Diet-pill rules issued

WASHINGTON — Those in the dietary supplement industry have 815 pages of new federal regulations to read over the weekend, and they are actually happy about it.

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."

Seckman said it will increase confidence for consumers because they will know products they buy are safe and conform to an overall set of standards. He said the new rules do not require an expiration date — something the association had wanted — but this means in some instances the industry's own rules will be stricter than what the government has approved.

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.