Sec. 3. Claims for conventional foods
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Section 403(r)(1)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343(r)(1)(B) ) is amended by inserting after health-related condition the following: , describes the effect that a nutrient may have on the structure or function of the human body, characterizes the documented mechanism by which that nutrient acts to maintain such structure or function, or describes general well-being from consumption of that nutrient, . Section 403(r) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343(r) ) is amended— by redesignating subparagraph
(7)as subparagraph (8); and by inserting after subparagraph
(6)the following: If the Secretary requests that a claim under subparagraph (1)(B) for food (other than a dietary supplement) be substantiated, then not later than 90 days after the date on which the Secretary makes such request, the manufacturer shall provide to the Secretary all documentation in the manufacturer's possession relating to the claim. . Section 403(r)(3)(A)(ii) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343(r)(2)(B) ) is amended by striking increases to persons in the general population the risk of a disease or health-related condition which is diet related and inserting may not be compatible with maintaining healthy dietary practices . Section 403(r)(2)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343(r)(2) ) is amended by striking paragraph
(B)and inserting the following: If a claim described in subparagraph (1)(A) is made with respect to a nutrient in a food and the Secretary makes a determination that the food contains a nutrient at a level that may not be compatible with maintaining healthy dietary practices, the label or labeling of such food shall contain, prominently and in immediate proximity to such claim, a statement which indicates the food is high in such nutrient. . In promulgating the regulations required by section 18, the Secretary of Health and Human Services shall revise section 101.13(h) of title 21, Code of Federal Regulations, by— updating the level of sodium requiring disclosure to align with the Daily Reference Value for sodium established in the final rule entitled Food Labeling: Revision of the Nutrition and Supplement Facts Labels published by the Food and Drug Administration in the Federal Register on May 27, 2016 (81 Fed. Reg. 33742 et seq.); including a level of added sugars requiring disclosure based on the Daily Reference Value for added sugars established in the final rule referenced in subparagraph (A); eliminating the requirement that meal products containing more than 26 grams of fat and main dish products containing 19.5 grams of fat per labeled serving must disclose that fat is present in the food; and authorizing the use of express and implied low added sugar claims on products containing 3 grams of added sugars or less per reference amount customarily consumed (or per 50 grams if the reference amount customarily consumed is 30 grams or less or 2 tablespoons or less). Section 403(r)(2)(A) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343(r)(2)(A) ) is amended— by redesignating subclauses
(v)and
(vi)as subclauses
(vi)and (vii), respectively; and by inserting after subclause
(iv)the following new subclause: may not be made with respect to the level of trans fats in the food, except on the Nutrition Facts Panel, unless the food contains less than one gram of saturated fat per serving or, if the food contains more than one gram of saturated fat per serving, unless the label or labeling of the food discloses the level of saturated fat in the food in immediate proximity to such claim and with appropriate prominence which shall be no less than one-half the size of the claim with respect to the level of trans fats; . Not more than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate a final rule revising section 101.14 of title 21, Code of Federal Regulations, to include a disqualifying nutrient level for added sugars.
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- 81 FR 33742
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