Judge’s opinion on Bayer’s substantiation of probiotic claims

Randomized, controlled human trials may not be necessary to substantiate dietary supplement claims in the opinion of Judge Linares of New Jersey District Court. Judge Linares ruled that the FTC did not have grounds to hold Bayer in contempt of a 2007 Consent Decree regarding substantiation of claims made by Bayer on their Phillips Colon Health probiotic product. See other writings on this topic here, here and here.

At stake was the level of evidence the Judge considered was required by law to make claims about occasional digestive symptoms on a dietary supplement and whether or not those claims constituted implied drug claims. The Judge’s opinion1 is worth a read, and can be found here.

The FTC’s expert witness, Loren Laine MD, stated that human trials are required to substantiate claims and that these trials must be:

  • Randomized
  • Placebo-controlled
  • Double-blind
  • Done with human subjects
  • Done in the target population
  • Conducted with the specific product at issue
  • Analyzed using appropriate statistical methods
  • Designed with the desired outcome as the primary endpoint

The FTC has imposed RCT requirements on food or supplement companies in the past (e.g. Dannon, Nestle), but the judge was not willing to hold Bayer to this standard for the following reasons:  (1) the Consent Decree didn’t specify this requirement and should not be imposed post hoc, (2) DSHEA doesn’t require this level of evidence for dietary supplements, and (3) FTC’s own guidance to industry states “the need for RCTs is driven by the claims [petitioners] have chosen to make.”

The Plaintiff’s experts offered testimony that disagreed with Laine. The judge considered the witnesses’ testimonies and offered the following thoughts:

  • “Congress developed the dietary supplement category to ensure that supplements can be marketed and sold without following the stringent requirements imposed on drugs”
  • “…you don’t need gold standard randomized control trials for these kinds of claims.”
  • FTCs own guidances: “competent and reliable scientific evidence” defined as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results” (by both the 2007 Consent Decree and 1991 Commission Order).

Some significant findings of this Court:

  • RCTs are not required to substantiate claims on dietary supplements
  • Species-level evidence on probiotics is likely enough for general digestive health claim on well-studied species, but not for immune or other claims
  • Using the word ‘prevention’ does not automatically signal a drug claim
  • You don’t necessarily need tests on the specific formulation being marketed
  • Since the FDA is notified of claims prior to marketing of dietary supplements, they should object at that point, not after the product is marketed

The FTC may appeal this decision, and has 60 days from the date of the decision to decide to do so.

This court action reinforces the concept that Congress intended that dietary supplements do not need drug-like evidence, and although well-controlled studies as described by expert Laine are the gold standard for determining causality, lesser evidence can adequately substantiate non-drug claims. However, it is clear that companies must carefully consider the evidence they have for their claims and develop a legitimate scientific rationale for why claims are suitably substantiated, including justification if evidence is on a product format that is different from what is being marketed.

 

1Civil Action No. 07-01(JLL), Linares, District Judge, United States District Court, District of New Jersey, Case 2:07-cv-00001-JLL-JAD, Document 196 *SEALED*, Filed 09/24/15, 38 pages, United States of America, Plaintiff v. Defendant