AWG Regulatory Roundup — December 16, 2025
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- FDA’s Proposed GRAS Rule Submitted to OMB
- FDA Issues Letter to Industry on Placement of the DSHEA Disclaimer
- Bill Introduced in Congress Requiring Warning Labels and Restricting Ads for “Junk Food”
- Is the “Click to Cancel” Rule Not Cancelled?
- FTC Approves Order Against Marketers of GLP-1 Weight Loss Program
- FDA Withdraws Talc Testing Proposed Rule
- 12 Attorneys General Sue Over SNAP Permanent Residents Guidance
- Litigation Trend Update: Is Citric Acid a Natural Flavor?
- State Legislators Prepare for the New Year with New Bills
- It’s a Wrap!
FDA’s Proposed GRAS Rule Submitted to OMB
As of December 1, 2025, FDA’s proposed GRAS reform rule was pending review by the White House Office of Management and Budget (OMB), which signals that FDA could issue it in the coming weeks. As previously reported, FDA’s Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions, released this fall, indicated that FDA would issue a proposed rule amending the GRAS regulations to require mandatory submission of GRAS notices for both human and animal food substances that are purported to be GRAS, which would essentially eliminate the self-affirmed GRAS pathway. Although FDA had aimed to publish the proposed rule in October 2025, the government shutdown likely delayed its issuance. Given the administration’s focus on GRAS reform and ongoing scrutiny of the self-affirmed GRAS process, the rule is expected to be fast-tracked. It may even have an abbreviated notice-and-comment period. Notably, questions have been raised about whether FDA can require mandatory GRAS submissions without federal legislation that amends the FD&C Act’s food additive provisions, raising the possibility of a legal challenge to the proposed rule.
FDA Issues Letter to Industry on Placement of the DSHEA Disclaimer
Following several deregulatory requests received by the agency, on December 11, 2025, FDA issued a letter to the dietary supplement industry regarding FDA’s labeling regulations governing the placement of the DSHEA disclaimer on dietary supplement labels that bear structure/function claims. Currently, the regulation (21 CFR 101.93(d)) requires that the disclaimer appear on each panel of a product label where such claims appear. However, the letter states that FDA is considering an amendment to the regulation to remove this requirement, as it would reduce label clutter and unnecessary costs. The letter also notes that enforcement of the requirement has been rare, if any. In addition, FDA intends to exercise enforcement discretion regarding this requirement while it considers whether to proceed with rulemaking, and given the rulemaking process can be lengthy.
This comes as welcome news to the supplement industry, which has been an ongoing target of complaints and numerous demand letters from class action plaintiffs alleging that placing the disclaimer on a panel other than where structure/function claims appear is deceptive and misleading under state consumer protection laws. AWG was pleased to have assisted CRN in drafting its comments to FDA requesting changes to the regulation to address this issue, along with other deregulatory requests.
Bill Introduced in Congress Requiring Warning Labels and Restricting Ads for “Junk Food”
On December 1, 2025, Representatives Don Beyer (D-VA), Mike Lawler (R-NY), and Scott Peters (D-CA) introduced the Childhood Diabetes Reduction Act of 2025, which, among other things, would require FDA to establish health warning labels for sugar-sweetened beverages, beverages containing non-sugar sweeteners, ultra-processed food, and foods that contain high levels of a “nutrient of concern,” such as added sugar, saturated fat, and sodium. It would also prohibit the marketing or advertising of such foods and beverages in a manner that “reasonably appears to be directed at children.” In addition, the legislation would provide the FTC with authority to restrict advertisements for “junk food” (foods and beverages that require health warning labels) directed at children and require disclosure of any health and nutrient warning labels in advertisements. Violations would constitute unfair or deceptive acts or practices under the FTC Act.
Is the “Click to Cancel” Rule Not Cancelled?
As previously reported, the FTC’s updated “click-to-cancel” was struck down by the Eighth Circuit Court of Appeals this past summer for procedural rulemaking issues. The revised rule included several consumer-friendly requirements, such as affirmative consent and online cancellation. To date, the Commission has not indicated a desire to restart the rulemaking, as it did not appeal the decision, and current Chair Andrew Ferguson voted against the rule’s initial enactment.
However, on December 3, 2025, the FTC published in the Federal Register a request for public comment on a joint petition it received from the Consumer Federation of America and the American Economic Liberties Project asking the FTC to revisit the rule. The notice does not indicate the Commission’s position and instead is intended to “facilitate public comment on the petition to aid the Commission in determining what, if any, action to take regarding the request contained in the petition.” The Commission specifically notes it does not “start, stop, cancel, or otherwise affect rulemaking proceedings in any way.” Comments are due by January 2, 2026, and AWG is happy to assist with any submissions.
