21 U.S.C. 343added (z)by H.R. 8385 Sec. 2(a)
(z)(1) Except as provided in subparagraphs (3), (4), and (5) of paragraph (q), if it is food (other than a dietary supplement) intended for human consumption and is offered for sale and otherwise required to bear nutrition labeling, unless its principal display panel bears interpretive nutrition information.(2) Final regulations regarding the interpretive nutrition information required under subparagraph (1) shall meet the following criteria:(A) There shall be a standardized symbol system that displays calorie information related to the serving size determined under paragraph (q)(1)(A), and interpretive nutrition information related to the content of added sugars, sodium, saturated fat, and any other nutrients that the Secretary determines the highlighting of which will assist consumers in maintaining healthy dietary practices, including by highlighting products containing high levels of such nutrients.(B) The system shall clearly distinguish between products of greater or lesser nutritional value.(C) The information shall—(i) appear in a consistent location on the principal display panels across products;(ii) have a prominent design that visually contrasts with existing packaging design; and(iii) be sufficiently large to be easily legible.(3) In promulgating regulations regarding the interpretive nutrition information required under subparagraph (1) and the standardized symbol system required under subparagraph (2)(A), the Secretary shall take into account published reports by the Health and Medicine Division of the National Academy of Sciences, Engineering, and Medicine regarding interpretive nutrition information, and base regulations on the following principles:(A) Consumers should be able to quickly and easily comprehend the meaning of the system as an indicator of a product’s contribution to a healthy diet without requiring specific or sophisticated nutritional knowledge.(B) The nutrition information should be consistent with the Nutrition Facts Panel and with the recommendations of the Dietary Guidelines for Americans.(C) The information should aim to facilitate consumer selection of healthy product options, including among nutritionally at-risk subpopulations.(4) The Secretary should periodically evaluate the standardized symbol system required under subparagraph (2)(A) to assess its effectiveness in facilitating consumer selection of healthy product options and the extent to which manufacturers are offering healthier products as a result of the disclosure.(5) The implementation of this paragraph should be accompanied by appropriate consumer education and promotion campaigns determined by the Secretary.
The bill says: Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the following:
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(r)(1)(B)addedby H.R. 8385 Sec. 3(a)
The bill says: 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,".
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(r)renumberedby H.R. 8385 Sec. 3(a)
The bill says: by redesignating subparagraph (7) as subparagraph (8); and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(r)added (7)by H.R. 8385 Sec. 3(a)
(7) 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.
The bill says: by inserting after subparagraph (6) the following:
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(r)(2)(B)changedby H.R. 8385 Sec. 3(a)
The bill says: 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".
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(r)(2)changedby H.R. 8385 Sec. 3(b)
The bill says: Section 403(r)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(r)(2)) is amended by striking clause (B) and inserting the following:
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(r)(2)(A)renumberedby H.R. 8385 Sec. 3(c)
The bill says: by redesignating subclauses (v) and (vi) as subclauses (vi) and (vii), respectively; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(r)(2)(A)added (v)by H.R. 8385 Sec. 3(c)
(v) 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,
The bill says: by inserting after subclause (iv) the following new subclause:
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(i)changedby H.R. 8385 Sec. 7(1)
The bill says: by striking "and (2)" and inserting "(2)";
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(i)changedby H.R. 8385 Sec. 7(2)
The bill says: by striking "and if the food purports" and inserting ", (3) if the food purports"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(i)changedby H.R. 8385 Sec. 7(3)
The bill says: by inserting ", and (4) if the food is food other than a dietary supplement and contains at least 10 milligrams of caffeine from all sources per serving, a statement (with appropriate prominence near the statement of ingredients required by this paragraph) of the number of milligrams of caffeine contained in one serving of the food and the size of such serving" after "vegetable juice contained in the food".
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 321(qq)added (3)by H.R. 8385 Sec. 8(a)
(3) Any other food ingredient that the Secretary determines by regulation to be a major food allergen, based on the prevalence and severity of allergic reactions to the food ingredient.
