In the United States, the dietary supplement industry is big business, with annual sales estimated to exceed $70 billion in 2025. Perhaps, you’ve read in the newspapers or on social media that dietary supplements are “unregulated” or “loosely regulated” by the U.S. Food and Drug Administration.
As the nation’s leading trade association advocating for the rights of consumers to access products that maintain and improve their health, as well as retailers’ and suppliers’ rights to sell those products, we are here to set the record straight.
Myth: FDA doesn’t oversee or regulate dietary supplement products.
Fact: Botanicals, vitamins, minerals and other “dietary supplements” (as defined in U.S. law and explained by FDA) are subject to comprehensive FDA oversight and associated regulations. For example, FDA rules govern how products are manufactured and labeled. (See NPA’s fact sheets on cGMPs (current good manufacturing practices) and structure/function claims).
Myth: FDA’s authority over supplements is limited to post-market oversight. Unlike FDA-approved drugs, dietary supplements do not have to undergo FDA review for efficacy or safety before they are sold to consumers.
Fact: The statements above — frequently echoed by news media and critics of the industry — are misleading and create a false dichotomy by comparing drugs to dietary supplements, recognized in federal law as a subcategory of food. Dietary supplement ingredients typically fall into two categories: old dietary ingredients and new dietary ingredients (NDIs). Old dietary ingredients (ODIs) — also commonly described by the industry as “grandfathered” ingredients — were marketed in the U.S. before Oct. 15, 1994, and are presumed safe based on their history of use. FDA can remove these ODIs from the market if they pose hazards to consumers, based on adulteration standards in the law. (See 21 U.S. Code § 342).
FDA has premarket safety authority over supplements containing “NDIs.” NDIs are generally subject to premarket review by FDA to demonstrate that the NDI-containing supplement “will reasonably be expected to be safe.” FDA reviews the identity and safety of these new dietary ingredients. (See FDA educational materials and videos on NDIs released by FDA in June 2025).
Regarding criticism that FDA does not approve the effectiveness of dietary supplements before they are marketed, that statement often is conveyed without the proper context. Dietary supplements are a subcategory of food, distinguishable from FDA-approved drugs and are not intended to treat, prevent or cure disease. Furthermore, many dietary ingredients have a long history of established health benefits. Finally, to make statements of nutritional support — such as describing the role of a dietary ingredient intended to affect the structure or function in the human body — manufacturers of a dietary supplement must have “substantiation” or evidence that the statement is truthful and not misleading.
Myth: FDA has little visibility into how dietary supplement products are made.
Fact: Every year, FDA inspects hundreds of dietary supplement facilities in the U.S., and some are inspected overseas as well. During these inspections, FDA reviews records to ensure the products are made to quality standards based on federal regulations (see 21 CFR Part 111) and don’t contain harmful substances. The agency has access to product labels as well. Companies that make claims of nutritional support, including so-called structure/function claims, are required to submit labels to FDA with the exact wording of the claim within 30 days of first marketing the supplement with the claim. As noted above, these claims must be truthful and not misleading, and manufacturers must have substantiation for these statements. (See FDA’s “Notifications for structure/function and related claims in dietary supplement labeling”). Additionally, FDA has access to the National Institute of Health’s (NIH) Dietary Supplement Label Database, which houses over 205,000 labels for on- and off-market dietary supplements.
Myth: FDA doesn’t have adequate authority to protect consumers from dietary supplements that contain potentially harmful substances and pose risks to the public.
Fact: Several provisions in the Dietary Supplement Health and Education Act of 1994 (DSHEA) define when a product or ingredient is adulterated or harmful. DSHEA gives FDA myriad tools to act against harmful products, including those that present “a significant or unreasonable risk of illness or injury.” In a 2004 final rule, FDA relied on the latter language to ban supplements containing ephedrine alkaloids. Also, the Food Safety Modernization Act (FSMA) of 2011 granted FDA mandatory recall authority for food under certain conditions.
Myth: FDA has little awareness of the negative side effects — or adverse events — associated with the use of dietary supplement products.
Fact: Distributors, manufacturers and packers are required to report to FDA “serious adverse events” associated with their products. Among other things, these serious adverse events include death, a life-threating experience and in-patient hospitalization. If a distributor, manufacturer or packer does not comply with the law, FDA can take various enforcement actions, including issuing warning letters, seizing products or requesting civil injunctions in collaboration with the U.S. Department of Justice. (See NPA’s fact sheet on AERs).
The bottom line on FDA oversight of supplements
In conclusion, dietary supplement products are subject to comprehensive FDA oversight. As explained above, FDA inspects facilities to ensure that dietary supplement products are made to quality standards and don’t contain harmful contaminants, regularly evaluates the identity and safety of new dietary ingredients prior to them being marketed in dietary supplements, and reviews serious adverse event reports associated with these products.
Finally, and perhaps most importantly, FDA has many different tools to protect consumers from adulterated or harmful products and ingredients. For specific information on how FDA has used these tools since DSHEA’s passage in 1994 to protect American consumers, see NPA’s fact sheet on important regulatory and enforcement actions.