AWG Regulatory Roundup — August 26, 2026
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- FDA Instructs its Staff on “Gold Standard Science”
- FDA Weighs in on PFAS in Medical Devices
- Nationalized Entry Review Program Launched by FDA
- FDA to Host Meeting on Food Allergen Thresholds
- Texas Claims Victory in Fight Against Food Dyes
- NYC Deems Kava an Unapproved Food Additive
- New Texas SMS/Texts Law Goes into Effect Sept.1
- Washington State to Hold Webinar on New EPR Program
FDA Instructs its Staff on “Gold Standard Science”
In accordance with Executive Order 14303, on August 15, 2025, FDA issued Staff Manual Guide (SMG) 9001, titled “Gold Standard Science at FDA.” The guide is intended to provide FDA staff with a detailed overview of the core tenets of “Gold Standard Science” (GSS) as defined in the EO and the accompanying Office of Science and Technology Policy memorandum. The nine core tenets of GSS include reproducibility; transparency; communicative of error and uncertainty; collaborative and interdisciplinary; skeptical of its findings and assumptions; structured for falsifiability of hypotheses; subject to unbiased peer review; accepting of negative results as positive outcomes; and without conflicts of interest. The manual explains how the agency should integrate these principles into its operations and also specifies procedures for resolving scientific disputes and reporting concerns about GSS adherence.
FDA Weighs in on PFAS in Medical Devices
On August 6, 2025, FDA published an informational page discussing the use of PFAS in medical devices. The page explains that the PFAS in medical devices are different than those linked to health concerns and are necessary for certain life-saving devices to function properly. It also notes that FDA is continuing to monitor the safety of devices and the PFAS used in these products.
Nationalized Entry Review Program Launched by FDA
Beginning August 4, 2025, FDA launched the Nationalized Entry Review (NER) program for import entry review. Under this program, FDA’s import reviews are no longer handled port by port but instead through a centralized nationwide system, designed to improve coordination with U.S. Customs & Border Protection and across FDA reviewers, streamline operations, and strengthen the detection of high-risk products through a Harmonized Real-Time Alert System.
The FDA NER Trade Communications Guide also provides industry stakeholders with detailed contact protocols and special shipment procedures under the new nationalized review system, along with information for communicating with NER teams, handling time-sensitive shipments, and understanding response timeframes and escalation procedures.
FDA to Host Meeting on Food Allergen Thresholds
FDA announced that it will host a virtual public meeting and listening sessions from November 18-20, 2025 to discuss recent scientific developments in food allergen thresholds and how these thresholds may improve public health, enhance labeling practices, and help consumers make informed choices.
Texas Claims Victory in Fight Against Food Dyes
On August 13, 2025, the Texas Attorney General’s Office announced a “historic” Assurance of Voluntary Compliance (AVC) through which Kellogg’s agreed to remove “toxic dyes” from its cereals. Although not the first company to verbally commit to eliminating synthetic food dyes, Kellogg’s is the first to sign a legally binding agreement.
NYC Deems Kava an Unapproved Food Additive
On August 7, 2025, the Southern District of New York ruled in favor of New York City Public Health and Safety in its decision to shut down restaurants selling steeped kava. NYC Public Health and Safety officials had determined that kava is an unapproved food additive, and the court agreed, saying “no one can seriously dispute, then, that kava ‘affects the characteristics of water,’ rendering kava a ‘food additive’ under the FDCA when steeped in water.” For additional reporting on this case, please see this NutraIngredients article with commentary from AWG’s Bob Durkin.
New Texas SMS/Texts Law Goes into Effect Sept.1
Texas recently amended its “Mini-TCPA,” which previously applied only to voice phone calls, to also cover text messages, effective September 1, 2025. The new Texas law defines “telephone solicitation” to include “a call or other transmission, including a transmission of a text or graphic message or of an image, initiated by a seller or salesperson to induce a person to purchase, rent, claim, or receive an item.”
As a result, all businesses sending marketing text messages to Texas residents, or from a location in Texas, must register with the Texas Secretary of State unless an exception applies. Violations are considered a false, misleading, or deceptive act or practice under the state’s Deceptive Trade Practices Act and are subject to penalties of up to $5,000 per violation. Notably, the law also allows for a private right of action, whereby consumers can seek treble damages and attorney’s fees, as well as damages for “mental anguish.”
Washington State to Hold Webinar on New EPR Program
Washington’s Department of Ecology will hold a webinar on September 9, 2025 to discuss the state’s approach to recycling and share an overview of the Recycling Reform Act, which was enacted earlier this year, and creates an extended producer responsibility (EPR) program for packaging and paper products. By July 1, 2026, producers must join a producer responsibility organization (PRO), or register as a PRO that will implement an individual plan.