While the “Click-To-Cancel” rule itself remains in limbo, automatic renewals are still clearly on the FTC’s radar, with a headlining action this year against Lifetime Fitness over its burdensome cancellation policies and a notable $2.5 billion settlement with Amazon for misleading enrollment in Prime memberships. As a reminder, states also have their own rules for auto-renewals. California’s rules, for example, are more stringent than the FTC’s and remain a perennial class action target.
FTC Approves Order Against Marketers of GLP-1 Weight Loss Program
On December 3, 2025, the FTC approved a consent order against telemedicine company NextMed and its principals for deceptively advertising GLP-1 weight-loss programs. The FTC’s initial complaint alleges that the company made unsubstantiated weight-loss claims, used fake testimonials, and employed deceptive billing and cancellation practices, such as failing to process cancellation and refund requests in a timely manner and failing to obtain express informed consent before charging consumers or making recurring debits. The company must also pay $150,000 in refunds to consumers.
FDA Withdraws Talc Testing Proposed Rule
On November 28, 2025, FDA withdrew a proposed rule entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” originally published on December 27, 2024. After considering comments received during the comment period, FDA withdrew the proposed rule due to other priorities and the complexity of asbestos testing. The agency stated that it will reconsider the best approach to addressing asbestos exposure and the use of a standardized method for detecting asbestos in talc-containing cosmetics to protect the public from asbestos-related harm.
12 Attorneys General Sue Over SNAP Permanent Residents Guidance
Attorneys General from 12 states filed a complaint against USDA over its October 31, 2025 guidance document limiting access to Supplemental Nutrition Assistance Program (SNAP) benefits to certain non-citizens and then denying the states a 120-day exclusionary period, or grace period, to implement the new guidance without benefit calculation errors counting against the states.
Litigation Trend Update: Is Citric Acid a Natural Flavor?
Products that contain citric acid and claim to be “Flavored with Other Natural Flavors” or “Flavored with Natural Flavors” have been a recent target for plaintiffs. Plaintiffs have capitalized on recent court orders deferring to later stages of litigation on the issue of whether citric acid is a flavor versus a pH balancer or enhancer. As to whether citric acid is natural, Plaintiffs acknowledge that citric acid is found naturally in citrus fruits, but they allege the majority of the citric acid used in food manufacturing is derived by a multi-step fermentation process using the fungus Aspergillus niger. This process allegedly renders the ingredient non-natural, and therefore the “Natural Flavors” claim is false and misleading. Although many of the recent proposed class actions target products containing citric acid, plaintiffs have also argued on similar grounds that “Flavored with Other Natural Flavors” is false and misleading if the products contain other ingredients, such as DL-malic acid and ascorbic acid.
State Legislators Prepare for the New Year with New Bills
State legislators introduced and prefiled various bills seeking to restrict color additives, food ingredients, certain cosmetics, PFAS, and more:
- Legislation in Missouri would require warning labels on foods containing “unsafe” chemicals such as blue 1, red 40, yellow 5, and yellow 6 (HB 1958), prohibit schools from serving, selling, or allowing third parties to sell ultra processed foods that contain ingredients such as titanium dioxide, yellow 5, yellow 6, blue 1, and green 3 (SB 1290), standardize front-of-pack labeling to clearly mark common allergens as well as disclose the percentage of grains, fruits, or vegetables in certain products (SB 1319), and add products containing bioengineered substances and natural flavoring to the definition of misbranded food, unless the product bears a website link or QR Code identifying the specific substances or flavoring (SB 1362).
- In New Hampshire, SB 639 would establish a study committee to investigate the health and safety of food additives such as red 40, brominated vegetable oil, propylparaben, and titanium dioxide, while HB 1080 would prohibit the sale of condoms and personal lubricants that contain intentionally added PFAS.
- New Jersey AB 6151 would require labels for over-the-counter and prescription drugs to disclose the presence of ingredients derived directly or indirectly from a major food allergen or a gluten-containing grain.
- Arizona SB 1005 would prohibit a cosmetic manufacturer from selling or offering for sale a product that went through animal testing during development and manufacture.
- New York SB 8598 would establish age restrictions on the sale of anti-aging skin care products to those under 18 and require retailers, including online retailers, to verify purchasers’ age prior to completing the sale of products containing vitamin A derivatives (retinoids, retinol, retinyl esters), alpha hydroxy acids (or similar compounds used for exfoliation or anti-aging purposes) such as glycolic, lactic, or citric acid, salicylic acid, DMDM hydantoin, quaternium-15, oxybenzone, octinoxate, or talc.
It’s a Wrap!
This will be our last AWG Regulatory Roundup of 2025. Thank you all for reading, subscribing, and letting us know you appreciated the important developments we brought to your attention. Be on the lookout for a whole lot of news in the new year, and, while we wish you could have all been at our holiday party, we “sang” a song just for you! WATCH HERE!
