TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS

The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS or department), adopts the amendments to §§300.100 - 300.103, 300.201 - 300.203, 300.301 - 300.303, 300.402 - 300.404, 300.501, 300.502, 300.601 - 300.606; and new §§300.204 - 300.208, 300.405 - 300.407, 300.701, and 300.702, concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

Sections 300.100, 300.102, 300.206, 300.404, 300.407, 300.602, 300.604, 300.605, and 300.702, are adopted without changes to the proposed text as published in the December 26, 2025, issue of the Texas Register (50 TexReg 8486). These rules will not be republished.

Sections 300.101, 300.103, 300.201 - 300.205, 300.207, 300.208, 300.301 - 300.303, 300.402, 300.403, 300.405, 300.406, 300.501, 300.502, 300.601, 300.603, 300.606, and 300.701 are adopted with changes to the proposed text as published in the December 26, 2025, issue of the Texas Register (50 TexReg 8486). These rules will be republished.

BACKGROUND AND JUSTIFICATION

The amendments are necessary to comply with Executive Order GA-56. House Bill (HB) 1325 (86th Legislature, Regular Session, 2019) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The resulting rules to implement HSC 443 are at 25 Texas Administrative Code (TAC) Chapter 300 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56, directing the department to amend the rules to prohibit the sale of CHPs to minors, to add age verification requirements, to update testing requirements, and to update record keeping requirements.

The adopted rules increase the initial and annual renewal licensing fees for consumable hemp manufacturers to $10,000 per facility, and the annual registration fees for retailers to $5,000 per location. The adopted rules add a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants. The adopted rules also include tetrahydrocannabinol acid (THCA) in the definition of total delta-9 tetrahydrocannabinol (THC) and in the definition of acceptable hemp THC level. The adopted rules update testing, packaging, labeling, and record-keeping requirements.

COMMENTS

The 31-day comment period ended January 26, 2026.

During this period, DSHS received comments regarding the proposed rules from 1,421 commenters. DSHS received comments from Alcohol and Drug Awareness for the Alcohol & Drug for the Concho Valley (ADACCV), GREENT Club, Good Spirits Beverages, Treehouse Dispensary, American Pharmacies, Delta Bros-Twisted Liquors, Cheech and Chong's Apothicaria West Frisco, the Banks Law Firm, LVLX Wellness LLC, Cannabis Retailers Alliance for Texas (CRAFT), Smokin Glassworks, The Happy Cactus, United Wholesale, PriceCatch, American Shaman, Texas Food & Fuel Association, C Good Staging LLC, Elevated, The CannaShack Co., Pinnacle Essentials, Sunmed CBD, Haus of Jayne, Reggie and Dro, ZAR, A to Z Ivestments and Wholesale LLC, CannaWize Co., 4K Pharm LLC, PrimeOne Sourcing LLC, Royal Habash LLC, C Better Days Inc, UFORIQ, Restart, Texas Hemp Coalition, Compliance Pros LLC, Hemp Industry and Farmers of America, Chubby's Green, Sacred Leaf, Sublingwell LLC, Happy Clouds, CBD Temptations, Frontline Farms CBD, Coastal Wellness and Gifts, Discount Pharms, 24hr Bud Delivery LLC, American Hemp Co/American Weed Co, Califlower Garden, Medanature LLC, East Texas Hemp Company LLC, American Trade Association for Cannabis and Hemp, Eureka Heights Brewing Co., High Tides LLC, HRD Investment LLC, Lonestar HempWorks, Cresent Canna, Blum Reserve Co, Wild Revival, Green Haus Wellness, Bullfrog Botanicals, Dope Daiquiris, the Green Hit Smoke Shop, DRMZ Brands, SMB Nation, Treeline, Delta Vine, Hummingbird Hemp, The Puebla Group, The Healing Herb, Healing Herbal LLC, Rebel Chef, San Antonio Council on Alcohol and Drug Awareness (SACADA), Hill Country Council on Alcohol and Drug Abuse (HCCADA), Texans for a Safe and Drug Free Youth, Reach Council, Ninja Consultation Group TTX LLC dba Habit Crafted, Rolling & CO Smoke CBD & Vapes, Elevated CBD & Smoke, Austinite Cannabis Co, Ropeace CBD Vape Smoke, Habit CBD, Bahama Mama, Farm Road Wellness, Texas Hemp and Honey, Wyatt Purp, Texas Hemp Business Council (THBC), Smoking Valley LLC, CBD American Shaman East McKinney, Hemp Beverage Alliance, Not Beer, Delta Bros, Waco CBD American Shaman, The Pink Cloud LLC, Eureka Chill LLC, Oak Cliff Cultivators and Ease Up, Texas Package Stores Association, Vitam, The Texas Cannabis Collective, 1937 Apothecary LLC & Custom Botanical Dispensary, Law Office of Susan Hays, High 9ine LLC, The Law Office of Jeffery W. Wells, Fire Holistics LLC, Elevated Stash, Pops Smoke and Vapor, Delta 8 Delton, Serenity Organics, Citizens for a Safe and Healthy Texas, Pheonix House, Jota Living, Total Wine, Jollypop Vape Shop, Bayou City Hemp Company Inc, SBT Law, THC Provisions LLC, MedCanna Ventures LLC dba Happy Hemp Co, Grateful Greens LLC DBA Morning Dew Farms, The Canna Busters, Third Coast Wellness LLC, Willie's Remedy, Solid Foundations, Concho Valley C.A.R.E.S Coalition-Community Coalitions Partnership (CCP), Hopes Family FDN, Fyr Flower, The Vapor Bar, MNG 2005 Inc, Victory Pluz, Mighty Distro, True Life Spirits, North Canna, True Hemp Science, Uniwyze Inc, The Concord, Levotic, VaporScape, Texas Cannabis Policy Center, CBD American Shaman, Public Health Texas Medical Association, ECL Testing, Hill Country Pregnancy Care Center, Oasis Farms, Texas Original, and 1,280 individuals. A summary of comments relating to the rules and DSHS's responses follow.

Comment: Multiple commenters oppose §300.404, which states the restrictions for bulk raw hemp material, isolates, or distillates that have a total delta-9 THC content exceeding THC limits. Commenters argue that imposing restrictions violate Texas Agriculture Code §122.356, which allows transport of hemp plant material in this state if it is produced in compliance with a state or tribal plan approved by the United States Department of Agriculture under 7 United States Code (U.S.C.) §1639p.

Response: DSHS disagrees and declines to revise the proposed rule in response to this comment. DSHS is aware that THC fluctuates during the extraction process, and the extractor must ensure the final extracted product is under 0.3 percent delta-9 THC. Section 300.206 and HSC §443.152 total THC limits apply to products distributed and sold at retail, otherwise introduced into commerce, and transported into Texas for further processing. HSC Chapter 481, Texas Controlled Substances Act, applies to products that meet the definition of a controlled substance. DSHS does not have the authority to permit products in excess of statutory limitations.

Comment: Most commenters oppose the proposed fees for consumable hemp manufacturers and retailers.

Response: DSHS agrees with this comment. DSHS revised §§300.202(c)(1), 300.202(c)(2)(A), and proposed 300.502(f)(1) (renumbered to subsection (g)(1)) to set the fee for a manufacturer's license at $10,000 per facility per year, and a retailer's registration at $5,000 per location per year. HSC §12.0111 authorizes DSHS to collect licensing fees to recover direct and indirect costs of administering and enforcing the program. To set these fees, DSHS made estimates of the costs necessary to support regular inspection of manufacturers and retailers, including inspector salaries and travel, laboratory testing costs, related legal and State Office of Administrative Hearing costs for resulting compliance actions, and assistance from the TABC and the Texas Department of Public Safety (DPS) per Executive Order GA-56. DSHS will reevaluate licensing fees periodically to ensure fees do not exceed the amount required to administer the program.

Comment: Most commenters oppose a ban on hemp.

Response: DSHS disagrees and declines to revise the rule in response to this comment. HB 1325 requires DSHS to develop rules regulating the manufacture, distribution, and sale of CHPs. The rules comply with Executive Order GA-56.

Comment: Most commenters oppose a ban on THCA flower.

Response: DSHS disagrees and declines to revise the rule in response to this comment. HB 1325 requires DSHS to develop rules regulating the manufacture, distribution, and sale of CHPs. The rules comply with Executive Order GA-56.

Comment: Multiple commenters suggested raising taxes on cannabis dispensaries.

Response: DSHS considers these comments outside the scope of rulemaking for this chapter.

Comment: Multiple commenters suggested revising the age limit to purchase CHPs to 25 years old.

Response: DSHS disagrees and declines to revise the rule in response to this comment. Executive Order GA-56 directed DSHS to set the age limit to 21 years of age.

Comment: Multiple commenters suggested restricting access to a hemp establishment if a person is less than 21 or 25 years old.

Response: DSHS disagrees and declines to revise the rule in response to this comment. Many retailers covered by these regulations offer a variety of non-hemp products and deliver numerous services unrelated to CHPs. Restricting access to their premises as proposed would likely cause substantial economic harm to these businesses and impose potential restrictions on consumers under the age of 21 or 25. Retailers are already required to verify the customer is at least 21 years old before completing any CHP sales or deliveries.

Comment: Many commenters oppose track and trace requirements.

Response: DSHS does not agree with the commenters and declines to revise the rule in response to this comment. These systems are essential to maintain regulatory compliance, uphold public safety, and ensure product quality. Furthermore, these systems enable quick, targeted recalls of contaminated or non-compliant products.

Comment: Multiple commenters oppose testing requirements.

Response: DSHS does not agree with the commenters and declines to revise the rule in response to this comment. HB 1325 requires DSHS to develop rules regulating the manufacture, distribution, and sale of CHPs in Texas. This includes developing rules for testing requirements.

