H.R. 8385 — Food Labeling Modernization Act of 2026

This section designates the short title of the Act as the “Food Labeling Modernization Act of 2026” and sets forth the table of contents.

This section establishes new front-of-package labeling requirements for certain foods (other than dietary supplements) by adding paragraphs (z), (aa), (bb), and (cc) to section 403 of the Federal Food, Drug, and Cosmetic Act, which deems foods misbranded if they fail to comply. Specifically, it (1) requires interpretive nutrition information via a standardized symbol system on the principal display panel displaying calories per serving size and highlighting added sugars, sodium, saturated fat, and other nutrients the Secretary determines relevant, with designs distinguishing greater or lesser nutritional value, in a consistent prominent location; (2) mandates disclosure of whole grains and refined grains as percentages of total grains immediately adjacent to whole grain claims (e.g., "whole wheat," "multigrain") unless 100% whole grains; (3) requires declaration of nutrient-dense fruit quantity per serving (e.g., whole, puree, 100% juice) adjacent to fruit claims or images, with Secretary-set thresholds below which products must state they contain no full serving of fruit; and (4) imposes parallel requirements for nutrient-dense vegetable quantity per serving adjacent to vegetable claims or images, with similar Secretary-set thresholds. (As background, these build on existing Nutrition Facts labeling to aid consumer selection of healthier options consistent with Dietary Guidelines for Americans.) The Secretary must issue regulations considering National Academy of Medicine reports, periodically evaluate the symbol system, and conduct consumer education campaigns.

This section revises food labeling requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for health-related claims and nutrient content claims on conventional foods (i.e., foods other than dietary supplements). Specifically, it (1) expands the scope of permissible claims under FD&C Act Section 403(r)(1)(B) to include statements on a nutrient's effect on body structure or function, its documented mechanism, or general well-being from its consumption; (2) requires manufacturers to substantiate such claims upon FDA request by submitting all relevant documentation within 90 days; (3) replaces the prior standard under Section 403(r)(3)(A)(ii) prohibiting claims that "increase...risk of a disease" with a prohibition on claims "not compatible with maintaining healthy dietary practices"; (4) requires prominent disclosure statements (e.g., "high in [nutrient]") adjacent to nutrient content claims on foods the Secretary determines contain disqualifying nutrient levels; (5) directs the Secretary to revise 21 CFR 101.13(h) by aligning sodium disclosure with the 2016 nutrition labeling rule's Daily Reference Value (DRV), adding an added sugars disclosure based on that rule's DRV, eliminating fat disclosure requirements for meals exceeding 26 grams of fat per serving or main dishes exceeding 19.5 grams, and authorizing "low added sugar" claims for products with 3 grams or less of added sugars per reference amount customarily consumed (or per 50 grams if the reference amount is 30 grams or less or 2 tablespoons or less); (6) prohibits trans fat level claims (except on the Nutrition Facts panel) unless the food has less than 1 gram of saturated fat per serving or discloses saturated fat levels nearby with prominence at least half that of the trans fat claim; and (7) requires a final rule within two years revising 21 CFR 101.14 to establish a disqualifying nutrient level for added sugars.

This section directs the Secretary of Health and Human Services, in regulations required by section 17, to regulate the use of the term "natural" on food labeling (other than dietary supplements)—including on the principal display panel and information panel with a prominent disclosure of its meaning regarding ingredients and manufacturing processes—and to define the term to exclude artificial food or ingredients (including artificial flavors or added colors), based on consumer surveys, studies, and public input (including on "natural" versus "organic"). The section further directs the Secretary to revise "healthy" labeling regulations for food (other than dietary supplements) as follows: (1) to account for added sugars and whole grains, requiring that any food containing grains consist of 100% whole grains; (2) to align sodium limits with the daily value in the most recent Dietary Guidelines for Americans; and (3) considering both food and nutrient criteria, with any required healthful ingredients limited to nutrient-dense forms of those comprising the core of a healthy eating pattern.

This section requires the Secretary of Health and Human Services, in promulgating regulations under section 17, to establish format requirements for ingredient lists on food labels (other than dietary supplements) under section 403(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)—(1) to improve readability; and (2) to assist consumers in maintaining healthy dietary practices. Such requirements include specifications for font size, uppercase and lowercase characters, serif and noncondensed font types, high contrast between text and background, and bullet points between adjacent ingredients, with exemptions for small packages or other considerations. The section further requires the Secretary to submit to Congress, not later than two years after enactment and biennially thereafter, reports on enforcement of section 403(i) of the FD&C Act (including the new regulations) and FDA ingredient labeling regulations at 21 C.F.R. § 101.4.

This section establishes a new misbranding provision under the Federal Food, Drug, and Cosmetic Act for foods intended for human consumption that contain phosphorus and are offered for sale, unless (1) the phrase “contains phosphorus”, along with the quantity of phosphorus in milligrams per serving, is printed immediately after or adjacent to the ingredient list in a type size no smaller than that list; or (2) the quantity of phosphorus, in milligrams, is reported in the Nutrition Facts Panel.

This section requires food other than dietary supplements that contains at least 10 milligrams of caffeine from all sources per serving to include a statement—prominently near the ingredients list on the information panel—disclosing the milligrams of caffeine in one serving and the serving size.

