Regulatory Roundup

Regulatory Roundup September 23, 2025

AWG Regulatory Roundup — September 23, 2025

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FDA Adverse Event Reporting Dashboard for Cosmetics Now Live

On September 12, 2025, FDA launched the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, which is intended to facilitate access to adverse event data. The dashboard includes both serious adverse reports (as required by the Modernization of Cosmetics Regulation Act of 2022) as well as voluntary reports submitted by healthcare professionals, consumers, and others.

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Final MAHA Strategy Report Released

On September 9, 2025, as required by Executive Order 14212, “Establishing the President’s Make America Healthy Again Commission,” the MAHA Commission released its Make Our Children Healthy Again Strategy, which was leaked last month, and is aimed at addressing and ending childhood chronic disease. The Strategy, which follows the Make Our Children Healthy Again Assessment Report released on May 22, 2025, outlines strategies and initiatives to be carried out by HHS, FDA, NIH, EPA, FTC, and USDA, and identifies four potential drivers of childhood chronic disease: 1) poor diet due to the increased prevalence and consumption of ultra-processed foods; 2) exposure to synthetic chemicals; 3) lack of physical activity, screen use, sleep deprivation and chronic stress; and 4) overprescribing of medications to children reportedly driven by “conflicts of interest in medical research, regulation, and practice,” resulting in “unnecessary treatment and long-term health risks.”

Several policy reforms are also listed and include actions already underway, such as FDA’s post-market assessment of chemicals in food, the phase-out of petroleum-based food dyes, front-of-pack nutrition labeling, and GRAS reform. Updates to the 2025 – 2030 Dietary Guidelines for Americans and limits on direct marketing of certain foods to children are also mentioned in the report. Notably, under the topic of “Water Quality, Fluoride, and PFAS,” it states that “FDA will also take action against unapproved products, often marketed as supplements.” The strategy also lists the “potential health benefits of select high-quality supplements” as a new initiative to support longitudinal research for chronic disease prevention.

Beyond food policy, the report highlights initiatives targeting direct-to-consumer pharmaceutical advertising (also the subject of a recent HHS/FDA announcement), promoting innovation in the sunscreen market, improving drug and device approvals by eliminating regulatory burdens such as animal testing requirements, and EPA process improvements.

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Scrutiny of Subscription Programs Continues to Trend

On September 15, 2025, the FTC announced a proposed order that will require Chegg Inc. to pay $7.5 million to settle allegations that Chegg made it extremely difficult to cancel recurring subscriptions and failed to honor cancellation requests. In its complaint, The FTC alleged that Chegg, a provider of online learning tools for high school and college students, buried the cancellation process on its website behind multiple clicks and failed to honor up to 200,000 cancellation requests from consumers who were able to navigate the cancellation process.

This settlement follows the FTC’s high-profile complaint against LA Fitness over its auto-renew memberships, suggesting the Commission is still very interested in subscription cancellation policies despite its Click-to-Cancel rule being vacated for rulemaking procedure issues. Beyond FTC enforcement, class action complaints targeting difficult-to-cancel recurring subscriptions continue to trend upward – serving as an important reminder to ensure subscription programs comply with the FTC and the often stricter state requirements.

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Temu Must Pay $2 Million for Failing to INFORM Consumers

In its first enforcement action under the INFORM Consumers Act, the FTC imposed a $2 million civil penalty on Temu as part of a settlement to resolve allegations that the online marketplace violated the Act by failing to provide consumers with the proper tools for reporting stolen, counterfeit, or unsafe goods. The INFORM Consumers Act (Integrity, Notification, and Fairness in Online Marketplaces for Consumers Act) went into effect in 2023 and requires online sellers to provide consumers with clear and conspicuous reporting mechanisms, such as a telephone number or email address, to report suspicious marketplace activity. The Act also requires online marketplaces to clearly and conspicuously disclose the identities of third-party sellers and provide their addresses and contact information.

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California Legislature Sends Multiple Bills to Governor

Several bills have passed the California State Legislature and are awaiting Governor Newsom’s signature, including:

  • SB 646 – Starting January 1, 2027, would require 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 would also be required to include heavy metal testing results on the product packaging and online.
  • AB 1264 –  Defines “ultraprocessed food” (UPF) and would require the California Department of Public Health (CDPH) to adopt regulations, on or before June 1, 2028, to define “ultraprocessed foods of concern” and “restricted school foods,” based on reputable peer-reviewed scientific evidence and whether a substance or group of substances are linked to health harms or adverse health consequences, among other factors. Schools would be required to phase out restricted school foods and UPFs of concern no later than July 1, 2029. Beginning July 1, 2032, vendors would be prohibited from offering restricted school foods and UPFs of concern to a school. The proposed definition of “ultraprocessed food” includes 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. The bill exempts several products from the definition, including raw agriculture commodities, unprocessed or minimally processed agriculture products, and certain milk, medical food, and infant formula products, and clarifies that specified additives, including salt or sodium chloride, spices or other natural seasonings and flavorings listed in 21 CFR 182.10, and natural color additives listed in 21 CFR Part 73, would not “by themselves cause a food or beverage to be categorized as a UPF.”
  • AB 823– Beginning January 1, 2029, would prohibit personal care products from containing plastic glitter, and would prohibit personal care products and cleaning products from containing more than one ppm of plastic microbeads. “Personal care products” are defined as articles “intended to be rubbed, poured, sprinkled, or sprayed on, introduced to, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and an article intended for use as a component of that type of article.”
  • SB 682– Beginning January 1, 2028, would prohibit cleaning products, dental floss, food packaging, and other covered products from containing intentionally added PFAS. Cookware would be added to the list starting January 1, 2030.
  • SB 754– Beginning December 31, 2026, would require manufacturers of disposable tampons and menstrual pads to maintain records of the concentration of lead, arsenic, cadmium, and zinc in their products. It also authorizes CDPH to add additional banned chemicals and establish acceptable testing methods.
  • SB 39– Would extend the ban on vaginal suppositories that contain intentionally added boric acid to January 1, 2035, and beginning January 1, 2027, would require such products to include a warning statement, with an exception for FDA-approved drugs.

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Essential News for Medical Device Professionals

Looking for the latest news affecting the medical device industry? Check out the collection of articles co-authored by AWG and Hansem Global, a leading provider of multilingual documentation and regulatory content development, which covers timely topics including visual aids in medical device IFUs, marketing a medical device in the U.S., and preparing IFUs for FDA submission.

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