Search results for: healthy

  • On June 22, 2025, Texas Governor Greg Abbott signed SB 25 into law to require on-pack warning labels for food and beverage products that contain any of the substances listed within the bill, including titanium dioxide and FDA approved food colors such as Red 40. As we previously reported, the Texas House passed SB 25 on May 26, 2025, with bipartisan support and backing from the Department of Health & Human Services Secretary Robert F. Kennedy, Jr.
  • The law adds Sections 431.0815, 431.0816, and 431.0817 to Subchapter D, Chapter 431 of the Texas Health and Safety Code. The law requires companies to either remove or place a warning label “in a prominent and reasonably visible location” on any product that contains any of the 44 listed substances. The warning label must read: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” This requirement applies to food product labels “developed or copyrighted” on or after January 1, 2027. In addition to seeking an injunction, the Attorney General may impose a civil penalty of up to $50,000 per day for each individual food product that violates this requirement.
  • Notably, the law includes a federal preemption provision (Section 431.0817) that should limit the law’s impact on warning label requirements. The provision states that a warning label is not required if FDA or USDA have (1) prohibited the use of the ingredient, (2) imposed conditions on the use of the ingredient (including the requirement of a warning or disclosure statement), or (3) determined an ingredient or class of ingredients is safe for human consumption by federal law or regulation promulgated by the FDA. A warning label is also not required if a federal law or regulation requires a labeling statement relating to ultra-processed or processed foods. This language was included in SB 25 following an amendment made by Representative Gary VanDeaver.
  • Based on the federal preemption provision’s language, if FDA has implemented a regulation authorizing the use of an ingredient, it will not require a warning label. For example, sodium hydroxide (also known as lye) is generally recognized as safe (GRAS) as a direct human food ingredient by FDA (21 CFR 184.1763). Sodium hydroxide is also approved for use in the European Union, United Kingdom, Australia, and Canada.
  • The law will take effect on September 1, 2025. Keller and Heckman will continue to monitor and post updates on similar state legislation requiring ingredient disclosures or labels.
  • On May 26, 2025, the Texas House passed SB 25 with bipartisan support. SB 25, also known as the ‘Make Texas Healthy Again’ bill, focuses on promoting nutritional awareness and physical education in schools and improving food labeling practices. The bill would also establish a Nutrition Advisory Committee to help establish, develop, and maintain nutritional guidance within the State.
  • SB 25 also requires food manufacturers to either remove prohibited ingredients listed within the bill­­—such as Red 40 and titanium dioxide—or place a warning label on the product that reads: “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.” This language was amended from what was reported on in a previous blog post. The latest version of the bill makes clear that it does not apply to dietary supplements (among other listed situations).
  • Notably, the bill removed high fructose corn syrup from the list of prohibited ingredients following opposition from numerous food companies after it was introduced. The industry’s opposition letter also urged legislators to remove the warning label requirement, but the proposed amendment did not pass through the House.
  • SB 25 is now heading to Governor Greg Abbott’s desk to be signed into law. The bill would take effect on September 1, 2025.
  • Yesterday, the Make America Healthy Again (MAHA) Commission, released its “Make Our Children Healthy Again” report outlining its priorities for improving the health of American children. President Trump requested the report in a February executive order establishing the MAHA Commission.  The report targets “ultra-processed foods” (UPFs), exposure to environmental chemicals (microplastics, pesticides), a decline in physical activity, and “overmedicalization” as some of the main drivers of an increase in childhood chronic diseases such as obesity and cancer. The MAHA Commission is set to issue further policy recommendations in August.
  • The report loosely defined UPFs as those that are high in added sugars, refined grains, unhealthy fats (such as seed oils), and sodium while low in fiber and essential nutrients. The report also identifies certain food additives, including food colorings (such as Red 40), titanium dioxide, propylparaben, butylated hydroxytoluene (BHT), and artificial sweeteners (such as aspartame, sucralose, saccharin).
