Regulatory Roundup

Regulatory Roundup July 14, 2026

AWG Regulatory Roundup — July 14, 2026

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FDA’s 2026 Regulatory Agenda Released

On July 3, 2026, the White House’s Office of Information and Regulatory Affairs released its 2026 Regulatory Agenda, which includes FDA’s anticipated rulemaking actions for 2026. Below are highlights from the Agency Rule List for 2026:

  • A proposed rule that would amend FDA’s GRAS regulations to require the submission of a GRAS notice for the use of a human or animal food substance that is purported to be GRAS under the conditions of its intended use. The rule would clarify that FDA maintains and updates the public-facing GRAS notice inventory for all substances that are the subject of mandatory GRAS notice for their intended use and clarify the process by which FDA would determine that the use of a substance is not GRAS. The agency expects the proposed rule to be issued by December 2026.

As previously reported, FDA had originally targeted October 2025 for the release date. Of note, the current “Statement of Need” accompanying the proposed rule indicates that the agency has somewhat narrowed its scope. For instance, it states that the rule “would require the submission of GRAS notices to FDA for certain uses of food substances.” (emphasis added). FDA also explicitly recognizes that under current regulations, a conclusion that a substance is GRAS under the conditions of its intended use may, but is not required to be, notified to FDA. It also clarifies that “uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met regarding the use of the substance” – in effect confirming that FDA intends to eliminate the self-affirmed GRAS pathway. Another notable addition under the “Anticipated Costs and Benefits” section is FDA’s mention of a “streamlined” and “time-limited” submissions process prior to the effective date of a final rule for existing GRAS substances. However, key information on timing, potential “grandfather” provisions, and other important details remain scarce.

  • A proposed rule (initially slated for January 2026), providing that a “specific ingredient” – likely N-Acetyl Cysteine (NAC) – is not excluded from the dietary supplement definition and allowing products containing the ingredient to be lawfully marketed as dietary supplements, provided they otherwise meet the definition of “dietary supplements.” FDA expects this rule to be published in July 2026.
  • A newly added proposed rule that would update definitions, terminology and provisions related to nutrient content claims and added sugars, and among other things, define a new “low added sugar” nutrient content claim. FDA anticipates releasing this rule in December 2026.
  • A proposed rule to identify certain substances as fragrance allergens and to require the disclosure of fragrance allergens on the labels of cosmetic products, which was initially slated for May 2026 and is now expected in November 2026.
  • A final rule for front-of-pack nutrition labeling and revision of certain nutrient content claim regulations, expected to be published in December 2026 (previously May 2026).
  • A final rule intended to broaden the regulatory criteria for studies exempt from investigational new drug (IND) requirements and provide clarity and consistency regarding when studies evaluating drug uses of products that are already lawfully marketed as conventional foods, dietary supplements, or cosmetics are subject to IND review. Originally slated for October 2025, the rule is now expected to be issued in July 2026.
  • A final rule that would permit the use of salt substitutes in standardized foods in which salt (sodium chloride) is a required or optional ingredient, which is intended to support industry efforts aimed at reducing sodium consumption. The rule is expected to be published in July 2026 (previously slated for May 2026).

The agenda also includes several proposed and final rules that would revoke certain standards of identity for canned fruit and vegetables, bakery products and cereal flours, frozen vegetables, dairy products, and other foods.

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Foods Program Guidance Under Development

On June 29, 2026, FDA’s Human Foods Program released its updated list of draft and final guidance documents under development. Among other topics, FDA expects to publish guidance documents on the following topics by the end of December 2026:

  • Action Levels for Cadmium in Processed Food Intended for Babies and Young Children;
  • Action Levels for Inorganic Arsenic in Food Intended for Babies and Young Children;
  • Action Level for Opiate Alkaloids on Poppy Seeds;
  • Fruit Juice and Vegetable Juice as Color Additives in Food;
  • New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI;
  • Food Labeling for Online Grocery Shopping Platforms;
  • Labeling Caffeine Content in Foods and Beverages;
  • Questions and Answers Regarding Use of the “Healthy” Claim; and
  • The Accredited Third-Party Certification Program: Questions and Answers.

Comments on the guidance topics can be submitted to Docket FDA-2022-D-2088.

