FDA in Flux — January 2026 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

FDA Loosens Digital Health Enforcement Policies

What is happening: FDA Commissioner Dr. Marty Makary announced on January 6, 2026 at the Consumer Electronics Show and on social media that the agency was creating new policies to relax regulatory enforcement for certain digital health products. That same day, FDA released revised guidances on clinical decision support (CDS) software and general wellness products. Significant changes include:

1. Clinical Decision Support Software Guidance

• Expanded FDA’s interpretation of Criterion 3 from Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) for determining whether a CDS software function is exempt from device regulations. The agency will now exercise enforcement discretion for CDS software functions that output a single preventive, diagnostic, or treatment recommendation when “only one option is clinically appropriate” and the software function meets all other exemption criteria. However, FDA still prefers that CDS software functions provide a prioritized list of recommendations for users, and there remain questions about when certain functionalities that fail Criterion 3 require device pre-market review.
• Clarified that “medical information about a patient” for purposes of Criterion 2 is information whose “relevance to patient care is supported by well-understood and accepted sources [which are widely accepted by physicians or scientists and supported by scientific evidence] and can be appropriately understood in context.” This update helps resolve ambiguities in the previous version of the CDS guidance.
• Clarified that enabling a health care professional’s (HCP) independent review of a CDS software function output for purposes of Criterion 4 may be met by providing information about “underlying sources” in “plain language,” as well as context about what is known and unknown for each recommendation, to ensure the intended HCP user understands the basis of the output. These clarifications indicate that proprietary information about the CDS software’s underlying technologies may not be required to meet Criterion 4, so long as a “sufficient” description can be provided to end users. In addition, the guidance states that the “level of software automation” and the “time-critical nature” of the intended use cases must be appropriate to give the HCP adequate opportunity to review the bases for the software function’s output and to help avoid automation bias.

2. General Wellness Guidance

• Added that products are general wellness products if they (a) use non-invasive sensors to measure certain health-related physiologic factors, such as blood pressure, oxygen saturation, blood glucose, and heart rate; (b) are intended only for wellness uses (i.e., not for diagnosis, cure, mitigation, prevention, or treatment of any disease or condition); and (c) meet other specific criteria, such as not posing safety risks to users and not claiming to substitute for an FDA-authorized device. FDA also expects all user manuals, other labeling, and advertising for a wellness product to be consistent with its non-device intended uses.
• Added that a general wellness product may notify users that “evaluation” by an HCP “may be helpful when outputs fall outside ranges appropriate for general wellness use,” so long as it does not provide diagnostic information or clinical determinations. The product also may not suggest that the result is “abnormal,” which may prove challenging, as many wellness products provide user alerts relating to physiologic data.
• Added a new general wellness product example describing a “wrist-worn wearable product intended to assess activity and recovery that outputs multiple biomarkers, among which are hours slept, sleep quality, pulse rate, and blood pressure” with no claims relating to a specific disease or condition or use in a medical or clinical context.

Why it matters: FDA’s revisions to these digital health guidances amount to a reversal of the agency’s historically conservative approach to CDS software functions and general wellness products. The new policies allow greater flexibility for software developers in the health and wellness space to avoid FDA’s regulatory territory. Notably, the revisions to the General Wellness Guidance appear specifically tailored to address wearable technology company WHOOP Inc.’s advocacy for broader enforcement discretion in the wake of receiving a warning letter for including blood-pressure data in its wearables’ output capabilities. The “wrist-worn wearable” described in the guidance’s newly added product examples closely resembles WHOOP’s wearable, including its “Blood Pressure Insights” function that led to last summer’s warning letter.

Who may be affected: Digital health product developers, health care providers, investors, and patients each stand to benefit from these FDA interpretative and enforcement policy changes. Nationwide reception to these announcements was generally positive, tempered by reminders from researchers and consumer advocates that the loosening of regulatory oversight should be paired with an increased emphasis on data validation and robust design controls. Further, because the two guidance documents are only interpretations of the FD&C Act’s language, they are both non-binding and open for potential challenge as being at odds with the language duly enacted by Congress. FDA’s decision to announce these significant changes using non-traditional channels and to not provide for a pre-change public comment period may make them more susceptible to future legal challenge. Industry members should continue to be thoughtful in performing comprehensive risk assessments of product deployment and life cycle strategies given these external uncertainties. In the short term, however, the changes appear to signal a more relaxed enforcement stance toward products claiming to be intended for wellness uses only, which bolsters industry investments in more complex products for general health uses.

