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), adopts new §229.1001, concerning Purpose and Scope, §229.1002, concerning Definitions, §229.1003, concerning Exemptions, §229.1004, concerning Warning Label Requirements, and §229.1005, concerning Enforcement.
Sections 229.1002, 229.1003, and 229.1004 are adopted with changes to the proposed text as published in the September 26, 2025, issue of the Texas Register (50 TexReg 6301). These rules will be republished. Sections 229.1001 and 229.1005 are adopted without changes to the proposed text published in the September 26, 2025, issue of the Texas Register (50 TexReg 6301). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The new sections are necessary to comply with Senate Bill (SB) 25, 89th Legislature, Regular Session, 2025, which amended Health and Safety Code (HSC) Chapter 431, Subchapter D by adding §§431.0815, 431.0816, and 431.0817, which requires the department to adopt rules to implement the changes.
COMMENTS
The 31-day comment period ended October 27, 2025.
During this period, DSHS received comments regarding the proposed rules from 21 commenters. DSHS received comments from Albertsons Companies, American Bakers Association, American Beverage Association, Brookshires, Consumer Brands Association, Food Ingredient Safety Coalition, Healthcare Nutrition Council, Infant Nutrition Council of America, International Association of Color Manufacturers, International Flavors & Fragrances Inc, International Foodservice Distributors Association, National Association of Wheat Growers, North American Millers' Association, Texas Food & Fuel Association, Texas Restaurant Association, Texas Retailers Association, Texas Wheat Producers Association, The Food Industry Association, and Wei Chuan USA. DSHS also received a comment jointly signed by The Senate of the State of Texas and the Texas House of Representatives. A summary of comments relating to the rules and DSHS responses follows.
Comment: One commenter requested §229.1001(b)(3) include the warning label requirements do not apply to food product labels developed or copyrighted before January 1, 2027.
Response: DSHS disagrees and declines to make the requested change at this time since this section includes the requirements that are applicable to food product labels developed or copyrighted on or after January 1, 2027.
Comment: One commenter requested definitions for "developed" and "copyrighted" since the statute and rule are applicable to food product labels developed or copyrighted on or after January 1, 2027.
Response: DSHS disagrees that definitions for "developed" and "copyrighted" are necessary and declines to make the requested changes at this time. For enforcement purposes, DSHS defers to The Copyright Act where developed or copyrighted refers to the date the label was created.
Comment: One commenter suggested "developed" be defined as, "A food product label initially created or substantially redesigned in a way that materially alters the content, layout, or presentation after January 1, 2027."
Response: DSHS disagrees a definition for "developed" is necessary and declines to make the suggested change at this time. For enforcement purposes, DSHS defers to The Copyright Act where developed or copyrighted refers to the date the label was created.
Comment: Three commenters suggested changes to allow minimal or minor changes to food product labels as it relates to warning labels when any change is made to a food product label on or after January 1, 2027. Commenters wrote that "any change to a food product label on or after January 1, 2027" is too broad or beyond the legislature's intent.
Response: DSHS disagrees and declines to make the suggested changes because it is inconsistent with The Copyright Act where developed or copyrighted refers to the date the label was created.
Comment: One commenter requested clarification on the following. "The proposed regulation states that the warning label requirement applies to 'food product labels developed or copyrighted on or after January 1, 2027.' The language preceding the proposed regulation states that '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.' Reading the proposed regulation and preceding language together, we understand that labels which are existent prior to January 1, 2027, but copyrighted thereafter, would not be subject to any new labeling obligations."
Response: DSHS agrees and for enforcement purposes will defer to The Copyright Act where developed or copyrighted refers to the date the label was created.
Comment: One commenter requested guidance on the following. "Section 19(b): Section 431.0815, Health and Safety Code, as added by this Act, applies only to a food product label developed or copyrighted on or after January 1, 2027. We interpret this to mean that any change to an existing label after January 1, 2027, would be considered a 'label developed,' thereby triggering the new warning label requirements under the Act. However, we are seeking clarification on the sell through period for existing labels that were not changed, developed, or copyrighted after January 1, 2027. For products with these existing labels, how long may such products remain on retail shelves without violating the Act? For example, if a non-perishable item with a long shelf life has a label that was created prior to January 1, 2027, and remains unchanged, can that item be sold with its original label for 3 months? 6 months? 12 months etc.? Or is there a specific grace period or sell-through timeline contemplated under the law?"
