From Deseret News archives:
Diet-pill rules issued
Utah's supplement industry welcomes rules by the FDA
The Food and Drug Administration released the final good manufacturing practices (GMP) guidelines for dietary supplements Friday, which the industry has been waiting more than a decade to see completed.
"These regulations will formalize industry standards that most companies have been doing for years," said Loren Israelsen, executive director of the United Natural Product Alliance, an international group based in Salt Lake City. "I'll be looking for the nitty-gritty."
Supplements are a $4.6 billion industry in Utah.
The new FDA rules set standards for testing ingredients that go into products along with other rules, whether the companies make one pill or hundreds of different ones.
Companies with fewer than 20 employees have three years to adhere to the new standards while those with 500 or more employees have one year.
David Seckman, executive director of the Natural Products Association, said that while he has not read the whole rule yet, he expects it to be "fair for both the industry and consumers."
He said that seven out of 10 people take a dietary supplement and that the new rules will assure that standards are applied uniformly throughout the industry.
Sen. Orrin Hatch, R-Utah, and Sen. Tom Harkin, D-Iowa, along with other sponsors, created the Dietary Supplement Health and Education Act of 1994, which Congress approved. It directed the FDA to write these regulations, which have taken this long to complete.
"I can't believe this day is finally here," Hatch said.
The guidelines are crucial because they assure the public that the products they are buying live up to their labels," Hatch said. "It took a long time to publish these (guidelines), and they're more than 800 pages. So I'm going to review them very carefully to make certain they are good regulations. But every indication leads me to believe the administration was very sensitive to the impact they might have on the supplement industry, especially smaller companies."
Harkin also said he looks forward to reading the rules.
"It is my hope that these GMPs will increase consumers' confidence that all dietary supplement manufacturers are adhering to the highest standards of quality," Harkin said. "In the absence of FDA action, many companies have taken steps to adopt GMPs on their own, and I have applauded those steps. I hope that today's announcement can build on that work."
Israelsen said he would have liked to see the regulations apply to the raw material suppliers, not just the manufacturers, because now the burden rests on the company buying the raw materials.
"I was afraid this was going to happen," he said. "We had argued for comprehensive coverage."
He said companies are likely to conduct business as if the rules do cover the raw materials suppliers, making sure those suppliers comply with the same rules manufacturers must follow.
Israelsen and Seckman said they would be reviewing the documents over the weekend for other details.
E-mail: suzanne@desnews.com
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