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Testing standards available for ephedra

The U.S. government's National Institute of Standards and Technology has released the first of 13 planned testing standards for botanical dietary supplements.

NIST's Standard Reference Materials for supplements are designed primarily to help laboratories develop quality control standards for botanicals, which can be difficult to accurately analyze because of their complex components. NIST has previously issued SRMs for a wide variety of materials that are tested in labs, ranging from nonfat milk powder to fossil fuels. The SRMs consist of pure samples of the botanical to be tested, as well as certificates of analysis.

Although NIST plans to develop SRMs for common supplements including carrot extract, ginkgo biloba and saw palmetto, it launched the program with the banned botanical ephedra.

Ephedra products were pulled from the market in 2004 by the Food and Drug Administration, but NIST began working on ephedra SRMs in 2002 because "ephedra was identified as the highest priority by FDA's Center for Food Safety and Applied Nutrition," according to a NIST researcher. NIST spokesman Michael Baum said the ephedra SRM is valuable to testers who want to assure that new products don't contain ephedra.

NIST Chief of Public and Business Affairs Sharon Shaffer said researchers use NIST SRMs to make sure a lab's testing methods are accurate, and for quality assurance of bulk ingredients and finished products. "They would be used by manufacturers [and contract labs] to ensure the quality of their products—making sure the products contain what they're purported to contain in the quantities stated on the labels and they don't contain anything that they shouldn't."

SRMs are also important to the FDA, because they provide definitive standards the agency can rely on if it wants to regulate or otherwise "take a product to task," said Roy Upton, executive director of the American Herbal Pharmacopoeia. AHP, along with other organizations, has testing standards for botanicals, but NIST standards are considered "the government stamp of approval," Upton said.

"NIST standards are much more rigorously tested for purity and regularity. They take the variability out of the reference standard world," Upton said. "You can take a product into a lab [using NIST standards] and have 100 percent confidence the result is accurate.

However, Upton said, NIST SRMs are more expensive than testing materials from organizations like AHP, so labs may not want to use NIST testing on every batch of supplements they produce.

Shaffer said NIST has completed its analyses for carrot extract and is almost finished with ginkgo. The agency hopes to release SRMs for both products within a year. Next up would be multivitamins, bitter orange and saw palmetto, followed by oils with omega 3 and 6 fatty acids, green tea, cranberries, blueberries, black cohosh and St. John's wort.

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