FDA Issues Dietary Supplement Rules

The U.S. Food and Drug Administration announced Friday that manufacturers of vitamins, herbal pills and other dietary supplements would have to test the ingredients of all their products for safety and purity.

The new standards follow concerns that existing regulations are too weak in that they allow supplements on the market that were contaminated or whose ingredients didn't match claims made on the label.

But while the rules may strengthen enforcement in these areas, some experts say that the real question is the effectiveness of these products.

"This final rule establishes industrywide standards," said Robert Brackett, director of the center for food safety and applied nutrition at the FDA, in a press conference this morning. "Consumers should have increased confidence that the dietary products that they purchase are safe."

Published in an 800-plus page report, the regulations set so-called good manufacturing processes for the 29,000 dietary supplement products currently on the market -- including vitamins, minerals, botanicals, sports nutrition supplements, weight management products and specialty supplements.

The supplement makers will have to test the ingredients of all their products for purity, and accurately report ingredients on their labels.

Before his, supplements fell under the same regulatory guidelines used for food. But according to the FDA, regulating supplements in this way missed some critical problems.

"[The final rule] tries to be more specific about regulating the processes used to make diet supplements, which are quite different from the way you process food," said Vasilios Frankos, division director of the office of dietary supplements at the FDA.

The requirements also apply to imported supplements manufactured outside the U.S. Enforcement of the new guidelines begins Aug. 24.

"The aim is to prevent the wrong ingredients getting into supplements," said Frankos. The regulations also try to prevent contamination of supplements as well as the accidental inclusion of pesticides, glass or heavy metals like lead.

Fable-Free Labels

"These new regulations will at least take the quality issue off the table," says Dr. Brent Bauer, director of the complementary and integrative medicine program at the Mayo Clinic. "If a patient wants to try ginseng, they can be assured that when they purchase a ginseng brand that claims to have 5 percent ginsenosides, they will know that is what they are getting."

But what happens when a company doesn't deliver what it promises?

In these situations, the FDA would issue a warning to the company, asking it to correct the problem. The next step would be a mandatory order to pull the product off shelves, possibly accompanied by a fine.

The FDA is leaving much of the enforcement of the new regulations to supplement manufacturers themselves, a $21.4 billion industry. It has recently become law for the supplement industry to report serious health problems associated with their products to the FDA.

"The ruling is appropriate, but it will just be a paper tiger if there is no FDA staff to monitor things," says Keith Ayoob, associate professor of pediatrics at Albert Einstein College of Medicine. "The big pharm companies that do supplements will be compliant. The ones I'm more worried about are the fringe companies that produce nothing but supplements. … If they get caught, they'll just fold up shop and reopen under another name."

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