Regulatory Roundup

Regulatory Roundup February 10, 2026

AWG Regulatory Roundup — February 10, 2026

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After 120 Years, FDA Has an Official Agency Seal

On January 28, 2026, FDA Commissioner Marty Makary announced the release of a new FDA seal to mark the agency’s 120 years of service and that “signifies the many public health strides” the agency has made over the decades. The seal features eight stars to represent the product areas FDA oversees (food, drugs, medical devices, radiation-emitting products, vaccines and biologics, animal and veterinary products, cosmetics, and tobacco), a double-helix DNA to denote FDA’s commitment to robust science and medical technology, grains to symbolize FDA’s role of setting and enforcing food safety standards, and other details such as an eagle with open wings to signify the FDA’s “sweeping mission of public health protection.”

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FDA Releases Human Foods Program 2026 Priority Deliverables

On January 23, 2026, FDA’s Human Foods Program (HFP) released its priority deliverables for 2026, which FDA states will advance implementation of its Make America Healthy Again agenda. Building off of 2025 activities and guided by three core risk pillars (microbiological food safety, nutrition, and food chemical safety, dietary supplements, and innovation), planned activities for 2026 include:

  • GRAS reform, aimed at strengthening food additive oversight through a proposed regulation to require the submission to FDA of GRAS notices for all new substances claimed to be GRAS;
  • Continued post-market safety reviews of food chemicals, starting with safety reviews of those that are most concerning to consumers, e.g., phthalates, propylparaben, butylated hydroxyanisole (BHA), and butylated hydroxytoluene (BHT), among others;
  • Guidelines for caffeine labeling;
  • Release of final guidance on New Dietary Ingredient Notifications and evaluation of “new and modernized regulatory approaches” to dietary supplement oversight;
  • Continued collaboration with USDA to define and reduce risk associated with “ultra-processed foods;”
  • Final Rule on Front-of-Package (FOP) Nutrition Labeling;
  • “Healthy” claim implementation, including potential guidance that identifies a symbol to depict the “healthy” claim;
  • Draft guidance on food labeling for online grocery shopping; and
  • Recall process modernization.

Other activities may include research on microplastics, advancing the Closer to Zero initiative for the reduction of heavy metals and other contaminants in food for infants and young children, as well as continued research on general consumer exposure to contaminants in food such as PFAS, expedited review of new “natural” color additives under FDA regulations, implementation of Operation Stork Speed focused on expanding options for safe, reliable, and nutritious infant formula, new proposed rules to continue to eliminate outdated standards of identity, strategies for added sugar and sodium reduction, and improving the safety of imported foods, produce, eggs, and dairy products.

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FDA Issues Draft Guidance on Records Access Authority for Cosmetics

On January 23, 2026, FDA released a draft guidance entitled “FDA Records Access Authority for Cosmetics: Guidance for Industry,” which clarifies the agency’s authority to access records related to cosmetic products added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Using a frequently asked questions format, the draft guidance provides insights into FDA’s current thinking on topics including the agency’s access to adverse event records and records related to products that may pose a threat of serious adverse health consequences or death, and FDA’s extended inspection authority over records from facilities that manufacture or process cosmetic products. FDA is accepting comments on the draft guidance through March 23, 2026.

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FDA Sued Over Rejection of Health Claims

Trade association Alliance for Natural Health USA, supplement companies Living Fuel International, Inc. and Cardio Miracle, and online retailer The Health Ranger Store, Inc. filed a complaint in the District Court for the District of Columbia against HHS and FDA following the agency’s rejection of a petition seeking to allow the use of 114 nutrient-disease risk reduction health claims. Some of the denied claims include “vitamin A reduces the risk of respiratory disease/pneumonia,” “boron may reduce the risk of osteoarthritis,” and “riboflavin may reduce the risk of migraine headaches.” The plaintiffs argue that these claims are supported by authoritative statements published by the NIH, ODS, and CDC and are therefore permitted under the FD&C Act. Section 403(r)(3)(C) of the Act permits the use of health claims, including nutrient-disease risk reduction claims, based on authoritative statements from an appropriate scientific body of the U.S. government, or the National Academy of Sciences, or any of its subdivisions. The plaintiffs argue that FDA’s denial of the claims violates the plain meaning of the statute and the First Amendment. The complaint cites the D.C. Circuit Court of Appeals’ decision in Pearson v. Shalala, in which the court ruled that FDA violated the First Amendment by suppressing health claims that lacked “significant scientific agreement” without first considering whether clear disclaimers could adequately protect consumers from being misled.

