AWG Regulatory Roundup — October 21, 2025
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- FDA Drug Establishment and Listing Renewal Deadline Approaching
- Texas Seeks Comments on Food Additive Warning Regulation
- West Virginia Hit with Lawsuit Over its Ban on Food Dyes
- New Mexico Proposes Rule to Implement Ban on PFAS in Consumer Products
- California Governor Signs Bills Into Law, Vetoes Others
- IN-DEPTH: Prop 65 Enforcement Trends and Updates
FDA Drug Establishment and Listing Renewal Deadline Approaching
It’s that time of year again – annual renewals for drug establishment registrations and National Drug Code (NDC) listings must be submitted by December 31, 2025. FDA will automatically de-register and/or de-list any drug establishment registrations and NDC listings that are not: (1) certified as accurate with no changes by submitting a “No Change Notification”/“Blanket No Changes Certification of Product Listing”; (2) updated; or (3) already de-registered/discontinued prior to that date. “No Change” submissions, updates, and de-registrations/discontinuations should be submitted via FDA’s online portal, CDER Direct. Our firm is happy to assist if you need help.
Texas Seeks Comments on Food Additive Warning Regulation
Texas recently opened the comment period for a proposed rule implementing Senate Bill 25, which requires a warning label on foods containing certain ingredients, including bleached flour, FD&C numbered food dyes, and titanium dioxide. The proposed rule closely mirrors the requirements outlined in the bill and includes the exception for dietary supplements. It also clarifies that the warning label requirement applies only to food labels developed or copyrighted on or after January 1, 2027. Therefore, if a food contains one of the listed ingredients, the requirement applies only when the manufacturer chooses to change the label, even if that occurs after January 1, 2027. The comment period closes October 27, 2025, and comments may be emailed to the Health and Human Services Rules Coordination Office.
West Virginia Hit with Lawsuit Over its Ban on Food Dyes
On October 6, 2025, the International Association of Color Manufacturers (IACM) filed a complaint against the state of West Virginia in response to House Bill 2354, which became law earlier this year and bans the use of certain food dyes and ingredients. IACM alleges the law is unconstitutional because it encroaches on FDA’s authority to regulate food safety, interferes with interstate commerce, and inflicts economic harm on IACM member companies and their customers without any rational basis.
New Mexico Proposes Rule to Implement Ban on PFAS in Consumer Products
On October 8, 2025, the New Mexico Environment Department (NMED) published a proposed rule implementing the PFAS Protection Act, which passed this year as House Bill 212. Beginning January 1, 2027, the Act prohibits the sale of food packaging, dental floss, cookware, and “juvenile products” (products designed or marketed for use by children under 12) that contain intentionally added PFAS; beginning January 1, 2028, the ban extends to cleaning products, cosmetics, feminine hygiene products, and other consumer goods. By January 1, 2032, all non-exempt products containing intentionally added PFAS would be prohibited unless the PFAS use is declared a “Currently Unavoidable Use.” Medical devices, drugs, and their packaging, among other products, are exempted. The proposed rule also includes reporting and labeling (English and Spanish) requirements. Interested parties are encouraged to submit comments through the public comment portal. NMED’s website provides additional information and resources on the law and proposed rule, and an informational webinar will be held on October 22, 2025 at 1 pm MT.
California Governor Signs Bills Into Law, Vetoes Others
As previously reported, in September, several bills were sent to Governor Newsom for signature. The Governor signed the following bills:
- SB 862 – Among other things, amends the definition of “baby food” to expressly exclude dietary supplements. Existing California law (AB 899) requires baby food manufacturers to test a representative sample for toxic elements, which include arsenic, cadmium, lead, and mercury, and imposes related labeling requirements.
- SB 646 – Starting January 1, 2027, requires prenatal multivitamin manufacturers to test a representative sample from each lot sold in California for heavy metals, including arsenic, cadmium, lead, and mercury. Brand owners will also be required to include a statement on the product packaging and on any online listings directing consumers to a website for information on heavy metal testing of the product.
