Fed Regist. 1998 Jun 22;63(119):34101-4.
The Food and Drug Administration (FDA) is issuing this interim final rule to prohibit the use on foods of a claim relating to the relationship between calcium, bone density, and the risk of fractures. 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 is prohibiting the claim because section 303 of FDAMA does not apply when FDA has an existing regulation authorizing a health claim about the relationship between the nutrient and the disease or health-related condition at issue. A health claim concerning the relationship between calcium and osteoporosis is already authorized. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.
美国食品药品监督管理局（FDA）发布本暂行最终规则，禁止在食品上使用与钙、骨密度和骨折风险之间关系相关的声明。本暂行最终规则是对根据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禁止该声明，因为当FDA已有一项关于所涉营养素与疾病或健康相关状况之间关系的健康声明授权法规时，FDAMA第303条不适用。一项关于钙与骨质疏松症之间关系的健康声明已获授权。根据FDAMA第301条的规定，本规则自发布之日起立即生效。