The bill says: Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)) is amended by adding at the end the following:
Bill text · Current law (21 U.S.C. 321)
21 U.S.C. 343(w)(1)changedby H.R. 8385 Sec. 9(a)
(1) If it is not a raw agricultural commodity and it is, or it contains an ingredient that bears or contains, a major food allergen or gluten-containing grain, unless either— (A) the word "Contains", followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the…
The bill says: in the matter preceding clause (A), by inserting "or gluten-containing grain" after "major food allergen";
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(A)changedby H.R. 8385 Sec. 9(a)
(A) the word "Contains", followed by the name of the food source from which the major food allergen is derived , or the gluten-containing grain is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i); or
The bill says: by inserting ", or the gluten-containing grain is derived" after "is derived"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(A)changedby H.R. 8385 Sec. 9(a)
(A) the word "Contains", followed by the name of the food source from which the major food allergen is derived, is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i)is printed as specified in subparagraph (8); or
The bill says: by striking "is printed immediately after or is adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under subsections (g) and (i)" and inserting "is printed as specified in subparagraph (8)"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(B)changedby H.R. 8385 Sec. 9(a)
(B) the common or usual name of the major food allergen or gluten-containing grain in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when— (i)…
The bill says: by inserting "or gluten-containing grain" after "of the major food allergen";
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(B)changedby H.R. 8385 Sec. 9(a)
(B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i)as so printed is followed in parentheses by the name of the food source from which the major food allergen is derived, except that the name of the food source is not required when— (i) the common or usual name of the ingredient uses the name of the…
The bill says: by striking "in the list of ingredients required under subsections (g) and (i)" and inserting "as so printed"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(B)changedby H.R. 8385 Sec. 9(a)
(B) the common or usual name of the major food allergen in the list of ingredients required under subsections (g) and (i) is followed in parentheses by the name of the food source from which the major food allergen is derived, or the gluten-containing grain is derived, except that the name of the food source is not required when— (i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived; or (ii) the name of the food source from which…
The bill says: by inserting "or the gluten-containing grain is derived," after "is derived,";
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(B)(i)changedby H.R. 8385 Sec. 9(a)
(i) the common or usual name of the ingredient uses the name of the food source from which the major food allergen is derived , or the gluten-containing grain is derived; or
The bill says: in subclause (i), by inserting ", or the gluten-containing grain is derived" after "is derived"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(B)(ii)changedby H.R. 8385 Sec. 9(a)
(ii) the name of the food source from which the major food allergen is derived , or the gluten-containing grain is derived, appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title.
The bill says: by inserting ", or the gluten-containing grain is derived," after "is derived"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(1)(B)(ii)changedby H.R. 8385 Sec. 9(a)
not—(I) a major food allergen under section 201(qq)(2)(A) or (B); or(II) a gluten-containing grain.
The bill says: by striking "not a major food allergen under section 201(qq)(2)(A) or (B)" and inserting the following:
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(3)changedby H.R. 8385 Sec. 9(a)
(3) The informationSubject to subparagraph (8)(B), the information required under this subsection may appear in labeling in lieu of appearing on the label only if the Secretary finds that such other labeling is sufficient to protect the public health. A finding by the Secretary under this paragraph (including any change in an earlier finding under this paragraph) is effective upon publication in the Federal Register as a notice.
The bill says: in subparagraph (3), by striking "The information" and inserting "Subject to subparagraph (8)(B), the information";
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(4)changedby H.R. 8385 Sec. 9(a)
(4) Notwithstanding subsection (g), (i), or (k), or any other law, a flavoring, coloring, or incidental additive that is, or that bears or contains, a major food allergen or gluten-containing grain shall be subject to the labeling requirements of this subsection.
The bill says: in subparagraph (4), by inserting "or gluten-containing grain" after "major food allergen";
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(7)(A)changedby H.R. 8385 Sec. 9(a)
(7)(A) A person need not file a petition under paragraph (6)subparagraph (6) to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing— (i) scientific evidence (including the…
The bill says: by striking "paragraph (6)" and inserting "subparagraph (6)"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(7)(A)changedby H.R. 8385 Sec. 9(a)
(7)(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsectionallergen and gluten-containing grain labeling requirements of this paragraph, if the person files with the Secretary a notification containing— (i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where…
The bill says: by striking "allergen labeling requirements of this subsection" and inserting "allergen and gluten-containing grain labeling requirements of this paragraph"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)(7)(B)changedby H.R. 8385 Sec. 9(a)
(B) The food ingredient may be introduced or delivered for introduction into interstate commerce as a food ingredient that is not a major food allergen or gluten-containing grain 90 days after the date of receipt of the notification by the Secretary, unless the Secretary determines within the 90-day period that the notification does not meet the requirements of this paragraph, or there is insufficient scientific evidence to determine that the food ingredient does not contain allergenic protein or does not cause an allergenic response that poses a risk to human health.
The bill says: in clause (B), by inserting "or gluten-containing grain" after "major food allergen"; and
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 343(w)added (8)by H.R. 8385 Sec. 9(a)
(8) The information required by subparagraph (1) to be conveyed to the consumer shall be—(A) printed immediately after or adjacent to the list of ingredients (in a type size no smaller than the type size used in the list of ingredients) required under paragraphs (g) and (i); or(B) in the case of a nonpackaged food being offered for sale at retail, and not subject to the requirements of paragraphs (g) and (i), placed on a sign adjacent to the food (in a type size no smaller than the name of the food item).
The bill says: by adding at the end the following:
Bill text · Current law (21 U.S.C. 343)
21 U.S.C. 350g(b)(1)(A)changedby H.R. 8385 Sec. 9(b)
(A) biological, chemical, physical, and radiological hazards, natural toxins, pesticides, drug residues, decomposition, parasites, allergens, gluten-containing grains, and unapproved food and color additives; and
The bill says: in subsection (b)(1)(A), by inserting "gluten-containing grains," after "allergens,"; and
Bill text · Current law (21 U.S.C. 350g)
21 U.S.C. 350g(o)(3)(D)changedby H.R. 8385 Sec. 9(b)
(D) A food allergen and gluten-containing grain control program.
