AWG Regulatory Roundup — August 12, 2025
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- Federal Court Partially Dismisses Challenge to FDA’s Homeopathy Policy
- What are “Ultra-Processed Foods”? HHS, FDA, and USDA Aim to Find Out
- Former FDA Commissioner Targets Ingredients in Ultra-Processed Foods
- NMN Response Pushed to September
- FDA Debuts New Toxicity Screening of Food Chemicals Tool
- FDA Gets a New Top Lawyer
- Warning Letter Spotlight: WHOOP! FDA Raises Compliance Pressures for Wearable Manufacturers
- Proposition 65 Enforcement Trends and Updates
- Speaking of Prop 65…
Federal Court Partially Dismisses Challenge to FDA’s Homeopathy Policy
On July 15, 2025, the U.S. District Court for the District of Columbia granted in part the federal government’s motion to dismiss in a case brought by the Alliance for Natural Health USA (ANH-USA) and Meditrend, Inc., a developer and distributor of homeopathic drug products. ANH-USA and Meditrend, Inc. challenged FDA’s 2022 denial of a petition seeking to exclude homeopathic products from the new drug approval process and FDA’s subsequent risk-based enforcement guidance for homeopathic drug products, arguing that these actions were arbitrary and capricious in violation of the Administrative Procedure Act (APA), among other things. The court dismissed all but one of the plaintiffs’ claims, finding that whether FDA’s safety concerns justified the denial of the petition cannot be determined without a full administrative record. Notably, the court also found that although FDA’s denial of the petition is a final agency action that is reviewable, the enforcement guidance is not, and thus cannot be challenged under the APA. The court also determined that there is no statutory basis upon which to conclude that Congress intended to exempt homeopathic products from the new-drug approval process, or otherwise “relax or heighten regulatory burdens on homeopathic drugs.”
What are “Ultra-Processed Foods”? HHS, FDA, and USDA Aim to Find Out
As part of the “Make America Healthy Again” Initiative, HHS, FDA, and USDA jointly announced a Request for Information intended to aid the agencies in gathering information to establish “a federally recognized uniform definition of ultra-processed foods.” The July 23, 2025 announcement notes the lack of a single authoritative definition for ultra-processed foods and the need for consistency in research and policy to help address the health concerns that may be associated with consuming them. Developing the definition is also a key deliverable of the “Make Our Children Healthy Again Assessment,” which cites overconsumption of ultra-processed foods as a driving factor of childhood chronic disease.
Former FDA Commissioner Targets Ingredients in Ultra-Processed Foods
A New York Times article published on August 7, 2025 reports that former FDA Commissioner Dr. David Kessler has filed a Citizen Petition with FDA arguing that the agency has the authority and evidence to deem certain ingredients in ultra-processed foods as no longer GRAS, including high-fructose corn syrup and certain refined flours and starches. The petition contends that FDA can effectively regulate these foods “[b]y going after core components…like refined sugars and starches,” and therefore a precise definition of ultra-processed foods is not needed.
NMN Response Pushed to September
In a July 28, 2025 court filing staying a case between FDA and the Natural Products Association, FDA indicated it will not make its July 31 deadline to address Citizen Petitions requesting clarity on the regulatory status of beta-nicotinamide mononucleotide (NMN) due to staffing cuts at the agency. FDA now expects to issue its final response by September 30, 2025.
As background, in November 2022, FDA declared that NMN cannot be marketed as a dietary supplement under the drug exclusionary clause in the FD&C Act. Industry trade associations then filed Citizen Petitions with FDA, urging the agency to reverse its decision or exercise enforcement discretion regarding supplements containing NMN, as well as clarify the agency’s position on the drug exclusionary clause.
FDA Debuts New Toxicity Screening of Food Chemicals Tool
On July 30, 2025, FDA announced its new Expanded Decision Tree (EDT) chemical toxicity and risk screening tool, which is intended to help address potential data gaps for chemicals in food and be used in both pre- and post-market evaluation of chemicals to assist in ensuring the safety of the food supply. The agency also expects to incorporate the EDT into its ongoing efforts to prioritize food chemicals for post-market review.
FDA Gets a New Top Lawyer
On August 4, 2025, FDA announced the appointment of Sean Keveney as Chief Counsel. Mr. Keveney most recently served as the Acting General Counsel of HHS and also held senior roles in the Department of Justice’s Civil Rights Division.
