FDA, Congress to look at supplement safety

By STEVE MITCHELL, UPI Medical Correspondent

WASHINGTON, July 29 (UPI) -- The Food and Drug Administration is planning to step up its regulation of the safety of dietary supplements and Congress appears poised to increase the agency's authority for overseeing the class of products.

The FDA has commissioned the National Academy of Sciences to develop a framework for evaluating the safety of dietary supplements and the first draft was released last week. An FDA spokeswoman told United Press International the framework is part of a larger effort by the agency to examine the safety of supplements, a power that was granted FDA under a 1994 act passed by Congress.


The safety of these supplements is "of concern" to the FDA and "that's why we asked NAS to help us propose the safety framework," the spokeswoman said.

Several senators also have expressed concern about the safety of supplements and a Senate governmental affairs subcommittee will take up the issue at a hearing Tuesday. In addition to taking a closer look at the current system of oversight and regulation of supplements, the committee will pay particular attention to supplements touted for weight loss and the validity of their claims to help people lose weight.


The hearing, titled "When diets turn deadly: Consumer Safety and Weight-Loss Supplements," will "take a good hard look at the claims those in the dietary supplement industry make and whether the government has a role in ensuring there are proper safeguards for the consumers," Joe Shoemaker, spokesperson for committee chair Sen. Richard Durbin, D-Ill., told UPI.

"There's a great concern that there isn't" adequate safeguards for supplements, Shoemaker said. In addition, the system for reporting adverse events due to dietary supplements "is completely faulty," he added. An FDA study found the agency only receives information on less than 1 percent of all adverse events associated with dietary supplements.

"Our goal is to hold the hearing and see where we can make improvements," Shoemaker said.

The NAS committee developing the safety framework for the FDA plans to conduct a mock analysis of six common supplements: chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto and shark cartilage. As soon as this is completed and the FDA receives comments from interested parties, it will proceed to implement the framework, the spokeswoman said.

Meanwhile, the supplement industry seems supportive of FDA's increased focus on safety.


"It is absolutely essential for FDA to be attentive to the safety of dietary supplements," Michael McGuffin, president of industry lobbying group American Herbal Products Association, told UPI. "I don't see anything nefarious in FDA's pointed focus at safety."

The consumer advocacy group Center for Science in the Public Interest also applauded FDA's actions.

"This is the first systematic attempt to determine if dietary supplements are safe," Bruce Silverglade, CSPI's director of legal affairs, told UPI. He said the government needs more authority to oversee dietary supplements because under current regulations industry does not have to prove that their product is safe and the FDA is charged with the burden of demonstrating a product is unsafe before it can remove it from the market. The agency either has to wait for consumers to be injured by a supplement or proceed through litigation, which can takes years, Silverglade said.

McGuffin said the FDA holds all the authority it needs to take a product off the market. "What we want to see is better enforcement" of existing regulations, he said.

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