This section (1) expands the definition of major food allergen under the Federal Food, Drug, and Cosmetic Act (FFDCA) by adding a third category for any other food ingredient that the Secretary of Health and Human Services determines by regulation to be one, based on the prevalence and severity of allergic reactions; and (2) directs the Secretary, not later than two years after enactment, to update FDA Compliance Policy Guide §555.250 to conform to applicable laws related to major food allergens and gluten-containing grains, including sections 9 and 10 of this Act. (Major food allergens currently include eight specified ingredients—milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans—and trigger mandatory labeling on packaged foods under FFDCA §403(w).)

This section revises food labeling requirements under FFDCA §403(w) (21 U.S.C. 343(w)) to require disclosure of gluten-containing grains (i.e., alongside the eight major food allergens defined in FFDCA §201(qq)) either immediately after or adjacent to the ingredients list (in the same type size) or, for nonpackaged retail foods, on an adjacent sign (in a type size no smaller than the food name). It further (1) includes gluten-containing grains in hazard analysis and preventive controls for human food under FFDCA §418 (21 U.S.C. 350g); and (2) expands FDA inspections under the Food Allergen Labeling and Consumer Protection Act of 2004 (§205, 21 U.S.C. 374a) to cover gluten-containing grains.

This section requires manufacturers or importers of any packaged food introduced into interstate commerce to submit to FDA all label information—including the nutrition facts panel, ingredients list, principal display panel image, major allergens and gluten-containing grains, nutrient-content claims, health-related claims, and other information required by law—and to update such information to keep it current. The section imposes a civil penalty of up to $10,000 for each day of knowing violations and directs FDA to establish and maintain a searchable, sortable public database of the submitted information on its website.

This section directs the Secretary of Health and Human Services, not later than two years after enactment, to review food standards of identity (i.e., FDA regulations specifying minimum composition requirements for foods labeled with particular names) that mandate minimum levels of nutrients strongly associated with public health concerns (e.g., sodium) or ingredients containing such nutrients and to report the findings to the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions. The section further requires the Secretary, when promulgating regulations under section 17, to amend those standards of identity to (1) provide for the use of salt substitutes where appropriate and (2) require yogurt, lowfat yogurt, and nonfat yogurt to contain a minimum level of live and active cultures per gram.

This section directs the Secretary of Health and Human Services, not later than two years after enactment, to submit to Congress a report on the effect of the FDA's April 15, 2016, final rule permitting folic acid addition to corn masa flour (81 Fed. Reg. 22176) on folic acid intake in the U.S. population by race and ethnicity. The report must compare actual exposure with modeled exposure estimates from the final rule.

This section establishes a new misbranding provision under the Federal Food, Drug, and Cosmetic Act for foods intended for human consumption that contain allulose, polydextrose, sugar alcohols, or isolated fibers (i.e., sugar substitutes and bulking agents often used to reduce calories or added sugars). It requires prominent disclosure of such ingredients on the principal display panel and directs the Secretary of Health and Human Services to establish by regulation quantities per serving above which a warning label is required for levels determined to cause deleterious health effects.

This section directs the Secretary of Health and Human Services to (1) conduct a study on food labeling legibility on principal display panels not later than two years after enactment of this Act; (2) issue proposed regulations, not later than one year after completing the study, revising type size and color contrast requirements under 21 CFR 101.2(c) based on the study's results; and (3) finalize those regulations not later than two years after completing the study.

This section establishes requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA) for the sale of food online or by other remote electronic means. It deems such food misbranded unless all required label information—including nutrition facts (in the same format as under current FFDCA section 403(q)), ingredients (under sections 403(g) and (i)), and allergen information (under section 403(w))—is available to consumers at the point of selection prior to purchase and appears prominently on the first product page without intervening marketing, as specified by FDA regulation. The section further prohibits online platforms assisting such sales from preventing the provision of this information or charging an additional fee for it. Finally, it establishes civil monetary penalties of up to $10,000 per violation (and up to $1 million for all violations adjudicated in a single proceeding) for both misbranding violations and platform prohibitions, with a prior warning and opportunity to correct, consideration of correction efforts, and no criminal penalties.

This section specifies that, for purposes of this Act, the terms *food* and *dietary supplement* have the meanings given those terms in the Federal Food, Drug, and Cosmetic Act (FFDCA). The section amends the FFDCA (21 U.S.C. 321) to define the following terms: (1) *artificial*, with respect to food or an ingredient, as synthetically produced (whether or not matching a natural counterpart), chemically changed via synthetic chemicals or processing aids (e.g., corn syrup, high-fructose corn syrup, chemically modified starch), or as specified by regulation—excluding traditional processes to make food edible, safe, or preserved (e.g., smoking, fermenting) or physical processes that do not fundamentally alter the product (e.g., grinding grains); (2) *synthetic*, with respect to a substance in food, as formulated or manufactured by chemical process or by chemically changing a naturally extracted substance (excluding substances created by naturally occurring biological processes); (3) *gluten-containing grains*, as wheat (genus *Triticum*), rye (genus *Secale*), barley (genus *Hordeum*), or crossbred hybrids thereof; (4) *gluten*, as proteins naturally occurring in gluten-containing grains that may cause adverse health effects in persons with celiac disease; (5) *online*, as on or by any data communication system such as the internet; and (6) *online point of selection*, as any consumer food purchase space online, including websites, e-commerce platforms, web applications, and mobile applications.

This section directs the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to issue proposed regulations to implement sections 2, 3, 4, 5(a), 6, 7, 9, 10, 11, 13, 15, and 16(b) and their amendments not later than one year after enactment and final regulations not later than two years after enactment, with proposed regulations becoming final automatically if finals are not issued by the deadline. The amendments made by those sections apply beginning three years after enactment.