley legal team for Bayer was led by Jonathan Cohn and also included Mark Hopson, Benjamin Mundel, and Blair Greenwald.

NPA: This is a win for the industry and consumers

The Natural Products Association hailed the decision to not hold Bayer AG in contempt for claims made by the supplement manufacturer regarding a drug it marketed to promote digestion. NPA filed two Amicus briefs in support of Bayer during the case.

“We are happy with the decision of the court and it appears our Amici were considered heavily in the decision as only NPA’s comments were repeated verbatim in the opinion”​ said Dan Fabricant PhD, NPA's CEO and executive director. “Still, 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. As we said throughout the court proceedings, NPA felt the FTC would have set a dangerous precedent had the overbearing standards it was seeking become affirmed.​”

To read NPA's full statement, please click HERE​.

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1 comment

Thanks you Bayer

Posted by Rob Verkerk PhD,

Seemingly we need a drug company to take a stand on this issue, and it's gratifying that the FTC has been stopped in its tracks. Now we nee the European Commission and EFSA to take note and stop the blackout on probiotic health claims, including allowing the term probiotic to be used commercially. Increasingly it looks like targeted defensive and offensive legal actions are going to be needed to resolve a situation that ultimately prevents consumers learning about the intended use of products

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