WASHINGTON

Representatives from FTC and FDA spoke about their respective approaches to dietary supplement immunity claims at a Mar. 11 Webinar hosted by the Food and Drug Law Institute (FDLI). Richard Cleland, from the division of advertising practices at FTC, said the agency is concerned about implicit claims made for immunity products, reminding structure function claims such as boosts immune function still require adequate substantiation. He noted probiotics are currently a hot marketing category, causing FTC to pay particular attention to immunity claims in this product category. Similarly, Robert Moore, from FDAs Center for Food Safety and Applied Nutrition (CFSAN), reviewed what his agency looks for in substantiation of health claims and structure-function claims, including what types of evidence and studies are needed.

Both agencies appeared convinced consumers interpret boosts and strengthens immune function as implying  taking the product will reduce the risk of contracting a disease such as cold or flu. However, Cleland indicated supports and maintains immune function are innocuous enough claims that consumers dont assume means reduced risks; instead he said consumer likely look at these maintenance claims as promises to help them stay at their current level of immune function. For the implicit therapeutic claims, he said supporting studies must show benefit to the proper endpoint, not just immune function biomarkers; however mechanism of action on markers would be fine to support maintenance claim, provided those markers are relevant.

Cleland went over the agencys recent actions on Airborne knock-offs, including products from Rite Aid and CVS. Also discussed was Northwest Natural Products closing letter, which involved immune boost and implicit disease claims for childrens supplements. Looking ahead, he said the probiotics market is forewarned of FTCs focus on immunity claims for beneficial bacteria products, especially functional foods. Noting Europe has also taken issue with this category, he said the agency is concerned with that study results on probiotics and immune benefits are inconsistent, and they often rely too heavily on symptom reports instead of actual examinations to gauge improvements. He added studies on immune markers are not sufficient to show specific benefits.

Among the revelations from Moore said FDA sometimes relies on metatags to determine if web marketing constitutes an implicit claim. He also noted the agency finds companies overlook the need for evidence that a structure-function claim is not misleading and is adequately substantiated. OF course, he reaffirmed there is no set formula or list of what satisfies this requirement, as it is determined on a case-by-case basis. He did offer anecdotal and traditional use will not rise to meet the standard of evidence required. The more criteria that is met, the more likely the company is to meet the standard, he said.

One complicating factor may be the presence of other ingredients either in the product bearing the claim or in the research offered as support for the claim, as it becomes harder to definitively tie the specific study to the specific product/ingredient.  Overall, he explained it is the totality of the evidence, both qualitative and quantitative, considered by FDA, and one negative study does not necessarily mean failure of the claim. Companies have the opportunity to explain why a negative outcome does not represent the product or benefit included in the claim.

Moore reported FDA has not done a lot of work in the false and misleading area of claims, instead choosing to focus on the illegal disease claims, saying it is a more effective use of agency resources. However, he said one thing that troubles FDA about structure-function claims is studies are often done in diseased population, where the structure-function claim allowance is for benefit to healthy populations.

Numerous questions rounded out the Webinar, with Moore summarizing the FDA as: the evidence required is whatever allows you to say what you want to say. As vague as this appears, he said there is no safe harbor, nor is there one right or wrong approach to adopt or avoid; it comes down to whether a company can prove its claim enough to satisfy FDA, based on the agencys substantiation standard. And Cleland reiterated simply showing an effect on some markersthere are hundreds of markers linked to immune functionmeans nothing. He said the immune system is more complex than previously thought, as many modern scientists now believe the concept of the single immune system is probably flawed.

For more information on the Webinar, visit FDLI.org.