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1 草本等制品应区分为药品和饮食补充品。如属药品,在进入美国市场前必须经FDA批准;如属饮食补充品,进入美国市场前无需向FDA注册或获得其批准,但必须保证产品的安全性和有效性,并符合FDA饮食补充品标签的有关规定。2 饮食补充品标签(须用英文)必须真实、不误导,不能使用“诊断、治疗或预防疾病”等字眼。凡属饮食补充品都必须在标签上注明“饮食补充品”。 生产厂家可在产品标签上作一些有关产品作用的说明,但须注明“上述内容未经FDA审核,该产品不宜用于诊断、
1 Herbs and other products should be divided into medicines and dietary supplements. In the case of drugs, they must be approved by the FDA before entering the US market; in the case of dietary supplements, there is no need to register or obtain approval from the FDA before entering the US market, but the safety and efficacy of the product must be ensured and the FDA dietary supplements must be complied with. The relevant provisions of the label. 2 Labels for dietary supplements (in English) must be true, not misleading, and should not use the words “diagnose, treat, or prevent disease.” All dietary supplements must be marked on the label “dietary supplements.” Manufacturers can make some explanations on the role of the product on the product label, but must indicate "The above content has not been FDA audited, the product should not be used for diagnosis,