TITLE 25. HEALTH SERVICES
PART 1. DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229. FOOD AND DRUG
SUBCHAPTER
II.
The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new Subchapter II, §§229.1001 - 229.1005, concerning Warning Label Requirements for Food.
BACKGROUND AND PURPOSE
The proposal is necessary to comply with Senate Bill (S.B.) 25, 89th Legislature, Regular Session, 2025, which amends Health and Safety Code (HSC) Chapter 431, Subchapter D by adding §§431.0815, 431.0816, and 431.0817.
Section 431.0815 requires any food manufacturer offering food for human consumption for sale in Texas to include a warning label if the food contains certain ingredients outlined in the statute. A food manufacturer or a food retailer, who is provided content information by the manufacturer, must disclose all required labeling information to the consumer if the product is offered for sale in Texas on the manufacturer's or retailer's website. The warning label requirements apply only to food labels developed or copyrighted on or after January 1, 2027. The warning label requirements do not apply to food not offered for human consumption; food labeled, prepared, served, or sold in a restaurant or retail food establishment; a drug or dietary supplement; or products regulated by the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS), or labeled with a governmental warning with a recommendation from the Surgeon General of the United States Public Health Service (USPHS).
S.B. 25 provides specific language for the required warning label and includes font size, placement, and contrast requirements when the warning label is placed on a food label. S.B. 25 includes exceptions to the warning label requirement for certain ingredients as outlined in HSC §431.0817.
SECTION-BY-SECTION SUMMARY
Proposed new Subchapter II, Warning Label Requirements for Food, adds a new subchapter in Chapter 229 for rules related to warning label requirements for food as listed below.
Proposed new §229.1001 describes the purpose of the rule, establishes the scope of the rule, and provides for the adoption of federal regulations.
Proposed new §229.1002 provides terms and definitions used throughout the subchapter.
Proposed new §229.1003 establishes exemptions for certain ingredients; foods produced in a restaurant or retail food establishment; products regulated by the United States Department of Agriculture (USDA) or Food Safety and Inspection Service (FSIS), or labeled with a governmental warning with a recommendation from the surgeon general of the United States Public Health Service (USPHS); drugs; dietary supplements; a pesticide chemical, soil or plant nutrient, or other agricultural chemical used in the production, storage, or transportation of a raw agricultural commodity; and exemptions related to a specific ingredient for food and color additive in HSC §431.0815.
Proposed new §229.1004 lists food ingredients that require a warning label and warning label requirements.
Proposed new §229.1005 establishes criminal, civil, administrative penalties, and other enforcement actions, for violations to rules in subchapter II.
FISCAL NOTE
Christy Havel Burton, Chief Financial Officer, has determined for each year of the first five years that the rules will be in effect, there will be an estimated additional cost to state government as a result of enforcing and administering the rules as proposed. Enforcing or administering the rules does not have foreseeable implications relating to costs or revenues of local government.
The effect on state government for each year of the first five years the proposed rules are in effect is an estimated cost of $2,500,000 in fiscal year (FY) 2026; $2,500,000 in FY 2027; $2,500,000 in FY 2028; $2,500,000 in FY 2029; and $2,500,000 in FY 2030.
GOVERNMENT GROWTH IMPACT STATEMENT
DSHS has determined that during the first five years that the rules will be in effect:
(1) the proposed rules will not create or eliminate a government program;
(2) implementation of the proposed rules will create new DSHS employee positions;
(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;
(4) the proposed rules will not affect fees paid to DSHS;
(5) the proposed rules will create a new regulation;
(6) the proposed rules will expand existing regulations;
(7) the proposed rules will not change the number of individuals subject to the rules; and
(8) the proposed rules will not affect the state's economy.
SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS
Christy Havel Burton has also determined there will be an adverse economic effect on small businesses or micro-businesses, or rural communities.
DSHS estimates the number of small businesses subject to the proposed rules is 11,466. The projected economic impact for a small business is based on current licensed food manufacturers with DSHS. This estimate excludes manufacturers that are licensed and have gross annual sales greater than $10 million.
Costs to businesses will only occur if labels are developed or copyrighted on or after January 1, 2027. If labels are never changed, businesses are not required to comply. A business may choose not to continue using any of the listed ingredients; this would not incur any additional costs for the business.
LOCAL EMPLOYMENT IMPACT
The proposed rules will not affect a local economy.
COSTS TO REGULATED PERSONS
Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules.
PUBLIC BENEFIT AND COSTS
Timothy Stevenson, DVM, Ph.D., Deputy Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rules are in effect, the public benefit will include increased awareness of food consumption by requiring a warning label on food containing specific ingredients. This will assist consumers in making informed decisions on food products to purchase or consume.
Christy Havel Burton has also determined that for the first five years the rules are in effect, persons who are required to comply with the proposed rules may incur economic costs for label development. The actual costs are unknown.
TAKINGS IMPACT ASSESSMENT
DSHS has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.
