Regulatory Roundup

Regulatory Roundup June 3, 2025

AWG Regulatory Roundup — June 3, 2025

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FDA Announces Steps to Review Food Chemicals

On May 15, 2025, FDA announced “a stronger, more systematic review process for food chemicals already on the market.” To achieve this aim, FDA plans to take the following actions in the “coming months”:

  • A modernized, evidence-based prioritization scheme for reviewing existing chemicals. FDA states that it will soon release a draft for public comment.
  • A final, systematic post-market review process shaped by stakeholder input.
  • An updated list of chemicals under review, including BHT, BHA, and ADA. FDA will also expedite its review of chemicals currently under review, like phthalates, propylparaben, and titanium dioxide, with updates available on its website.

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MAHA Commission Releases Its “Make Our Children Healthy Again” Report

On May 22, 2025, HHS and the Make America Healthy Again (MAHA) Commission released a “Make Our Children Healthy Again Assessment,” which describes what the authors believe are a range of factors contributing to “the chronic disease crisis” affecting children. The 73-page report outlines four potential drivers behind this crisis, including poor diet and a shift toward ultra-processed food, aggregation of environmental/synthetic chemicals, lack of physical activity and chronic stress, and overmedicalization due to overprescribing of medication to children. By August 2025, the Commission will release a “Make Our Children Healthy Again Strategy” to address the concerns raised in the report.

Note: After several media outlets reported that the report contained references to studies that do not exist, among other concerns, the White House stated that the report has been corrected.

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FY 2025 OMUFA User Fees Due

Under the FDA’s OTC Monograph Drug User Fee Program (OMUFA), drug establishments registered as a manufacturer or contract manufacturer of finished OTC monograph drug products must pay an annual user fee. Fee-qualifying OTC monograph drug establishments registered at any point between January 1, 2024 and December 31, 2024 must pay the FY 2025 OMUFA user fee within 20 calendar days of the June 2, 2025 due date (i.e., June 22, 2025). Drug establishments that fail to pay the OMUFA user fee will be placed on a publicly available arrears list, and all OTC monograph drugs manufactured by the drug establishment will be deemed misbranded.

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FDA Releases Final & Draft Guidance to Facilitate Q-Submissions

On May 29, 2025, FDA issued its final guidance on Q-Submissions, a voluntary, pre-submission mechanism that enables medical device sponsors and applicants to engage in early communication with FDA on product development or regulatory strategy before submitting a formal application to the agency. FDA also issued a draft guidance on using the Electronic Submission Template (eSTAR) for submitting Q-Submissions, which will establish the implementation date for the required use of eSTAR for Pre-Submissions.

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USDA Approves SNAP Restrictions on Soda and Candy

USDA has recently approved three state-requested waivers to restrict the use of Supplemental Nutrition Assistance Program (SNAP) funds for the purchase of certain food items. Nebraska’s SNAP waiver request was signed by U.S. Secretary of Agriculture Brooke Rollins on May 19, 2025 and restricts SNAP purchases of soda and energy drinks in the state. A few days later, on May 22, USDA also approved SNAP waiver requests submitted by Indiana and Iowa, which would restrict SNAP purchases of soft drinks and candy, among other products. All three waivers will take effect on January 1, 2026. Other states have submitted, or plan to submit, similar requests to USDA.

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Washington State Enacts EPR Law

On May 17, 2025, Washington’s Governor signed into law Senate Bill 5284, making Washington the 7th state to adopt EPR legislation. Like the EPR programs in California, Oregon, Colorado, and Minnesota, Washington’s EPR program will require covered producers to either join a Producer Responsibility Organization (PRO) or act as their own PRO. By March 1, 2026, the producers and PRO must register with the Washington State Department of Ecology. Of note, the program exempts packaging containing FDA-regulated drugs, medical devices, and dietary supplements.

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Delaware School Lunch Law Prohibits Use of Color Additive

On May 22, 2025, Delaware’s Governor signed into law Senate Bill 69, which prohibits school districts and charter schools from selling or serving foods that contain red dye 40.

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Beverage Companies Continue to Get Hit for “100% Natural Flavors” Claims

Continuing a trend of lawsuits based on a similar theory, a pair of recent complaints accuse beverage companies of falsely labeling products with “100% Natural Flavors,” despite containing an allegedly synthetic ingredient. According to the complaints, the companies use industrially manufactured citric acid, a synthetic compound that “influences the flavor profile” of the beverages. Plaintiffs claim that although citric acid is a naturally occurring substance, the manufacturing process of the citric acid used in the products renders the substance not “natural.” . This trend, noted in our January Roundup, is likely to continue throughout 2025.

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Ca1ifornia Corner: Update on SB 54 Implementation; Senate Passes Prenatal Vitamin Bill

On May 20, 2025, CalRecycle released revised draft regulations for California’s Senate Bill 54, which established a statewide mandatory manufacturer-funded packaging stewardship program. CalRecycle updated the draft regulations following concerns raised by Governor Newsom regarding the expanded scope of the initial draft regulations. Among other changes, the updated draft regulations deviate from the previous draft by exempting all nonprescription drugs from regulation. The public comment period on the draft regulations closes on June 3, 2025.

California Senate Bill 646 passed the Senate on May 28, 2025 and would require prenatal vitamin manufacturers to test each lot of final products for “toxic elements” (defined as arsenic, cadmium, lead, and mercury) and make such information public, effective January 1, 2027. It also establishes related labeling requirements, including a QR code or other scannable code that contains test results and a link to FDA’s guidance on the health effects of the toxic elements, as well as a statement that directs consumers to the QR code.

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Hemp Happenings®: States Target THC & Online Sales

States across the country continue to crack down on hemp cannabinoid products, particularly those containing THC, and are also taking aim at direct-to-consumer sales.

  • In Alabama, House Bill 544 was recently signed into law and, effective January 1, 2026, establishes a range of requirements for consumable hemp products, including testing, labeling, packaging, retailer requirements, and THC limits. The law also prohibits direct-to-consumer sales (e.g., online shipments) of such products.
  • In a similar move, Tennessee enacted House Bill 1376, and effective January 1, 2026, prohibits the shipping of hemp-derived cannabinoid products directly to consumers. All product sales must take place at a licensed retail location in a face-to-face transaction. The law imposes a range of other requirements, including updated cannabinoid limits, licensing requirements, and a ban on THCa products.
  • Texas Senate Bill 3 was delivered to the Governor on May 27, 2025, and restricts consumable hemp products from containing any cannabinoid other than CBD or CBG. It also establishes a range of new product requirements along with new criminal offenses related to the sale and distribution of hemp products, including the offense of providing hemp-derived cannabinoid products by courier, delivery, or mail service. If signed into law, the legislation will take effect on September 1, 2025.
  • Following the passage of Senate Bill 375, Montana has also banned THC in products, effective May 5, 2025.
  • Finally, on March 26, 2025, Michigan’s Cannabis Regulatory Agency issued a proposed rule limiting THC in hemp products to 1.75 mg/serving, 10 mg per package, and 1/15th of the amount of CBD in the product.  A hearing on the proposal was held on May 6, 2025.

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