What is the FDA's Role in Ensuring Dietary Supplement Safety?

Dietary supplements are regulated by the FDA as foods, not drugs. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. Products that contain hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it's important to consult with a health professional before using any dietary supplement.

Despite the many provisions of the Dietary Supplement Health and Education Act (DSHEA), implementing it remains a difficult task. The DSHEA places the burden on the FDA to prove that a supplement is unsafe or that it is being marketed without proper safety notification or testing. The FDA must demonstrate that a product is unsafe in serving size, under the conditions of use and for the intended purpose, as specified on the manufacturer's label. Even if a supplement is normally used in an unauthorized way, this cannot be used to demonstrate its unsafety.

These provisions apply even after an immediate ban on a product has been issued, as the FDA must immediately lift the ban if it cannot provide substantial evidence. In addition, manufacturers are still legally allowed to continue selling the product until the FDA successfully defends the ban in court. Supplement manufacturers do not need to get FDA approval before selling their products. The FDA is constantly monitoring for products that may not be safe or that make false or misleading claims, but it can only do so after the product has already been released on the market.

With its limited resources, the FDA reviews supplement labels and other information such as leaflets, statements, and online advertisements. However, it is impossible to review all of the many products that are available today. The DSHEA requires that every case of alleged adulteration of supplements be tried again; in other words, a legal precedent in the matter cannot be used to influence future results. For a list of possible serious reactions to watch out for and to learn how to report an adverse event, see the FDA website, How to Report a Problem with Dietary Supplements.

The American public is not well protected by current laws and regulations, and there are potential harms from using supplements ranging from financial losses to serious adverse health consequences. Multivitamins, vitamin D, echinacea, and fish oil are just some of the dietary supplements found on store shelves or available online. If you experience an adverse effect while taking a dietary supplement, stop using it immediately, seek medical attention or advice, and report the adverse event to the FDA. Certain dietary supplements can block or accelerate the body's ability to break down some medications.

The FDA provides educational resources such as fact sheets and videos for consumers so they can make informed decisions about their health. This site includes fact sheets and videos on dietary supplements for the public, educators, and health professionals. In addition, people in the United States are virtually participating in clinical trials on dietary supplements without their knowledge or consent due to inadequate government protection. Most supplement users believe that dietary supplements are safe and effective and assume that supplements are regulated in a similar way to over-the-counter medications; however, a 2003 investigation by the Office of the Inspector General confirmed that most supplement labels are misleading, uninformative and inconsistent, and that consumers have considerable difficulty interpreting supplement labels correctly.

Dietary supplements are intended to add to or supplement the diet and are different from conventional foods. The FDA plays an important role in ensuring dietary supplement safety by monitoring products for potential risks and taking action when necessary.

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