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Still no GMPs, CRN

By staff reporter, 08-Dec-2006

Related topics: Regulation

As the year inches to a close, dietary supplement industry associations are left wondering when good manufacturing practices will be finalized - the last indication was that they would come through in December, yet there is still no news to this effect.

Good Manufacturing Practices (GMPs) form part of the 1994 Dietary Supplement Health and Education Act, and are the final piece of the puzzle before this law governing the supplements industry is fully implemented.

Adoption of GMPs is seen by the supplement industry as a means to quelling criticism from outside the industry that products from the United States lack sufficient regulatory oversight.

The 12-year wait has been a source of frustration to the industry, who has badgered FDA all along to get the guidelines materialized.

"We need this rule finalized as a means to level the playing field for companies and to ensure safe consumer products," Judy Blatman, vice president of communications with the Council for Responsible Nutrition, told NutraIngredients-USA.com.

Yet industry is still in the dark as to when exactly GMPs will be issued.

"Every time we see FDA we tell them we would really like to see good manufacturing practices issued," said Blatman. "We don't understand what the delay is."

It was announced last October that the GMPs were with the Whitehouse's Office of Management and Budget - the final step in the law-making process that usually takes 90 days, bringing the estimated date of publication to December 2006.

In March the CRN held a lobbying day on Capitol Hill, at which it stressed the need for final GMPs.

"We are going to keep trying," said Blatman.