The bill says: in subsection (o)(3)(D), by inserting "and gluten-containing grain" after "allergen".
Bill text · Current law (21 U.S.C. 350g)
21 U.S.C. 374achangedby H.R. 8385 Sec. 9(c)
The bill says: Section 205 of the Food Allergen Labeling and Consumer Protection Act of 2004 (21 U.S.C. 374a) is amended by inserting "and gluten-containing grains" after "allergens" each place it appears.
Bill text · Current law (21 U.S.C. 374a)
21 U.S.C. 343-3added 403Dby H.R. 8385 Sec. 10
403D. Submission and availability of food label information.—(a) Submissions.—(1) Requirement.— The Secretary shall require the manufacturer or importer of any food that is introduced or delivered for introduction into interstate commerce in package form to submit to the Secretary all information to be included in the label of the food, including—(A) the nutrition facts panel;(B) the ingredients list;(C) an image of the principal display panel;(D) major allergens and gluten-containing grains;(E) claims under section 403(r)(1)(A) (commonly known as "nutrient-content claims");(F) claims under section 403(r)(1)(B) (commonly known as "health-related claims"); and(G) other relevant information required by law to be published in the labeling of the food.(2) Updates.— The Secretary shall require the manufacturer or importer of food to update or supplement the information submitted under paragraph (1) with respect to the food in order to keep the information up-to-date and complete.(3) Civil penalty.— Whoever knowingly violates paragraph (1) with respect to any food shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each day on which such violation continues with respect to such food.(b) Public database.— The Secretary shall establish and maintain a public database containing the information submitted under this section that—(1) is available to the public through the website of the Food and Drug Administration; and(2) allows members of the public to easily search and sort information.
The bill says: The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 403C of such Act (21 U.S.C. 343–3) the following:
Bill text · Current law (21 U.S.C. 343-3)
21 U.S.C. 331added (jjj)by H.R. 8385 Sec. 15(b)
(jjj) In the case of a person providing a platform for, or otherwise assisting, the sale of food online or by other remote written electronic means, the prevention by the person of the provision to consumers of information required under section 403(z) or the charging by such person of an additional fee for the provision of such information.
The bill says: Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the following:
Bill text · Current law (21 U.S.C. 331)
21 U.S.C. 333added (h)by H.R. 8385 Sec. 15(b)
(h)(1) Notwithstanding subsection (a), any person who violates section 301(jjj) shall be liable to the United States for a civil penalty in an amount not to exceed $10,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding.(2) The Secretary shall provide the person subject to a penalty under paragraph (1) with a warning and opportunity to correct the violation prior to issuing the first civil penalty under that paragraph.(3) In determining the amount of a civil penalty under paragraph (1), the Secretary shall take into consideration whether the person is making efforts to correct the violation for which such person is subject to such civil penalty.(4) No person shall be subject to criminal penalties as described in subsection (a) for a violation of section 301(jjj).
The bill says: Section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the following:
Bill text · Current law (21 U.S.C. 333)
21 U.S.C. 321added (tt)by H.R. 8385 Sec. 16(b)
(tt) The term artificial, with respect to food or any ingredient of food, means—(1) food or an ingredient that is synthetically produced whether or not it has the same chemical structure as a naturally occurring food or ingredient;(2) food or an ingredient that has undergone chemical changes through the introduction of synthetic chemicals or processing aids (such as corn syrup, high-fructose corn syrup, high-maltose corn syrup, maltodextrin, chemically modified starch, and cocoa processed with alkali), excluding—(A) food or an ingredient that has undergone traditional processes used to make food edible, to preserve food, or to make food safe for human consumption (such as smoking, roasting, freezing, drying, and fermenting processes); or(B) food or an ingredient that has undergone traditional physical processes that do not fundamentally alter the raw product or which only separate a whole intact food into component parts (such as grinding grains, separating eggs into albumen and yolk, or pressing fruits to produce juice); or(3) any food or ingredient that the Secretary specifies by regulation to be artificial for purposes of this Act.(uu) The term synthetic, with respect to a substance in food or any ingredient of food, means a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from a naturally occurring plant, animal, or mineral source, except that such term does not apply to a substance created by naturally occurring biological processes.(vv) The term gluten-containing grains means any one of the following grains (or any crossbred hybrid thereof):(1) Wheat, including any species belonging to the genus Triticum.(2) Rye, including any species belonging to the genus Secale.(3) Barley, including any species belonging to the genus Hordeum.(ww) The term gluten means the proteins that—(1) naturally occur in a gluten-containing grain; and(2) may cause adverse health effects in persons with celiac disease.(xx) The term online means on or by any system of data communication and transmission, such as the internet.(yy) The term online point of selection means any space in which consumers are allowed to purchase food online, including websites, e-commerce platforms, web applications, and mobile applications.
The bill says: Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:
Bill text · Current law (21 U.S.C. 321)