A recent United States District Court (New Jersey) decision has scored a small but significant win in a battle between Bayer and the federal government. As was described in the Court’s opinion[1], Bayer was the defense in a case brought by the Federal Trade Commission (FTC), although Bayer was the ultimate victor in the courtroom battle. This case illustrates that the government can be found to be unconvincing in its arguments against a manufacturer, if the manufacturer has had the foresight to prepare adequate supporting evidence of a claim. However, other supplement manufacturers must take the findings of this case with caution; the circumstances were specific and related to previous enforcement actions against the company.
In order to fully evaluate the findings of the case, some background of the interaction between Bayer and FTC is necessary.[2] In 2007, Bayer entered into a Consent Decree (CD) with the United States government stemming from an alleged violation of the 1991 FTC administrative order (entered into by Miles, Inc., a predecessor to Bayer) that required a cease and desist on certain advertising practices stemming from the One-A-Day WeightSmart brand of vitamin and mineral supplements (the claims revolved around metabolism enhancement and weight control). Part of the decree prevented the manufacturer from making any representation of the benefits, performance, or efficacy of any dietary supplement it markets or sells unless the manufacturer possesses and relies upon competent and reliable scientific evidence[3] to substantiate a claim at the time a claim is made.[4]
In 2008, Bayer began an advertising campaign to market Phillips Colon Health (PCH), a probiotic dietary supplement product. Bayer notified the Food and Drug Administration (FDA) for each claim that was made for the PCH product (i.e., “to promote overall digestive health” and “helps defend against occasional constipation, diarrhea, gas and bloating); the label contained the FDA disclaimer “This product is not intended to diagnose, treat, cure or prevent any disease.” In 2011, the FTC began investigating Bayer to ensure that the manufacturer had adequate evidence to substantiate the information that was used in advertising for PCH. Bayer supplied documents to FTC in 2011 and 2012 as evidence to support the advertising campaign associated with PCH. Apparently, those documents were not adequate to persuade the FTC that Bayer was complying with the CD. Upon making this conclusion, FTC transferred the case to the Department of Justice (DOJ), who filed a motion for an Order to Show Cause in 2014. The DOJ filed a contempt motion against Bayer on September 12, 2014, and the District Court granted the motion from the DOJ and ordered Bayer to show cause as to why it should not be held in contempt.
The contempt hearing was held in June 2015, when both parties presented evidence in support of their position. After seven days of testimony, and deliberation over the next few months, the Court ultimately found that Bayer was not in violation of the CD and that the government had failed to establish by “clear and convincing evidence” that Bayer had violated the 2007 CD. In order to describe how the government failed to establish that Bayer had violated the 2007 CD, the main points in the Court’s opinion will be reviewed.
First, the government alleged that Bayer failed to substantiate the claims it was making for its PCH product. Bayer conducted an internal review of publically available literature (via searchable databases) in support of the use of probiotics for gut and immune health. The government claimed that Bayer was in violation of the CD simply because the company did not print out, copy, or otherwise record all of the studies it relied upon to substantiate the PCH claims. The Court pointed out that the CD does not require Bayer to make copies of the studies and that Bayer only needed to “possess and rely upon competent and reliable scientific evidence”. In fact, one government witness testified that the “obligation to maintain documents does not require printing or filing of documents.” The Court found that Bayer did not violate the terms of the CD in this respect.
Second, the government argued that Bayer made implied disease claims for the PCH product, suggesting that the terms used in Bayer advertisements are “euphemisms for ‘treat, cure, and prevent’” in relation to a disease. The Court determined that the government never asserted that Bayer made disease claims; rather, that the government asserted that the disease claims were implied. No evidence was presented to support the argument that Bayer was making any disease claims (i.e., no consumer survey data or the testimony from a marketing expert). Therefore, the Court found that the government failed to provide evidence that Bayer made such claims. Further, the Court, referencing FDA rules, stated that the claims for PCH are structure/function claims, which are appropriate for dietary supplements. The Court found that the government did not meet the burden of showing “clear and convincing evidence” that Bayer made implied disease claims.
