Last month the US Federal Trade Commission brought a motion against Bayer for claims made in relation to Phillips’ Colon Health. The FTC case focuses on two sets of claims – the expressed claims (structure-function claims for dietary supplements) and alleged implied claims.
In the FTC motion, the agency lists the alleged implied health claims as:
“For example, one of Bayer’s television commercials for Phillips’ Colon Health features a spokesperson (the ‘Colon Lady’) emphasizing ‘diarrhea, constipation, gas, bloating,’ and then a consumer praising ‘what a difference Phillips’ Colon Health has made.’ […] other television commercials for Phillips’ Colon Health make similar implied claims.
“Likewise, Bayer’s print advertisements make claims implying that Phillips’ Colon Health prevents, treats, or cures constipation, diarrhea, and gas and bloating. ([For example,] depicting a large SOS-distress signal with the repeated words ‘constipation’, ‘diarrhea’, ‘gas’, and ‘bloating’, and stating ‘[m]aybe your colon is trying to tell you something’, which implies Phillips’ Colon Health can treat or cure active symptoms [and] asserting that a person should take Phillips’ Colon Health ‘when your system is under distress from [o]ccasional diarrhea or constipation’, which also implies Phillips’ Colon Health can treat or cure active symptoms).”
Bayer “strongly disagrees with the US FTC decision”, the company told us, and will defend itself “vigorously”.
“It is important to note that Bayer never made any claims suggesting that Phillips’ Colon Health should be used to mitigate, prevent or treat any disease,” added the company.
In its brief, the CRN argues that by requiring multiple randomized, placebo-controlled, and double-blind human clinical trials using the specific product for which the claims are made and are performed in the population at which the claims are directed, the 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.”
The brief further outlines the negative consequences that would come as a result of the government overreaching its authority, saying the change “would significantly impair the flow of truthful, valuable, and scientifically sound information about dietary supplement products and limit consumers’ ability to make fully-informed nutrition-related decisions.”
“We are concerned that, if successful, FTC’s attempt to impose this legally-unprecedented review of advertising claims for supplements could eliminate many structure-function claims and disregard a wealth of rigorous scientific data that does not meet the narrow drug-like requirements,” said Steve Mister, president & CEO, CRN. “It would chill the First Amendment rights of manufacturers, marketers and consumers to communicate and to receive truthful information about the health benefits of these products.”
“Using consent orders to re-write federal law”
In its brief, NPA states that claims made on the product to ‘defend against occasional constipation, diarrhea, and gas and bloating’ are sufficiently qualified and limited in scope to declaim any implied disease origins as structure/function claims permitted under the Jan. 6, 2000 Structure/Function Final Rule, which was written exclusively for dietary supplements.
“While these are structure/function claims, the government contends that Bayer needs randomized, controlled, clinical trial (RCT) studies for the product for every strain,” stated the NPA. “The sole support for this unprecedented argument is the report of the government’s expert Dr. Loren Laine, a gastroenterologist, who contends that such RCTs – and only such RCTs – are ‘competent and reliable scientific evidence’.
“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.”
The association stated that demanding two clinical trials to substantiate claims made on dietary supplements would curtail consumer choice, which is protected under the Dietary Supplement Health and Education Act (DSHEA). Such an imposition is not consistent with DSHEA, it said.
“NPA is very concerned that the government is using consent orders to effectively re-write federal law on dietary supplements,” said Daniel Fabricant, Ph.D., NPA Executive Director and CEO. “It’s important to point out that consent orders, which are meant to be case specific, may have unintended consequences for consumers if applied across the industry. Those include not just increased costs, but also the possibility of the reduced quality and quantity of information about products available to consumers.
“We urge the court to carefully consider this case and recognize that the outcome could result in major consequences for consumers, retailers and manufacturers of dietary supplements.”