Looking To Boost Your Immune System? You May Need To Boost Your Clinical Evidence

Representatives from the FTC and FDA offered valuable insight into the agencies’ current thinking on immune system claims for food and dietary supplement products last week. Richard Cleland, Assistant Director of the FTC Division of Advertising Practices, and Robert Moore of the FDA’s Center for Food Safety and Applied Nutrition confirmed that immune system claims are on the radar screens of both agencies.

Speaking at an FDLI webinar, Mr. Cleland stated that, under a new standard the FTC is looking to set for claim substantiation, products that claim to do anything more than simply support a healthy immune system will be subject to a standard of evidence only previously seen in the drug testing world. He further confirmed that probiotics, the healthy bacteria found in many yogurt products as well as in dietary supplements, are high on the agency’s radar screen and that enforcement is coming.

On behalf of the FDA, Mr. Moore also indicated that claims such as Boost immune defenses” may be implied disease claims. He further noted that the agency is looking beyond the much-publicized Front of Packaging Labeling Initiative to the metatags on websites and reliance on disease treatment studies to determine whether a product is being properly marketed as a food/dietary supplement or as a drug.

Neither representative discussed whether consumers actually rely on these messages in deciding whether to purchase products. Regardless, it is clear that both agencies are looking closer than ever at what is behind the claims on food labels.