April 24, 2008
On May 10, the U.S. Food and Drug Administration announced the pending publication of a final rule for good manufacturing practices for dietary supplements, nearing the conclusion of a process begun 13 years earlier, when the Dietary Supplement Health and Education Act stipulated the creation of GMPs for the supplements industry.
The GMPs, which are rumored to run to more than 1,300 pages, will be published in the Federal Register in the coming weeks, and will become law one year after publication. Industry reaction to the announcement has been positive, but until the time of publication, industry groups won't know which comments on the 2005 proposed rule have been adopted and which have been ignored.
"We've been working on this for so long, it's a welcome announcement," said David Seckman, executive director of the Natural Products Association. "We don't yet know what's in the final reg, but we hope they seriously considered the 150 pages of comments from our association."
The long wait for a final rule began in 1997, when FDA first presented proposed GMPs developed in conjunction with an industry working group which included experts from companies associated with the American Herbal Products Association, the Council for Responsible Nutrition, Natural Products Association (formerly National Nutritional Foods Association) and other industry groups.
In late 2005, after a public comment period, a final rule cleared the FDA and was sent to the Office of Budget and Management for review. There it has stalled, until the recent announcement. "It's about time," said Marc Ullman of the Washington, D.C. law firm, Ullman Shapiro & Ullman, which specializes in dietary supplements issues. "I hope they come back in a form palatable to the industry. We should be very happy that the issuing of GMPs appears to be imminent. Today there are zero barriers to entering this field, and hopefully GMPs will change that."
When the proposed rule was first published in 2005, many manufacturers felt that the rule required excessive testing for both raw ingredients and final products. "We felt some of the proposed testing was not necessary," Seckman said. "We'll just have to wait and see."
What the industry does welcome is legislation which clearly counters the misapprehension that the dietary supplements industry is not regulated. "This will go a long way for setting the standard for the industry and will help educate consumers so they understand this is a regulated industry," Seckman said.
According to Ullman, GMPs will also level the playing field, so that the industry as a whole isn't tainted by actions of a few, less scrupulous manufacturers. "If [the] FDA actually enforces the GMPs, it will make it more difficult for companies [that] either don't want to or can't do what's necessary to make sure the products they sell are of proper quality and purity that people can be confident ingesting them," Ullman said. "It's about time we raise the bar off the floor."
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