More than half of all Americans, 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.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, but not necessarily directly caused by, dietary supplements. 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 per 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 known that such products, unlike drugs, do need agency approval and their makers do not to prove their safety and efficacy before they go on sale.
The F.D.A. currently regulates dietary supplements as ingestible non-food 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 themselves 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 which could be harmful to consumers. So far, only three of those companies have voluntarily recalled their products.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 themselves, provide a list of products and copies of product labels, and to report all reports of health problems, not just hospitalizations and deaths.
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 wrote 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. wrote.
