New FDA safety rules for dietary products

WASHINGTON — For the first time, makers of vitamins, herbal pills and other dietary supplements will have to test all product ingredients.

The Food and Drug Administration (FDA) said it is phasing in new rules to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain ingredients claimed on the label.

The new rules will govern manufacturing, packaging, storage and labeling and will set testing guidelines for ingredients and final products.

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, heavy metals such as lead and cadmium or other improper ingredients.

Supplement makers, seeking lower-cost ingredients, have begun importing many of their raw materials from abroad. China's emergence as a leading ingredient supplier has raised new fears after a recent pet-food scare was traced to adulterated Chinese wheat gluten.

The new rules apply to all domestic and foreign supplement companies selling in the United States.

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 and publisher of Consumer Reports.

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.

If the FDA finds that supplements do not contain the claimed ingredients, the agency would consider the products adulterated or misbranded.

In minor cases, the agency could ask the manufacturer to remove an ingredient or revise its label. In more serious cases, it could seize the product, file a lawsuit or seek criminal charges.

The FDA proposed the rules in 1997, but the process was slowed by the bureaucratic rule-making process, concerns by consumers and industry groups, and revisions sought by the White House.

Steve Mister, president and chief executive officer of The Council for Responsible Nutrition, the supplement industry's leading trade association, said manufacturers are eager to implement the guidelines.

"We are optimistic that these new dietary-supplement [guidelines] will enhance consumer confidence in these popular products by raising the bar on production standards," he said.

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, director of the Health Research Group at Public Citizen, a consumer-watchdog agency.

The Consumers Union's Duncan added, "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."

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.