PUBLIC COMMENT
Written comments on the proposal, including information related to the cost, benefit, or effect of the proposed rule, as well as any applicable data, research, or analysis, may be submitted to the Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4601 West Guadalupe Street, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhs.texas.gov.
To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 25R043" in the subject line.
STATUTORY AUTHORITY
The new sections are authorized by Texas Government Code §524.0151 and Texas Health and Safety Code §1001.075, which authorize the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code §431.0815 and §431.241, and Texas Health and Safety Code Chapter 1001.
The new sections implement Texas Government Code §524.0151 and Texas Health and Safety Code Chapter 1001.
§229.1001.
(a) This subchapter implements Texas Health and Safety Code (HSC) Chapter 431. HSC Chapter 431 requires the Department of State Health Services (DSHS) to adopt rules about warning labels on foods that have specific ingredients and requires rules for website disclosures if food that is subject to the warning label requirements is offered for sale in Texas on the manufacturer's or retailer's website.
(b) This subchapter applies to:
(1) any manufacturer that offers a food product for sale in Texas, no matter where the food product was originally made;
(2) any ingredient meant to be consumed by humans, which the United States Food and Drug Administration (FDA) requires to be listed on the food label; and
(3) food product labels developed or copyrighted on or after January 1, 2027. For purposes of this subchapter, any change to a food product label on or after January 1, 2027, must follow the rules in §229.1004 of this subchapter (relating to Warning Label Requirements) unless exempt.
(c) The department adopts by reference:
(1) 21 Code of Federal Regulations (CFR) Part 70, Color Additives, Subpart B, Packaging and Labeling, as amended;
(2) 21 CFR Part 73, Listing of Color Additives Exempt From Certification, Subpart A, Foods, as amended;
(3) 21 CFR Part 74, Listing of Color Additives Subject to Certification, Subpart A, Foods, as amended;
(4) 21 CFR Part 81, General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;
(5) 21 CFR Part 82, Listing of Certified Provisionally Listed Colors and Specifications, as amended; and
(6) 21 CFR Part 101, Food Labeling, as amended.
§229.1002.
(a) Dietary supplement--A product a person can consume that has a "dietary ingredient" to add to the diet. A "dietary ingredient" includes vitamins and minerals, herbs, amino acids, enzymes, live bacteria (called "probiotics"), or other substances found in food. The dietary supplement can also be a mix or concentrate of any of these ingredients.
(b) Drug--Articles that are:
(1) listed in the official United States Pharmacopoeia National Formulary (USP-NF) or any of the USP-NF supplements;
(2) intended for diagnosing, curing, mitigating, treating, or preventing diseases in humans or animals;
(3) other than food, meant to influence the structure or any function of the body of humans or animals; and
(4) intended to be used as a component of any article mentioned in this definition.
(5) The term does not include devices or their parts, components, or accessories.
(6) A food for which a claim is made in accordance with Section 403(r) of the Federal Food, Drug, and Cosmetic Act (21 United States Code (U.S.C.) §301), and for which the claim is approved by the United States Secretary of Health and Human Services, is not a drug solely because the label or labeling contains such a claim.
(c) Food--Any article used by humans for food or drink, including chewing gum and items used as ingredients in other food or drink.
(d) Food manufacturer--A person who combines, purifies, processes, or packages food to sell through a wholesale outlet. This term also includes:
(1) a retail outlet that packages or labels food before selling it; and
(2) a person responsible for the purity and proper labeling of a food item by labeling the food with the person's name and address.
(e) Raw agricultural commodity--Any food in its natural state, including all fruits that can be washed, colored, or treated in their unpeeled form before being marketed. Treatment includes waxing, fumigating, or removing foreign objects or other parts of the plant, such as leaves, stems, and husks. This definition excludes transforming a harvested raw agricultural commodity into processed food by actions such as cutting, cooking, heating, chopping, irradiating, or pasteurizing.
(f) Restaurant--A place where food is made and sold directly to people for immediate eating, examples include:
(1) cafeterias;
(2) lunchrooms;
(3) cafes;
(4) bistros;
(5) fast food places;
(6) food stands;
(7) saloons;
(8) taverns;
(9) bars;
(10) lounges;
(11) catering facilities;
(12) hospital kitchens;
(13) day care kitchens; and
(14) nursing home kitchens.
(15) "Restaurant" does not include places that provide food for interstate travel, central kitchens, and other similar places that don't serve food directly to the consumer.
(16) For purposes of this subchapter, a restaurant is a food establishment as defined in other department rules, including:
(A) §229.371 of this chapter (relating to Definitions);
(B) §229.471 of this chapter (relating to Definitions); and
(C) §228.2 of this title (relating to Definitions).
(g) Retail food establishment--A place that sells food products directly to consumers as its primary function, like:
(1) grocery stores;
(2) convenience stores;
(3) vending machines; and
(4) some farm-run businesses.
(5) "Retail food establishment" includes places that make, process, pack, or store food to sell directly to consumers. The value of food products sold directly to consumers must be higher than the sales of food products to all other buyers. "Consumers" does not include businesses.