  • The report also criticizes the Dietary Guidelines for Americans (DGA) for not specifically addressing UPFs in its dietary recommendations and “remaining largely agnostic to how foods are produced or processed.” The report is also critical of the DGA and nutrition research at large claiming they are being improperly influenced by the food industry, citing an analysis that found $60 billion in industry funding for nutrition research, without acknowledging the significant cuts to research funding undertaken by the administration in the last several months. (Pages 30-32)
  • The report goes on to criticize other government programs. It claims that children who are Supplemental Nutrition Assistance Program (SNAP) participants consume more unhealthy food and beverages than income-eligible non-participants, leading to worse health outcomes. The report further claims that the National School Lunch Program (NSLP) fails to limit UPF consumption and allows food companies to make minor ingredient adjustments to qualify their products for the Smart Snack program. (Pages 32-34)
  • Cumulative chemical exposure, increased use of technology, and overtreatment/overdiagnosis of common illnesses are all claimed to be drivers of chronic disease. The report calls for studies on the effect of cumulative exposure to chemicals including PFAS, phthalates, bisphenols, microplastics, fluoride, electromagnetic radiation, and crop protection tools (e.g., pesticides, herbicides, and insecticides).  (Pages 43-44)
  • The report made a single reference to GRAS Oversight reform, recommending that independent studies are funded to evaluate “the health impact of self-affirmed GRAS food ingredients.” (Page 72)
  • Yesterday Texas Attorney General Ken Paxton announced that it had sent General Mills a Civil Investigative Demand as part of a new investigation regarding the company’s marketing of its cereal products as “healthy” and a “good source” of vitamins and minerals despite containing what Texas calls “petroleum-based food colorings.”
  • The announcement alleges, without pointing to evidence, that a host of negative health outcomes can be attributed to these synthetic food colorings and voices support for the Trump administration’s battle against such colorings.
  • This move follows the Trump administration’s announcement of its planned phase-out of the use of synthetic dyes last month as well as a similar investigation against Kellogg by Texas, which was announced last month.
  • On April 5, 2025, Texas Attorney General Ken Paxton announced an investigation of W.K. Kellogg Co. (Kellogg) for potential violation of Texas consumer protection laws, alleging that Kellogg’s marketing of its cereals as “healthy” is deceptive marketing because they include artificial food dyes and butylated hydroxytoluene (BHT).
  • As we previously reported, the Texas Senate recently passed SB 25, which if passed into law would require food labels to warn Texas consumers if a food product contains ingredients banned in other countries.  The bill is now under review with the Texas House Committee on Public Health.  AG Paxton’s announcement signals the Texas government’s continued focus on food additives and “healthy” claims by food manufacturers.
  • AG Paxton alleges that Kellogg’s “healthy” claim is deceptive because the artificial dyes “have been linked to hyperactivity, obesity, autoimmune disease, endocrine-related health problems, and cancer in those who consume them.”  However, not all food scientists agree with this link to health issues, and many of the food dyes and additives are currently approved for use by the U.S. Food and Drug Administration (FDA).
  • Keller and Heckman will continue to monitor this investigation and relay any developments.
  • FDA has delayed the effective date of the final rule on use of the term “healthy” in food labeling until April 28, 2025, in response to a presidential memorandum recommending a regulatory freeze to review questions of fact, law, and policy that recently published rules may raise. We previously blogged about the “healthy” final rule here and the regulatory freeze here.
  • According to the Agency, the temporary delay “is necessary to give Agency officials the opportunity for further review and consideration of the new regulation, consistent with the memorandum described previously.” FDA is not seeking public comment due to the limited impact of the delayed effective date, since the February 25, 2028 compliance date remains unchanged. FDA also reiterated that “parties are free to begin implementing the rule earlier than the compliance date.”
  • Keller and Heckman will continue to share updates on the “healthy” rule and other FDA actions.
  • On February 13, 2025, President Donald J. Trump signed an Executive Order establishing the President’s Make America Healthy Again Commission.  This initiative, chaired by the newly-confirmed U.S. Health and Human Services Secretary Robert F. Kennedy Jr., aims to tackle the root causes of chronic diseases that affect millions of Americans.
  • According to the order, six in ten Americans have at least one chronic disease, and four in ten have two or more.  The commission aims to review the American diet, “absorption of toxic material,” and “food production techniques,” as part of its objectives.
  • The Commission has outlined four main policy directives to achieve its goals: (1) requiring federally funded research to be transparent; (2) prioritizing researching the root causes of illness; (3) working with farmers to ensure our food supply is healthy and abundant; and (4) increasing the flexibility of health insurance coverage to provide better support for disease prevention.
  • The composition of the Make America Healthy Again Commission will include the Secretary of Health and Human Services as Chair, and the Assistant to the President for Domestic Policy as Executive Director, and top officials across several federal agencies related to health, the environment, food and drugs, and others.
  • The EO requires that within 100 days of the order, the commission will provide a preliminary assessment identifying the causes of childhood chronic disease in America.
  • Keller and Heckman will continue to monitor the new commission and any activities or initiatives taken under its directive.
  • FDA currently plans to hold a webinar on February 20, 2025, to provide an overview on the updated definition of the nutrient content claim “healthy.”
  • As we discussed on this blog, in December 2024, FDA published a final rule updating the requirements to use the implied nutrient content claim “healthy” on human foods. To make a “healthy” claim, a product must:
    • Contain a certain amount of food from at least one of the food groups or subgroups recommended by the Dietary Guidelines for Americans; and
    • Meet specific limits for added sugars, saturated fat, and sodium.