- AB 1264– Defines “ultraprocessed food” (UPF) as food or beverages that contain certain stabilizers, thickeners, emulsifiers, colors, and flavors and enhancers and either high amounts of saturated fat, sodium, or added sugar, or a nonnutritive sweetener or other substances such as sugar alcohols and steviol glycosides, and by June 1, 2028, requires the California Department of Public Health to adopt regulations defining “ultraprocessed foods of concern” and “restricted school foods.” Schools are required to phase out restricted school foods and UPFs of concern no later than July 1, 2029, and beginning July 1, 2032, school vendors are prohibited from offering them.
- SB 754 – Beginning December 31, 2026, requires manufacturers of disposable tampons and menstrual pads to maintain records of the concentration of lead, arsenic, cadmium, and zinc in their products.
- SB 39 – Extends the ban on vaginal suppositories that contain intentionally added boric acid to January 1, 2035, and beginning January 1, 2027, requires such products to include a warning statement, with an exception for FDA-approved drugs.
The Governor vetoed AB 823, which sought to prohibit personal care products from containing plastic glitter, and personal care products and cleaning products from containing more than one ppm of plastic microbeads, and SB 682, which would have prohibited cleaning products, dental floss, food packaging, cookware, and other covered products from containing intentionally added PFAS.
IN-DEPTH: Prop 65 Enforcement Trends and Updates
Below is the latest round of updates on California’s Proposition 65, the “right to know” law that requires companies doing business in California to provide a warning for products sold to California residents if they expose consumers to certain chemicals at levels “known” to the state to cause cancer, birth defects, or reproductive harm. Alleged violations of Prop 65 can result in monetary penalties of up to $2,500 per day and significant attorneys’ fees and costs.
- Cosmetics: At the request of the Personal Care Products Council (PCPC), the Office of Environmental Health Hazard Assessment (OEHHA) has extended the public comment deadline until November 7, 2025, for its proposal to set safe harbor levels for 1-bromopropane (1-BP) and diethanolamine (DEA). OEHHA has proposed a “no significant risk level” (NSRL) for 1-BP of 54 micrograms per day (µg/day) and an NSRL of 6.4 µg/day for dermal exposures to DEA. Although many argue that the proposed levels are impossibly low, others support the certainty a safe harbor value could provide. In addition, OEHHA announced that its safe harbor level for titanium dioxide (airborne, respirable-size unbound particles) went into effect on October 1, 2025. Notably, these levels do not affect the federal district court’s issuance of a permanent injunction in PCPC v. Bonta, which, on First Amendment grounds, prohibits enforcement of the cancer warning for airborne titanium dioxide in cosmetics and personal care products.
- Food/Supplements: In recent months, dozens of Prop 65 notices of violation have been issued by newcomer Center for Consumer Safety, LLC concerning two chemicals that had previously remained off enforcer radars: aflatoxins and retinol. Aflatoxins have been listed as cancer-causing agents under Prop 65 since 1988, but the recent notices – identifying paprika, chili powder, nut butters, and corn meal– are the first of their kind since their listing. Aflatoxins are naturally occurring compounds produced by certain molds that are known to contaminate certain crops. The notices for retinol, listed as a developmental toxicant, mostly target Vitamin A supplements and are the first issued in over a decade. A 2014 consent judgment was entered in the San Francisco Superior Court, wherein no Prop 65 warning is required unless the daily dose of retinol in Vitamin A supplements exceeds 10,000 International Units (IU). OEHHA has not established safe harbor levels for either aflatoxins or retinol, but it has endorsed the same 10,000 IU (or 3,000 retinol equivalents) exposure limit for retinol.
- In the news, Consumer Reports recently published two separate articles spotlighting lead test results for protein powders and shakes, and tapioca pearls made from cassava. Consumer Reports recommends consumers enjoy boba in moderation and makes the dubious claim that more than two-thirds of protein supplements are “unsafe” to consume daily. Already heavily targeted by bounty hunters, supplement companies should be aware that these types of publications often fuel an escalation in Prop 65 enforcement actions.
