NAD Sees Health Claims Without Clinical Trials As Risky But Possible

The National Advertising Division agrees with the Federal Trade Commission on expecting randomized controlled clinical trials as competent and reliable evidence for health claims, but acknowledges other support can be adequate.

To adequately support health performance claims, “what you are looking at generally speaking is a randomized, placebo-controlled study that is significant, 95% confidence level, and is done on humans, said Kat Dunnigan, senior NAD attorney, at the Council of Better Business Bureaus division’s annual conference in New York.

“In vitro and animal studies in and of themselves are insufficient when you are talking about a claim when you say a product has a specific effect,” she said during a Sept. 28 panel session, “Art and Science: Getting Claim Substantiation Right.”

However, clinical trials sometimes are not the only accepted support, Dunnigan adds.

“NAD’s standard and review is meant to be flexible. If there is something you can say or show us that says an RCT is not the best and most efficacious way or might be unethical to do, certainly that is an argument to be made,” she said. “There is a bit more risk in that approach.”

As an example of a non-human trial NAD accepted as support for a health claim it reviewed, Dunnigan noted an oral care marketer claimed its toothbrush was more gentle on dentin – the part of the tooth exposed when enamel is stripped away – than a competitor’s brush.

“It would have been somewhat painful to do that test on humans, so they did it on in vitro models. It’s all about what’s reasonable,” she said, adding that those models represented adequate support for the gentleness claim.

NAD attorneys’ reports on their reviews commonly cite FTC guidelines in explaining their expectations for substantiation of ad claims. However, questions about FTC’s and NAD’s recommendations for clinical trials as support for health claims by consumer products could grow due to court rulings about FTC’s insistence on RCTs for supplement structure/function claims.

FTC’s position took a hit in September when a US district court denied the Department of Justice’s motion to find Bayer AG in contempt of a 2007 consent decree, resolving allegations the firm made unsubstantiated claims for its WeightSmart line of One-A-Day vitamins. In the ruling, the judge said FTC’s standard of competent and reliable scientific evidence to substantiate consumer health care product claims does not require drug-level clinical trials (Also see "FTC Stretched Standards In Enforcement Against Bayer Probiotic Claim" - Pink Sheet, 5 Oct, 2015.).

Dunnigan was asked about NAD’s current position on RCTs in light of a January ruling in the US Court of Appeals for the District of Columbia that upheld FTC’s 2012 order against [POM Wonderful LLC] while saying the agency’s argument did not justify requiring two RCTs for all disease-related claims (Also see "Court Upholds FTC Order Against POM, But Scrutinizes Clinical Trial Requirement" - Pink Sheet, 30 Jan, 2015.).

Superiority Claims, Head-to-Head Tests

Expanding on NAD’s expectations, Dunnigan said advertisers also must show the treatment intervention is relevant to the claim. “Just because you tested significantly and you can see a difference, it doesn’t mean it’s meaningful,” she said.

She also urged companies to match populations in studies to consumers likely to use their products. “The population should be like the people you’re advertising to.”

The panel also discussed challenges with superiority claims and head-to-head testing that is essential to substantiating them.

Spring Potoczak, associate general counsel for Novartis Consumer Health Inc., said superiority claims generally are broken down into two types – superiority and comparative parity. She said Novartis marketers tend toward superiority claims, but she encourages comparative parity claims.

“Comparative superiority claims are challenging and tough to make, requires you to in essence support not only your product’s claim but your competitive product claim as well as the relationship between the two,” she said. “So the onus is pretty high to get to the point where you have confident and reliable scientific evidence to support claims.”

“The gold standard particularly when you are talking about efficacy or performance claims is head-to-head studies looking at both your product and a product or products in your class,” Potoczak added.

There are exceptions, she says, noting that Sanofi, without conducting head-to-head tests,supported the claim NAD reviewed that its Nasacort Allergy 24HR product is “the most effective OTC medicine for the treatment of nasal allergy symptoms.”

“The key in this from NAD’s perspective was that in the absence of head-to-head [tests], looking at the statements from experts” there was “competent and sufficient medical evidence” to support the claims, Potoczak said.

She pointed out the decision underscores that NAD’s review process allows for “some flexibility” when substantiating claims.

In the review on a challenge by the marketer of competing allergy reliever Claritin, Sanofi provided NAD with “strong scientific consensus with regard to product efficacy” that took the place of head-to-head testing (Also see "Nasacort 24HR Superiority Claims OK Without Head-To-Head Tests – NAD" - Pink Sheet, 7 Aug, 2014.).