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FTC Enforcement Priorities Reflected in Recent Actions

Recent FTC actions emphasize the Commission’s continued enforcement priorities, including deceptive fees, unqualified Made in USA claims, and subscription/auto-renewal program terms:

  • On July 2, 2026, the FTC announced a $35 million settlement with the companies that operate Hopper travel apps following allegations that they unfairly charged hidden fees and misrepresented the total prices consumers would pay for travel booking services. The Commission’s complaint alleges the Hopper apps advertise services and products as “free to use” and as having no hidden fees, but routinely charge consumers hidden or “gotcha” fees without the consumers’ express informed consent.
  • A few days later, the FTC issued Warning Letters to seven companies that appear to have misrepresented certain products as “Made in the USA” and one company that appears to have misrepresented products as “Made in Texas.” The Warning Letters were issued to companies selling drums, industrial laser machinery, coordinate measuring machines, and e-cigarettes.
  • In June, the FTC filed a complaint against Genesis Tech’s owner and multiple affiliates, alleging that they deceive consumers with misleading subscription programs and supposedly free trials or low-cost offers, while hiding the true cost and recurring nature of charges. For example, the FTC asserts that defendants’ product “Wisey” contains a high-price automatic renewal clause in small, obscure text under its low-cost short-term offer in a big type size, and has a difficult cancellation and refund process – despite claims promising a money-back guarantee and convenient refund process. The Commission’s press release also notes that the administration “is engaged in robust enforcement to address deception and illegal subscription offerings.”

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Wisconsin Representative Introduces “REAL Butter Act”, Targeting Lab-Created Butter Labeling

Representative Tony Wied (R-WI) recently introduced the “Recognizing Engineered Alternatives as Lab-Created Butter Act” (H.R. 9387), which would require “synthesized butter products” to be labeled as “lab-created butter” or with the statement “contains lab-created butter” immediately before the product name. The bill defines “synthesized butter product” as a product marketed as butter that utilizes sources of milkfat synthesized through non-agricultural processes and fails to conform to the standard of identity for butter.

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Multiple States Sue California Over EPR Law

Seventeen states and the National Association of Wholesaler-Distributors filed a complaint against the California Department of Resources Recycling & Recovery and Circular Action Alliance, Inc., alleging that California attempts to impose its own policy preferences on the entire nation. The plaintiffs allege the Plastic Pollution Prevention and Packaging Producer Responsibility Act improperly vests power in the Circular Action Alliance, and saddles manufacturers and consumers with costs. The plaintiffs also argue the law violates the U.S. and California Constitutions by discriminating against and burdening interstate commerce, imposing unfairly apportioned taxes, violating the Import-Export Clause, restricting speech in violation of the First Amendment, and unconstitutionally delegating governmental authority to a private organization.

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Complaint Alleges Oregon’s Packaging EPR Law Is Unconstitutional

In related news, Lollicup USA Inc. filed a complaint against the Oregon Department of Environmental Quality, alleging that Oregon’s Plastic Pollution and Recycling Modernization Act is unconstitutional as it violates the Dormant Commerce Clause by burdening an inherently national packaging market and requiring nationwide producers to adjust packaging design, material sourcing, and pricing decisions to abide by Oregon-specific requirements. The complaint further alleges the Oregon law violates the Due Process Clause by requiring producers to join the sole state-approved producer responsibility organization (PRO), or face hefty costs to establish an independent PRO, when the sole PRO is under minimal oversight, its fees are calculated under an undisclosed methodology, and it limits producers to the sole remedy of arbitration for fee disputes.

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U.S. Supreme Court Agrees to Review Key Trademark Dispute

On June 29, 2026, the Supreme Court granted cert in the case of RiseandShine Corp. v. PepsiCo, Inc. Plaintiff RiseandShine Corp. challenged the Second Circuit’s application of the “strength of the trademark” factor in the likelihood of confusion analysis. The “inherent strength” of a trademark, as opposed to its “commercial strength,” is determined based on how the trademark falls on a spectrum of distinctiveness, from generic to fanciful. In other words, the more unique and non-descriptive a trademark is, the stronger that trademark inherently is. The Second Circuit decided that the “inherent strength” of a trademark was a legal, rather than a factual, question. Accordingly, it was to be decided by the judge rather than the jury. The plaintiff argues that the determination of inherent distinctiveness is a factual matter for the jury. If the Court agrees, it may become even more difficult to resolve trademark cases at an early stage, as the already-existing fact-intensive inquiries make it difficult to determine non-infringement as a matter of law.

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