NPR Airs "Regulation of Dietary Supplements"

November 1, 2000

4 Min Read
NPR Airs "Regulation of Dietary Supplements"

WASHINGTON--On Nov. 1, National Public Radio's (NPR) "Talk of the Nation" program broadcasted industry and media views regarding the regulation of dietary supplements. Guest host Melinda Penkava spoke with Michael McGuffin, president of the American Herbal Product Association (AHPA), and Bruce Silverglade, director of legal affairs at the Center for Science in the Public Interest. In addition, an interview with Washington Post science reporter and devil's advocate for the industry, Guy Gugliotta, was broadcasted in a separate segment within the program. According to Penkava, the Food and Drug Administration (FDA) declined the opportunity to sit in on the discussion.

Penkava stated that the current bad press revolving around ephedra stimulated a heightened concern for dietary supplement regulations. Gugliotta admitted that ephedra is regulated by the FDA as a food, but he stated that ephedra works more like a drug and should be regulated as such. "Companies do not have to report adverse effects if they take place, so pretty much everyone is flying blind about how dangerous or effective this particular substance is."

He added that research has not been conducted on the safety or the effectiveness of ephedra because ephedra companies lack the "incentive" to fund the kind of involved research used by prescription drug companies. "Unlike prescription drug [manufacturers, ephedra manufacturers] cannot patent [ephedra products]," he explained. "So it doesn't make any sense, or at least good financial sense, for them to fund this kind of research a drug company could fund for prescription drugs. [Ephedra companies] have no patent protection because [ephedra] has been known in the world at large for thousands of years."

This began the start of a lively discussion between McGuffin and Silverglade, whose respective views on this highly controversial herb clash. "I find myself in agreement with some of the things that Mr. Gugliotta has stated. In fact ephedra products are regulated as foods with one important difference," McGuffin said. "Supplements are allowed to provide warning statements. We have recommended that any [AHPA] members that sell ephedra products provide a warning statement to caution sensitive populations and to caution against possible side effects." McGuffin admitted this was a voluntary statement, but AHPA and three other trade groups have petitioned FDA to adopt this industry regulation as national standard. This standard would also encompass recommended serving sizes and appropriate consumer use.

Silverglade claimed that the proposed national standard submitted to FDA was weakly worded, and it only warns children, nursing and pregnant women from taking ephedra. "The FDA's [proposed label] wanted to say that exceeding the recommended doses [for ephedra] could cause heart attacks, stroke or death. [The industry's proposed] warning label.talks about serious adverse health effects," Silverglade said, adding that the industry's "marketing hype" masks potential death from taking ephedra products.

McGuffin responded that an expert panel review that convened in August "concluded that there is not an association between supplements containing ephedra and the serious adverse events that FDA has reported." McGuffin added that ephedra is not for every consumer at every time in any quantity.

In regards to better regulating all dietary supplements, McGuffin mentioned that the Presidential Commission was approached to have FDA reopen the investigation into an over-the-counter designation for traditional medicine, under which dietary supplements would fall. Until then, McGuffin recommends buying herbal brands that have good reputations and calling the product's manufacturer with any questions.

The issue of Good Manufacturing Practices (GMPs) was brought up by Silverglade, who said that because dietary supplements are regulated as food, these practices are geared toward food manufacturing facilities. "These [herbal supplements] that we take more like drugs should really be manufactured to a much higher standard than food products," he said.

The discussion also touched on the idea of using supplements in lieu of more traditional treatments and questions about whether medical professionals shouldn't be the ones suggesting proper courses of action. "I don't want to go into a store and pick up something off the shelf to use instead of chemotherapy if I've got advanced cancer," McGuffin said, adding that for more minor conditions, such as a cold, a consumer should have the choice of an herbal treatment.

In the meantime, research and lobbying may be the key in spreading a better reputation for herbal supplements. "The dietary supplement industry should pitch in and pay for [research]," Silverglade said. "Research pools could be created that could be funded by the industry as a whole based on companies' gross annual sales."

Penkava asked which Web sites would offer unbiased views on different dietary supplements: Silverglade suggested ConsumerReports.com; McGuffin suggested becoming a member of the Herb Research Foundation (www.herb.org) or the American Botanical Council (www.herbalgram.com); and Penkava recommended ConsumerLab.com.

For a transcript of the program, call (877) NPR-TEXT or visit www.npr.org.

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