Comment: Multiple commenters suggested a grace period to implement rules.

Response: DSHS disagrees and declines to revise the rule in response to this comment. Governor's Executive Order GA-56 tasked DSHS with reviewing and updating rules, especially those prohibiting access to minors. Immediate enforcement is necessary to address the concerns raised by Executive Order GA-56.

Comment: Multiple commenters stated the Texas Compassionate Use program, while well-intentioned, remains out of reach for many due to cost and limited availability.

Response: DSHS considers this comment outside the scope of rulemaking for this chapter.

Comment: Multiple commenters suggested legalizing marijuana.

Response: DSHS considers this comment outside the scope of rulemaking for this chapter. HB 1325 requires DSHS to develop rules regulating the manufacture, distribution, and sale of CHPs in Texas.

Comment: Most commenters oppose total THC reclassification via THCA conversion (§300.101) for both total THC and total delta-9 THC. The commenters suggest the compliance threshold exceeds statutory authority.

Response: DSHS does not agree and declines to revise the rule in response to this comment. The Texas Agriculture Code §121.001 defines hemp to include "all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis." The Texas Department of Agriculture rules at 4 TAC §24.26 state that testing methodology should account for the potential conversion of delta-9 tetrahydrocannabinolic acid (THCA) in hemp to delta-9 tetrahydrocannabinol (THC). HSC Section 443.051 requires rules to be consistent with federal laws and regulations; the federal regulations account for THCA conversion. Furthermore, the test results must accurately represent the total available THC, calculated as the sum of both THC and THCA content. Executive Order GA-56 directed DSHS that testing methods account for THCA conversion to THC.

Comment: Multiple commenters suggested recognizing established third-party compliance programs, training providers, and independent audits as valuable partners in achieving regulatory goals.

Responses: DSHS disagrees and declines to revise the rule in response to this comment. Businesses may conduct third-party compliance programs at their own discretion.

Comment: Multiple commenters suggested restricting cannabidiol (CBD)/THC seltzers to liquor stores or knowledgeable CBD retailers, instead of vape shops or gasoline stations.

Response: DSHS disagrees and declines to revise the rule in response to this comment. HSC Chapter 443 makes no distinction between gas stations, convenience stores, liquor stores, consumable hemp stores, and vape shops. Businesses that sell CHPs are required to obtain a license or registration from DSHS and to comply with HSC Chapter 443, and with 25 TAC Chapter 300.

Comment: Multiple commenters suggested dosing, serving size, and milligram restrictions and guidance.

Response: DSHS disagrees and declines to revise the rule in response to this comment. The label must include the serving size as per 21 Code of Federal Regulation (CFR) 101, declared on the product label. HB 1325 adopts federal food labeling requirements.

Comment: Multiple commenters stated that the proposed rules prohibit transporting hemp.

Response: DSHS disagrees with the commenters and declines to revise the rule. HB 1325 requires DSHS to develop rules regulating the manufacture, distribution, and sale of CHPs. CHPs may be legally transported across state lines and exported to foreign countries in a manner that is consistent with federal law and the laws of respective foreign countries.

Comment: One commenter stated §300.501(b) deletes the limitation that retail registration applies only to products "containing CBD." However, HSC §443.2025(b) requires registration only for retail locations selling "consumable hemp products containing cannabidiol [CBD]," and the fee schedule authority in HSC §443.2025(f) is likewise tied to locations where "consumable hemp products containing cannabidiol [CBD] are sold."

Response: DSHS disagrees with the commenter and declines to revise the rule in response to this comment. HB 1325 ensures Texas has primary regulatory authority over CHPs in this state, not just CBD.

Comment: Multiple commenters stated §300.601(b) purports to count each day a violation continues as a separate violation; however, HSC §443.201 requires the Department to provide fair notice of a potential violation and an opportunity to cure.

Response: DSHS disagrees with the commenters and declines to revise the rule in response to this comment. The department is statutorily required to notify retailers of potential violations and to provide an opportunity to resolve unintentional or negligent violations. Section 300.606(b) is consistent with this requirement. Section 300.601(b) applies to violation of department licensure or registration requirements.

Comment: One commenter suggested clarification that product labels must identify the licensed legal entity, with DBA's requiring additional licenses.

Response: DSHS disagrees with the commenter and declines to revise the rule in response to this comment. HB 1325 only requires the manufacturer's name on the product label. Section 300.201(f)(2), relating to application for license or renewal, requires applicants to list other names under which the firm does business.

Comment: Multiple commenters stated that extensive compliance burdens, such as child-resistant packaging, could be more appropriately addressed through targeted legislation rather than sweeping agency rulemaking.

Response: DSHS disagrees with the commenters and declines to revise the rule in response to this comment. These requirements are essential for public safety, primarily designed to mitigate the risks of accidental ingestion by minors and to comply with state and federal requirements, such as the Poison Prevention Packaging Act (PPPA). The revisions are consistent with Executive Order GA-56.

Comment: Multiple commenters oppose proposed rules in general.

Response: DSHS disagrees with these commenters and declines to revise the rule in response to this comment. HB 1325 requires DSHS to develop rules regulating the manufacture, distribution, and sale of CHPs. The revisions are consistent with Executive Order GA-56.

Comment: Multiple commenters stated testing could be more appropriately addressed through targeted legislation rather than sweeping agency rulemaking.

Response: DSHS disagrees with the commenters and declines to revise the rule in response to this comment. HB 1325 states the executive commissioner shall adopt rules and procedures necessary to administer and enforce this chapter. The revisions are consistent with Executive Order GA-56.

Comment: Multiple commenters stated warning labels could be more appropriately addressed through targeted legislation rather than sweeping agency rulemaking.

Response: DSHS disagrees with the comment and declines to revise the rule in response to this comment. HB 1325 states the executive commissioner shall adopt rules and procedures necessary to administer and enforce this chapter. The revisions are consistent with Executive Order GA-56.

Comment: Multiple commenters stated recall procedures could be more appropriately addressed through targeted legislation rather than sweeping agency rulemaking.

Response: DSHS disagrees with the commenters and declines to revise the rule in response to this comment. HB 1325 states that the executive commissioner shall adopt rules and procedures necessary to administer and enforce this chapter. Recalls are essential because they safeguard the public from products that could cause injury, illness, or even death.

Comment: Multiple commenters asked to clarify that Texas CHP standards apply to out-of-state products sold in Texas.

Response: DSHS agrees with the commenters and revised §300.403 to clarify the standards apply to all out-of-state products sold in Texas.

Comment: One commenter suggested standardizing reporting of the measurement of uncertainty.

Response: DSHS disagrees with the commenter and declines to revise the rule in response to this comment. No mandatory, general-purpose, or maximum bounds are set for the calculation of laboratory measurement uncertainty. Such metrics are instead controlled through laboratory testing performance standards.

Comment: Multiple commenters stated that converted cannabinoids and synthetic products are not addressed directly in the proposed rules, raising product safety concerns.

Response: DSHS disagrees and declines to make the suggested change at this time. The rules are consistent with Executive Order GA-56. DSHS will consider the requested definition change in a future rulemaking.

Comment: Multiple commenters suggested prohibition of the sale of other intoxicants such as kratom, tianeptine, nitrous oxide, synthetic cannabinoids, hallucinogenic mushrooms, or psilocybin products.

Response: DSHS considers these comments outside the scope of rulemaking for this chapter. The rules are consistent with Executive Order GA-56.

Comment: Three commenters requested that DSHS align Subchapter G with 16 TAC §35.6 adopted by the TABC.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. 16 TAC §35.6 applies only to persons who have a TABC license or permit. HB 1325 applies to firms that manufacture, process, or retail sale CHPs. The rules are consistent with Executive Order GA-56.

Comment: Multiple commenters stated packaging and labeling rules are an undue burden on retailers. Sections 300.402, 300.405, and 300.406 put the burden on retailers to evaluate product labeling and packaging for compliance with Subchapter D and requires the retailers to develop written procedures for doing so. The commenters recommend limiting the task only to "qualified individuals."

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. HB 1325 requires retailers to ensure labeling and packaging requirements comply with this chapter.

Comment: Multiple commenters propose to remove gas chromatography from the total delta-9 THC provision.

Response: DSHS does not agree with this comment and declines to revise the rule in response to this comment. The rule allows, but does not require, the use of gas chromatography.

Comment: One commenter suggested removal of the definition of "marihuana."

Response: DSHS agrees with this comment and has removed §300.101(25), the definition of marihuana. The paragraphs in §300.101 have been renumbered accordingly.

Comment: Most commenters disagree with the hemp definition stating the definition is not the same as the federal definition.

Response: DSHS disagrees with this comment but revised §300.101(20) and §300.203(b), to align with the Texas Agriculture Code definition of hemp. The Texas definition is not required to mirror the Federal definition.

Comment: Multiple commenters oppose the definition of "Facility" to include U.S. Food and Drug Administration (FDA) Facility registration.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. FDA requires all food manufacturers, including consumable hemp manufacturers that manufacture CHPs for ingestion, to register according to the Food Safety Modernization Act (FSMA) unless exempted.

Comment: Multiple commenters oppose the definition of "cannabis" and want it deleted.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. The definition of "cannabis" informs the stakeholders of the type of plant.

Comment: Multiple commenters ask for clarification regarding whether licensing for an approved hemp source applies only to the Texas-based distributor or retailer selling the final, retail-ready products. Do the requirements for the manufacturer or brand apply whether based in or out of state?

Response: DSHS agrees that a clarification is needed and revised §300.101(5) to clarify approved hemp source.

Comment: One commenter states the definition of accredited laboratory should only have one clear standard, ISOIEC 17025 and delete "comparable or successor standard."

