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食品标签:健康声称;锌与成年人抵抗感染和伤口愈合的能力——美国食品药品监督管理局。暂行最终规则。

Food labeling: health claims; zinc and the body's ability to fight infection and heal wounds in adults--FDA. Interim final rule.

出版信息

Fed Regist. 1998 Jun 22;63(119):34112-5.

Abstract

The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a claim relating to the relationship between zinc and the body's ability to fight infection and heal wounds in adults. This rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed statements tht the petitioner submitted in that notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim because the statements submitted as the basis of the claim are not "authoritative statements" of a scientific body, as required by FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.

摘要

美国食品药品监督管理局(FDA)正在发布一项暂行最终规定,禁止在食品上使用与锌和成年人身体抗感染及伤口愈合能力之间关系相关的声明。该规定是对根据1997年《FDA现代化法案》(FDAMA)第303条提交的健康声明通知做出的回应。FDA已审查了请愿人在该通知中提交的声明,并且根据FDAMA的要求,该机构禁止该声明,因为作为该声明依据提交的声明并非FDAMA所要求的科学机构的“权威声明”;因此,FDAMA第303条未授权使用此声明。根据FDAMA第301条的规定,本规定自发布之日起立即生效。

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