Response: DSHS agrees with the requestor's interpretation of "label developed" and when it would trigger compliance with the requirement. The food product labels described in the example would not be subject to the rule since the labels were developed before January 1, 2027, so a grace period would not be needed. No revision is made to the rule in response to this comment.
Comment: Two commenters asked for the rule to be amended to provide clarification on whether brand owners or private label brand owners, who are not engaged in the manufacturing process, but are involved in marketing and distribution, are responsible for complying with warning label requirements. They also sought guidance on responsibility when ingredient information comes from the manufacturer, but the manufacturer does not sell directly to consumers, to ensure clear compliance and prevent unnecessary burdens on distributors not engaged in direct-to-consumer sales.
Response: DSHS disagrees with the comment and declines to make any changes to the rule in response to the comments. To the extent the brand owner or private label brand lists their name and address on the food product label, they bear responsibility for the purity and proper labeling of the food. This is included in the food manufacturer definition.
Comment: One commenter wrote the retail food establishment definition in §229.1002(g) and exemption in §229.1003(a)(3) raise issues of fairness and increased confusion. The comment provided examples of products that can be prepared, packaged, and served in a retail food establishment or farm-run business that contain the same ingredients as products that are subject to the warning label but do not require a warning and asked how the state will reconcile the inconsistencies and how this serves the public interest.
Response: DSHS considers the comment out of scope considering the amendments to HSC Chapter 431 were enacted by the Texas Legislature.
Comment: One commenter recommended to-go food be added to the restaurant definition and include restaurant websites and third-party delivery applications as examples.
Response: DSHS disagrees with adding to-go food to the restaurant definition and declines to make the recommended change. The rule includes the adoption of 25 Texas Administrative Code §229.371(2)(B)(ii) which addresses offsite consumption, and the definition adequately addresses customary restaurant operations as described in the comment.
Comment: One commenter recommended restaurant suppliers be added to the restaurant definition. The commenter wrote many products are manufactured, packaged, and labeled with the sole intent to be sold to restaurants for food preparation. The commenter wrote including restaurant suppliers in the restaurant definition will align with the legislature's intent to not regulate the food supply chains that serve restaurants.
Response: DSHS disagrees that restaurant suppliers are restaurants for purposes of the rule and declines to make the recommended change. The warning label requirements on the food product label apply to food manufacturers that manufacture food for wholesale distribution, which includes distribution to restaurants.
Comment: One commenter recommended adding "food trucks" and "commissary or central kitchens" to the list of examples in §229.1002(f) and removing "central kitchens" from the exception language in §229.1002(f)(15).
Response: DSHS disagrees the recommended changes are necessary at this time and declines to make additional changes. The definitions in the proposed rule for "restaurant" and "retail food establishment" address these types of operations.
Comment: One commenter suggested §229.1004(c) include clarification that posting information through a link, pop-up window, or secondary tab with a clear label like "nutrition and ingredients" satisfies the rule.
Response: DSHS agrees these examples are acceptable but declines to make additional changes considering the language in §229.1004(c)(3) of the adopted version.
Comment: One commenter requested DSHS clarify the applicability of the rule to foodservice distributors. The commenter wrote, "We understand that, if a foodservice distributor receives ingredient content information from a manufacturer indicating that a food contains ingredients required to bear a warning statement under proposed §229.1004, the foodservice distributor is not required to disclose this information to customers via a website or ordering platform, since the foodservice distributor is neither engaging in manufacturing activities nor selling products directly to consumers as its primary function, and thus does not qualify as a "manufacturer" or "retailer" under the proposed rule. We request that the Department of State Health Services confirm alignment with this interpretation."
Response: DSHS agrees "food distributors" or "food wholesalers" as defined in other department rules that are not engaged in manufacturing activities or retail sales are also exempt from the requirements in the rule. No revision is made to the rule in response to this comment.
Comment: One commenter requested medical food, as defined in Section 5(b)(3) of the Orphan Drug Act, 21 United States Code 360ee(b)(3), and foods for special dietary use as defined in 21 Code of Federal Regulations Part 105 be exempted from the rule.
Response: DSHS agrees federal regulations preempt requirements from the rule and an exemption is not needed since it is out of the scope of the rule.
Comment: One commenter requested infant formula be exempted from the rule.
Response: DSHS agrees federal regulations preempt requirements from the rule and an exemption is not needed since it is out of the scope of the rule.
Comment: One commenter requested the date in HSC §431.0817, September 1, 2025, be included in the federal preemption section. The commenter wrote, "The intent of that portion of the bill, as reflected in the bill's language, is for only those federal laws and regulations enacted or issued after September 1, 2025, to be preemptive of the labeling requirements in Senate Bill 25. The legislative history of the bill confirms this."