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. HB 1325 includes "comparable standard" language.

Comment: One commenter stated that the definition of "Process" includes "intended for incorporation" and could be interpreted too broadly and unintentionally include pilot or experimental batches that never reach consumers. Clarifying that intent applies only to materials reasonably expected to become consumer-ready products would reduce regulatory uncertainty while keeping safety and compliance intact.

Response: DSHS disagrees with the comment and declines to revise the rule in response to this comment. Consistent with HB 1325, Texas Agriculture Code §§121.001-121.020, 25 TAC §§300.101-300.104, and FDA intended-use principles under Federal Food, Drug, and Cosmetic Act (21 U.S.C. §321g, h, and k), materials intended or reasonably expected to be incorporated into CHPs must remain subject to regulatory oversight to prevent gaps in safety and compliance.

Comment: One commenter suggested amendment of the definition of "manufacturer" to clarify the distinction between manufacturing, distribution, and allowed modifications to reduce regulatory risk for lawful hemp-derived products.

Response: DSHS agrees with this comment and revised §300.101(23), (24), and proposed (34) (renumbered to paragraph (33)) to provide a distinction between hemp manufacturers and distributors.

Comment: Multiple commenters suggested halting these rule changes until there is clearer federal guidance and a comprehensive economic impact study on Texas' small businesses.

Response: DSHS disagrees and declines to revise the rule in response to this comment. The revisions are consistent with Executive Order GA-56.

Comment: One commenter stated, "Moving distributor licensing out of the hemp regime is not advisable."

Response: DSHS agrees with this comment and has made clarifying edits to state distributors must obtain a wholesaler license under HSC 431. DSHS clarified the licensing requirements for distributors throughout the rules.

Comment: One commenter suggested an amendment to the definition of "cannabis" to indicate "any plants or plant matters from plants in the genus Cannabis Sativa L."

Response: DSHS agrees with this comment and revised §300.101(8) in response to this comment.

Comment: One commenter suggested that TABC be allowed to access records per §300.203.

Response: DSHS agrees with this comment and revised §300.203(a) in response to this comment.

Comment: One commenter suggested clarification of who approves suppliers and whether the approval process includes all ingredients.

Response: DSHS disagrees and declines to revise the rules in response to this comment. All ingredients used in hemp production must be from approved sources. Approved source is defined in TAC §229.211(7). Unprocessed materials must originate from vendors that adhere to relevant state and federal regulations and are licensed, if appropriate, and evaluated by the governing body responsible for overseeing the processing and distribution of these raw materials.

Comment: One commenter suggested that DSHS require and enforce batch-specific Certificate of Analysis (COA) results.

Response: DSHS agrees with this comment and revised §300.205(2) in response to this comment.

Comment: One commenter stated, "In 25 TAC §300.402(a)(6) consider a QR code rather than a universal resource locator (URL). QR codes are easier for consumers to use (two-clicks rather than trying to read a small font URL then type in the text) and are more expected in the marketplace now."

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. HB 1325 requires the product's label to have a URL linked to the certificate of analysis. A firm has the option to also incorporate a QR code, but the URL is required.

Comment: One commenter suggested consideration of a font size minimum for recommended serving size and servings per container in §300.402(a)(7).

Response: DSHS disagrees and declines to revise the rule in response to this comment. DSHS follows 21 CFR 101.2(c) and (f), which provide guidance on serving size and servings per container.

Comment: Multiple commenters suggested DSHS consider allowing a universal THC symbol.

Response: DSHS disagrees and declines to revise the rule in response to this comment. Currently, there is no standard for a universal THC symbol. However, a firm may add a THC symbol to their label.

Comment: Two commenters suggested removal of "All THCs have psychoactive properties that may produce an effect similar to or greater than the effect of marihuana, a controlled substance" due to tetrahydrocannabivarin (THCV) not being psychoactive.

Response: DSHS agrees with this comment and has revised §300.402(b)(3).

Comment: One commenter suggested the word "marihuana" within the warning statement is not commonly known to the typical consumer and should be deleted.

Response: DSHS agrees with this comment and has amended §300.402(b)(3).

Comment: Two commenters oppose §300.405(b)(5)(E), which prohibits packaging with images of any celebrities as many are not known to children.

Response: DSHS agrees and has revised §300.405.

Comment: One commenter suggested standardized warnings on dosing, driving, and age restrictions.

Response: DSHS disagrees and considers this comment outside the scope of Executive Order GA-56. DSHS will consider the requested revision in future rulemaking. CHPs are prohibited from being marketed or sold to minors.

Comment: One commenter suggested requiring standard operating procedures as part of the license renewal.

Response: DSHS disagrees and declines to make the suggested change at this time. The rules are consistent with Executive Order GA-56. DSHS will consider the requested revision in future rulemaking.

Comment: One commenter suggested "Remote inspections (Zoom/document audits)" become standard and on-site visits are only triggered by "risk flags."

Response: DSHS does not agree with this comment and declines to revise the rule in response to this comment. Though remote inspections have been used under certain conditions, remote inspections require inspections be announced. This can limit the effectiveness of the inspection.

Comment: One commenter suggested "Licensees upload COAs into a DSHS system or via QR-linked database."

Response: DSHS disagrees and declines to make the suggested change at this time. The rules are consistent with HB 1325 and Executive Order GA-56. DSHS will consider the requested revision in future rulemaking.

Comment: One commenter stated §300.103 is too broad and should require a "defined inspection basis (routine schedule, complaint-driven, follow-up, or targeted risk), require written notice when feasible, and require inspectors to provide a written scope statement at the start of an inspection so licensees know what is being examined and why."

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. Pursuant to HSC Chapters 431 and 443, the department is authorized to conduct unannounced inspections to ensure compliance with consumable hemp requirements. Requiring notice or predefined inspection scope would limit effectiveness of inspections. Regulated entities already receive written inspection findings and enforcement notices upon conclusion of inspections.

Comment: Multiple commenters suggested clarification of §300.204 and §300.205, specifically, who maintains these records, who must have access, or how compliance would be verified, especially for out-of-state suppliers.

Response: DSHS disagrees and declines to revise the rules in response to this comment. Consumable hemp manufacturers are required to comply with §300.204 and §300.205. DSHS must review records to ensure compliance with Chapter 300. Non-resident suppliers are obligated to adhere to all relevant federal regulations as well as the statutory requirements of the destination state.

Comment: Multiple commentors stated the definition for "Approved Hemp Source" is overly broad, internally conflicting, and confusing.

Response: DSHS agrees and revised §300.101(5) in response to this comment.

Comment: One commenter stated recalls should be the responsibility of the manufacturer, not the distributor or retailer.

Response: DSHS disagrees with this comment but revised §300.207 to differentiate the requirements for retailers and manufacturers. Although manufacturers have a significant responsibility for recalls, retailers also need a plan for recalls.

Comment: One commenter stated §300.203 is only appropriate for in-state manufacturers, but is not applicable to farmers, retail shops, or distributors.

Response: DSHS agrees with the comment and declines to revise the rule in response to this comment. Section 300.203 is applicable to manufacturers, not farmers, retail shops, or distributors.

Comment: Multiple commenters suggested complaint files should be the manufacturer's responsibility instead of the store owners.

Response: DSHS agrees with the comment but declines to revise the rule. Section 300.208 relating to complaints only applies to manufacturers and processors.

Comment: One commenter suggested clarifying sampling methodology enforcement.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. DSHS samples are based on whether the inspection is routine, compliance, investigation, or complaint based.

Comment: One commenter opposes §300.402, Packaging and Labeling Requirements, as ambiguous and subjective standards.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. The revisions are consistent with Executive Order GA-56.

Comment: One commenter suggested §300.403, Relating to Retail Sale of Out-Of-State Consumable Hemp Products, is ambiguous.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. Section 300.403 is consistent with federal and state requirements.

Comment: One commenter opposes the term "attractive to children" because it is opinion based.

Response: DSHS agrees and has revised §300.405.

Comment: One commenter opposes §300.406 because it does not define the terms "clear," "sufficient detail," and "qualified individual."

Response: DSHS does not agree with this comment and declines to revise the rule in response to this comment. A "qualified individual" is defined in 25 TAC §229.211(54).

Comment: One commenter suggested deleting §300.407 "Misleading Consumable Hemp Packaging."

Response: DSHS does not agree with this comment and declines to revise the rule in response to this comment. It is important for the consumer to be able to determine whether the package contains a hemp-derived cannabinoid and whether the product is intended for medical purposes. Consumable hemp product packaging must clearly indicate that the package contains a hemp-derived cannabinoid and that the product is not intended for medical purposes. This requirement ensures informed consumers and is consistent with Executive Order GA-56.

Comment: One commenter stated that introduction into commerce is not defined.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. "Commerce" is defined in Texas Business and Commerce Code §17.45(6).

Comment: One commenter opposes §300.701(a) citing that it is too subjective.

Response: DSHS agrees and has revised §300.701(a). The revisions are consistent with Executive Order GA-56.

Comment: One commenter opposes §300.603 and suggested this section allows inspectors to take "full control over business owners" property without checks and balances.

Response: DSHS does not agree with the commenter and declines to revise the rule in response to this comment. The revisions are consistent with Executive Order GA-56 and HSC §443.002, which incorporates recall and embargo authority under HSC §431.048.

Comment: One commenter opposes §300.605, "Correction by Proper Labeling or Processing."

Response: DSHS does not agree with this comment and declines to revise the rule in response to this comment. HSC §431.052 authorizes Correction by Proper Labeling or Processing.

Comment: One commenter suggested recognizing smokable flower and pre-Rolls as "cigar lounge-style products."

Response: DSHS disagrees and declines to make the suggested change at this time. The revisions are consistent with Executive Order GA-56. DSHS will consider the requested revision in a future rulemaking.

