Regulatory Roundup

Regulatory Roundup August 25, 2026

AWG Regulatory Roundup — August 25, 2026

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Overton Nominated for FDA Commissioner

On August 19, 2026, President Trump announced his intent to nominate Dr. Heidi Overton as FDA Commissioner, following the resignation of Dr. Marty Makary from the post in May. Overton is a physician and deputy director of the White House Domestic Policy Council, where she has worked closely with HHS Secretary Kennedy on the administration’s health policy agenda. Kyle Diamantas remains Acting Commissioner pending Senate confirmation of Overton.

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HHS and USDA Advance UPF Definition

On August 10, 2026, alongside the proposed GRAS rule (discussed in detail below), HHS announced that it and USDA have submitted the federal government’s first proposed definition of ultra-processed foods to the Office of Management and Budget (OMB) for final review. The text has not been released. HHS said the definition draws on feedback from stakeholders and is intended to address the lack of a standardized federal definition, which the agency says has limited research consistency across the government.

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Texas AG Investigates “Heart-Healthy” Food Label Claims

On August 3, 2026, Texas Attorney General Ken Paxton announced another investigation into food manufacturers, this time focused on products marketed as “heart-healthy” to determine whether the companies’ advertising practices violate the Texas Deceptive Trade Practices Act by misrepresenting the health value of their products to Texas consumers. Paxton claims that “evidence suggests many ‘heart-healthy’-labeled products fall short of the promise consumers rely on,” calling them “Trojan Horses packed with added sugars, refined grains, and inflammatory properties.”

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Court Rejects Prop 65 Warning for Cadmium in Frozen Spinach

A California court has ruled that cadmium levels in frozen spinach do not trigger the Proposition 65 warning requirement. In The Chemical Toxin Working Group v. The Pictsweet Company, the court followed earlier rulings on lead and held that cadmium exposure should be measured by the reasonably anticipated intake of an average consumer rather than by single-day consumption. The court also endorsed NHANES data as an appropriate source for determining average consumption.

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IN-DEPTH: FDA Moves to Make GRAS Notification Mandatory

On August 11, 2026, FDA released its long-anticipated proposed rule to reform the GRAS process. The proposed rule shifts the current voluntary GRAS Notification program into a mandatory one, while also establishing an abbreviated and expedited review for self-affirmed GRAS ingredients on the market before a final rule goes into effect. The rule would amend 21 CFR parts 170 and 570 and apply to substances used in human food and animal food, including certain food contact substances. Comments are due December 9, 2026.

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Key Provisions:

  • Mandatory notice. After the effective date of a final rule, anyone introducing a substance into interstate commerce on the basis that it is GRAS for its intended use in food under section 201(s) of the FD&C Act would be required to submit a GRAS notification to FDA for that substance.
  • When the streamlined notification applies. Companies marketing substances already in interstate commerce under a self-affirmed GRAS before the effective date of a final rule have the option to submit an abbreviated notice. Notifications for ingredients qualifying for the abbreviated process must include the name(s) of the submitter, the substance and its conditions of use, and evidence of market entry before the effective date of the rule. No safety narrative or underlying data is required. The option is closed to any conditions of use that previously drew an insufficient basis letter or an FDA determination that the intended use is not GRAS. The window for companies to submit an abbreviated notification runs one year from the effective date of the rule, after which the option closes and a full GRAS notification would be required.
  • The notification process is not a premarket review. Notably, notice is required, but premarket approval is not. Under the proposed rule, a company could rely on a GRAS determination to market a substance before filing a GRAS notification with FDA and continue marketing it during FDA’s review of any subsequent notification. FDA does not state that failure to file a notification would by itself make the substance unlawful, but the agency would weigh noncompliance when prioritizing substances for post-market review and enforcement.
  • Review timeline. FDA would have 45 days to decide whether to file a notification, then 180 days to substantively respond, with two 90-day extensions available. The notification obligation is met when FDA files the submission, not when a company sends it. Responses from FDA would come in three forms: no questions, insufficient basis, or cease to evaluate.
  • Exceptions to mandatory GRAS notification. The proposal lists seven exceptions, including GRAS-notified substances with prior no questions letters, substances listed or affirmed in Parts 182, 184, and 186, certain pre-1958 natural substances, an expanded Threshold of Regulation exemption covering direct food uses, effective food contact notifications, and the one-year streamlined option for self-affirmed GRAS ingredients already in commerce. However, FDA would be able to request additional information on previously GRAS-notified substances and possibly rescind a no questions letter.
  • Public disclosure. Submissions and FDA responses would be posted publicly, but inclusion on the list is not a finding that the use is GRAS (and note that FDA can still request a full notice or food additive petition at a later date). Confidential information must be identified at the time of submission or FDA may treat the claim as waived.
  • A final rule would become effective 60 days after publication. The streamlined submission window would close one year after the effective date, and compliance with the notification requirement would be due 18 months after the effective date.

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Key Takeaways: 

GRAS status applies to a substance under specified conditions of use, not to the substance itself, so a change in identity, manufacturing process, specifications, food category, or use level can trigger the need to submit a new notice even for a codified or previously notified substance. Dietary supplement companies should also be aware that if an ingredient’s GRAS status shifts under a final rule, the NDI notification exemption at section 413(a)(1) of the Act may no longer be available. In addition, excipients used in supplements (e.g., sweeteners, thickeners, preservatives) are not dietary ingredients and remain subject to the GRAS framework, so any that rely on a self-affirmed GRAS conclusion are also impacted.

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Action Items:

In preparing for these changes, companies should:

  • Confirm the regulatory basis for each food ingredient, whether a food additive regulation, a GRAS regulation, a prior notification, or a self-affirmed GRAS conclusion, including any GRAS basis a supplement ingredient relies on.
  • Confirm that actual conditions of use match what that basis covers, including any supplier documentation and affirmations.
  • Finalize pending self-affirmed GRAS conclusions for substances expected to enter commerce before the effective date, which preserves access to the streamlined option.
  • Revisit supplier and customer agreements to address who holds the GRAS dossier, who files the notice, and who controls confidentiality designations at submission.
  • If relying on a GRAS determination to qualify a dietary supplement ingredient as a “dietary substance” under section 201(ff)(1)(E) of the FD&C Act, preserve evidence that the ingredient was marketed in the conventional food supply before the effective date of a final rule.
  • Submit comments by December 9, 2026, individually or through a trade association. We are here to help, so do not hesitate to reach out.

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