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FDA beefs up DSHEA.

WASHINGTON -- Thirteen years after the Dietary Supplement Health and Education Act (DSHEA) was passed, the Food and Drug Administration last month issued its final ruling establishing regulations that require current good manufacturing practices (cGMP) for dietary supplements. The rule is intended to ensure that supplements are produced "in a quality manner," do not contain contaminants or impurities, and are accurately labeled.

"This rule helps ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," says food and drugs commissioner Andrew von Eschenbach. "In addition, as a result of recent amendments to the Federal Food, Drug and Cosmetic Act, by the end of the year industry will be required to report all serious dietary supplement-related adverse events to the FDA."

Under DSHEA, supplements do not have to win approval by the FDA for safety and effectiveness before they can be marketed. Under the final rule, however, manufacturers are required to evaluate the identity, purity, strength and composition of their supplements. If they contain contaminants or do not contain the ingredients they are represented to contain, the FDA will consider them adulterated or misbranded.

Consequently, the final rule is intended to prevent the use of wrong ingredients, too much or too little of a dietary ingredient, contamination by natural toxins, bacteria, pesticides or other harmful substances as well as improper packaging or labeling.

"The dietary supplement cGMPs should increase consumers' confidence in the quality of the dietary supplement products that they purchase," says Robert Brackett, director of the FDA's Center for Food Safety and Applied Nutrition. "These regulations provide more accountability in the manufacturing process so that consumers can be confident that the products they purchase contain what is on the label."

But the FDA is also issuing an interim final rule that provides a petition process for manufacturers who wish to request an exemption from the cGMP requirement for 100% identity testing of specific dietary ingredients used. A maker may be exempt from the ingredient identity-testing requirement if it can adequately document that a lower frequency of testing would ensure the ingredient's identity.

Both the final cGMP and the interim final rule go into effect on August 24. The rule has a three-year phase-in to limit disruption for manufacturers with fewer than 20 employees. Companies with fewer than 500 employees have until June 2009 to comply, while those with more than 500 staffers have until June 2008.

"Responsible manufacturers have been waiting for final GMPs since 1994, when DSHEA was first passed," says Connie Barry, president and chief executive officer of Pharmavite LLC. "We commend FDA for passing this final rule. FDA now has the power to enforce rigorous manufacturing standards that will rid the industry of noncompliant manufacturers. Ultimately it will build consumer confidence in our industry."

David Smith, Pharmavite's chief science officer, says the GMPs are vigorous, borrowing from pharmaceutical GMPS.

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Title Annotation:SPOTLIGHT; Dietary Supplement Health and Education Act
Author:Jacobson, Greg
Geographic Code:1USA
Date:Jul 16, 2007
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