Comment: One commenter suggested DSHS require one certified THC Handler per licensed store.

Response: DSHS disagrees and declines to make the suggested change at this time. The revisions are consistent with Executive Order GA-56. DSHS will consider the requested revision in a future rulemaking.

Comment: One commenter suggested a centralized DSHS portal for managing licensee compliance, training, and inspection reports.

Response: DSHS agrees in part and disagrees in part. DSHS has a portal that manages license compliance, and inspection reports. DSHS declines to make the suggested change for a training portal at this time. DSHS will consider the comment in a future rulemaking.

Comment: One commenter suggested the establishment of a Hemp Regulatory Commission.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. DSHS considers this comment outside the scope of rulemaking for this project and Executive Order GA-56.

Comment: Multiple commenters recommend specific penalties for noncompliance, such as: $500 - $1,000 per unregistered product, $10,000/day for unlicensed operation, and $20,000/day for operation after license revocation. Some commenters suggest the rules "should also include clear, automatic penalties for violations such as falsified certificates of analysis, sales to minors, and distribution of unauthorized products."

Response: DSHS does not agree with the commenter and declines to revise the rule in response to this comment. DSHS relies on an administrative penalty matrix in making enforcement determinations. All enforcement actions taken by DSHS are administrative or civil rather than criminal.

Comment: Multiple commenters suggested banning THC-Infused Foods and Beverages in Violation of Federal Law.

Response: DSHS disagrees with this comment and declines to revise the rule in response to this comment. HB 1325 requires DSHS to develop rules regulating the manufacture, distribution, and sale of CHPs in Texas. The revisions are consistent with Executive Order GA-56.

Comment: Multiple commenters suggested DSHS should establish a cost-recovery grant program to assist local law enforcement and municipal partners in conducting compliance checks, underage stings, and inspections; the best practice already used in tobacco and alcohol enforcement programs. Underage sting operations should be conducted once per quarter with retailers, as a recommended best practice.

Response: DSHS disagrees and declines to revise the rule in response to this comment. DSHS has established fees that will support TABC underage sting operations. TABC has already implemented undercover underage sting operations. DSHS also collaborates with Texas Department of Public Safety, as directed by Executive Order GA-56.

Comment: Multiple commenters suggested aligning with Federal Product Standards, which limit finished products to no more than 0.4 milligrams of total THC per serving.

Response: DSHS disagrees and declines to make the suggested change at this time. DSHS will consider the requested revision in a future rulemaking when the federal amendments take effect.

Comment: Multiple commenters suggested DSHS require Third-Party Lab Testing and QR-Code COAs that include THC content, a complete analyte list, and documentation of the absence of contaminants or adulterants.

Response: DSHS does not agree with this comment and declines to revise the rule in response to this comment. HB 1325 has already incorporated requirements for testing. CHP manufacturers are required to test for, as appropriate, cannabinoids, residual solvents, microbiological contaminants, pesticides, and heavy metals.

Comment: Multiple commenters suggest DSHS incorporate the ability to quickly update prohibited product forms, potency structures, and compliance triggers as the market evolves.

Response: DSHS disagrees and declines to make the suggested change at this time. The revisions are consistent with Executive Order GA-56. DSHS will consider the requested revision in a future rulemaking.

Comment: Multiple commenters suggest strengthening accountability for out-of-state products, including consideration of a distributor or importer responsibility mechanism to prevent retailer only enforcement.

Response: DSHS declines to revise the rule in response to this comment. A consumable hemp product distributor is required to hold a wholesaler license from the department per HSC Chapter 431. Out of state manufacturers' products must comply with Texas statutes and rules in order to be sold in Texas.

Comment: One commenter suggested the DSHS Commissioner include guidance on acceptable forms of identification issued by another country.

Response: DSHS agrees and revised §300.701(c) in response to this comment.

Comment: Multiple commenters oppose the inclusion within the warning statement "…greater effect than marihuana."

Response: DSHS agrees with this comment and has revised §300.402(b)(3).

Comment: Multiple commenters oppose batch date labeling requirements.

Response: DSHS disagrees and declines to revise the rule in response to this comment. HB 1325 requires a batch date.

Comment: Multiple commenters oppose packaging and Child Resistance Requirements for 750ml containers.

Response: DSHS disagrees and declines to revise the rule in response to this comment. Executive Order GA-56 directed the department to implement rules to prevent minors access to all consumable hemp products.

Comment: Multiple commenters stated rules should follow only food Good Manufacturing Practices (GMPs).

Response: DSHS does not agree and declines to revise the rule in response to this comment. HB 1325 provides that a consumable hemp products means food, a drug, a device, or a cosmetic that contains hemp or one or more hemp-derived cannabinoids. Food, drug, device, and cosmetic are defined by HSC §have their own regulations.

Comment: Multiple commenters suggested recordkeeping obligations are often impractical for lawful operators to satisfy, particularly for those whose activities are limited to repackaging, relabeling, or distribution of finished products manufactured elsewhere.

Response: DSHS disagrees and declines to revise the rule in response to this comment. HSC §431.044 requires records to be kept showing movement in commerce, which includes finished product distribution. Repackaging, relabeling, and private labeling operations are considered manufacturing and are subject to these rules.

Comment: One commenter suggested "approved hemp source" creates confusion about hemp from outside the United States, which complies with federal law.

Response: DSHS agrees and revised §300.101(5) in response to this comment.

Comment: Multiple commenters suggested §300.407 restricts labeling and marketing for medical use or therapeutic benefit but does not clearly distinguish between explicit disease-treatment claims (which are appropriately restricted) and general wellness language or imagery common in food and supplement contexts.

Response: DSHS disagrees and declines to revise the rule in response to this comment. The FDA regulates wellness claims on conventional foods, classifying them into three categories: authorized health claims, nutrient content, and structure/function claims. All such claims require substantiation, must be truthful, and typically highlight a nutrient's specific role in health, like calcium for bone strength, without claiming a cure.

Comment: One commenter opposes random testing in general.

Response: DSHS disagrees and declines to revise the rule in response to this comment. HB 1325 requires DSHS to establish a process for the random testing of CHPs.

Comment: Multiple commentors suggested zoning regulations to be established for specific areas that are distant from schools and churches.

Response: DSHS disagrees and declines to revise the rule in response to this comment. HSC Chapter 443 does not authorize zoning restrictions.

Comment: Multiple commentors suggested proposed rules exceed those authorized under the governor's executive order.

Response: DSHS does not agree and declines to revise the rule in response to this comment. The revisions are consistent with Executive Order GA-56 and HSC §443.002, which incorporates HSC Chapter 431.

Comment: One commenter suggested implementation of a secure purchase environment.

Response: DSHS disagrees and declines to make the suggested change at this time. The revisions are consistent with Executive Order GA-56. DSHS will consider the requested revision in a future rulemaking.

Additionally, DSHS made minor editorial changes to the rules to improve clarity, readability, and to correct an error as follows.

DSHS revised §300.101(15) to improve clarity. DSHS revised §300.101(24) by adding "mixes" to improve clarity. DSHS also revised proposed §300.101(35) (renumbered to paragraph (34)) to remove "or leading" and include "processor" to improve clarity.

DSHS revised §300.103(a) to clarify that TABC may enter the premises to ensure compliance with this chapter; added the acronym for Texas Health and Safety Code in §300.103(b); corrected a clerical error in §300.103(c) replacing "prescription drug or restricted device" with "consumable hemp products," and updated a citation in §300.103(c)(5)(B).

DSHS revised §300.201 to clarify which license consumable hemp product distributors are required to hold and made minor grammatical revisions to improve clarity.

DSHS revised §300.202(f)(2) by replacing "denied" with "approved" and replacing "denial" with "approval" to be consistent with Texas Government Code Chapter 2005.

DSHS revised §300.203(d) to clarify who must maintain the records and made minor grammatical revisions in subsections (d) and (e) to improve clarity.

DSHS revised §300.204(b) to remove proposed paragraph (4) to eliminate a duplicate ingredient measurement requirement. The paragraphs were renumbered accordingly.

DSHS revised §300.208 and §300.402 to include "processor" to provide clarity. The title of §300.208 was revised to "Complaints" for clarity.

DSHS revised §300.301(c) to spell out "certificate of analysis" and §300.301(d)(2) to include "hemp processor" to provide clarity. DSHS also revised subsection (e) removing "with the intent to deceive" to be consistent with HSC 431.

DSHS revised §300.302(a) by removing "section" and replaced with "chapter" to clarify low-THC cannabis does not apply to 25 TAC Chapter 300.

DSHS revised §300.303 language to clarify who is responsible for complying with each requirement. DSHS revised §300.303(b) to include "retailer" as also responsible for providing testing results. This section was also revised to include the "consumer" and "Texas Alcoholic Beverage Commission" be provided testing results upon request. DSHS deleted proposed §300.303(c) since these requirements are now reflected in §300.303(b) and renumbered the subsections accordingly. DSHS revised proposed §300.303(g) - (i) (renumbered to subsections (f) - (h)) by replacing "or" with "and" to clarify what is required by stakeholders.

DSHS revised §300.403(3) to clarify out of state consumable hemp products must comply with acceptable hemp THC levels.

DSHS revised §300.406(b) to correct punctuation and §300.501(a) by removing "section" and replacing with "chapter" to correct a clerical error.

DSHS revised §300.502(b)(7) to include "sold" to provide clarity. DSHS updated §300.502 for consistency with §300.202 by revising subsection (c); adding subsections (d) and (h); revising proposed subsection (f)(2) (renumbered to subsection (g)(2)) and adding paragraphs (3) - (4). The subsections were renumbered accordingly.

DSHS revised §300.601(a)(1) to include "processing" to improve clarity.

