Are dietary supplements medications? Review article
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Published:
Jun 30, 2020
Keywords:
prescription drug, over-the-counter drug, dietary supplement
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Abstract
Dietary supplements are not over-the-counter (OTC) drugs and, unlike Rx and OTC drugs, supplements are not required to demonstrate efficacy and/or safety prior to marketing. Unfortunately, patients, pharmacists, and even healthcare providers may mistakenly equate supplements with OTC drugs and may have the impression that dietary supplements are subject to the same or similar rigorous regulatory standards of safety, efficacy, and good manufacturing practices required for OTC medications.
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How to Cite
Postuła, M. (2020). Are dietary supplements medications?. Medycyna Faktow (J EBM), 13(2(47), 174-177. https://doi.org/10.24292/01.MF.0220.5
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2. Miller E, Pastor-Barriero R. Meta-analysis: high-dosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med. 2005; 142: 37-46.
3. Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group. The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med. 1994; 330: 1029-35.
4. Omenn G, Goodman G, Thornquist M et al. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med. 1996; 334: 1150-5.
5. Feskanich D, Singh V, Willett W et al. Dense low density lipoprotein subspecies with diminished oxidative resistance pre-dominate in combined hyperlipidemia. JAMA. 2002; 287: 47-54.
6. Office of Nutritional Products, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition, US Food and Drug Administration. Letter responding to a request to reconsider the qualified claim for a dietary supplement health claim for omega-3 fatty acids and coronary heart disease. Docket No. 91N-0103.
7. FDA/CFSAN. Dietary Supplement Health and Education Act of 1994. U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, December 1, 1995 (Access: 20.03.2020).
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9. European Food Safety Authority. Food supplements (Access: 20.03.2020).
10. Food and Drug Administration Center for Drug Evaluation and Research (Access: 20.03.2020).
11. Dietary Supplement Health and Education Act of 1994 (Access: 20.03.2020).
12. Cohen PA. Hazards of hindsight–monitoring the safety of nutritional supplements. N Engl J Med. 2014; 370: 1277-80.
13. American Cancer Society. Dietary supplements: what is safe? (Access: 20.03.2020).
14. Dietary supplements: what you need to know (Access: 20.03.2020).
15. Tucker J, Fischer T, Upjohn L et al. Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Netw Open. 2018; 1: e183337.
16. Harel Z, Harel S, Wald R et al. The frequency and characteristics of dietary supplement recalls in the United States. JAMA Intern Med. 2013; 173: 926-8.