Hatch: Dietary Supplement GMPs Finalized

Completes Effort to Implement Key Aspect of DSHEA

Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.

“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”

Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing. The GMPs are expected to be published within the next five weeks.

“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”

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