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FDA, supplement firms often at odds

About 70 percent of the nation’s supplement companies have run afoul of the U.S. Food and Drug Administration’s manufacturing regulations over the past five years, according to a top agency official.

Recall notices and agency inspection records have shown that consumers are put at risk by poorly measured ingredients, uncleaned manufacturing equipment, pesticides in herbal products, supplements contaminated with illegal prescription medications – even bacteria in pediatric vitamins.

“We’re seeing some real problems out there,” said Dr. Daniel Fabricant, who heads the FDA’s Division of Dietary Supplement Programs.

While most vitamins and supplements are not harmful – and at least one vitamin brand was credited with an 8 percent reduction in cancer among men older than 50 – the industry is beset by repeated recalls, manufacturing problems and adverse reactions caused by tainted products, health experts and regulatory officials say.

And there is little the FDA can do to improve the situation, Fabricant said, unless Congress legislates more regulatory authority for the agency.

Roughly half the U.S. population – 150 million people – consumes multivitamins, mineral tablets, weight-loss aids, herbal remedies, protein powders and a host of other products that fall under the vast rubric of dietary supplements.

Supplements, a $28 billion industry made up of about 450 U.S. companies, are deemed “food” by law and are not subject to the tough regulatory scrutiny of prescription drugs.

Sixteen nationwide recalls and warnings have been issued in the past month and a half, including vitamins that contained the risky steroids dimethazine, dimethyltestosterone and methasterone. More than 3,000 products were recalled nationwide last year.

Written product recipes at numerous supplement companies are nonexistent, Fabricant said, and many recipes – known as master manufacturing records – are apparently cobbled together when owners learn that government inspectors are on their way.

Worse, drums in which products are mixed are not always appropriately cleaned, Fabricant added, and in some firms, these vessels are damaged from age or overuse. Debris left from previous batches sometimes winds up in newly made products, he said.

Too often, dangerous drugs of all kinds – from male sexual enhancement compounds to weight-loss medications – are turning up in vitamins and other supplements nationwide.

About 6,300 people nationwide complained about adverse reactions to dietary supplements between 2008 and 2012, according to FDA statistics.

But the actual number may be more than eight times higher, some experts say, because most people don’t believe health products can make them sick.

The FDA began inspecting how vitamins and other dietary supplements are manufactured only in 2008. And there is little the FDA can do to exercise more power over supplement safety without an act of Congress, Fabricant said.

U.S. Senate lawmakers reintroduced a measure this month to grant the agency more power. The bill was initially introduced in 2011.

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