Response: DSHS has agreed to remove federal preemption from the adopted version of the rule considering the comment and refer to HSC §431.0817.
Comment: Several commenters addressed federal preemption and requested that HHSC recognize that the Food and Drug Administration (FDA) has found bleached flour, as well as specified bleaching agents, to be safe for human consumption and therefore be exempted from the warning label requirements.
Response: DSHS has determined including federal preemption in the adopted version of the rule is unnecessary at this time and will refer to HSC §431.0817. DSHS has also determined bleaching ingredients when used in accordance with existing federal regulations and that are considered generally recognized as safe or determined to be safe by the FDA or the United States Department of Agriculture (USDA) are not subject to the rule requirements.
Comment: Two commenters requested the state's interpretation of federal preemption as written in §229.1003(b)(3) since the ingredients listed in §229.1004 are the subject of FDA regulations and have been determined to be safe for people to eat.
Response: DSHS has determined including federal preemption in the adopted version of the rule is unnecessary at this time and will refer to HSC §431.0817. DSHS has also determined ingredients considered generally recognized as safe or determined to be safe by the FDA or USDA are not subject to the rule requirements.
Comment: Several commenters requested §229.1003(b) be revised to be consistent with HSC §431.0817. Additionally, one commenter wrote HSC §431.0817 is a federal preemption statute, not an exemption statute, and these are two distinct legal concepts.
Response: DSHS agrees and has removed federal preemption from the adopted version and will refer to HSC §431.0817.
Comment: One commenter opposes the warning's wording and described it as inaccurate for most listed ingredients but supports a proposed exemption for ingredients deemed safe or regulated by the FDA or USDA. The commenter wrote this exemption is especially important for color additives that have been evaluated by the FDA and other international authorities. The commenter wrote requiring a warning label on FDA-approved colors would mislead customers and erode trust. Additionally, the commenter provided a table to demonstrate that a color additive's lack of authorization in some jurisdictions is often due to the absence of approval rather than an active ban. The commenter further stated the inclusion of FD&C Red No. 4 and Red No. 3 is unnecessary because they are no longer permitted in U.S. food products.
Response: DSHS agrees some ingredients, including red 4 (CAS 4548-53-2), listed in the statute and rules are currently not approved for use in food. DSHS declines to make any changes to the ingredient list or based on the comment since the amendments to HSC Chapter 431 were enacted by the Texas Legislature. Federal preemption relating to ingredients that are not currently allowed for use in human food will take precedence over the warning label requirements outlined in the statute and rule.
Comment: One commenter requested clarification on the proposed preamble and whether food made in store at a retail food establishment is not required to have a warning label.
Response: DSHS agrees food made in store at a retail food establishment is exempt from the warning label requirements. No revision is made to the rule in response to this comment.
Comment: One commenter recommended the rules confirm restaurants that operate from dine-in and retail operations from the same kitchen that prepare food for immediate consumption qualify for an exemption. Additionally, they include food prepared for immediate consumption by restaurants, including food served on-site, packaged for takeout, or prepared for catering as examples of operations to be included in the restaurant exemption.
Response: DSHS agrees the examples provided by the commenter are restaurant activities and exempt from the requirements in the rule. DSHS declines to make changes to the restaurant definition.
Comment: One commenter recommended acetylated esters of mono- and diglycerides (acetic acid ester) and diacetyl tartaric and fatty acid esters of mono- and diglycerides (DATEM) be removed from the list of ingredients that require a warning label. The commenter included a summary with references to expert panel reviews and links to the use of the ingredients in the countries required to be included in the warning label as well as FDA reviews. The commenter recommended HHSC work with state legislators to remove these ingredients and in the interim not enforce the rule requirements with respect to these ingredients.
Response: DSHS disagrees and declines to remove the ingredients in response to the comment considering the amendments to HSC Chapter 431 were enacted by the Texas Legislature.
Comment: Three commenters wrote that the warning required to be on the food product label is misleading since the ingredients are considered safe by global food safety agencies in those regions and elsewhere. One of the commenters also wrote the statement conflicts with United States regulations and puts manufacturers in untenable situations, raises questions of legality and may result in costly litigation for the state.
Response: DSHS considers the comments out of scope considering the amendments to HSC Chapter 431 were enacted by the Texas Legislature.
