AWG Regulatory Roundup — June 30, 2026
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- FDA Updates Its PFAS Webpage
- Comment Period Extended for Evaluation of Phthalates in Food Contact Materials
- FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Requirements
- Court Order Vacates USDA’s Approval of SNAP Waivers
- Texas Attorney General Launches Investigation into Protein Powder Manufacturers
- Prop 65 Update – A Win for Industry in DEA lawsuit, Acrylamide Warning Gets Cooked
FDA Updates Its PFAS Webpage
On June 18, 2026, FDA updated its webpage on per- and polyfluoroalkyl substances (PFAS) to indicate that the agency is considering potential priority targets for future risk management actions, which could include setting action levels or allowable levels. Potential areas of focus include:
- Bottled Water: FDA states it is working on a regulation to establish allowable levels for certain PFAS in bottled water.
- Seafood: FDA will continue issuing Import Alert 99-48 and is reviewing data to evaluate future actions, which might include additional risk management actions for clams.
- Infant Formula: FDA plans to conduct further testing for additional contaminants, work with manufacturers to reduce contaminant levels, and establish action levels for contaminants in infant formula.
Comment Period Extended for Evaluation of Phthalates in Food Contact Materials
At the request of stakeholders, FDA is extending the public comment period by 30 days for its scientific evaluation of phthalates currently authorized as plasticizers for food contact use. Comments may now be submitted to docket FDA-2026-N-5776 through July 26, 2026.
FDA Issues Guidance Exempting Certain Unclassified Medical Devices from 510(k) Requirements
FDA issued its final guidance “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements” on June 5, 2026. The final guidance supersedes the June 14, 2019 version and adds five additional preamendment unclassified device types to the exemption list. The guidance now covers these product-code categories: ear, nose, and throat; gastroenterology-urology; general and plastic surgical; obstetrical and gynecological; physical medicine; neurological; toxicology; and ophthalmic devices. Specific preamendment devices include:
- Hearing Protectors (Product Codes EWD & EWE);
- Speech Training Aids (Product Codes LEZ & LFA);
- Hemorrhoid Cushions (Product Code LRL);
- Device Disinfectant Alcohol Pads (Product Code LKB);
- Nail Prosthesis (Product Code MQZ);
- Proceptive Fertility Trackers (Product Code LHD);
- Optical Contour Sensing Devices (Product Code LDK);
- Spine Curvature Monitors (Product Code LZW);
- Acupressure Devices (e.g., acupressure bands) (Product Code MVV);
- Isoniazid Tests (Product Code MIG);
- Ophthalmic Eye Cups (Product Code LXQ).
The issuance of this guidance satisfies an FDA commitment made during the user-fee reauthorization process for MDUFA III (2012), whereby FDA agreed to identify and propose exemptions from 510(k) premarket notification requirements for certain low-risk medical devices.
Court Order Vacates USDA’s Approval of SNAP Waivers
On June 22, 2026, a judge in the District of Columbia District Court vacated the U.S. Department of Agriculture’s approval of Supplemental Nutrition Assistance Program (SNAP) waivers in Colorado, Iowa, Nebraska, Tennessee and West Virginia, which restricted the purchase of sugary foods and drinks with SNAP benefits.
The court held that USDA exceeded its statutory authority by approving SNAP pilot projects in the five states under a provision authorizing administrative efficiency pilot projects. The projects waived the statutory definition of “food” to exclude sugary beverages, candy, and similar items from SNAP-eligible purchases. Although Congress had enacted a separate provision specifically authorizing health and nutrition pilot projects, USDA sidestepped it because that provision imposed stricter requirements and did not authorize waiving the statutory definition of “food.” Additionally, the court found that the USDA failed to post any notice in the Federal Register regarding the pilot projects, rejecting USDA’s conclusion that the projects would not have a significant impact on the public.
Texas Attorney General Launches Investigation into Protein Powder Manufacturers
Texas Attorney General Ken Paxton announced an industry-wide investigation into protein powder manufacturers, citing concerns with heavy metals, including lead and cadmium, found in popular protein powders. The investigation targets potential violations of the Texas Deceptive Trade Practices Act and will examine whether companies falsely marketed or misrepresented the safety and contents of their products and whether they failed to disclose known information about heavy metal contamination.
Prop 65 Update – A Win for Industry in DEA lawsuit, Acrylamide Warning Gets Cooked
As previously reported, earlier this year, the Personal Care Products Council (PCPC) filed a landmark lawsuit against the Attorney General of California in the U.S. District Court, Eastern District of California, alleging that Proposition 65 compelled cancer warnings for Diethanolamine (DEA) in personal care products violate the First Amendment. (The Personal Care Products Council v. Bonta, Case No. 2:26-CV-00682-DJC-CKD (E.D. Cal.)). PCPC argued that forcing businesses to label products with warnings violates the First Amendment, as no California or federal agency has made a scientific determination that DEA causes cancer in humans.
In an unexpected turn of events, the Attorney General has conceded that compelled Prop 65 DEA cancer warnings violate the First Amendment. On June 24, 2026, a judge in the Eastern District of California entered judgment in favor of PCPC, stating that “[B]ased on the current state of the relevant science, the Proposition 65 warning requirement for cancer as applied to diethanolamine cannot be constitutionally enforced, consistent with the First Amendment, by the Attorney General of the State of California, his officers, employees, and agents, and all those acting in privity or concert with the Attorney General and those individuals . . .”
The judgment comes less than one week after the Office of Environmental Health Hazard Assessment (OEHHA) released an amended proposal to set a safe harbor level for dermal exposure to DEA. Despite industry criticism, OEHHA doubled down and returned with an even more stringent proposal of 5.8 µg/day than its original level of 6.4 µg/day. The impact of the PCPC judgment on the scores of pending state court litigation is developing and is an issue AWG will monitor closely.
In another about-face, Attorney General Bonta has moved to dismiss the appeal of the Eastern District of California’s May 2025 ruling that the Prop 65 warning for acrylamide in food products violates the First Amendment. Bonta had appealed the decision to the Ninth Circuit Court of Appeals, but following its own motion to dismiss, the Ninth Circuit dismissed the appeal on May 29, 2026 – meaning that warnings for acrylamide in food are officially cooked.
