By NATASHA SINGER
Published: March 3, 2009
More than half of all American adults, or at least 114 million people, use dietary supplements like vitamin pills, diet pills, herbs and energy drinks. But the Food and Drug Administration does not have enough authority to ensure that the products are safe, and it should seek more oversight power, according to a government audit released Tuesday.
The new report from the federal Government Accountability Office acknowledged that the F.D.A. had taken some steps in the last few years to supervise the supplement industry more closely — but the report said those steps did not go far enough.
In the first 10 months of last year, for example, the audit said the F.D.A. received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them. Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations. Even so, the number of problems is underreported. The F.D.A. recently estimated that there are more than 50,000 minor and serious health problems a year related to dietary supplements. “Consumers,” the G.A.O. report said, “remain vulnerable to risks posed by potentially unsafe products.”
Besides advising that the agency ask for more power from Congress to regulate supplements, the report recommended that the agency make sure consumers know that such products, unlike drugs, do not need agency approval and that their makers do not have to prove their safety and efficacy before they go on sale.
Although the G.A.O. cannot compel the drug regulators to act, an F.D.A. spokeswoman said her agency welcomed the report as a way of “calling attention to the challenges that the agency faces with respect to regulating dietary supplements.”
The audit of dietary supplements was commissioned by several members of Congress, including Representative Henry A. Waxman, a Democrat of California who has been investigating the safety of certain prescription drugs as chairman of the House Committee on Energy and Commerce.
The market for dietary supplements is growing. Americans spent an estimated $25 billion on such products last year — up from about $23.7 billion in 2007 — according to Nutrition Business Journal, which covers the industry.
The F.D.A. currently regulates dietary supplements as ingestible nonfood substances, but it does not have the same authority over the products as it does with drugs. The agency, for example, lacks basic information about the supplement industry: although dietary supplement makers are required to register with the F.D.A. as food manufacturers, they do not have to identify themselves as makers of specific supplements or supply the agency with product information, the report said.
Moreover, the F.D.A. cannot require manufacturers to remove tainted supplements from shelves. The F.D.A. recently published a report citing 69 brands of weight-loss supplements that illegally contained active drug ingredients that could be harmful to consumers. So far, only three of the brands have been voluntarily recalled. Such limited authority over supplements, along with inadequate allocation of F.D.A. resources, leaves consumers vulnerable, the report said.
To improve oversight, the report recommended that the F.D.A. seek authority to require supplement makers to register as such, provide lists of products and copies of product labels, and to disclose all reports of health problems — not just hospitalizations and deaths, as they have been required to do since the end of 2007.
In a written response, which the G.A.O. published with the report, the F.D.A. generally agreed that it could better ensure the safety of dietary supplements if it received more comprehensive information about supplement companies, products and health problems. But the agency also said that additional requirements could lead to information overload.
“We are uncertain whether, in practice, such information would advance the agency’s ability to identify unsafe dietary supplements or to do so quickly,” the F.D.A. said.