AWG Regulatory Roundup — July 1, 2025
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- FDA Seeks Input on Method for Ranking Food Chemicals for Post-Market Review
- FDA Prioritizes Defining “Ultra-Processed Foods”
- Oregon Bottle Bill Update
- Compliance Reminder – A Tale of Two Sweepstakes
- California Corner – Updates on Cosmetic Ingredient Bans, Microplastics, & Implementation of Senate Bill 54
- Hemp Happenings® – Industry Declares Victory in Texas, Enforcement on the Rise in Florida
FDA Seeks Input on Method for Ranking Food Chemicals for Post-Market Review
On June 18, 2025, FDA released its proposed method for ranking chemicals in food for post-market review. The agency plans to use a Multi-Criteria Decision Analysis (MCDA) approach to prioritize chemicals, incorporating public health and other decision-making criteria. This method takes into account factors specific to food exposure and uses a scoring method similar to the FDA’s Risk Ranking Model for Traceability.
Criteria that FDA would use to determine a chemical’s ranking include whether:
- The chemical may produce severe health effects (e.g., cancer, cardiovascular toxicity);
- Dietary exposure to the chemical has increased;
- The chemical is found in or could potentially be present in food intended for vulnerable subpopulations (e.g., infants);
- Newly available information, data, or science indicates a potentially high impact on the conclusions of the previous assessment of the chemical;
- There is high attention (e.g., Congressional and/or national news media coverage) on the chemical, multiple organizations monitoring it, and/or multiple stakeholder groups active in setting standards;
- Multiple other governmental agencies are making decisions or taking action on the chemical; and
- Not assessing the chemical could result in the public losing confidence in the safety of the U.S. food supply.
FDA encourages the public to submit comments via the docket through July 18, 2025, in response to the questions listed in Section 4 of the method description document.
FDA Prioritizes Defining “Ultra-Processed Foods”
On June 10, 2025, FDA Commissioner Dr. Marty Makary and the director of FDA’s Center for Biologics Evaluation and Research, Dr. Vinay Prasad, published an article in The Journal of the American Medical Association titled “Priorities for a New FDA.” Among other topics such as harnessing AI and controlling drug prices, the article notes that FDA has “begun work on defining ultra-processed foods.” It also mentions FDA has initiated an investigation into talc, “which is ingested by millions of Americans every day” through pills and candy, despite the ingredient’s removal from baby powder due to its potential carcinogenicity.
Oregon Bottle Bill Update
Beginning July 1, 2025, wine in a can will be a redeemable beverage container under Oregon’s Bottle Bill program. “Wine in a can” includes table/still wine, cider with more than 8.5% ABV, sake, mead, and sparkling/fortified wine in cylindrical metal containers sizes 4 oz to 1.5 liters. To give industry time to comply with the bottle bill expansion, companies have until October 1, 2026 to label cans containing the newly covered wine beverages with “OR 10¢.” However, wine in a can will be redeemable even without the refund value indication starting July 1, 2025.
Compliance Reminder – A Tale of Two Sweepstakes
Recently, two class actions involving sweepstakes came to an end, one with a dismissal and one with a settlement. In a case brought in the Northern District of Illinois, consumers alleged that after receiving notification that they won a sweepstakes to receive free toilet paper, the defendant failed to award the prize. However, shortly after notifying the consumers they had won, the defendant sent a follow-up email explaining the original email was sent erroneously. The court dismissed the class action claims because the defendant had included a class action waiver in its sweepstake rules. In the other sweepstakes case, the defendants agreed to a $2.25 million settlement after the sweepstakes participants, who thought the only way to enter was to make a transaction or purchase, filed a complaint in the Northern District of California after learning of a free method of entry. The plaintiffs alleged they would have utilized the free method of entry had it not been hidden on a rules page that was separate from the sweepstakes announcement.
