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FDA Needs Authority Over Diet Supplements
Over half of all Americans use some kind of dietary supplements such as vitamin pills, diet pills, herbs, and energy drinks, according to a recent article in The New York Times, the numbers are huge—Americans spent close to $25 billion on dietary supplements last year, according to the Nutrition Business Journal. But a new study shows that the Federal Food and Drug Administration, cannot guarantee these products are safe because it does not have enough authority to oversee their production.
This is becoming a bigger problem with more and more supplements being produced in other countries without the same safety standards as in the US. And some of those products are proving to be unsafe. In 2008, the FDA received 948 reports of health problems related to dietary supplements; of those there were 9 deaths, 64 life-threatening illnesses, and 234 people admitted to the hospital. The report by the Government Accountability Office (GAO) says those numbers don’t include everyone—the problems are underreported. The GAO report suggests that Congress give the FDA the authority they need to oversee these dietary supplements that don’t currently have approval by the FDA.
Most people don’t realize the FDA does not have authority over these kinds of products. The GAO report was commissioned by the House Committee on Energy and Commerce, led by Representative Henry A. Waxman, to investigate the safety of certain drugs. The F.D.A. is the federal agency charged with overseeing the safety of drugs, medical devices, food, cosmetics and many other health-related products. But the FDA only regulates certain products.
The FDA currently regulates dietary supplements as nonfood substances, but it doesn’t have the same authority over these products as it does with drugs. Although dietary supplement makers are required to register with the F.D.A. as food manufacturers, they don’t have to identify themselves as makers of specific supplements or supply the agency with product information, the report said.
Another recent article, says that Public Citizen has found that some drug information sheets are dangerously wrong or misleading. The FDA has required that pharmacies provide consumer guides with some drugs that explain the medicines' risks. These guides, written by the FDA, are often far more comprehensive than the drug information sheets traditionally given by pharmacists. According to the article, Public Citizen wants to see the FDA have the authority it needs to write medication safety sheets for all drugs, including diet supplements.
To improve oversight, the GAO report recommended that the F.D.A. seek authority to require supplement makers to register, provide lists of products and copies of product labels, and to disclose all reports of health problems.
The FDA has sent out public health advisories about potential drug problems and created a consumer information Web site. After Congress required it, the FDA has created a quarterly list of potential drug problems that safety reviewers are in the middle of investigating.