DSHS revised §300.603 and §300.606(g) - (i) by making minor grammatical changes to improve clarity.

SUBCHAPTER A. GENERAL PROVISIONS

25 TAC §§300.100 - 300.103

STATUTORY AUTHORITY

The amended sections are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, HSC §1001.075, which authorizes 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 HSC Chapter 1001, Texas Government Code §524.0005, and HSC §12.001, HSC Chapter 431, and HSC Chapter §443.051.

§300.101. Definitions.

The following words and terms, when used in this chapter, have the following meanings unless context clearly indicates otherwise:

(1) Acceptable hemp THC level--A total delta-9 tetrahydrocannabinol content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3% or less.

(2) Accredited laboratory--A laboratory, including at an institution of higher education, accredited in accordance with the International Organization for Standardization ISO/IEC 17025 or a comparable or successor standard.

(3) Act--House Bill 1325, 86th Legislature, Regular Session, 2019, relating to the production and regulation of hemp in Texas, codified in Texas Health and Safety Code Chapter 443.

(4) Analyte--A chemical, compound, element, bacteria, yeast, fungus, mold, or toxin identified and measured by accredited laboratory analysis.

(5) Approved hemp source--Hemp and hemp products for human use and consumption must be grown under a state or compatible federal, foreign, or Tribal plan. These plans must be approved by the United States Department of Agriculture under 7 United States Code (U.S.C.) Chapter 38, Subchapter VII, or Texas Agriculture Code Chapter 121. The products must comply with federal law and the laws of respective foreign jurisdictions.

(6) Batch date--The date a product batch was made, used for tracking and quality control. This is also called the lot date.

(7) Batch ID number--A number that identifies a specific amount of raw or processed hemp product that meets standards for identity, strength, purity, and composition. Each batch ID number must include the manufacturer's, processor's, or distributor's number and a sequence for inventory, traceability, and identification of the plant batches used in making consumable hemp products. This is also called the lot number.

(8) Cannabis--A type of flowering plant in the Cannabaceae family. Any plants or plant matters from plants in the genus Cannabis Sativa L.

(9) Cannabidiol (CBD)--A phytocannabinoid produced by cannabis.

(10) Certificate of Analysis (COA)--An official document from an accredited laboratory available to the manufacturer, processor, distributor, retailer, public, or department. The COA shows the concentrations of cannabinoid analytes and other measurements required by the department, including data on THC levels, and states whether a sample passed or failed content analysis limits.

(11) Consumable hemp product (CHP)--Any product processed or manufactured for consumption that contains hemp, including food, a drug, a device, and a cosmetic, as defined by Texas Health and Safety Code §431.002. The definition excludes any hemp product containing a hemp seed or hemp seed-derived ingredient that the FDA has designated as Generally Recognized as Safe (GRAS).

(12) Consumable hemp products license--A license issued to a person or facility engaged in the act of manufacturing, extracting, or processing consumable hemp products for human consumption or use.

(13) Decarboxylation--The removal or elimination of a carboxyl group from a molecule or organic compound.

(14) Delta-9 tetrahydrocannabinol (d-9 THC)--A tetrahydrocannabinol isomer known as the primary psychoactive component of cannabis.

(15) Department--The Texas Department of State Health Services.

(16) Distributor--A person who distributes consumable hemp products for resale, either through a retail outlet owned by that person or through sales to another retailer. A distributor is required to hold a wholesaler license per Texas Health and Safety Code Chapter 431.

(17) Facility--A place of business engaged in manufacturing, processing, or distributing consumable hemp products subject to the requirements of this chapter and Texas Health and Safety Code Chapter 431. A facility includes a domestic or foreign facility required to register under the Federal Food, Drug, and Cosmetic Act, Section 415 in accordance with the requirements of 21 Code of Federal Regulations Part 1, Subpart H.

(18) FDA--The United States Food and Drug Administration or its successor agency.

(19) Federal Act--Federal Food, Drug, and Cosmetic Act (Title 21 U.S.C. 301 et seq.).

(20) Hemp--The plant, Cannabis sativa L. and any part of that plant, including the seeds of the plant and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.

(21) Hemp-derived cannabinoid product--Any intermediate or final product derived from hemp (other than industrial hemp), that:

(A) contains cannabinoids in any form; and

(B) is intended for human or animal use through any means of application or administration, such as inhalation, ingestion, or topical application.

(22) Independent contractor--A person or entity contracted to perform work or sales for a registrant.

(23) License holder--The person who is legally responsible for the operation as a consumable hemp manufacturer or processor and possesses a valid license.

(24) Manufacturer--A person who makes, mixes, extracts, processes, packages, or repackages consumable hemp product from one or more ingredients. The definition includes synthesizing, preparing, treating, modifying, or manipulating hemp, hemp crops, or ingredients to create a consumable hemp product. It also includes private-labeling. For farmers and persons with farm mixed-type facilities, manufacturing and processing do not include activities related to growing, harvesting, packing, or holding raw hemp product. Manufacturers may only distribute products they manufactured.

(25) Measurement of uncertainty--The parameter, associated with the results of an analytical measurement that characterizes the dispersion of the values that could reasonably be attributed to the quantity subjected to testing measurement. For example, if the reported total d-9 THC content concentration level on a dry weight basis is 0.35% and the measurement of uncertainty is +/- 0.06%, the measured total d-9 THC content concentration level on a dry weight basis for this sample ranges from 0.29% to 0.41%. Because 0.3% is within the distribution or range, the sample is within the acceptable hemp THC level for the purpose of plan compliance.

(26) Minor--A person under 21 years of age.

(27) Non-consumable hemp processor--A person who intends to process hemp products not for human consumption and who is registered with the Texas Department of Agriculture.

(28) Non-consumable hemp product--As defined by Texas Agriculture Code §122.001(8), means a product that contains hemp, other than a consumable hemp product as defined by Texas Health and Safety Code §443.001. The term includes cloth, cordage, fiber, fuel, paint, paper, particleboard, construction materials, and plastics derived from hemp.

(29) Pathogen--A microorganism of public health significance, including molds, yeasts, Listeria monocytogenes, Campylobacter, Salmonella, E. coli, Yersinia, or Staphylococcus.

(30) Person--An individual, business, partnership, corporation, or association.

(31) Private labeling--When a person or manufacturer labels a CHP with the person's name and address, thereby representing itself as responsible for the purity and labeling of a CHP.

(32) Process--Extraction of a component of hemp, including CBD or another cannabinoid, that is:

(A) sold as a consumable hemp product;

(B) offered for sale as a consumable hemp product;

(C) incorporated into a consumable hemp product; or

(D) intended for incorporation into a consumable hemp product.

(33) Processor--A person who operates a facility that processes raw agriculture hemp into consumable hemp products for manufacture, distribution, and sale. A hemp processor is required to hold a consumable hemp products license.

(34) QR code--A quick response machine-readable code that can be read by a camera, consisting of an array of black and white squares used for storing information or directing a user to product information regarding manufacturer or processor data and accredited laboratory COA.

(35) Raw hemp--An unprocessed hemp plant, or any part of the plant, in its natural state.

(36) Registrant--A person who sells consumable hemp products directly to consumers, and who submits a complete registration form to the department for purposes of registering the place of business to sell consumable hemp products at retail to the public.

(37) Reverse distributor--A person registered with the federal Drug Enforcement Agency as a reverse distributor that receives controlled substances from another person or entity for return of the products to the registered manufacturer or to destroy adulterated or impermissible THC products.

(38) Smoking--Burning or igniting a substance and inhaling the resultant smoke or heating a substance and inhaling the resulting vapor or aerosol.

(39) Supplier--A person or entity that manufactures or processes a material used in the processing or manufacturing of hemp. This term also includes a person or entity that manufactures hemp-derived cannabinoids or sells products containing hemp-derived cannabinoids to retailers.

(40) Tetrahydrocannabinol (THC)--A cannabinoid found in cannabis and considered the primary psychoactive component of the cannabis plant.

(41) Tetrahydrocannabinolic acid (THCA)--A precursor to all tetrahydrocannabinols (THC).

(42) Texas Department of Agriculture--The state agency responsible for regulation of planting, growing, harvesting, and testing of hemp as a raw agricultural product.

(43) Texas.gov--The online registration system for the State of Texas found at https://www.texas.gov.

(44) Total THC--The value determined after the process of decarboxylation, or the application of a conversion factor if the testing methodology does not include decarboxylation, that expresses the potential total tetrahydrocannabinol content derived from the sum of all THC isomers and THCA content and reported on a dry weight basis. This technique requires the use of the following conversion: [Total THC = (0.877 x THCA) + THC], which calculates the potential total THC in a given sample.

(45) Total delta-9 THC--The value is determined after decarboxylation or by applying a conversion factor if the testing method does not include decarboxylation. This shows the potential total delta-9 THC content from the sum of delta-9 THC and THCA, reported on a dry weight basis. The post-decarboxylation value of delta-9 THC can be calculated using a chromatograph technique with heat, like gas chromatography, which converts THCA. This test calculates the potential total delta-9 THC in a sample. The total delta-9 THC can also be calculated using a liquid chromatograph technique, which keeps THCA intact. This technique uses the conversion: [Total delta-9 THC = (0.877 x THCA) + delta-9 THC]. This test calculates the potential total delta-9 THC in a sample.

§300.103. Inspections.

(a) Authorized employees of the department or the Texas Alcoholic Beverage Commission, after showing proper credentials to the owner, operator, or person in charge, may:

(1) enter the premises at reasonable times, conduct inspections, collect samples, and take photographs to determine compliance with this chapter and Texas Health and Safety Code (HSC) Chapters 431 and 443;

(2) enter a vehicle being used to transport or hold a consumable hemp product in commerce; or

(3) inspect at reasonable times, within reasonable limits, and in a reasonable manner, the facility or vehicle and all equipment, finished and unfinished materials, containers, and labeling of any item and obtain samples necessary for the enforcement of this chapter.

