AWG Regulatory Roundup — December 2, 2025
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- HHS and FDA Announce New Director of CDER
- FDA Issues Warning Letters to Marketers of Illegal Botox and Yellow Oleander Products
- Michigan Bill Aims to Restrict Weight Loss and Muscle Building Dietary Supplements
- New Jersey Bills Take Aim at GRAS and 1,4-Dioxane
- Washington Finalizes New PFAS Rule
HHS and FDA Announce New Director of CDER
Dr. Richard Pazdur, a 26-year veteran of FDA, has been appointed director of the agency’s Center for Drug Evaluation and Research (CDER). Dr. Pazdur is the founding director of FDA’s Oncology Center of Excellence and spearheaded a series of initiatives at the agency aimed at streamlining oncology drug approvals, access, and labeling.
FDA Issues Warning Letters to Marketers of Illegal Botox and Yellow Oleander Products
On November 5, 2025, FDA announced the issuance of 18 Warning Letters to online marketers of unapproved and misbranded botulinum toxin products (Botox) and related products. The agency notes that it is aware of adverse events associated with these illegal products, including botulism symptoms, which can lead to difficulty breathing and death.
Two days earlier, the agency sent mul tiple Warning Letters to marketers of dietary supplements that contain yellow oleander, based on analytical testing performed by FDA. FDA’s alert states that yellow (Thevetia peruviana) is a poisonous plant native to Mexico and Central America that poses a public health risk. Many of the targeted products are labeled as containing tejocote (Crataegus mexicana) root or Brazil seed but instead contain yellow oleander, rendering the products both adulterated and misbranded.
Michigan Bill Aims to Restrict Weight Loss and Muscle Building Dietary Supplements
On November 12, 2025, Michigan House Bill 5250 was introduced, and if passed, would prohibit the sale of weight loss dietary supplements, muscle building dietary supplements, and “over-the-counter diet pills” to minors. The bill defines “dietary supplement for weight loss or muscle building” as a product “labeled, marketed, or represented for the purpose of achieving weight loss, fat burning, appetite control, or muscle building, or that contains an ingredient that is regulated by the United States Food and Drug Administration for weight loss.” “Over-the-counter diet pills” are defined as “drugs labeled, marketed, or otherwise represented for the purpose of achieving weight loss, that are lawfully sold, transferred, or furnished over-the-counter with or without a prescription.” Similar to the New York law passed in 2024, the bill provides further criteria for the state government to consider when determining whether a supplement or OTC falls under the bill’s restrictions, including whether the product contains ingredients such as creatine, green tea extract, raspberry ketone, garcinia cambogia, or coffee bean extract. In addition, like the New York law, it would require online sellers to use a method of shipping that both: 1) prohibits a minor from accepting the delivery and 2) requires that the consumer accepting the delivery provide valid identification that proves that the consumer is not a minor.
New Jersey Bills Take Aim at GRAS and 1,4-Dioxane
Two recently introduced bills in New Jersey seek to impose reporting requirements for products containing ingredients that are self-affirmed GRAS and restrict levels of 1,4-dioxane in cosmetics:
- Senate Bill 4748 would require food and dietary supplement companies to report to the state each food additive the manufacturer self-determines as GRAS. The reports would be publicly accessible, and it would be unlawful to sell products containing self-affirmed GRAS ingredients in the state without submitting this report. The bill provides several exemptions from the reporting requirement, including for GRAS substances for which FDA has received a GRAS notice and has issued a “no questions” letter and any substance the Commissioner of Health determines is safe
- Senate Bill A6013 proposes to prohibit the sale of cosmetics containing more than 10 parts per million of 1,4-dioxane. The bill also aims to prohibit the sale of personal care products, defined as “any product intended for cleaning or cleansing any part of the body,” containing more than two parts per million of 1,4-dioxane. Two years after the enactment of the bill, the allowable trace concentration of 1,4-dioxane will reduce to one part per billion for personal care products.
These bills are part of a growing trend across the states focused on self-affirmed GRAS and cosmetic ingredient restrictions.
Washington Finalizes New PFAS Rule
On November 20, 2025, the Washington State Department of Ecology adopted amendments to its Safer Products and Reporting rule, which establishes upcoming bans on manufacturing, selling, or distributing several categories of consumer products that contain intentionally added PFAS, as well as reporting requirements for other categories. The rule provides that detection of total fluorine above 50 parts per million indicates the PFAS are “intentionally added.” Starting January 1, 2027, the rule prohibits the manufacture, sale, or distribution of certain apparel and accessories (including reusable underwear for incontinence and reusable period underwear), automotive washes, and household cleaning products that contain intentionally added PFAS.
Starting January 1, 2026, manufacturers of specified products must submit annual reports on products containing intentionally added PFAS, including apparel intended for extreme and extended use, certain footwear, floor waxes and polishes, and cookware and kitchen supplies, defined as “durable houseware items intended to contact food or beverages and used to prepare, dispense, or store food, foodstuffs, or beverages.”
