December 30, 2014
Bayer Corp. has found itself in a heated battle with FTC over advertising claims for its Phillips’ Colon Health probiotic supplement product. The industry has a keen interest in the outcome of Bayer’s matter because the industry’s long-standing reliance on a flexible advertising substantiation standard could be adversely impacted.
FTC has jurisdiction over the advertising of a wide variety of consumer products, including dietary supplements. The basis for this jurisdiction is the FTC Act, which declares unfair or deceptive acts as unlawful and expressly prohibits false advertising. Customarily, FTC requires claims for dietary supplements be supported by “competent and reliable scientific evidence," which is defined as "tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area that have 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." FTC previously stated, there is no fixed formula for the number or type of studies required, nor is there guidance on specific parameters for studies including sample size or study duration. However, FTC has recently redefined its position on “competent and reliable scientific evidence" through a series of consent decrees with dietary supplement companies.
In 2010, FTC entered into consent decrees with Nestle HealthCare Nutrition Inc. and Iovate Health Sciences U.S.A. The consent decrees stated that claims for weight loss (Iovate) and claims for the treatment of diarrhea in children and/or prevention of absences from school for children (Nestle) must be substantiated by competent and reliable scientific evidence in the form of at least two randomized, double blind, placebo-controlled clinical trials (RCTs) that have been conducted by “different research independently of each other" and are consistent with the totality of evidence available. The consent decrees further discussed parameters of what constitutes “competent and reliable," in that the advertised product must contain the identical ingredients as were tested, except that inactive ingredients may differ, and these identical ingredients must be in the same form, dosage and route of administration as was tested. For the first time, FTC provided its position on the number of studies and the types of study parameters it felt met the “competent and reliable scientific evidence" standard.
In 2007, Bayer Corp. entered into a consent decree with FTC that prohibited the company from making unsubstantiated claims for any dietary supplement it markets to consumers. The 2007 matter was spurred by FTC’s challenge of claims made by Bayer through marketing of its One-A-Day WeightSmart supplement product. However, unlike the Iovate and Nestle consent decrees, Bayer’s consent decree made no specific mention of a two RCT requirement. Recently, the Department of Justice filed a motion of contempt against Bayer, alleging that the company violated the 2007 order by making unsubstantiated structure/function claims about its Phillips’ Colon Health product. In 2011, FTC began investigating Bayer’s advertising for Phillips’ Colon Health. Bayer gave FTC nearly a hundred publications and cover letters as a basis for its advertising claims relating to constipation, diarrhea, gas and bloating. In furthering its position on what constitutes “competent and reliable scientific evidence," FTC presented Dr. Loren Laine, a board-certified gastroenterologist and Professor at Yale University School of Medicine, as an expert witness. Laine explained that competent and reliable scientific evidence for Bayer’s Phillips’ Colon Health claims requires human clinical trials that (1) are RCTs; (2) use the specific product for which the claims are made; (3) are performed in the population at which the claims are directed; and (4) use validated methods and appropriate statistical methods to assess outcomes such as constipation, diarrhea, or gas and bloating. The motion then went on to address specifics of what constitutes competent and reliable scientific evidence as interpreted by Laine and FTC. Bayer continues to oppose the government’s motion, asserting that not only are its claims substantiated by competent and reliable scientific evidence, but FTC also seeks to impose an erroneous substantiation standard for dietary supplements.
Enforcement of the more rigid standard by FTC drew considerable backlash from the dietary supplement industry. Industry trade groups such as the Council for Responsible Nutrition (CRN), Consumer Health Products Association (CHPA) and Natural Products Association (NPA) voiced their displeasure with FTC’s imposition of a drug-based level of evidence standard for non-pharmaceutical products. CRN, deeply concerned with FTC’s recent action against Bayer, filed an Amicus Brief arguing that by specifically requiring multiple RCTs in humans, FTC is invoking “a rigid standard for the substantiation of non-disease claims made about dietary supplements that is a significant departure from the current well-established, consistent and flexible federal regulatory regime, upon which the entire dietary supplement industry has long relied." CRN believed that in supporting its contention, FTC “selected the wrong type of expert, out of either a misunderstanding or disregard for the differences between drugs and dietary supplements, and between claims of disease treatment and claims to defend against or even treat non-disease symptoms and promote health." NPA also voiced its displeasure with FTC’s actions against Bayer in its own Amicus Brief, noting, “there is no legal basis at present for the government to require one or multiple RCTs as the only accepted form of evidence for claim substantiation."
While the industry awaits a resolution in the Bayer matter, questions remain unanswered. First, should dietary supplement companies consider the terms of individual consent decrees between FTC and certain companies? The short answer is yes. It is unlikely FTC would take the position that a more rigid level of substantiation is required for companies entering into consent decrees with FTC, and a lesser, more flexible standard for those companies who have not. However, the important thing to keep in mind is that the rigorous standard of multiple RCTs is not explicitly supported by the law. It is merely FTC’s interpretation of what constitutes “competent and reliable scientific evidence" rendering a specific advertising claim truthful and non-misleading under the FTC Act. The dietary supplement industry has long been relying upon the documented flexible standard of “competent and reliable scientific evidence," and will likely continue to do so for the foreseeable future.
While the flexible standard in FTC’s guidance on dietary supplement advertising remains unchanged at the moment, the industry should carefully follow the Bayer matter in order to gain additional insight into FTC’s position, and perhaps to understand FTC’s application of the rigid “competent and reliable scientific evidence" standard moving forward.
For more on the laws that regulate the industry, visit INSIDER’s Regulatory Content Library.
Abhishek Gurnani is a partner at Amin Talati. Gurnani provides regulatory, transactional and litigation services to food, drug, dietary supplement, medical device and cosmetic companies.
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