The FDA on Product Claims

A couple of days ago, we learned the FTC's perspective on product claims in advertising. Now, it's time for FDA, which examines product claims on labels, to have its say.

Readers, how do you feel about what's being said from the two agencies? Are you sympathetic to the their plights? Is it the same old song-and-dance. With NDI notification now on the table, are you confident FDA can handle that responsibility?

Here are the highlights of my interviews with Daniel Fabricant, director of FDA's dietary supplement program division, and FDA spokesperson Siobhan DeLancey.    

Leads come from different places: Consumers call in tips, so do manufacturers. AERs are huge. Another source: the spouses of FDA employees, who have a sharpened awareness of what's appropriate. "We all shop," DeLancey says. "Contrary to popular belief, regulators do eat."

Inappropriate product claims aren't a black-and-white issue:  A customer may see one thing, FDA another, Fabricant says. "It may not be the text per se, it may be a picture on an ad, plus the text that is grossly violative," he explains. "[The ad] may not meet the legal threshold of what violative." Fabricant adds that each questioned claim is looked at objectively.

Labeling is an across-the-board job:  "We have not only the division of dietary supplement regulation, but an office of compliance, but it's for conventional foods, cosmetics, and dietary supplements," DeLancey says. "Once we know about a particular product or have concerns about a product, and they're the ones who look at the labeling from a regulatory standpoint." 

DeLancey adds that regulators are cross-trained, so nobody handles one topic. "We don't want anyone sitting on their hands."

Like FTC, FDA can only do so much: "We're not going to get everyone, but we can help deter," says Fabricant, who refers to the agency as the cop on the highway. "You'll slow down," he adds. "That helps us."

What galvanizes FDA? According to DeLancey, that would be products making claims for treating or curing a disease, especially ones targeted toward a community where loved ones have a disease with no known cure. Think chelation products and autism from a few years back. For Fabricant, it's a matter of the public health impact of the product claim.

Remember how the Internet was a pain for FTC? Same for FDA:  "It's easy to be nimble," says DeLancey, though FDA monitors the Web for violations. How? She's not saying. "That's a carefully guarded trade secret."

It's not just the Internet that's nimble:  DeLancey admits that with some questionably claimed products, the distribution chain is so twisty -- and its participants so unwilling to talk -- that it can be impossible to find the manufacturer. 

Want to avoid an FDA crackdown? Do your homework: For DeLancey, knowing the rules for product claims (including structure function claims), even if means hiring outside help -- she stresses that FDA can't handle this role -- is a big help. What FDA requires is not big secret. Start here to learn more.