Micronutrient Supplements

Half of adults take a dietary supplement. 

Micronutrient supplements are vitamins and/or minerals sold over the counter without a prescription (Food and Drug Administration (FDA) 2022). They provide additional nutrients that individuals may not get through food alone. Supplements that contain several nutrients are called multivitamins or multiminerals (MVMs). About half of U.S. adults report using a dietary supplement, and about one-third specifically take an MVM (Office of Dietary Supplements (ODS) 2024, Bailey 2020). 

Supplements do not require FDA approval before sale. 

Unlike drugs, dietary supplements do not need FDA approval before being offered for sale (Dietary Supplement Health and Education Act (DSHEA) 1994). However, manufacturers must still notify the FDA of a new ingredient’s identity, history of use, and safety information at least 75 days before a product is offered for sale. They must also follow FDA manufacturing standards to ensure product quality and consistency. The FDA verifies manufacturing compliance through periodic inspections. On average, roughly 5% (500 out of 10,000) of facilities are inspected annually (Long 2024). 

Supplement packaging must include a “Supplement Facts” label listing a product’s ingredients and amounts (DSHEA 1994). Packaging must also provide a way for consumers to report problems or adverse events.  

The FDA monitors safety, and the Federal Trade Commission (FTC) monitors advertising. 

Once a supplement is offered for sale, the FDA oversees supplement safety, and the FTC enforces truth-in-advertising standards (Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006, DSHEA 1994). Any claims made by manufacturers must be followed by a statement that the supplement has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent disease (DSHEA 1994). This disclaimer does not overrule the FTC's requirement that advertising claims are based on adequate scientific evidence (FTC 2022). If a product has unsubstantiated health claims, the FTC can require the manufacturer to stop the advertisement and can impose penalties ranging from fines to marketing bans (Government Accountability Office (GAO) 2017, FTC 2022).  

Manufacturers must report serious adverse events such as hospitalization, permanent disability, birth defects, or death to the FDA within 15 business days (Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006). The FDA relies on these reports to identify safety problems, like heavy metal contamination or drug interactions, and to issue product recalls (Li & Wertheimer 2023, Bailey 2020, Food Safety Modernization Act 2011).  

State and local governments cannot establish separate adverse-event reporting systems (Dietary Supplement and Nonprescription Drug Consumer Protection Act 2006, DSHEA 1994). However, they can regulate other parts of supplement safety. For example, CA requires manufacturers to add warning labels if product levels of harmful chemicals, like heavy metals, exceed state safety thresholds (California Health and Safety Code 1987). 

Figure 1. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) Regulatory Oversight of Dietary Supplements. Micronutrient supplements are a type of dietary supplement. The FDA (blue) oversees the safety of supplements, while the FTC (yellow) monitors accuracy in advertising. “Sale” refers to a product’s public availability for purchase. 

References 

Bailey RL (2020) Current Regulatory Guidelines and Resources to Support Research of Dietary Supplements in the United States. Critical Reviews Food Science and Nutrition 60(2): 298 – 309. https://pubmed.ncbi.nlm.nih.gov/30421981/  

California Health & Safety Code §§ 25249.6, 25249.10(c), 25249.11(f). 1987. https://leginfo.legislature.ca.gov/faces/codes_displayText.xhtml?lawCode=HSC&division=20.&title=&part=&chapter=6.6.&article=  

Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) Pub. L. 109-462, 120 Stat. 3469. https://www.congress.gov/bill/109th-congress/senate-bill/3546  

Dietary Supplement Health and Education Act (DSHEA) (1994) Pub. L. 103-417, 108 Stat. 4325. https://www.congress.gov/bill/103rd-congress/senate-bill/784  

Federal Trade Commission (2022) Health Products Compliance Guidance. https://www.ftc.gov/business-guidance/resources/health-products-compliance-guidance  

Food and Drug Administration (FDA) (2022) FDA 101: Dietary Supplements. U.S. Department of Health and Human Services. https://www.fda.gov/consumers/consumer-updates/fda-101-dietary-supplements  

Food Safety Modernization Act, Public Law 111-353, 124 Statute 3885 (2011). https://www.fda.gov/food/food-safety-modernization-act-fsma/full-text-food-safety-modernization-act-fsma  

Government Accountability Office (2017) Memory Supplements: Clarifying FDA and FTC Roles Could Strengthen Oversight and Enhance Consumer Awareness. GAO-17-416. https://www.gao.gov/products/gao-17-416  

Li WQ, Wertheimer A (2025) Narrative Review: The FDA’s Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Effects. Innovations in Pharmacy 14(1): 10.24926. https://pubmed.ncbi.nlm.nih.gov/38035313/  

Long J (2024) FDA Increases Annual Domestic, Foreign Dietary Supplement Inspections. SupplySide Supplement Journal. https://www.supplysidesj.com/supplement-regulations/fda-increases-annual-domestic-foreign-dietary-supplement-inspections  

Office of Dietary Supplements (ODS) (2024) Multivitamin/Mineral Supplements. National Institutes of Health, U.S. Department of Health and Human Services. https://ods.od.nih.gov/factsheets/MVMS-HealthProfessional/