Monday, March 02, 2009

Vitamins, supplements need stronger FDA oversight

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.

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 said the GAO.

Steven Mister, president and CEO of the Council for Responsible Nutrition which represents supplement makers and ingredient suppliers, said the report "illustrates we are improving."

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 it said such work must compete with other agency tasks given its limited resources.

Steve - I wholeheartedly agree that there needs to be much better education and oversight over dietary supplements. While most companies follow very strict safety guidelines, there are some extremely unsavory companies that offer unsafe products. This is what we have said for a long time. Luckily, we have provided a research and safety net for our clients for over two decades.

As the FDA alluded to, they are getting a lot of minor side effect complaints, which shows that it is very rare that dietary supplements cause life--threatening reactions. 948 complaints in three quarters of a year for nation of dietary supplement takers is not a very high number, especially when compared to prescription and over-the-counter medication.

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