AWG Regulatory Roundup — November 18, 2025
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- GMO Labeling: Ninth Circuit Rules on Highly Refined Foods, “Bioengineered” Versus “GMO,” and QR Codes
- Senator Aims to Close the “GRAS Loophole” With the “Better Food Disclosure Act”
- Texas AG Opines No Registration Needed for Consent-Based Text Message Marketing Campaigns
- Proposition 65 Update: Potential Listing of p,p’-bisphenol Chemicals
- Key Trends in Recent Medical Device Warning Letters
- Hemp Happenings® – New Federal Restrictions on THC in Hemp
GMO Labeling: Ninth Circuit Rules on Highly Refined Foods, “Bioengineered” Versus “GMO,” and QR Codes
On October 31, 2025, the Ninth Circuit Court of Appeals issued a significant decision impacting USDA’s bioengineered food disclosure rule, which generally requires covered foods to bear one of four regulated disclosures if they are “bioengineered” or contain “bioengineered” ingredients. At issue was whether USDA acted arbitrarily and capriciously by (1) only allowing the term “bioengineered” instead of more recognizable terms such as “genetically modified” to be used on the disclosures; (2) excluding “highly refined foods” with “undetectable” amounts of genetically modified material from what is considered covered food; and (3) including QR Code and text message disclosure formats, which the plaintiffs argued are inadequate and inaccessible.
The court upheld USDA’s authority to require the uniform term “bioengineered,” rejecting arguments that more familiar terms like “GMO” should be permitted. However, with respect to the issue of highly refined foods, it found that USDA improperly equated “nondetectable” modified genetic material with “non-presence” and remanded the issue back to the lower court and USDA for further review. As for the disclosure formats, the Ninth Circuit disagreed with the lower court’s decision not to vacate the QR Code and text message disclosure methods and sent this issue back to the district court. Thus, the continued availability of both the “highly refined” exemption and use of the QR Code and text message disclosure formats is now uncertain, pending further USDA and court actions.
Senator Aims to Close the “GRAS Loophole” With the “Better Food Disclosure Act”
On November 6, 2025, Senator Roger Marshall (R-Kansas) introduced the “Better Food Disclosure Act,” or the “Better FDA Act of 2025,” which would amend the Federal Food, Drug, and Cosmetic Act to establish mandatory notification and public listing of substances that are considered “generally recognized as safe” (GRAS) – essentially, eliminating the self-affirmed GRAS pathway for food ingredients. Within two years of the bill’s enactment, any substance already in commerce that purports to be GRAS would have to either be included on a list maintained by FDA or be under review by FDA for inclusion on the list. GRAS substances that are not listed or under review would be deemed unsafe. For new substances introduced after enactment of the bill, companies would have to submit a notice to FDA not later than 120 days before the first use of the food substance. If FDA fails to make a determination within 180 days after receiving a notice, the food substance will be automatically listed. If the agency determines that the substance should be excluded or removed from the list, a company may either: 1) request reconsideration based on additional information; 2) submit a food additive petition; or 3) provide a plan to phase out use of the food substance.
In addition, the bill would establish a postmarket assessment process for FDA to reassess any food additive, color additive, or GRAS substance upon its own initiative, or in response to a citizen petition or notice from state government, with priority given to those for which there is “clear and convincing evidence” supporting the safety concerns. FDA would be required to initiate a rulemaking to remove a substance or additive from the food supply, and any action taken regarding safety, exclusion, delisting, or reclassification would be subject to a review and recommendation by qualified career appointees at FDA.
Texas AG Opines No Registration Needed for Consent-Based Text Message Marketing Campaigns
Earlier this year, Texas passed Senate Bill 140, which appeared to expand the state’s telemarketing registration and reporting rules to cover text message marketing, prompting companies to prepare for compliance and potential lawsuits, as the law also provided for possible private enforcement by plaintiff’s attorneys for failure to register. A legal challenge followed, arguing the law unconstitutionally restricted consent-based text messaging campaigns – i.e., Telephone Consumer Protection Act (TCPA) compliant opt-in text messaging. On November 6, 2025, the case was dismissed after the Texas Attorney General clarified that SB 140 does not apply to consent-based text message marketing programs. As a result, companies that use opt-in texting are not required to register or report and are not exposed to class actions for failing to do so. The AG’s position highlights a critical point: campaigns must have valid consumer consent to fall outside the law’s scope.
Proposition 65 Update: Potential Listing of p,p’-bisphenol Chemicals
The California Office of Environmental Health Hazard Assessment (OEHHA) has requested information from the public for consideration of the possible listing of p,p’-bisphenol chemicals under Prop 65, and submissions of relevant studies are due December 1, 2025. The potential listing could impact a wide range of consumer products, particularly where previously-listed bisphenol A (BPA) and bisphenol S (BPS) chemicals were replaced with other p,p’-bisphenol alternatives.
Key Trends in Recent Medical Device Warning Letters
Please see our latest AWG publication focused on medical devices, which provides an overview of device-related FDA Warning Letters issued during the first nine months of the Trump administration, along with insights into evolving regulatory enforcement priorities and key compliance areas such as QSR requirements, device modifications, and promotional activities impacting the industry.
Hemp Happenings® – New Federal Restrictions on THC in Hemp
On November 12, 2025, President Trump signed legislation into law that, effective November 13, 2026, severely restricts the level of THCs and THCA permitted in final form hemp products and essentially bans THC/THCA in such products. Specifically, the legislation redefines the statutory definition of “hemp” under 7 U.S.C. 1639o by changing the current 0.3% delta-9 THC concentration limit to a total THC concentration (including THCA) limit of 0.3%. It also excludes from the definition of “hemp”:
- Any final form hemp-derived products containing cannabinoids that are naturally produced by the Cannabis plant but are synthesized or manufactured outside of the plant (e.g., delta-8 THC), or containing greater than 0.4 milligrams combined total per container of all THCs (including THCA) and any other cannabinoids with similar effects, as determined by FDA, and
- Intermediate hemp-derived products containing cannabinoids that are naturally produced by the Cannabis plant but are synthesized or manufactured outside the plant, or containing more than 0.3% combined total of all THCs (including THCA) and any other cannabinoids with similar effects.
Notably, products that are excluded from the definition of “hemp” are designated as Schedule I substances (marijuana). In addition, the scope of products affected includes products containing cannabinoids in any form and intended for human or animal use through any means of application or administration, such as inhalation, ingestion, or topical application. Industry efforts are underway to address these restrictions and revise the limits prior to the one-year effective date, given the significant impact of this legislation on the entire hemp supply chain.
