Food Labeling: Health Claims; Antioxidant Vitamin A and Beta- Carotene and the Risk in Adults of Atherosclerosis, Coronary Heart Disease, and Certain Cancers

Resumen

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 vitamin A and beta-carotene and the risk in adults of atherosclerosis, coronary heart disease, and 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. DATES: The interim final rule is effective June 22, 1998; comments by September 8, 1998. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Christin