(b) The inspection of a facility where consumable hemp products are manufactured, processed, distributed, packed, repackaged, sold, or held, for introduction into commerce must undergo inspection to determine if the consumable hemp product is:

(1) adulterated or misbranded; or

(2) manufactured, processed, held, distributed, packed, or sold in violation of this chapter or HSC Chapters 431 and 443.

(c) An inspection of a facility where a consumable hemp product is being manufactured, processed, packed, or held for introduction into commerce under subsection (b) of this section must not extend to:

(1) financial data;

(2) sales data other than shipment data;

(3) pricing data;

(4) personnel data other than data relating to the qualifications of technical and professional personnel performing functions under this chapter; or

(5) research data other than data:

(A) relating to new consumable hemp products; and

(B) subject to reporting and inspection under 21 United States Code (U.S.C.) §§355, 360i, or 360j.

(d) The inspector must start and complete the inspection under subsection (b) of this section with reasonable promptness.

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 March 2, 2026.

TRD-202601064

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: March 31, 2026

Proposal publication date: December 26, 2025

For further information, please call: (512) 719-3521


SUBCHAPTER B. MANUFACTURE, PROCESSING, AND DISTRIBUTION OF CONSUMABLE HEMP PRODUCTS

25 TAC §§300.201 - 300.208

STATUTORY AUTHORITY

The amendments and new sections are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, HSC §1001.075, which authorizes 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 HSC Chapter 1001, Texas Government Code §524.0005, and HSC §12.001, HSC Chapter 431, and HSC Chapter §443.051.

§300.201. Application for License or Renewal.

(a) A person must hold a consumable hemp products license issued by the department before engaging in manufacturing or processing of consumable hemp products. A person must hold a wholesaler license per Texas Health and Safety Code (HSC) Chapter 431 before engaging in the distribution of consumable hemp products.

(b) A person must apply for a consumable hemp products license by submitting an application to the department for each location engaged in manufacturing or processing consumable hemp products. The application must include:

(1) a legal description of each location, including the global positioning system coordinates for the perimeter of each location:

(A) where the applicant intends to manufacture or process consumable hemp products; and

(B) where the applicant intends to store consumable hemp products;

(2) written consent from the applicant or property owner, if the applicant is not the property owner, for the department, the Department of Public Safety, Texas Alcoholic Beverage Commission, and any other state or local law enforcement agencies to enter all premises where consumable hemp is manufactured, processed, or delivered for physical inspection or to ensure compliance with this chapter; and

(3) a fingerprint-based criminal background check from each applicant at the applicant's expense.

(c) If the applicant has been convicted of a felony relating to a controlled substance under federal law or the law of any state within 10 years before the date of application, the department must not issue a consumable hemp products license under this subchapter.

(d) If the department receives information that a license holder has been convicted of a felony relating to a controlled substance under federal law or the law of any state within 10 years before the license was issued, the department must revoke the consumable hemp products license.

(e) A person holding a consumable hemp products license under this subchapter must undergo a fingerprint-based criminal background check at the person's own expense.

(f) Applications must contain the following information:

(1) the name of the license applicant;

(2) the business name, if different from the applicant's name, and any other names under which the firm does business, if applicable;

(3) the mailing address of the business;

(4) the street address of the facility;

(5) the primary business contact telephone number;

(6) the personal email address of the applicant; and

(7) the email address of the business, if different than the applicant's email address.

(g) If a person owns or operates two or more facilities, each facility must have a separate license with its own application form, listing the name and address of each facility.

(h) Applicants must submit an application for a consumable hemp products license request under this subchapter electronically through www.Texas.gov. The department is authorized to collect fees to recover costs associated with application and renewal application processing through www.Texas.gov.

(i) All fees required by the department must be submitted with the application.

(j) Applicants must provide any additional information required by the department, as specified on the application forms.

(k) The facility must display the consumable hemp products license issued by the department in an obvious and conspicuous public location.

§300.202. License Term and Fees.

(a) A consumable hemp product license is valid for one year from the date displayed on the license and must be renewed annually. An expired license is not current or valid. A person must not process hemp or manufacture a consumable hemp product without a valid license.

(b) The department must issue and renew a license if the license holder:

(1) is eligible to obtain a license under §300.201 of this subchapter (relating to Application for License or Renewal);

(2) submits a license fee to the department;

(3) does not owe outstanding fees to the department;

(4) possesses testing results of consumable hemp products before manufacture, distribution, or sale into commerce, and provides those testing results upon department request;

(5) has not been convicted of a felony relating to a controlled substance under federal law or the law of any state in the 10 years before the date of renewal of the license;

(6) submits a complete application; and

(7) has not had a consumable hemp products license revoked for sale to a minor in the preceding five years from the date on which an application is submitted to the department.

(c) Fees.

(1) Before manufacturing or processing consumable hemp products, a license holder must pay a fee of $10,000 per facility. License renewal fees are $10,000 per facility.

(2) For each facility, a license holder must pay:

(A) a $10,000 fee for an amendment to a new license due to a change of ownership of the licensed facility; or

(B) a $125.00 fee for any amendment during the licensure period due to minor changes, such as change of location, change of name, or change of address.

(3) Fees are not prorated.

(4) A person who files a renewal application after the expiration date of the current license must pay an additional delinquency fee of $1,000.

(d) An application for an amendment of a consumable hemp product license is complete when the department has received, reviewed, and found acceptable the application information and fee required by subsection (c) of this section.

(e) An initial and renewal application for a consumable hemp product license must be processed in the following time periods:

(1) the first time period of 45 calendar days begins on the date the department receives a completed application. If the department receives an incomplete application, the period ends on the date the department issues a written notice that the application is incomplete. The department must issue the written notice within 60 calendar days after receiving the incomplete application and describe the specific information or fee required before the application is considered complete;

(2) the second time period of 45 calendar days begins on the date the department receives a completed application and ends on the date the department issues the license or issues a written notice that the application is being proposed for denial; and

(3) the third time period of 135 calendar days begins on the date the department issues the written notice to the applicant as described in paragraph (1) of this subsection. If the applicant fails to submit the requested information or fee within this period, the department considers the application withdrawn.

(f) Reimbursement of fees:

(1) in the event the application is not processed within the time periods stated in subsection (e) of this section, the applicant has the right to make a written request within 30 business days after the end of the second time period that the department shall reimburse in full the fee paid in that application process; and

(2) if the department finds that good cause does not exist for exceeding the established periods, the request shall be approved, and the department shall notify the applicant in writing of the approval of the reimbursement within 30 business days after the department's decision.

§300.203. Access to Records.

(a) A person who is required to maintain records under this chapter or 21 United States Code (U.S.C.) §360i or §360j must maintain records on site for immediate inspection. Upon request by the department or the Texas Alcoholic Beverage Commission, the person must provide access to records for review or copying to verify that consumable hemp products are being produced in accordance with United States Department of Agriculture under 7 U.S.C. Chapter 38, Subchapter VII, or Texas Agriculture Code Chapter 121.

(b) A person regulated under Texas Agriculture Code Chapter 122 must provide the department with test results of hemp or hemp products upon request. These results must show that the total delta-9 tetrahydrocannabinol concentration is not more than 0.3 percent on a dry weight basis.

(c) Records described in this chapter must be maintained for a period of no less than three years after the date the records are created.

(d) A consumable hemp manufacturer or processor must maintain the following records, as applicable:

(1) certificate of analysis (COA) of raw hemp and hemp ingredients in accordance with §300.301(b)(1) - (3) and §300.301(c) of this chapter (relating to Testing Required);

(2) COA of finished hemp products by batch number;

(3) source of ingredients, including:

(A) receiving records with address and contact information from suppliers, distributors, warehouses, or any person engaged in the business of making a consumer product directly or indirectly; or

(B) licensing documentation, if applicable, from the supplier's respective hemp or food regulating authority;

(4) batch production records;

(5) recalled product information;

(6) consumer complaints;

(7) other records required by the department, including corrective action logs, destruction logs, equipment calibration records, or other accurate reproductions of the original records, or electronic records; and

(8) master production records.

(e) Records must contain actual values and observations. Records must be accurate, permanent, legible, and created concurrently with performance of the activity documented. Records can be electronic. Records must be detailed enough to provide a history of work performed, and include:

(1) the name and, if more than one, the location of the plant or facility;

(2) the date and time of the documented activity

(3) the signature or initials of the person performing the activity; and

(4) the identity of the product and the batch number.

§300.204. Master Production Records.

(a) To ensure uniformity from batch to batch, one person must prepare, date, and sign with full handwritten signature, the master production records for each consumable hemp product, including batch size. A second person must independently check, date, and sign these records. The preparation of master production and control records must be described in a written procedure that the firm must follow.

(b) Master production records must include:

(1) the name and weight or measure of each ingredient;

(2) a complete list of ingredients;

(3) a statement of any calculated excess of a by-product; and

(4) complete manufacturing instructions and specifications.

§300.205. Batch Production Records.

Batch production records must be prepared for each batch of consumable hemp product produced and must include complete information regarding each batch. These records must include, if applicable:

(1) the appropriate master product record, checked for accuracy, dated, and signed; and

(2) documentation that each step in the manufacture, processing, packaging, or holding of the batch was accomplished, including:

(A) dates;

(B) identity of individual major equipment and lines used;

(C) weight and measure of ingredients;

(D) in-process results;

(E) laboratory control results, if applicable;

(F) inspection of the packaging and labeling area before and after use;

(G) statement of the actual yield;

(H) complete labeling records, including copies of all labeling used;

(I) any sampling performed;

(J) any investigation conducted;

(K) any destruction of tetrahydrocannabinol;

(L) any rework conducted; and

(M) certificate of analysis of hemp or hemp derivative used in the manufacture of a consumable hemp product.

