Ullman on Bayer-FTC issue: ‘Be as careful with your implied claims & testimonials as you are with the express claims’
Marc Ullman of the firm Ullman, Shapiro and Ullman told NutraIngredients-USA: “The take home for industry is that you need to be as careful with your implied claims and testimonials as you are with the express claims.”
Express and implied claims
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.
The FTC case focuses on two sets of claims – the express 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).”
‘Potential vulnerability on the implied claims’
“The motion is very interesting in the way the government is trying to lump express and implied claims together,” said Ullman. “The express claims by Bayer/ Philips’ Colon Health are what we would consider mainstream structure-function claims. The implied claims, and there may be some merit here, seem to push the envelope on structure-function claims.
“I see potential vulnerability on the implied claims.”
“We do not know how the court will react. If they dismiss it then FTC may think that they should have only gone after the implied claims. If they agree with the motion then it means Bayer would have to have human clinical trials to substantiate the claims.”
The science
The FTC also alleges that “none of the nearly 100 documents that Bayer provided to the FTC and associated with Bayer’s claims about constipation, diarrhea, and gas and bloating are clinical trials of Phillips’ Colon Health or a product with the same three bacterial strains as Phillips’ Colon Health.”
The motion goes on to state:
“Studies done using products containing a different combination of bacterial strains than Phillips’ Colon Health do not qualify as substantiation for Bayer’s claims, because different combinations of ingredients can have different effects […] Furthermore, one cannot ‘extrapolate’ (or generalize) the health effects of one bacterial strain to another strain of the same species of bacteria in the absence of a separate clinical study assessing whether that other strain has the same effect.”
Ullman noted that there seems to have been a long term FTC argument against ingredient specific claims.
“I’m sure Bayer will come back with experts,” he said, “and they’ll show at least three separate studies with each of these strains [Lactobacillus gasseri KS-13; Bifidobacterium bifidum G9-1; and Bifidobacterium longum MM-2], and argue that there is no reasonable basis to argue that by combining the strains that one negates another.”
