Transcript for the audio podcast: Dietary Supplements
From the Office of Inspector General of Department of Health and Human Services
Roberta Baskin, Director of Media Communications, sits down with Melissa Hafner, Program Analyst for the Office of Evaluation and Inspections (OEI) in Boston to discuss two recent reports, Dietary Supplements: Companies May Be Difficult to Find in an Emergency and Structure/Function Claims Fail to Meet Federal Requirements.
[Roberta Baskin] I'm Roberta Baskin, the Director of Media Communications, speaking with Melissa Hafner, a program analyst for the Office of Evaluation and Inspections. And, we're talking about two new reports about dietary supplements. And, Melissa, let's just start with what are dietary supplements and who uses them.
[Melissa Hafner] Well, there's really a wide array of products that could be considered dietary supplements, and about 80 percent of U.S. adults take one. A dietary supplement is a product you take to supplement your diet-it could be anything from a multivitamin to a drink mix for weight loss or a capsule of Echinacea. FDA regulates dietary supplements as food, so you don't need a prescription for them, and FDA doesn't review or approve them the way it does with drugs.
[Roberta Baskin] So what inspired the Office of Inspector General to study dietary supplements?
[Melissa Hafner] Well, we were specifically interested in a type of claim that manufacturers can place on a dietary supplement label called a structure/function claim. Things like, "supports healthy immune function," or "promotes weight loss" are examples. Consumers rely on these claims for information on the supplements' intended effects, so it's important that the claims have science to back them up. If they don't, consumers might not only be wasting their money, but they could endanger their health if they take a supplement in place of a drug thinking it will have the same effect.
[Roberta Baskin] And how does FDA make sure these so called structure-function claims are not misleading?
[Melissa Hafner] FDA has two main ways of regulating these types of claims. First, dietary supplement makers are required to send FDA a written notification of the claim within 30 days of marketing the supplement. Second, they are required to have scientific proof showing that the claims are truthful and not misleading. FDA has published recommendations saying that evidence used to back up structure/function claims should come from high-quality human studies, and that the evidence should be directly related to the claim on the label. But it's important to know that manufacturers don't have to share that evidence with FDA, they just have to possess it.
[Roberta Baskin] So how did you go about looking at these claims?
[Melissa Hafner] So we bought a sample of 127 dietary supplements. We bought half of the supplements from five cities around the U.S.-from convenience stores, supermarkets, health food stores, specialty stores. And we purchased the other half from the internet. Now all of the supplements we bought had structure/function claims related to weight loss or immune support because various experts had told us these were some of the most popular types of supplements.
So we asked the makers of the supplements in our sample to share the scientific evidence behind their claims so that we could review it against FDA's recommendations. And then we looked for disease claims on the labels. FDA-approved drugs can claim to treat or prevent illness, but it's prohibited for supplements. And then finally we also checked with FDA to see if they had been notified of the claims as is required.
[Roberta Baskin] And did the evidence meet FDA's guidelines?
[Melissa Hafner] Now overall, the documents they sent us didn't reflect what FDA recommends. Most of the evidence didn't involve the actual supplement, and most didn't even test the supplement or its active ingredients in humans, as FDA recommends. Some of the documents didn't qualify as evidence at all. One supplement maker gave us a hand-written, 30-year-old college term paper. Others gave us Wikipedia pages on an ingredient in the supplement, advertisements, or press releases.
[Roberta Baskin] Okay well translate this for consumers who buy these supplements.
[Melissa Hafner] We think it means buyer beware. Based on this research, the documents didn't appear to meet FDA's guidelines for quality evidence. We also discovered that FDA couldn't tell us whether it had received notifications for all of the claims in our sample because their tracking system is so out of date.
[Roberta Baskin] So what about these supplements with labels that claim to prevent diseases?
[Melissa Hafner] Well, on top of that, 20 percent of the supplements in our sample actually had disease claims, which is illegal. Some of the products claimed to treat influenza, the common cold, herpes, or HIV, while others claimed to reduce cholesterol or prevent diabetes.
[Roberta Baskin] So what can the FDA do about this?
[Melissa Hafner] OIG is recommending that FDA seek explicit authority to review the scientific evidence behind structure/function claims, and to update their tracking system for the claims so they'll know if manufacturers are complying with the notification requirement. We're also recommending that they step up their surveillance of supplements to make sure they're catching illegal disease claims. They generally agreed with those recommendations so we're hopeful that FDA will enhance its oversight of these claims and that consumers can feel assured that what they're reading on the label is truthful.
[Roberta Baskin] Melissa Hafner, thank you so much. The supplement reports affect all of us.
[Melissa Hafner] Thank you.
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Unimplemented OIG recommendations summarized.
FY 2013 Work Plan
OIG projects planned for 2013.
Significant OIG activities in 6-month increments.