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Editor's Note |

How Can We Know if Supplements Are Safe if We Do Not Know What Is in Them?  Comment on “The Frequency and Characteristics of Dietary Supplement Recalls in the United States”

Mitchell H. Katz, MD
JAMA Intern Med. 2013;173(10):928. doi:10.1001/jamainternmed.2013.415.
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Americans spend over $20 billion annually on dietary supplements.1 Although supplements are regulated by the US Food and Drug Administration (FDA) under the Dietary Supplement Health and Education Act, there is no requirement for supplement manufacturers to demonstrate efficacy or safety of their products prior to marketing them. However, companies may not include unapproved ingredients. It turns out that even this minimal requirement is not fulfilled. Harel et al identified 237 dietary supplements that were recalled by the FDA owing to inclusion of unapproved drug ingredients. Given the limited regulation of these products, it is likely that the number of recalls grossly underestimates the number of products on sale with unapproved ingredients. Dietary supplements should be treated with the same rigor as pharmaceutical drugs and with the same goal: to protect consumer health.


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