WASHINGTON — After more than 10 years of development, the Food and Drug Administration on Friday announced new regulations for the safe manufacture of dietary supplements.
Consumer advocates hailed the final rules as a good first step but chided the FDA for not requiring supplements to be tested for safety or effectiveness before they hit store shelves.
"Consumers still have no idea if a given product works or whether it is dangerous," said Janell Mayo Duncan, senior counsel for Consumers Union, a watchdog group.
The new rules will govern the manufacture, packaging and storage of dietary supplements and will help ensure that products contain no contaminants or impurities and are properly labeled. The final rules set guidelines for quality control procedures, the design and construction of manufacturing plants and the testing of ingredients and finished products.
The new measures, and new federal amendments that require supplement manufacturers to report serious adverse events to the FDA, will help "ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label," said FDA Commissioner Andrew von Eschenbach.
Supplement makers, seeking lower-cost ingredients, have begun importing much of their raw materials from abroad. China's emergence as a leading ingredient supplier for the supplement industry has raised new fears since a recent pet food scare was traced to adulterated Chinese wheat gluten.
The FDA first proposed the rules in 1997, but the bureaucratic rulemaking process, concerns by consumers and industry groups, and revisions sought by the White House have slowed the process.
Steve Mister, the president and CEO of The Council for Responsible Nutrition, the supplement industry's leading trade association, said manufacturers are eager to implement the new guidelines.
"We've waited a long time for this new rule to be published. We applaud FDA for bringing closure to this long, arduous process," Mister said. "We are optimistic that these new dietary supplement (guidelines) will enhance consumer confidence in these popular products by raising the bar on production standards."
The $22 billion supplement industry has a history of suspect quality and safety. Independent lab tests have found one in four supplements tested to be substandard. Some have been tainted with pesticides, salmonella, glass, bacteria and heavy metals such as lead and cadmium. Others failed for various reasons, including a lack of ingredients, improper ingredients, failure to disintegrate properly and mislabeling.
Because they're classified as a category of food, most dietary supplements — vitamins, minerals, herbs, amino acids and other substances such as enzymes and metabolites, which are taken orally and intended to augment diets — don't need to be registered or approved by the FDA before they're sold.
"Congress should address this enormous deficiency in the law," said Sidney Wolfe, the director of the Health Research Group at Public Citizen, a consumer watchdog agency.
"In large part, it is still 'buyer beware' for consumers of dietary supplements because manufacturers are not required to list known health risks for their products, or make sure that they are safe or effective," Duncan added.
Companies with more than 500 employees have until June 2008 to comply with the new rules. Those with fewer than 500 employees must comply by June 2009, and those with fewer than 20 employees have until June 2010.