Senior vice president of pharmacy practice and government affairs at the American Pharmacists Association in Washington, DC.
Former director of health policy at the American Pharmacists Association in Washington, DC.
AMA J Ethics. 2022 May 1;24(5):E390-395. doi: 10.1001/amajethics.2022.390.
Dietary supplements do not require premarket approval by the US Food and Drug Administration (FDA), yet they can have side effects; interact with medications, food, or other supplements; or be unsafe, so it is important for clinicians to discuss dietary supplement use with patients. This article provides an overview of dietary supplement requirements related to safety, manufacturing, labeling, advertising, and adverse event reporting; discusses tainted supplements and the FDA's and Federal Trade Commission's enforcement actions against dietary supplements; and offers recommendations to clinicians on matters of key clinical and ethical importance during clinical encounters.
膳食补充剂不需要美国食品和药物管理局(FDA)的上市前批准,但它们可能会有副作用;与药物、食物或其他补充剂相互作用;或者不安全,因此临床医生与患者讨论膳食补充剂的使用非常重要。本文概述了与安全性、制造、标签、广告和不良事件报告相关的膳食补充剂要求;讨论了受污染的补充剂以及 FDA 和联邦贸易委员会对膳食补充剂的执法行动;并就临床医生在临床接触期间的关键临床和伦理问题提供了建议。