Page:United States Statutes at Large Volume 104 Part 4.djvu/45

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PUBLIC LAW 101-535—NOV. 8, 1990 104 STAT. 2361 (I)(A) Within 12 months of the date of the enactment of this Regulations. Act, the Secretary of Health and Human Services shall issue proposed regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act. Such regulations— (i) shall identify claims described in section 403(r)(l)(A) of such Act which comply with section 403(r)(2) of such Act, (ii) shall identify claims described in section 403(r)(l)(B) of such Act which comply with section 403(r)(3) of such Act, (iii) shall, in defining terms used to characterize the level of any nutrient in food under section 403(r)(2)(A)(i) of such Act, define— (I) free, (II)low, (III) light or lite, (IV) reduced, (V) less, and (VI) high, unless the Secretary finds that the use of any such term would be misleading, (iv) shall permit statements describing the amount and percentage of nutrients in food which are not misleading and are consistent with the terms defined in section 403(r)(2)(A)(i) of such Act, (v) shall provide that if multiple claims subject to section 403(r)(l)(A) of such Act are made on a single panel of the food label or page of a labeling brochure, a single statement may be made to satisfy section 403(r)(2)(B) of such Act, (vi) shall determine whether claims respecting the following nutrients and diseases meet the requirements of section 403(r)(3) of such Act: Calcium and osteoporosis, dietary fiber and cancer, lipids and cardiovascular disease, lipids and cancer, sodium and hypertension, and dietary fiber and cardiovascular disease, (vii) shall not require a person who proposes to make a claim described in section 403(r)(l)(B) of such Act which is in compliance with such regulations to secure the approval of the Secretary before making such claim, (viii) may permit a claim described in section 403(r)(l)(A) of such Act to be made for butter, (ix) may, in defining terms under section 403(r)(2)(A)(i), include similar terms which are commonly understood to have the same meaning, and (x) shall establish, as required by section 403(r)(5)(D), the procedure and standard respecting the validity of claims made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances and shall determine whether claims respecting the following nutrients and diseases meet the requirements of section 403(r)(5)(D) of such Act: folic acid and neural tube defects, antioxident vitamins and cancer, zinc and immune function in the elderly, and omega-3 fatty acids and heart disease. (B) Not later than 24 months after the date of the enactment Regulations, of this Act, the Secretary shall issue final regulations to implement section 403(r) of the Federal Food, Drug, and Cosmetic Act. (2) If the Secretary does not promulgate final regulations under paragraph dXB) upon the expiration of 24 months after