U.S. Targets Impurities, Fraud in Food Supplements

WASHINGTON — Millions of users of St. John’s wort, calcium and other dietary supplements may soon know for sure they’re getting what they pay for. The government proposed the first manufacturing standards for the $19-billion supplement industry Friday in an attempt to cut fraud and contamination.

Some companies have sold products with impurities or with lower or higher doses of ingredients listed on the bottle, Food and Drug Administration Commissioner Mark McClellan said.

Under the rules, expected to be finalized next year, the FDA will inspect companies to make sure they are producing accurately labeled and uncontaminated products, he said.

“The public wants this. There is too much of a ‘buyer beware’ market now,” McClellan said. “Too often, consumers purchase dietary supplements based on inaccurate or incomplete information on what they are getting.”

The FDA does not require supplement makers to prove that their products are safe and effective before they can be sold, as it does for medicines, and the new rules will not change that.

The proposed standards set out requirements for quality control, testing, record-keeping and handling consumer complaints.

Companies that do not meet the manufacturing standards could have their products pulled from the market or face other FDA action, McClellan said. He estimated there are about 1,000 manufacturers selling supplements in the United States.

The FDA cited problems that the rules are designed to resolve.

One firm recalled a supplement with folic acid, which women take to reduce chances of having a baby with birth defects, because it contained only 35% of the amount claimed on the label. Another firm recalled supplements with excessive amounts of potentially dangerous lead. Some supplement makers have been following industry standards for manufacturing voluntarily, at the same time pushing for government rules to weed out unscrupulous firms and boost public confidence.

“The industry has been asking for this rule for a long time and we’re extremely pleased that it’s finally here,” David Seckman, executive director and chief executive of the National Nutritional Foods Assn., said in a statement.

The organization will examine the FDA’s proposal “to determine if it’s appropriate and tough enough,” Seckman said.