FDA must boost vitamin, supplement review—report

The U.S. Food and Drug Administration needs to improve its oversight of vitamins and other dietary supplements as reports of consumers experiencing side effects continue to rise, a government report concluded.

The FDA must be given additional power to require more information from supplement manufacturers each year, including an updated list of all products sold, the Government Accountability Office said in its findings released on Monday.

Agency officials also should better educate consumers as well as offer the industry advice about using new ingredients and marketing their products, the GAO said.

Although the FDA has tried to address some safety concerns, it is hampered by insufficient funding and staff, a lack of power to recall products and limited information about existing supplement companies, its report found.

“The FDA clearly needs to have more resources to give consumers real protection,” said U.S. House of Representatives Energy and Commerce Committee Chairman Henry Waxman, who released the report along with other lawmakers.

Dietary supplements such as vitamins, herbs, minerals and other products are sold on their own, but are increasingly being used as ingredients in beverages and other foods. Common ones include ginseng, ginkgo biloba, vitamin E and echinacea, among many others.

Reported side effects from supplement products have jumped threefold since December 2007 when companies were forced to start telling the FDA about consumer side effects.

The FDA saw 948 reported problems from January 2008 to October 2008 compared with 298 during those months the year before, said the GAO, the investigational arm of Congress.

Complications may still be underreported, it added.

Some consumer advocacy groups, which have long pointed to a lack of supplement oversight, said the report simply highlights a long and growing list of products the FDA cannot regulate sufficiently.

Agency officials have been stretched in recent years amid a steady stream of problems with drug safety issues, tainted pet food and contaminated human food, such as the current peanut recall.

“When it comes to dietary supplements, it’s like the Wild West and the bad guys know they don’t have to take the sheriff seriously,” said Bruce Silverglade, legal affairs director for the Center for Science in the Public Interest.

In 1994, a new law allowed dietary supplements to forgo safety tests before being sold, unlike other food ingredients. They also cannot be marketed as therapies to treat disease.

Representatives for the industry could not be immediately reached for comment.

The FDA, in comments to the GAO, said it was working on ways to better sort data for potential safety problems, although it was concerned about its ability to manage all the information if it were to begin to see more reported problems.

“An unintended outcome of receiving such reports might be that the huge increase in minor adverse event reports might make it more difficult to filter out signals of potential toxicity” and delay the agency’s ability to identify real problems, the agency wrote.

It also said it recognized the need to provide guidance to the industry and educating consumers, but said such work must compete with other agency tasks given its limited resources.

By Susan Heavey
WASHINGTON (Reuters)