(6) For purposes of this subchapter, a retail food establishment is also known as a food establishment as defined in other department rules, including:
(A) §229.371 of this chapter;
(B) §229.471 of this chapter; and
(C) §228.2 of this title.
§229.1003.
(a) This subchapter does not apply to:
(1) an ingredient used in a product that is not meant for humans to consume;
(2) food labeled, prepared, served, or sold in a restaurant;
(3) food labeled, prepared, or served in a retail food establishment;
(4) a product regulated by the United States Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS);
(5) a product labeled with a governmental warning with a recommendation from the surgeon general of the United States Public Health Service (USPHS);
(6) a drug or dietary supplement; or
(7) a pesticide chemical, soil or plant nutrient, or other agricultural chemical used in the production, storage, or transportation of a raw agricultural commodity.
(b) Texas Health and Safety Code (HSC) §431.0815 and this subchapter do not apply to an ingredient, including a food additive and color additive, if a federal law or a regulation issued by the United States Food and Drug Administration (FDA) or USDA:
(1) prohibits the use of the ingredient;
(2) sets conditions for using the ingredient, such as needing a warning or disclosure statement;
(3) says an ingredient or group of ingredients is safe for people to eat; or
(4) requires a labeling statement for foods that are ultra-processed or processed.
§229.1004.
(a) Food that contains any of the following ingredients must include a warning label described in subsection (b) of this section:
(1) acetylated esters of mono- and diglycerides (acetic acid ester);
(2) anisole;
(3) azodicarbonamide (ADA);
(4) bleached flour;
(5) blue 1 (CAS 3844-45-9);
(6) blue 2 (CAS 860-22-0);
(7) bromated flour;
(8) butylated hydroxyanisole (BHA);
(9) butylated hydroxytoluene (BHT);
(10) calcium bromate;
(11) canthaxanthin;
(12) certified food colors by the United States Food and Drug Administration (FDA);
(13) citrus red 2 (CAS 6358-53-8);
(14) diacetyl;
(15) diacetyl tartaric and fatty acid esters of mono and diglycerides (DATEM);
(16) dimethylamylamine (DMAA);
(17) dioctyl sodium sulfosuccinate (DSS);
(18) ficin;
(19) green 3 (CAS 2353-45-9);
(20) interesterified palm oil;
(21) interesterified soybean oil;
(22) lactylated fatty acid esters of glycerol and propylene glycol;
(23) lye;
(24) morpholine;
(25) olestra;
(26) partially hydrogenated oil (PHO);
(27) potassium aluminum sulfate;
(28) potassium bromate;
(29) potassium iodate;
(30) propylene oxide;
(31) propylparaben;
(32) red 3 (CAS 16423-68-0);
(33) red 4 (CAS 4548-53-2);
(34) red 40 (CAS 25956-17-6);
(35) sodium aluminum sulfate;
(36) sodium lauryl sulfate;
(37) sodium stearyl fumarate;
(38) stearyl tartrate;
(39) synthetic trans fatty acid;
(40) thiodipropionic acid;
(41) titanium dioxide;
(42) toluene;
(43) yellow 5 (CAS 1934-21-0); or
(44) yellow 6 (CAS 2783-94-0).
(b) The warning label must include the following statement, if the food contains an ingredient listed in subsection (a) of this section: "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." The warning label must:
(1) be printed in a font size not smaller than the smallest font used to disclose other consumer information required by the FDA;
(2) be placed in a prominent and reasonably visible location; and
(3) have sufficiently high contrast with the immediate background to ensure the warning is likely to be seen and understood by the ordinary individual under customary conditions of purchase and use.
(c) Food manufacturers and retailers who sell their products via internet that require warning labels under subsection (a) of this section must provide all labeling information required by subsection (b) of this section to consumers by:
(1) posting a legible statement on the manufacturer's or retailer's website on which the product is offered for sale;
(2) posting pictures of the entire food product label, including the warning label on the website; or
(3) providing the information in other ways with the consumer.
§229.1005.
(a) Criminal penalties stated in Texas Health and Safety Code (HSC) §431.059 can be imposed for violations of this subchapter.
(b) Civil penalties stated in HSC §431.0585 can be imposed for violations of this subchapter.
(c) Administrative penalties as described in HSC §431.054, §431.055, §431.056, §431.057, and §431.058, and §229.261 of this chapter (relating to Assessment of Administrative Penalties), can be imposed for violations of the previously stated sections. Before a penalty is imposed, the person accused of a violation must be given an opportunity for a hearing.
(d) Hearings regarding administrative penalties and emergency orders will be held according to, Texas Government Code §§2001.051 - 2001.902, and the department's formal hearing rules in §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures).
(e) The commissioner or the commissioner's designee may issue emergency orders according to HSC §431.045.
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on September 9, 2025.
TRD-202503197
Cynthia Hernandez
General Counsel
Department of State Health Services
Earliest possible date of adoption: October 26, 2025
For further information, please call: (512) 834-6670