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Report: Vitamins, supplements need stronger FDA

3 March 2009 877 views No Comment

WASHINGTON (Reuters) – 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.


“Consumers confront an extensive variety of dietary supplements available in the marketplace, but little is known about the safety and efficacy of these products,” it 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, saying the FDA has estimated total cases of side effects may be more than 50,000 per year.


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.


Still, it took the FDA nearly 10 years to pull ephedra from the U.S. market despite thousands of reported problems and deaths from consumers who used weight-loss products containing the ingredient. It banned such products in 2004.

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