Fed Regist. 2000 Jan 6;65(4):1000-50.
The Food and Drug Administration (FDA) is issuing final regulations defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body. The regulations also establish criteria for determining when a statement about a dietary supplement is a claim to diagnose, cure, mitigate, treat, or prevent disease. This action is intended to clarify the types of claims that may be made for dietary supplements without prior review by FDA and the types of claims that require prior authorization as health claims or prior approval as drug claims.
美国食品药品监督管理局（FDA）正在发布最终法规，界定有关膳食补充剂对人体结构或功能影响的可表述类型。这些法规还确立了判定关于膳食补充剂的一项表述何时属于诊断、治愈、减轻、治疗或预防疾病的声称的标准。此行动旨在厘清无需FDA事先审查即可针对膳食补充剂做出的声称类型，以及作为健康声称需要事先批准或作为药品声称需要事先核准的声称类型。