Comment: One commenter requested clarification on how the state will determine who an ordinary individual is and what customary conditions are with regards to §229.1004(b)(3).
Response: DSHS considers the comment out of scope because the rule language reflects the amendments to HSC Chapter 431 enacted by the Texas Legislature.
Comment: One commenter requested clarification on what §229.1004(c)(3) means.
Response: DSHS agrees to revise §229.1004(c)(3) to, "providing the information in other ways to the customer" to remain consistent with statute language. This section in the adopted version is consistent with statute language and gives manufacturers and retailers flexibility when determining how the warning label is communicated to the consumer.
Comment: One commenter recommended §229.1004(b)(1) be revised to, "be printed in a font size not smaller than the smallest font used to disclose the list of ingredients as required by the FDA."
Response: DSHS declines to make the recommended change at this time to prevent any potential conflict with federal food labeling regulations.
Comment: Two commenters recommended §229.1004(c)(2) be revised to only require a photo of the label and be limited to the label panel in which the warning label appears.
Response: DSHS agrees and has made the recommended revision.
Comment: Two commenters requested §229.1004 be revised to include the warning label requirements apply to ingredients that are required to be listed on the label by the FDA.
Response: DSHS declines to make the requested revision at this time since this is addressed in §229.1001(b)(2).
Comment: One commenter wrote the warning label requirements infringe on the FDA's authority regarding labeling and Texas cannot make its own warning labels for food and beverage products.
Response: DSHS considers the comment out of scope considering the amendments to HSC Chapter 431 were enacted by the Texas Legislature.
Comment: One commenter has concerns regarding the manufacturer's responsibility for online labeling disclosures under §229.1004(c) and Texas placing responsibility on manufacturers in an area over which they do not have control, since manufacturers do not have the ability to dictate what a retailer puts on their website. Additionally, the commenter wrote that Texas should provide reasonable notice and specify how manufacturers will be able to protect themselves from penalties for something outside of their control. The commenter also expressed concerns about the online proliferation of a warning label they feel is misleading and exceeds what is required under U.S. law.
Response: DSHS considers the comment out of scope considering the amendments to HSC Chapter 431 were enacted by the Texas Legislature. Additionally, DSHS does not intend to hold manufacturers or retailers accountable for websites that they do not control.
Comment: One commenter requested clarification as to whether the website must be updated when the digital shelf is copyrighted or when the label is copyrighted.
Response: DSHS has determined the statute does not address digital shelf copyright. The warning label requirements are applicable to food product labels developed or copyrighted on or after January 1, 2027. The website disclosures under §229.1004(c) of the adopted version are applicable to food product labels that are subject to the rule. No revision is made to the rule in response to this comment.
Comment: One commenter requested Chemical Abstract Substance (CAS) identifiers be included in the rule where one has been assigned to an ingredient by the FDA.
Response: DSHS disagrees that the Chemical Abstracts Service (CAS) identifiers are necessary to identify the ingredients. The ingredients are sufficiently described in Texas law.
Comment: One commenter requested clarification on the rule requiring a warning label for certified colors by the FDA. The commenter wrote the rule includes certified colors that are listed separately, which has created ambiguity in the commenter's interpretation of the regulation. The commenter asked, "Could you please clarify if Item 12 means that all FDA-certified food colors (including but not limited to those separately listed in the bill such as color additives are exempt from certification) must have a warning label on the product?"
Response: DSHS considers all certified colors, including the certified colors listed separately in the list of ingredients, subject to the warning label requirements. Colors that are exempt from certification are not subject to the warning label requirements unless the ingredient is explicitly listed in the statute. No revision is made to the rule in response to this comment.
Comment: Several comments were received urging HHSC to consider the burdens the requirements place on businesses and consumers. The commenters included the costs to relabel products, product reformulation, and impacts of state-specific labeling that may affect consumer access and increase consumer costs.
Response: DSHS considers the comments out of scope considering the amendments to HSC Chapter 431 were enacted by the Texas Legislature.
DSHS made a minor revision to §229.1002(f) and changed "eating" to "consumption" in the definition of "restaurant."
STATUTORY AUTHORITY
The new sections are adopted under 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.
§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 consumption, 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.
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.
§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 food product label in which the warning label appears on the website; or
(3) providing the information in other ways to the consumer.
The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.
Filed with the Office of the Secretary of State on February 3, 2026.
TRD-202600496
Cynthia Hernandez
General Counsel
Department of State Health Services
Effective date: February 23, 2026
Proposal publication date: September 26, 2025
For further information, please call: (512) 834-6670