Are Dietary Supplements Regulated by the FDA? - An Expert's Perspective

Are you wondering if dietary supplements are regulated by FDA? Learn more about it in this expert's guide.

Are Dietary Supplements Regulated by the FDA? - An Expert's Perspective

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. The FDA is not authorized to approve dietary supplements due to their safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA.

Drugs must be approved by the FDA before they can be sold or marketed. On the other hand, supplement companies are responsible for having proof that their products are safe, and the claims on the label are truthful and not misleading. But, as long as the product does not contain a “new dietary ingredient” (one introduced since October 15, 1999), the company does not have to provide these safety tests to the FDA before the product is marketed. This fact sheet from the Office of Dietary Supplements (ODS) of the National Institutes of Health (NIH) provides information that should not replace medical advice. You're more likely to have side effects from dietary supplements if you take them in high doses or instead of prescription drugs, or if you take many different supplements.

That changed when Congress defined the term dietary supplement in the Dietary Supplement Health and Education Act (DSHEA) of 1994. We also investigate reports of adverse events and complaints from consumers, health professionals, other regulatory bodies and the industry. Anyone can report an adverse event considered related to a dietary supplement directly to the FDA by accessing the safety reporting portal. The other statements on dietary supplement labels that require exemption from liability are claims about a benefit related to a classic nutrient-deficiency illness and statements about general well-being derived from the consumption of a dietary ingredient. However, FDA regulations require that specific labeling items, including nutrition information, appear on most foods, including dietary supplements. The FDA recommends that consumers consult with a health professional before deciding to take a dietary supplement. Accordingly, DSHEA requires that, when the label of a dietary supplement or other label includes such a claim, the statement be accompanied by a disclaimer informing consumers that the FDA has not evaluated the claim. However, companies must submit a pre-marketing safety notification to the FDA at least 75 days before marketing dietary supplements containing certain “new dietary ingredients” (which were not marketed in the U.

S.). UU.). In general, the FDA is limited to enforcing the law after marketing because, unlike drugs that must be shown to be safe and effective for their intended use before they are marketed, the law does not require the FDA to approve dietary supplements for safety reasons before they reach the consumer. Since dietary supplements fall under the category of foods, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for the agency's oversight of these products. Consumers can contact the manufacturer of the dietary supplement or a commercial laboratory to analyze the contents of a product.

Manufacturers must indicate the serving size of food and specific information about nutrient content of each serving on nutrition label (or on “Supplement Information” label for dietary supplements).