§300.207. Recalls.

(a) Recall Procedures. All facilities engaged in the manufacture, processing, distribution, or retail sale of consumable hemp products must maintain written recall procedures. The recall procedures must describe the steps, assign responsibility, and include at a minimum:

(1) identification of recalled products;

(2) immediate removal and segregation of recalled products from sale and active inventory;

(3) return holding, or disposal of recall products; and

(4) notification to the public about any hazards presented by the product to protect public health.

(b) Recall plan. Manufacturers, distributors, or processors must establish a recall plan. The recall plan must include the following procedures:

(1) directly notify the direct consignees of the hemp product, including how to return or dispose of the affected product;

(2) notify the public about any hazards presented by the product to protect public health;

(3) conduct effectiveness checks to verify that the recall is carried out; and

(4) dispose of recalled product appropriately by reprocessing, reworking, diverting to a safe use, or destroying the product.

§300.208. Complaints.

(a) Each manufacturer or processor must maintain complaint files relating to product safety. Each manufacturer or processor must establish and maintain procedures for receiving, reviewing, and evaluating complaints. The procedures must ensure that:

(1) all complaints are processed in a uniform and timely manner;

(2) oral complaints are documented upon receipt; and

(3) complaints are evaluated to determine whether the complaint represents an event that must be reported to the FDA and the department.

(b) Each manufacturer or processor must review and evaluate all complaints to determine whether an investigation is necessary. All safety-related complaints must be investigated. If no investigation is made, the manufacturer or processor must maintain a record that includes the reason for not investigating and the name of the individual responsible for the decision.

(c) Any complaint about labeling or packaging not meeting specifications must be reviewed, evaluated, and investigated, unless a similar complaint has already been investigated and another investigation is not needed.

(d) The record of the investigation must include:

(1) the name of the product;

(2) the date the complaint was received;

(3) the batch number and batch date of product used;

(4) the name, address, and phone number of the complainant;

(5) the nature and details of the complaint;

(6) the dates and results of the investigation;

(7) any corrective action taken; and

(8) any reply to the complainant.

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 March 2, 2026.

TRD-202601065

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: March 31, 2026

Proposal publication date: December 26, 2025

For further information, please call: (512) 719-3521


SUBCHAPTER C. TESTING OF CONSUMABLE HEMP PRODUCTS

25 TAC §§300.301 - 300.303

STATUTORY AUTHORITY

The amended sections are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, HSC §1001.075, which authorizes 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 HSC Chapter 1001, Texas Government Code §524.0005, and HSC §12.001, HSC Chapter 431, and HSC Chapter §443.051.

§300.301. Testing Required.

(a) Before a hemp plant is processed or otherwise used in the manufacture of a consumable hemp product, a representative sample must be tested to determine:

(1) the concentration and identity of the cannabinoids, including all acids in the plant;

(2) the presence and quantity of heavy metals, pesticides, microbial contamination, and other substances prescribed by the department;

(3) the presence and concentration of d-9 THC, total d-9 THC, and total THC; and

(4) a total delta-9 tetrahydrocannabinol concentration of 0.3% or less on a dry weight basis.

(b) Before a consumable hemp product, including hemp-derived ingredients used for further processing into another consumable hemp product, is sold at retail, distributed, or otherwise introduced into commerce in this state, a representative sample must be tested to determine:

(1) the presence, concentration, and identity of cannabinoids;

(2) the presence and concentration of d-9 THC, total d-9 THC, and total THC;

(3) the presence and quantity of residual solvents, heavy metals, pesticides, and harmful pathogens; and

(4) the total delta-9 tetrahydrocannabinol concentration is 0.3% or less on a dry weight basis.

(c) A certificate of analysis (COA) documenting tests conducted under this subchapter must:

(1) be made available to the department upon request in an electronic format before manufacture, processing, or distribution into commerce; and

(2) include measurement of uncertainty analysis parameters.

(d) The COA must contain, at a minimum, the following information:

(1) laboratory name, address, and contact information;

(2) hemp cultivator, hemp processor, or hemp manufacturer's name and address;

(3) sampler identification;

(4) sample identifying information, including matrix type;

(5) lot identification number of sample;

(6) sample received date and the dates of sample analyses and corresponding testing results;

(7) units of measure;

(8) analytical methods, analytical instrumentation used, and corresponding limits of detection (LOD) and limits of quantitation (LOQ);

(9) expiration date;

(10) QR code on the COA verifying the authenticity of testing conducted at an accredited laboratory;

(11) measurement of uncertainty analysis parameters; and

(12) results of all requested analyses performed for the sample, including percentage of delta-9 THC, total delta-9 THC, and total THC per container.

(e) It is a violation if a person forges, falsifies, or alters the results of a laboratory test authorized or required by this chapter. Consumable hemp products found in violation of this subsection must be retested and are subject to detention or embargo under Texas Health and Safety Code §431.048.

(f) Expired COAs are not valid. Consumable hemp products with expired COAs must be retested and are subject to detention or embargo under Texas Health and Safety Code §431.048.

§300.302. Sample Analysis of Consumable Hemp Products.

(a) This chapter does not apply to low-THC cannabis regulated under Texas Health and Safety Code Chapter 487.

(b) Regardless of any other law, a person must not sell, offer for sale, possess, distribute, or transport a consumable hemp product in this state if the consumable hemp product contains any material extracted or derived from the plant Cannabis sativa L., other than from hemp produced in compliance with 7 United States Code (U.S.C.) Chapter 38, Subchapter VII, and:

(1) a representative sample of the consumable hemp product has been tested by an accredited laboratory and found to have a total delta-9 THC concentration of 0.3% or less on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3% or less; and

(2) testing results are provided to the department upon request.

(c) The department must conduct random testing of consumable hemp products at various retail and other facilities that sell or distribute products to ensure the products:

(1) do not contain harmful ingredients;

(2) are produced in compliance with 7 U.S.C. Chapter 38, Subchapter VII; and

(3) have a total delta-9 THC content concentration level on a dry weight basis, that, when reported with the accredited laboratory's measurement of uncertainty, produces a distribution or range that includes a result of 0.3% or less.

(d) Upon request by the department, the manufacturer, processor, distributor, or retailer of consumable hemp products must provide representative raw or finished consumable hemp product samples to the department. These samples must be provided at the licensee's or registrant's expense.

§300.303. Provisions Related to Testing.

(a) A consumable hemp product that exceeds the acceptable hemp THC level or is adulterated in a manner harmful to human consumption must not be sold at retail or otherwise introduced into commerce in this state.

(b) A hemp manufacturer, processor, distributor, and retailer must provide the results of testing required by §300.301 of this subchapter (relating to Testing Required) to the consumer, the Texas Alcoholic Beverage Commission, and department upon request.

(c) A license holder must not use an independent testing accredited laboratory unless the license holder:

(1) has no ownership interest in the accredited laboratory; or

(2) holds 10 percent or less ownership interest in the accredited laboratory if the accredited laboratory is a publicly traded company.

(d) A manufacturer, processor, or retailer must pay the costs of raw and finished hemp product testing in an amount prescribed by the accredited laboratory selected by the license holder.

(e) The department may require that a copy of the test results be sent directly to the department.

(f) A manufacturer, processor, and retailer must retain results from samples for at least three years from the date that testing results are received.

(g) A manufacturer and processor of consumable hemp products must conduct sampling and testing using acceptance criteria determined by the department.

(h) A manufacturer, processor, and retailer must ensure all products are tested for the most current list of analytes maintained by the department.

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 March 2, 2026.

TRD-202601066

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: March 31, 2026

Proposal publication date: December 26, 2025

For further information, please call: (512) 719-3521


SUBCHAPTER D. RETAIL SALE OF CONSUMABLE HEMP PRODUCTS

25 TAC §§300.402 - 300.407

STATUTORY AUTHORITY

The amendments and new sections are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, HSC §1001.075, which authorizes 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 HSC Chapter 1001, Texas Government Code §524.0005, and HSC §12.001, HSC Chapter 431, and HSC Chapter §443.051.

§300.402. Packaging and Labeling Requirements.

(a) All consumable hemp products marketed as containing cannabinoids must, in addition to the requirements of §300.102 of this chapter (relating to Applicability of Other Rules and Regulations), be labeled in the manner provided by this section with the following information:

(1) batch number;

(2) batch date;

(3) product name;

(4) name of the product's manufacturer or processor;

(5) telephone number and email address of manufacturer or processor;

(6) a uniform resource locator (URL) that provides or links to a certificate of analysis (COA) for the product or each hemp-derived ingredient of the product, including the amount of cannabinoid in each serving or unit of the product, the amount of total THC, and total delta-9 THC. The URL must:

(A) be conspicuously marked; and

(B) directly link to a webpage where the required COA may be found in three or fewer steps; and

(7) recommended serving size in milligrams and servings per container.

(b) Labels must include the following specific warnings:

(1) keep out of reach of children;

(2) product may contain tetrahydrocannabinol (THC) and can cause a user to fail a drug test;

(3) all THCs have psychoactive properties;

(4) pregnant or nursing women should consult a healthcare provider before use; and

(5) this product has not been evaluated by the FDA.

(c) The label required by this section must appear on the outer packaging of each product intended for individual retail sale.

§300.403. Retail Sale of Out-Of-State Consumable Hemp Products.

