May 2007

Final GMP regs go to FDA

The final regulations establishing good manufacturing practices (GMPs) for dietary supplements has cleared review by the Office of Management and Budget (OMB) and is now back at the Food and Drug Administration (FDA) 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.”

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.

Source: Natural Products Association, www.naturalproductsassoc.org

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