Natural Foods Merchandiser

FDA to implement DSHEA enforcement plan

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 Supplement Health and Education Act and ensure that dangerous supplements are more quickly removed from the market.

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 Supplement 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 includes 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.

Representatives from the supplements industry, including the Council for Responsible Nutrition, applauded the FDA's actions.

"Laws that sit on the books unenforced are no laws at all," said Loren Israelsen, executive director of the Utah Natural Products Alliance. "What was envisioned in 1994 [when Congress passed DSHEA] was proper enforcement. That's good for everybody and doesn't undermine DSHEA."

Israelsen did, however, question 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 mindset 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. We have become increasingly aware of the potential health problems some of these products pose."

Israelsen also expressed concern about how the DSHEA 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 and safety standards."

Crawford announced that the FDA will provide more information on its DSHEA enforcement plan during the next several months.

The agency is also developing supplements industry regulations for good manufacturing practices, and label guidelines addressing structure/function claims.

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