• The Texas Department of State Health Services (DSHS) has published its proposed rule (see p. 29, 50 TexReg 6301) implementing The “Make Texas Healthy Again” law (SB25) that was signed in June 2025, as we previously blogged. The law includes a provision requiring on-pack warning labels for food and beverage products that contain any of 44 listed substances, including certified food colors and titanium dioxide.
  • The proposed rule would add sections 229.1001-1005 to the Texas Health and Safety Code and would require the statement “WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom” on the label of any food containing one of the listed ingredients unless an exemption applies. The proposed rule also outlines formatting and placement requirements for the warning statement.
  • The proposed rule includes exemptions for products not intended for human consumption; food labeled, prepared, served, or sold in a restaurant or retail food establishment; products regulated by USDA; products bearing a governmental warning from the surgeon general of the United States Public Health Service; drugs and dietary supplements; and pesticide chemicals, soil or plant nutrients, or other agricultural chemicals used on raw agricultural commodities.
  • Notably, the proposed rule includes the federal preemption provision found in the statute. Section 229.1003(b) of the proposed rule states that it does “not apply to an ingredient, including a food additive and color additive, if a federal law or regulation issued by [FDA] or USDA: (1) prohibits the use of the ingredient; (2) sets conditions for using the ingredient, such as needing a warning or disclosure statement; (3) says an ingredient or group of ingredients is safe for people to eat; or (4) requires a labeling statement for foods that are ultra-processed or processed.” This regulatory language mirrors the statutory language without elaborating on its impact.  In our view, the statute and this regulatory language should significantly limit the impact of the proposed rule because it would mean a warning label will not be required if FDA has issued a regulation authorizing the use of an ingredient. Many of the ingredients listed in the proposed rule are subject to an FDA food additive or generally recognized as safe (GRAS) regulation.  We note, however, that Texas’s proposed regulatory language (an FDA regulation “says an ingredient . . . is safe for people to eat”) differs slightly from the corresponding statutory language (an FDA regulation “determines an ingredient . . . is safe for human consumption”) and would ideally refer in a more straightforward way to the existence of an FDA food additive or GRAS regulation reflecting FDA’s determination that the ingredient is safe.
  • In addition to the exemptions listed above, the Fiscal Note accompanying the proposed rule clarifies that the requirement will only apply to labels that are developed or copyrighted on or after January 1, 2027, and “[i]f labels are never changed, businesses are not required to comply.”
  • DSHS is accepting comments on the proposed rule until October 27, 2025 (31 days after the proposed rule was published in the Texas Register). Keller and Heckman will continue to monitor this proposed rule.