In the wake of its April ban on ephedra, the U.S. Food and Drug Administration is implementing a science-based plan to better enforce the Dietary Supplements Health and Education Act and ensure that dangerous supplements are more quickly removed from the market, said FDA Acting Commissioner Lester Crawford.
The agency's new approach to DSHEA enforcement is expected to include evaluating available pharmacology, published literature, evidence-based reviews and adverse-event information—the same methods used to justify the ephedra ban.
Supplements the FDA is said to be currently researching include kava, usnic acid and pyrrolizidine alkaloids.
An FDA spokesman said details of the science-based plan could be hammered out and released within the next several months, although no timeline has been set. The announcements could come in the form of guidance documents, letters, FDA evaluations or other communications, and will involve input from the FDA's Center for Food Safety and Applied Nutrition, and the Office of Nutritional Products, Labeling and Dietary Supplements, the spokesman said.
Supplements industry groups applauded the FDA's actions.
"We're very much in favor of the FDA fully enforcing DSHEA," said Judy Blatman, vice president of communications for the Council for Responsible Nutrition.
CRN wants the new DSHEA enforcement plan to use "common-sense science," Blatman said, including human clinical studies, when available, and history-of-use information. "We assume [the FDA] would continue to be reasonable, to use the science that's available to them under the law."
Blatman said CRN didn't approve of all the scientific methods the FDA used to evaluate ephedra. She didn't specify which methods caused concern among CRN members, but did say the scientific rationale behind ephedra appeared able to withstand legal challenges.
Loren Israelsen, executive director of the Utah Natural Products Alliance, is also in favor of tougher DSHEA enforcement. "What was envisioned in 1994 [when Congress passed DSHEA] was proper enforcement. That's good for everybody and doesn't undermine DSHEA," he said.
Like CRN, Israelsen has concerns about how the DSHEA scientific enforcement will be enacted. "Will it be an internal process where the industry will find out through trade and consumer publications? We want appropriate scientific standards and safety standards."
He also questioned why the FDA is outlining a science-based plan now.
"This is what they should have been doing all along. Whether it's lack of money, lack of will, it appeared the agency was unwilling to enforce the law. It now appears the mind-set has changed." In an April 19 speech before industry groups, Crawford said, "We have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days. We have become increasingly aware of the potential health problems some of these products pose."
Crawford noted that in the last six months, the FDA has inspected 180 U.S. supplements manufacturers, sent warning letters to 119 supps distributors and supervised destruction of almost $18 million worth of mislabeled or adulterated products.
Vicky Uhland is a free-lance writer in Denver.
Natural Foods Merchandiser volume XXV/number 6/p. 9