Not a good time to be the Federal Trade Commission. Last month, a New Jersey district court issued its decision in the United States (FTC) v. Bayer case involving advertising for the Phillips Colon Health (PCH) probiotic supplement. The court held that Bayer was not in contempt of an earlier order, ruling the company did not violate the 'competent and reliable scientific evidence' (CARSE) standard for advertising and rejecting the FTC's attempt to hold Bayer to a standard that requires at least two randomized clinical trials (RCTs) to support its advertising claims for PCH.
It was a good day for many of us in the supplement industry who insist that advertising must be substantiated to prevent misleading consumers but maintain that two RCTs are a drug-like standard that may not always be appropriate, practical or even possible to support the benefits of some supplements. The CARSE standard is a flexible one that allows a variety of research to support claims.
Not to throw a wet blanket on the celebration, but the decision also provides some cautionary advice for supplement marketers. It's worth pausing to examine the court's opinion to take notice of some lessons to be learned.
Lesson 1: First, marketers of dietary supplements must be cautious that express claims are not the end of the story. The takeaway message for consumers may go beyond the express claims in an ad. Accompanying images, context and suggestion in advertising can all contribute to implied claims that may go beyond what is express, and even suggest disease claims for the product. Indeed, the Food and Drug Administration, as well as FTC, has been known to point to nonverbal elements of advertising or labeling as evidence that a product is intended to be used as a drug. In Bayer, FTC argued that 'defends against occasional constipation, diarrhea, gas and bloating' transmitted that the product was actually intended to treat, prevent or cure these conditions on an acute basis.
The court disagreed and noted that the government offered no survey data, no consumer testimony, no expert opinion on consumer understanding, no marketing data, and no cost tests of the advertising to support its argument that Bayer was actually making implied claims to treat, prevent or cure a disease. But in other cases, like POM Wonderful, FTC has successfully argued that artwork and creative copy combine to produce implied claims that the advertiser must be prepared to substantiate. And what if FTC had gone to the trouble to do focus group or copy testing of the PCH claims - what would it have discovered is the consumer takeaway?
Supplement advertisers should be reminded that itâs better to know that answer before the ad is released. Doing some consumer testing of ads to determine the overall net impression of your claims is better than having FTC tell a court what your ad was intended to convey or how consumers actually understood it.
Lesson 2: Marketers have long insisted that they need not conduct studies on their product but rather may rely on studies of the individual ingredients. Indeed the FTCâs guidance for industry has expressly permitted claims to be substantiated using âborrowedâ research on the same ingredients without conducting new research on the specific formulation. In Bayer, FTC challenged this assumption when its expert asserted that the various strains of probiotics contained in PCH could be antagonistic with one another and thereby negate the positive benefits of the strains individually.
Ultimately, the court rejected this argument because Bayer's experts argued persuasively that this opinion, in the context of the specific probiotics used in PCH, was contrary to what most experts in the field would state. After extensive testimony, the court noted there was no biological plausibility, no evidence and no references to support the FTCâs expertâs conclusion. But it does raise the question, "what if there was?"
Savvy product developers and marketers will take caution from Bayer that the general principle that ingredient studies are sufficient to support claims for the final product is not unconditional. Sometimes ingredients that produce positive health benefits alone can have antagonistic effects, or even synergistic effects, when they are combined. The government's claim that studies must be conducted on the specific product in order to dismiss the possibility of an interaction of the ingredients failed, but the fact that the court raises this matter signals that it is a potential that must be considered and dealt with. Has your science team researched and evaluated the possibility of an interaction? Is it biologically plausible that two ingredients in combination could have an effect (or no effect) that they don't when used separately? Do references in the scientific literature suggest the ingredients are incompatible? In those cases, additional research may indeed be prudent to assure the claims for the ingredients individually will hold up when they are combined.
Now we can resume the celebration a little wiser and better prepared to serve our consumers.
What other lessons can we draw from this case?