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Dietary Supplement Federal Preemption Legislation Introduced

Representative Nick Langworthy (R-NY) has introduced the “Dietary Supplement Regulatory Uniformity Act,” which amends the FD&C Act to provide that state or local laws that are different from, in addition to, or that are not otherwise identical to federal requirements for dietary supplements would be preempted. The bill also provides an exemption process whereby FDA may, by regulation and after notice and opportunity for a hearing, allow such laws if the requirements are more stringent than applicable federal law or the requirement addresses a compelling local condition, and compliance with the requirements does not render the dietary supplement out of compliance with federal law.

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Bill Aims to Establish Federal Requirements for “Recyclable,” “Compostable,” and “Reusable” Claims

Introduced by Representative Randy Weber (R-TX), House Bill 6832 would amend the Federal Trade Commission Act and establish requirements for the use of claims including “recyclable,” “compostable,” and “reusable.” For example, the bill would require “recyclable” claims to be qualified with a statement explaining the percentage of consumers and communities that can recycle the packaging. However, such claims would not require qualification if a substantial majority of the consumers or communities in which the product is sold have a recycling program available, and the entire package, excluding minor incidental components, is recyclable through those programs. The bill also excludes certain products from bearing these claims, such as if a package’s shape, size, or other attribute prevents the otherwise recyclable packaging from being accepted in recycling programs.

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FTC Submits Advance Notice of Proposed Rulemaking on Negative Option Rule to OMB

On January 30, 2026, the FTC announced the submission of a Draft Advance Notice of Proposed Rulemaking (ANPRM) concerning the Negative Option Rule to the Office of Management and Budget (OMB) for approval. Once OMB approves the ANPRM, it will be published in the Federal Register and open for comments. The notice and proposed rule are not yet available, although subscription programs have been a trending enforcement target for the current administration.

As previously reported, the FTC attempted to amend the Negative Option Rule in 2024 with updates for subscription programs – an update commonly referred to as the “Click to Cancel” rule. The revised rule included several consumer-friendly requirements, such as affirmative consent and online cancellation, but was struck down by the Eighth Circuit Court of Appeals for procedural issues. While current FTC Chair Andrew Ferguson had voted against the rule’s initial enactment, on December 3, 2025, the FTC published in the Federal Register a request for public comment following a joint petition it received from the Consumer Federation of America and the American Economic Liberties Project asking the FTC to revisit the rule.

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New FTC Deputy Director for Bureau of Consumer Protection

The FTC announced the appointment of Levi Swank as Deputy Director for the Bureau of Consumer Protection on January 30, 2026. Swank was previously a consumer protection litigator at a Washington, DC law firm.

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NJ and NY Pass Menstrual Product Laws

Recently enacted laws in New Jersey and New York will require ingredient disclosures and restrict the use of certain substances in menstrual products.

  • In New Jersey, Assembly Bill 2437requires menstrual product labels, including tampons, sanitary pads, discs, menstrual cups, and period underwear, to include an ingredients list. Violators may face civil penalties of up to $1,000 per package or box that fails to comply. Civil penalties will not be assessed for noncompliant packaging manufactured before the January 12, 2026 effective date.
  • In New York, Senate Bill 1548was signed into law and prohibits intentionally added substances such as heavy metals, PFAS, formaldehyde, talc, phthalates, and parabens in products that fall under the state’s broad definition of “menstrual product,” which includes, but is not limited to, tampons, pads, and menstrual cups. The law also directs the state’s department of health to establish thresholds for these substances. Manufacturers must comply within two years of the thresholds being set, or by January 1, 2029, whichever comes first.

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NJ Governor Signs the Protecting Against Forever Chemicals Act

On January 12, 2026, Senate Bill 1042, known as the Protecting Against Forever Chemicals Act or the “PAFC Act,” became law in New Jersey. Starting January 12, 2028, the law bans the sale of cosmetics, carpet, fabric treatments, and food packaging that contains “forever chemicals” or PFAS, with an allowance for “unavoidable trace quantities of PFAS.” Violations may result in civil penalties up to $20,000 per violation, per day.

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