A person selling consumable hemp products in Texas, that are processed or manufactured outside of Texas must comply with this chapter, and upon request, submit to the department evidence that the products were processed or manufactured in another state or a foreign jurisdiction in compliance with:

(1) a state or tribal or jurisdiction's plan approved by the United States Department of Agriculture under 7 United States Code (U.S.C.) §1639p;

(2) a plan established under 7 U.S.C. §1639q if that plan applies to the state or jurisdiction; or

(3) the laws of a foreign jurisdiction if the products are tested in accordance with §300.301 of this chapter (relating to Testing Required), comply with acceptable hemp THC levels, and comply with federal regulations.

§300.405. Packaging Requirements.

Before selling or distributing a consumable hemp product, the product must be prepackaged or, at the time of sale, placed in packaging or a container that is:

(1) tamper-evident;

(2) child resistant; and

(3) resealable, if the product contains multiple servings or includes multiple products purchased in one transaction, while keeping the child-resistant mechanism intact.

§300.406. Packaging and Labeling Control.

(a) There must be clear written procedures describing in sufficient detail the process for receipt, identification, storage, handling, and examination of labeling and packaging materials.

(b) Labeling and packaging materials must be examined upon receipt and before use in packaging or labeling of a consumable hemp product. All labels and packaging material meeting appropriate written criteria must be approved by a qualified individual as defined in 25 TAC §229.211(54) (relating to Definitions) and released for use. Any labeling or packaging materials that do not meet such criteria must be rejected to prevent use in unsuitable operations.

(c) Records must be maintained for each shipment received of each different labeling and packaging material indicating receipt, examination, and whether accepted or rejected.

(d) Obsolete or rejected labeling and other packaging must be destroyed.

(e) Labeling materials issued for a batch must be carefully examined for identity and conformity to the labeling specified in the master production records.

(f) Labeling not currently being applied must be stored in a manner to prevent mix-ups with active labeling and ensure appropriate use.

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 March 2, 2026.

TRD-202601067

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: March 31, 2026

Proposal publication date: December 26, 2025

For further information, please call: (512) 719-3521


SUBCHAPTER E. REGISTRATION FOR RETAILERS OF CONSUMABLE HEMP PRODUCTS

25 TAC §300.501, §300.502

STATUTORY AUTHORITY

The amended sections are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, HSC §1001.075, which authorizes 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 HSC Chapter 1001, Texas Government Code §524.0005, and HSC §12.001, HSC Chapter 431, and HSC Chapter §443.051.

§300.501. Registration Required for Retailers of Certain Products.

(a) This chapter does not apply to:

(1) low-THC cannabis regulated under Texas Health and Safety Code Chapter 487; or

(2) products approved by the FDA, or recognized by the FDA under 21 Code of Federal Regulations Part 182, Substances Generally Recognized as Safe (GRAS).

(b) A person must not sell consumable hemp products at retail in Texas unless the person registers each location with the department. This includes any location owned, operated, or controlled by the person where consumable hemp products are sold.

(c) A person is not required to register with the department under subsection (b) of this section if the person is:

(1) an employee of a registrant; or

(2) an independent contractor of a registrant who sells the registrant's products at retail.

§300.502. Application.

(a) A person must register under this subchapter by submitting an application in the manner prescribed by the department.

(b) The owner, operator, or owner designee must submit an application that contains the following information:

(1) the name under which the business is operated;

(2) the mailing address of the facility;

(3) the street address of each location;

(4) the primary business contact telephone number;

(5) the phone number for each location;

(6) the primary business email address; and

(7) the written consent from the applicant or property owner, if the applicant is not the property owner, for the department, Department of Public Safety, Texas Alcoholic Beverage Commission, and other state or local law enforcement agencies to enter all premises where consumable hemp is manufactured, processed, sold, or delivered for physical inspection or to ensure compliance with this chapter.

(c) A retail hemp registration is valid for one year from the date displayed on the registration and must be renewed annually. An expired registration is not current or valid. A person must not sell at retail or offer to sell a consumable hemp product without a valid registration.

(d) An initial and renewal application for a retail hemp registration must be processed in the following time periods.

(1) The first time period of 45 calendar days begins on the date the department receives a completed application. If the department receives an incomplete application, the period ends on the date the department issues a written notice that the application is incomplete. The department must issue the written notice within 60 calendar days after receiving the incomplete application and describe the specific information or fee required before the application is considered complete.

(2) The second time period of 45 calendar days begins on the date the department receives a completed application and ends on the date the department issues the license or issues a written notice that the application is being proposed for denial.

(3) The third time period of 135 calendar days begins on the date the department issues the written notice to the applicant as described in paragraph (1) of this subsection. If the applicant fails to submit the requested information or fee within this period, the department considers the application withdrawn.

(e) Proof of registration from the department must be prominently displayed in a conspicuous location visible to the public.

(f) Applicants must submit an application for registration electronically through www.Texas.gov.

(g) All fees required by the department must be submitted with the application.

(1) A retail hemp registration or renewal fee of $5,000 for each location is required before the sale of consumable hemp product.

(2) A person who files a renewal application after the expiration date of the current registration must pay an additional delinquency fee of $1,000.

(3) A $125 fee is required for any amendment during the registration period due to minor changes, such as change of location, change of name, or change of address.

(4) Fees are not prorated.

(h) Reimbursement of fees:

(1) in the event the application is not processed within the time periods stated in subsection (d) of this section, the applicant has the right to make a written request within 30 business days after the end of the second time period that the department reimburse in full the fee paid in that application process; and

(2) if the department finds that good cause does not exist for exceeding the established periods, the request shall be approved, and the department shall notify the applicant in writing of the approval of the reimbursement within 30 business days after the department's decision.

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 March 2, 2026.

TRD-202601068

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: March 31, 2026

Proposal publication date: December 26, 2025

For further information, please call: (512) 719-3521


SUBCHAPTER F. ENFORCEMENT

25 TAC §§300.601 - 300.606

STATUTORY AUTHORITY

The amended sections are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, HSC §1001.075, which authorizes 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 HSC Chapter 1001, Texas Government Code §524.0005, and HSC §12.001, HSC Chapter 431, and HSC Chapter §443.051.

§300.601. Violation of Department License or Registration Requirement.

(a) A person commits a violation if the person manufactures, processes, distributes, sells, or otherwise introduces a consumable hemp product into commerce without a license or registration required by the department under:

(1) §300.201 of this chapter (relating to Application for License or Renewal) for manufacturing, processing, or distribution of consumable hemp products; or

(2) §300.502 of this chapter (relating to Application) for the retail sale of consumable hemp products.

(b) Each day a violation continues or occurs counts as a separate violation when calculating an administrative penalty.

§300.603. Detained or Embargoed Article.

The department must attach a tag or other appropriate marking to an article that is a food, drug, device, cosmetic, or consumer commodity that gives notice that the article is, or is suspected of being, adulterated or misbranded. The department tags or marks any detained or embargoed article if the department finds or has probable cause to believe the article:

(1) is adulterated;

(2) is misbranded so that the article is dangerous or fraudulent under this chapter; or

(3) is in violation of Texas Health and Safety Code §431.084, §431.114, or §431.115.

§300.606. Administrative Penalty.

(a) The department may impose an administrative penalty against a person who violates this chapter.

(b) The department must notify a retailer of consumable hemp products of a potential violation and provide the registrant an opportunity to resolve unintentional or negligent violations after being notified by the department.

(c) The department assesses administrative penalties based upon one or more of the following criteria:

(1) the seriousness of the violation, including the nature, circumstances, extent, and gravity of any prohibited acts, and the hazard or potential hazard created to the health, safety, or economic welfare of the public;

(2) the history of previous violations;

(3) the amount necessary to deter future violations;

(4) the efforts to correct the violation; and

(5) any other matter that justice may require in relation to the violation.

(d) If the department determines that a violation has occurred, the department must issue a notice of violation. The notice must state the facts on which the determination is based. The notice must include an assessment of the penalty.

(e) The notice of violation must be in writing and be sent to the license holder or registrant by certified mail. The notice must include a summary of the alleged violation and a statement of the amount of the recommended penalty and must inform the person of a right to a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.

(f) Within 20 business days after the date the person receives the notice of violation, the person in writing may accept the determination and recommended penalty of the department or may make a written request for a hearing on the occurrence of the violation, the amount of the penalty, or both the occurrence of the violation and the amount of the penalty.

(g) If the person accepts the determination and recommended penalty, the department issues an order imposing the recommended penalty.

(h) If the person charged with the violation does not respond in writing within 20 business days after the date the person receives the notice of violation, the department may determine that a violation occurred and assesses the penalty. The department must issue an order requiring that the person pay the penalty.

(i) If the person requests a hearing, the department refers the matter to the State Office of Administrative Hearings.

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 March 2, 2026.

TRD-202601069

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: March 31, 2026

Proposal publication date: December 26, 2025

For further information, please call: (512) 719-3521


SUBCHAPTER G. RESTRICTIONS ON SALE TO MINORS

25 TAC §300.701, §300.702

STATUTORY AUTHORITY

The new sections are adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, HSC §1001.075, which authorizes 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 HSC Chapter 1001, Texas Government Code §524.0005, and HSC §12.001, HSC Chapter 431, and HSC Chapter §443.051.

§300.701. Restriction on Sale to Minors.

(a) A person is prohibited from delivering, selling, or offering to sell a consumable hemp product to a minor.

(b) A person who sells CHP must verify each purchaser's age by reviewing a valid proof of identification before completing the sale of any CHP.

(c) A valid proof of identification may include a driver's license issued by Texas or another state, a passport, or an identification card issued by a state or government agency. A valid proof of identification must meet the following criteria:

(1) include a physical description and a photograph that matches the person's appearance;

(2) provide the individual's date of birth;

(3) be issued by a government agency; and

(4) is not expired.

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 March 2, 2026.

TRD-202601070

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: March 31, 2026

Proposal publication date: December 26, 2025

For further information, please call: (512) 719-3521