These cases are a reminder of the importance of well-drafted and adequately disclosed sweepstakes rules. Appropriate drafting and posting saved one company from continued litigation costs, while overlooking this detail cost the other company millions of dollars. Sweepstakes “Official Rules” serve as a contract between the company and the sweepstakes participants, and therefore careful drafting and disclosing of material terms are critical to both compliance and mitigating risk.
California Corner – Updates on Cosmetic Ingredient Bans, Microplastics, & Implementation of Senate Bill 54
- The California Department of Public Health (CDPH) has confirmed it does not have an enforcement or implementation role in the state’s new cosmetics ingredient bans, which are instead overseen by the Office of Attorney General. As of January 1, 2025, California law prohibits the manufacture, sale, or distribution of cosmetics containing specific chemicals, including formaldehyde, mercury, certain phthalates, parabens, and all PFAS compounds, with an additional 26 chemicals and chemical groups banned starting January 1, 2027. Notably, there is no sell through period provided in the law, and even salons must stop using or selling affected products.
Despite having no enforcement role, CDPH has identified numerous products reported to the California Safe Cosmetics Program (CSCP) containing banned ingredients that appear to still be in the market. Thus, companies should edit submitted product reports when reported products are discontinued or reformulated to no longer contain reportable ingredients.
- California’s Department of Toxic Substances Control (DTSC) announced a proposed rule that would add microplastics to California’s Candidate Chemicals List under the green chemistry program. Under the proposed definition, “microplastics” are broadly defined as “plastics that are less than 5 millimeters (mm) in their longest dimension, inclusive of those materials that are intentionally manufactured at those dimensions or are generated by the fragmentation of larger plastics.”
Although addition to the “candidate chemicals” list does not impose immediate regulatory requirements, it would allow DTSC to identify consumer products containing or generating microplastics for future evaluation and possible regulation as “priority products.” DTSC’s proposal does not distinguish between different types or sources of microplastics, does not take into account timeframe for degradation, and is not limited to products that contain microplastics by design. In other words, the proposal could encompass any products made with any amount of plastic. Stakeholders are encouraged to submit comments through on August 4, 2025, which may be submitted electronically through the CalSAFER data management system.
- CalRecycle hosted a “non-regulatory workshop” on June 23, 2025 to obtain feedback on two draft guidance documents intended to implement the Plastic Pollution Prevention and Packaging Producer Responsibility Act, also known as Senate Bill 54. The first addresses “Covered Material Categories” and how to categorize covered material items. The second addresses “Source Reduction Baseline” and how to report the weight of plastic covered material and number of plastic components for 2023 to update source reduction baseline. CalRecycle will also solicit feedback from interested parties on the covered material categories, specifically suggestions for changes to the categories themselves.
Hemp Happenings® – Industry Declares Victory in Texas, Enforcement on the Rise in Florida
Texas Governor Greg Abbott delivered a huge win for the hemp industry on June 22, 2025 by vetoing Senate Bill 3, which sought to prohibit nearly all hemp-derived cannabinoid products with the exception of CBD and CBG. In his veto message, Governor Abbott highlighted constitutional challenges posed by the legislation and the inability to enforce its provisions due to possible litigation. He also noted the bill’s sweeping prohibitions would invite “potential criminal entrapment for Texas farmers” and raised similar concerns about the imposition of criminal penalties on other Texas residents. In addition, the veto message calls for a Special Legislative Session in July to consider the issues and suggests that legislators consider a regulatory framework for hemp products similar to alcohol.
On June 24, 2025, Florida’s Commissioner of Agriculture Wilton Simpson announced results from the first week of “Operation Safe Summer,” the Florida Department of Agriculture and Consumer Services’ inspection sweep of hemp retailers and manufacturers to ensure compliance with new hemp product regulatory standards. “Operation Safe Summer” resulted in the removal of nearly 11,000 hemp products for violations of child-protection standards for packaging, labeling, and marketing.