Third, the government made the argument that the studies that Bayer relied upon were inadequate for substantiating claims. This argument was advanced by the expert witness used by the government, Dr. Loren Laine, who provided an expert opinion on the study design that he stated was required to provide competent and reliable scientific evidence. Dr. Laine posited that competent and reliable scientific evidence for PCH claims required a randomized control trial (the Court labeled this as a “Laine-Level RTC”). Laine-Level RCTs included eight requirements: randomization; placebo-control; double-blind; human clinical trial; trial conducted on the target population; trial involving the specific issue at hand; use of appropriate statistical methods; and designed so the that the outcome is the primary endpoint. However, Dr. Laine testified that he is not aware of any dietary supplement or probiotic that has a study design that meets all of these criteria and his trial design does not distinguish between drugs and supplements. As the Court pointed out, his testimony was inconsistent with FTC guidance, which indicates that there is no fixed formula for the type or number of studies required to substantiate competent and reliable scientific evidence.
The government contended that the CD that Bayer entered into looks to what experts in the field would require for substantiation of the claims made for PCH. The Court found that Dr. Laine did not possess the expertise necessary to prove what experts in the field would require. During testimony, Dr. Laine admitted that he is neither an expert on probiotics (although he is a professor of gastroenterology at Yale University) nor on dietary supplements. He also testified that he does not regularly use probiotics in his medical practice. Dr. Laine was not familiar with the details of the Dietary Supplement Health and Education Act (DSHEA) of 1994, did not rely on FTC guidance for his opinion, and was even quoted saying that he was “not paying attention to the law or regulations about the difference between dietary supplements and drugs”. In fact, he was not even informed by FTC on the regulatory differences between a structure/function claim and a disease claim. The Court pointed out that Congress recognized the benefits of dietary supplements and lowered the substantiation required for supplements in comparison to drugs. The Court determined that the testimony that Dr. Laine offered was an opinion not held by other experts in the relevant field, including two experts that testified on Bayer’s behalf. Overall, the Court appeared to be unimpressed by Dr. Laine’s testimony as it related to this case.
While the Court ultimately concluded that the government failed to establish that Bayer violated the 2007 order, this finding should not be viewed as a blanket dismissal of FTC enforcement actions against supplement manufacturers. The arguments made in this case were specific to the CD that both parties agreed upon. Language in other orders may be different and more limiting, thus restricting the ability of the defense to make similar arguments. However, it does point out the importance of complying with a CD (if established) and following applicable regulations when establishing a strong defense in the face of a violation claim. This decision also illustrates how important it is for a manufacturer (including Bayer, in this case) to rely on scientific evidence to support a claim made for a dietary supplement (even in the face of lofty Laine-Level RTC recommendations).
[1] Alex LeBeau has a Doctor of Philosophy degree in Toxicology and Risk Assessment, he is not an attorney, and does not represent this article as being a legal opinion.
[2] United States of America v. Bayer Corporation. Case 23:07-cv-00001-JLL-JAD Document 196: Opinion http://www.fdalawblog.net/Bayer%20decision%209-2015.pdf
[3] Background and finding summary based on the U.S. District Court opinion issued on September 24, 2015.
[4] Defined in the Federal Trade Commission Guidance Document Dietary Supplements: An Advertising Guide for Industry as tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area. https://www.ftc.gov/tips-advice/business-center/guidance/dietary-supplements-advertising-guide-industry
[5] The Dietary Supplement Health and Education Act (DSHEA) of 1994 states that a statement (i.e., claim) made by a manufacturer of a dietary supplement must be substantiated such that the statement is truthful and not misleading. https://ods.od.nih.gov/About/DSHEA_Wording.aspx#sec5