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US prepares to publish dietary supplement GMPs

After more than a decade of deliberation and many false starts, the US Food and Drug Administration's good manufacturing practices for dietary supplements have received White House approval and will be published within weeks.

The White House Office of Management and Budget approved the regulations that will establish GMPs for supplements makers and formed part of the original 1994 Dietary Supplements and Health Education Act, which authorised the Food and Drug Administration to write GMPs.

Thirteen years later that process is close to fruition, with a 1,300-page document expected in about a month. Senator Orrin Hatch, one of the original DSHEA authors, called it "very good news," but until the document is made public, many will be wondering how many changes have been made to the draft published in 2003.

Loren Israelsen, president of the United Natural Products Alliance, welcomed the document but expressed reservations about its likely content. "We understand there are significant changes. I don't dare speculate what that means," he said. "There's several key pieces. I hope the regulation is practical and that it understands real-world issues, which means companies will say, 'OK, we can do this — let's do it.;'"

"GMPs are crucial because they assure the public that the products they are buying live up to their labels," Senator 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."

While associations such as the Natural Products Association and the Council for Responsible Nutrition insist the industry is already regulated and implementing GMPs, it is accepted that statutory GMPs will grant further legitimacy to an industry prone to attack from elements of the mainstream media.

NPA and CRN said they had plans in place such as seminars, workshops and certification programmes to assist companies in their GMP compliance efforts.

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