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FDA announces news rules for listing the contents of vitamins and supplements

Friday, August 31, 2007 | 2:19 p.m. CDT; updated 12:04 a.m. CDT, Tuesday, July 15, 2008

BOHEMIA, N.Y. — Harvey Kamil swallows 50 pills a day. A firm believer in natural remedies, Kamil, 63, takes these vitamins and other supplements in hopes of maintaining a healthy heart, strong bones and an immune system equipped to fight everything from colds to cancer.

Not only an enthusiast, Kamil is president and chief financial officer of NBTY Inc., the country’s largest manufacturer of dietary supplements.

He also is one of an estimated 125 million Americans who take dietary supplements, which include vitamins, minerals, herbs, botanicals and sports nutrition products, according to the Nutrition Business Journal, a research and consulting firm based in Boulder, Colo. Americans spend more than $22 billion a year on these natural remedies.

Yet consumers still face the challenge of sifting through mountains of research to decide what benefits, if any, these supplements hold. Men who took multivitamins with lycopene to ward off prostate cancer, for example, are now learning that the substance may not play a role in prevention after all.

While health claims made in studies may still be confusing — or even conflicting — one aspect of supplement shopping is about to become a little more straightforward.

Large manufacturers are required to follow new Food and Drug Administration rules to ensure their supplements do not contain contaminants or impurities, and that packages are accurately labeled. Medium- and small-sized manufacturers will have until 2009 and 2010, respectively, to meet the new standards, which also mandate product testing and regulate the handling of raw ingredients and packaging.

In releasing the final rules, called Good Manufacturing Practices, the FDA cited a few cases in which products had been recalled because of contamination by microbes, pesticides or heavy metals or for containing more or less of the dietary ingredients than listed on the labels.

“We’ve had some instances where there were clear manufacturing failures,” says Vasilios Frankos, director of the FDA’s division of dietary supplements.

The FDA has long regulated the supplement industry and visits manufacturers in the United States and suppliers to the U.S. abroad, including China, to inspect the plants and their record keeping. Under GMPs, the agency has enforcement powers that range from warning letters to seizure of products that don’t comply with the new standards.

These manufacturing rules follow the passage of legislation in December that requires manufacturers of dietary supplements and over-the-counter drugs to notify the FDA of adverse reactions to their products. By the end of this year, companies must provide phone numbers for consumers to call to report serious reactions, such as hospitalization, birth defects, disability and surgical intervention. The manufacturers then have 15 days to report the reactions to the FDA, which will then report problems to the public.

The supplement industry and trade groups hail both the good manufacturing practices and the adverse-reactions legislation as ways to bolster consumer confidence in their products.

“What the consumer can begin to expect after the rules are fully implemented and the FDA is enforcing them is that fringe companies who aren’t manufacturing to high standards or are out to earn a quick buck won’t be around much longer,” says Andrew Shao, vice president of scientific and regulatory affairs for the Washington, D.C.-based Council for Responsible Nutrition, the industry’s leading trade association.

Long before the FDA regulations, large companies that make name-brand supplements “followed very, very tight standards, very strictly,” Shao says. “It’s really a minor adjustment for the FDA and major plants.”

In May, NBTY recalled three lots of shark-cartilage supplements after its inspectors discovered the pills were contaminated with salmonella, an organism that can cause serious and sometimes fatal infections, especially in people with weakened immune systems. The supplements had passed an initial inspection, so NBTY investigators believe salmonella emerged after the supplements were packaged. There were no reports of illness related to the incident. After the recall, NBTY launched an audit to avert future outbreaks, and it no longer buys raw ingredients from that shark-cartilage supplier.

People who take shark cartilage believe it improves the health of joints, and some even claim is can be used to treat or cure cancer.

“We would never make those claims,” Kamil says, noting that supplement companies are prohibited by law from making claims that are not approved by the FDA. “We can’t advertise claims that can’t be substantiated.” So, for example, a calcium manufacturer can say the mineral increases bone density, which has been proved in research, but it can’t claim calcium prevents or reverses osteoporosis.

Though consumers can be more confident about the purity and labeling of supplements under the new rules, they’re on their own to investigate the supplements themselves.


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