Warning Letter Spotlight: WHOOP! FDA Raises Compliance Pressures for Wearable Manufacturers
On July 14, 2025, FDA issued a Warning Letter to WHOOP, Inc. concerning its Blood Pressure Insights (BPI) feature of its wearable bands, which the company had positioned as a non-regulated general wellness product. FDA asserted it was an unapproved medical device that required 510(k) clearance.
The letter marks a notable shift in the agency’s enforcement strategy for wellness products. Historically, FDA has evaluated products based on their intended use as reflected in claims and labeling. However, in this case, FDA applied a broader “inherent use” doctrine, asserting that WHOOP’s blood pressure estimation feature is intrinsically linked to diagnosing hypertension—regardless of the company’s stated intended use or disclaimers. This approach suggests that FDA may now regulate certain physiological measurement technologies as medical devices, even if they appear to comply with the agency’s General Wellness Policy for Low-Risk Devices.
FDA rejected WHOOP’s argument that its blood pressure estimation feature is low-risk, emphasizing the potential harm of inaccurate readings and the public health importance of hypertension. As a result, the agency concluded that the feature did not meet wellness criteria and could not be exempt from device regulation, signaling increased scrutiny for health tech wellness products. Manufacturers should proactively review their product portfolios, ensure alignment with FDA wellness criteria, strengthen regulatory documentation, and avoid language implying diagnostic or medical utility.
Proposition 65 Enforcement Trends and Updates
By way of background, California’s Safe Drinking Water and Toxic Enforcement Act, known as Proposition 65, is a “right to know” law that requires companies doing business in California to provide a warning for products sold to California residents if they expose consumers to certain chemicals at levels “known” to the state to cause cancer, birth defects, or reproductive harm. Alleged violations of Proposition 65 can result in monetary penalties of up to $2,500 per day and significant attorneys’ fees and costs.
Over halfway through the year, private enforcement actions under Proposition 65 are again on the rise. July saw a 64% uptick in claims compared to June, with a total of 622 notices of violation issued. Retailers and restaurants were the hardest hit by the increase, with 253 new claims joining the prolific prosecution of Bisphenol S (BPS) exposure from thermal receipt paper. These actions are particularly challenging to defend because the state has not set a safe harbor level for BPS. Businesses using thermal paper should be aware of these actions, evaluate their sources, and consider posting warnings at all points of sale.
The food, beverage and herbal supplement industries continue to be a target for alleged exposures to heavy metals (predominantly lead and cadmium), “forever chemicals” (PFOA/PFOS), and Bisphenol A (BPA). The personal care aisle has been hit hard this year by PFOA claims, as well as an ongoing, industry-wide prosecution involving diethanolamine (DEA) in numerous products, from makeup to shaving gels. A variety of small household goods and accessories continue to be reliably noticed by bounty hunters for lead and phthalates (DINP, DEHP and DBP).
Also on the radar is the upcoming implementation of amendments to the short-form Proposition 65 warnings, which were adopted at the end of 2024 and require – among other things – the identification of at least one specific chemical within the warning. Although businesses have until January 2028 to comply, for many the shift may involve a significant and time-consuming effort.
Speaking of Prop 65…
Rebecca Lee and Jennifer Singh have joined our firm’s Litigation and Prop 65 practice groups as partners, expanding our highly experienced attorneys offering dispute resolution, trial practice, and Prop 65 counseling and litigation services.
Lee is a solutions-driven lawyer who works tirelessly to get the best results for clients involved in high-stakes commercial litigation and environmental matters. Particularly sought after for her deep knowledge of California’s Prop 65, she advises clients on complex compliance matters and high-stakes litigation. She also helps clients develop and implement environmental management systems.
Singh is a civil defense litigator with twenty years of experience who seeks to understand each client’s priorities and goals to achieve the best resolution. Specializing in product and chemical regulation, she provides strategic legal counsel to businesses of all sizes from diverse industries, skillfully guiding clients through the complexities of litigation, enforcement actions, settlements, compliance programs, exposure assessments, and/or risk mitigation. She brings to her practice the unique experience of having tried two of the rare Proposition 65 cases that went to trial in California, delivering two wins for prominent food manufacturer clients.