  • Registration is required to attend the webinar, which is free and open through the day of the webinar. During the webinar, FDA will discuss pre-submitted questions, which must be submitted through the registration page by January 31, 2025.
  • Keller and Heckman will continue to provide updates related to the “healthy” final rule.
  • On December 19, 2024, FDA released the pre-publication of the final rule updating the definition for the implied nutrient content claim, “healthy.” The final rule will be published in the Federal Register on December 27.  The final rule revises the requirements for making a healthy claim on human food products. FDA’s labeling rule is part of a broader initiative aimed at reducing diet-related disease and promoting health equity as part of the White House National Strategy on Hunger, Nutrition, and Health.  
  • This rule finalizes the 2022 proposed rule and updates the definition of “healthy” which was last defined at 21 CFR 101.65 thirty years ago.  The previous definition was based on outdated nutrition science and did not account for the latest dietary guidelines.
  • Under the final rule, for a food product to bear a “healthy” (or any derivative e.g., “healthful”) claim the food product must:
    • (1) Contain a certain amount of food from one of the Food Group Equivalents (FGE) established by the Dietary Guidelines, 2020-2025 (vegetables, fruits, dairy, grains, protein foods, and oils); and
    • (2) Adhere to specified limits related to saturated fat, sodium, and added sugar.
  • For example, for a vegetable product to make a “healthy” claim it must:
    • Contain at least ½ cup equivalent vegetable and
    • Contain no greater than 2% of the Daily Value (DV) of added sugar, no more than 10% of the DV of sodium, and no more than 5% of the DV of saturated fat.
  • In addition to the six categories of FGE’s established above, there are distinct requirements for mixed products, main dishes, and meal products:
    • Mixed Products: Must contain at least one total Food Group Equivalent (FGE) with no less than 1/4 FGE from at least two food groups and added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
    • Main Dish: Must contain at least one total FGE with no less than 1/4 FGE from at least two food groups and the added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
    • Meal Products: Must contain at least one total FGE with no less than 1/4 FGE from at least two food groups and added sugars content must be no greater than 10% DV, sodium content must be no greater than 15% DV, and saturated fat content (excluding inherent fats in seafood, nuts, seeds, and soy products) must be no greater than 10% DV.
  • The new rule makes modifications for certain foods that contain healthy fats such as fish and nuts that were before unable to qualify for the healthy claim.  For example, the final rule makes a note for seafood, nuts, seeds, and soy products that the DV limit established by the rule excludes saturated fat inherent in the food product. Further, the updated rule introduces specific limits on added sugars. Now, foods high in added sugars, which do not align with current nutrition science and dietary guidelines, can no longer be labeled as “healthy.”
  • These changes are designed to help consumers make better-informed choices and promote healthier eating patterns.  FDA is also developing a “healthy” symbol that manufacturers can use on food packaging to help consumers quickly identify products that meet the “healthy” criteria.
  • The rule goes into effect 60 days after publication in the Federal Register, which is expected to be published on December 27, 2024, and the compliance date is February 25, 2028. Keller and Heckman will continue to monitor developments related to the final rule’s implementation and enforcement.
  • FDA is in the process of updating its regulatory definition of the term “healthy” when it appears as an implied nutrient content claim on food labels. See FDA’s proposed rule published in September 2022. The current criteria for healthy claims (21 CFR 317.363) include limits for amounts of fat, saturated fat, cholesterol, and sodium, and also require foods to contain at least 10% of the daily value (DV) of one or more of vitamin A, vitamin C, calcium, protein, or fiber. The proposed criteria would establish a more complicated framework in which foods would be required to (1) contain at least one of the food groups or subgroups recommended by the 2020-2024 Dietary Guidelines for Americans (food group equivalents) and (2) would set limits for added sugars, saturated fats, and sodium. The required food group equivalents and the nutrient limitations would depend on product category.
  • The 2024 Consolidated Appropriations Act, which was signed into law in March 2024, includes provisions dealing with the effective date of any final rule FDA issues in connection with this proposal. Specifically, the Appropriations Act states that (1) food manufacturers may continue to comply with FDA’s current requirements regarding the term “healthy” on food labels throughout the compliance date FDA provides in the final rule establishing new criteria, and (2) any food products manufactured and labeled as “healthy” during the compliance period FDA provides in that final rule shall not be directly or indirectly subject to any state-law requirements that are not identical to either the current or updated FDA requirements. See Section 745. We read this language, particularly the words “directly or indirectly,” as being intended to preempt any lawsuits that might target “healthy” claims under state consumer protection laws.
  • We will continue to monitor and report on the updated healthy rule.