Fed Regist. 1998 Jun 22;63(119):34092-7.
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 antioxidant vitamins A and beta-carotene and the risk in adults of atherosclerosis, coronary heart disease, amd certain cancers. This interim final 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 that 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 interim final rule is effective immediately upon publication.
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抗氧化维生素A和β-胡萝卜素之间的关系以及成年人患动脉粥样硬化、冠心病和某些癌症风险相关的声明。这项暂行最终规定是对根据1997年《FDA现代化法案》(FDAMA)第303条提交的健康声明通知的回应。FDA审查了请愿人在该通知中提交的声明,并且根据FDAMA的要求,该机构禁止使用该声明,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,本暂行最终规定自发布之日起立即生效。