For those folks following FDA news on supplements and regulations, a good bit of news for the consumer, and for those not using GMP standards, a wake up call...
-Anthony Loera
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May 10, 2007
Final Good Manufacturing Practices Regulation for Dietary Supplements Goes Back to FDA
Final rule had been at Office of Management and Budget for nearly 18 months; may be issued as soon as next month
Late yesterday, the final regulation establishing good manufacturing practices (GMPs) for dietary supplements cleared review by the Office of Management and Budget (OMB) and is now back at the Food and Drug Administration to be finalized for publication in the Federal Register. According to Sen. Orrin Hatch (R-Utah), who along with Sen. Tom Harkin (D-Iowa), has been pushing to have the regulation released, the FDA could have the GMP rule ready for publication “in the next five weeks.”
“Federal GMP regulations for dietary supplements have been a long time in coming since the FDA was authorized to issue them by DSHEA [Dietary Supplement Health and Education Act] in 1994,” said Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs for the Natural Products Association. “The fact that OMB took so much time with them makes us cautiously optimistic that some of the unnecessary testing requirements we saw in the proposed rule are more reasonable and realistic.”
As part of any rulemaking process, the OMB reviews regulations to ensure they will not unduly harm the businesses affected by them, particularly smaller companies. At the time the proposed rule was issued in 2003, the Natural Products Association filed extensive comments asking the FDA to scale back finished product testing requirements, which were more stringent than those for pharmaceuticals. To read the association’s full comments, go to Comments to FDA Regarding Proposed Good Manufacturing Practices.
GMPs establish standards to ensure that dietary supplements and dietary ingredients are manufactured correctly, free of contaminants, and are labeled accurately to reflect the active ingredients and other ingredients in the product.
