New guidelines for supplements

After spending more than a decade in development, the U.S. Food and Drug Administration will be phasing in new regulations for the safe manufacture of dietary supplements, a move lauded by local manufacturers but raising concerns of at least two local naturopathic physicians.

Long sought by the $23 billion-a-year supplements industry, the new policies came amid concerns that existing regulations are too weak and do not protect consumers from products with unlisted or contaminated ingredients.

The 815-page overhaul will govern how minerals, multivitamins, botanicals and herbal remedies are manufactured, packaged and stored. Not only will manufactures have to test their ingredients for purity, they will have to disclose what is in their products, under the new regulations, which go into effect Aug. 24, with a three-year phase-in period.

"The industry has been begging the FDA for this," said Ed Smith, co-owner of The Herb Pharm, the nation's largest manufacturer of liquid herbal extracts. "We're just happy they finally did it."

Smith said anyone who thinks that the dietary supplements industry has gone unchecked is dead wrong. At his Williams facility, the FDA has made three routine inspections in the last 90 days, he said.

Most large manufacturers, such as Ashland-based Yerba Prima, already have so-called good manufacturing practices in place, and will likely have little to change to comply with the new regulations, said Peter Finkle, quality assurance director at Yerba Prima, a maker of dietary fiber products.

Aimed at keeping contaminants and impurities out of products, the new rules also set guidelines for quality control and how manufacturing facilities are to be designed and constructed.

"This is all very positive for the industry," Finkle said.

Gae Ryan, pharmacy director at Oregon Health Science University, said the new regulations "address a lack of oversight" by the federal government.

With the new regulations, she said, consumers will have better assurances that what the packaging label says is in the bottle is actually there and that the product is safe.

Among other things, manufacturers will have to report adverse reactions to the FDA, just as pharmaceutical companies do, she said in a telephone interview from her office at the Portland teaching hospital.

Dietary supplements, including energy boosters and weight-loss products, were classified as food. They still will not undergo the rigors of FDA testing before arriving on store shelves. For that reason, some consumer advocates said the new regulations fall short.

Lukewarm response

Such groups as Consumers Union have argued that while the new regulations will help ensure that supplements are labeled properly, the public continues to lack assurances that the products are truly safe and effective.

"The public is often not getting what they think they are getting, and sometimes they are getting things they don't expect," said Dr. Shandor Weiss, an Ashland naturopath. But he warned, "The FDA is having a hard enough time regulating, inspecting and enforcing standards for the general food industries."

Weiss said there is little doubt that the supplements industry needs stricter oversight, citing a grim statistic that up to 80 percent of supplements on retail shelves are either mislabeled, expired, contaminated, adulterated with unlabeled ingredients or do not meet the potency claimed on the label.

Dr. Geoff Houghton, an Ashland naturopathic physician, has no doubt the new regulations will help "clean up less scrupulous companies," but worries that the rules could be part of the pharmaceutical industry's endgame strategy.

He said, "There is nothing more that drug companies want to see" than more onerous regulations on the dietary supplement industry to increase their own market share.

Like Houghton, Weiss is suspicious of the FDA's efforts.

"The bigger issue is that the FDA is notorious for serving the interests of the pharmaceutical industry and the conventional medical-industrial complex," Weiss said. "Health supplements represent a significant financial and ideological challenge to the medical establishment."

Weiss added, "The FDA would like to control the supplement industry, either to suppress it as a competitor with the drug industry, or to take it over so that only the drug industry can manufacture and market health supplements."

covers government for the Ashland Daily Tidings. He can be reached at To post a comment on this story go to .

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