FDA Meets PFAS Report Deadline Under MoCRA; Findings Highlight Important Safety Data Gaps

What is happening: The Modernization of Cosmetics Regulation Act (MoCRA), which was enacted in December 2022 and summarized in a prior blog post, included a requirement that FDA issue a report within three years examining the use of per- and polyfluoroalkyl substances (collectively PFAS) in cosmetic products and their associated risks. FDA met that deadline when it released the PFAS Report on December 29, 2025, signaling that the directive had not been forgotten in the Trump administration’s adjustment of the agency’s priorities.

The PFAS Report relied on industry-level product data (so-called commercial product listings), which cosmetic product owners must submit under MoCRA. Following its review of product listing data available as of August 2024, FDA concluded that:

• 51 different PFAS are being used in 1,744 cosmetic product formulations (comprising only 0.41% of the total products listed);
• eye shadows, leave-on face and neck products, eyeliners, face powders, and foundations were the top five product categories and constituted approximately 56% of PFAS-containing products;
• the 25 most frequently used PFAS represent approximately 96% of the intentionally added PFAS in cosmetic products (this subset was further prioritized for the agency’s safety review);
• “toxicological data for a majority of these PFAS are incomplete or unavailable” because much of that owner-generated information is not published or available in the public domain for the agency to review.

FDA also found that “five PFAS appeared to present low safety concerns under their intended conditions of use” while “one PFAS was identified as having a potential safety concern with significant remaining uncertainty” (specifically, perfluorohexyl ethyl triethoxysilane when used in body lotion). Safety of the remaining 19 PFAS could not be definitively established with the data available to FDA, highlighting critical gaps in regulators’ and consumers’ knowledge about cosmetic product formulations.

Why it matters: There are currently no federal regulations prohibiting PFAS ingredients in cosmetic or personal care products, but there are increasingly state laws that do. FDA’s statements in the PFAS Report are likely to spur additional actions by state legislatures and governors seeking to protect consumers from potential long-term toxicological risks.

Further, the presence of any PFAS for which definitive safety concerns related to cosmetic uses can be established may be sufficient to render a marketed product adulterated and subject to FDA enforcement, especially in light of MoCRA amendments requiring owners to have “safety substantiation” for each cosmetic product. The agency alludes to this possibility in the press release announcing the PFAS Report, noting that it “will take appropriate action if safety concerns emerge related to such cosmetic products.” As governments, consumers, and plaintiffs’ lawyers continue to pay close attention to the emerging science on PFAS in various product categories, FDA’s actions will continue shaping the dialogue around safety and acceptability of certain ingredients in cosmetic and personal care products.

Who may be affected: FDA has missed several other regulatory deadlines under MoCRA, including orders from Congress to propose good manufacturing practice regulations for cosmetics and to require fragrance allergen labeling disclosures. The timely issuance of the PFAS Report suggests a renewed focus by the agency on its cosmetics mission and the possibility of movement in 2026 on those and other delayed administrative actions. For example, the fragrance allergen proposed rule appears in the most recent White House regulatory agenda with a target release date of May 2026. Stakeholders in the cosmetic and personal care industries should be on alert for significant actions from FDA related to implementing MoCRA and ensure effective engagement by providing comments, participating in meetings, and otherwise educating the staff in the newly reorganized Office of Cosmetics and Colors about their products and testing methods.

Agency Publicly Shames Multiple Retailers for Ineffective Infant Formula Recall Actions, Reminds Industry as a Whole of Legal Obligations

What is happening: In late 2025, infant formula manufactured by ByHeart Inc. was identified as being associated with an emerging cluster of botulism cases in babies, leading to a nationwide recall of all ByHeart formula products (see here and here). Although no infants have died from botulinum toxin exposure, at least 51 have been hospitalized and their families have almost certainly been traumatized by the experience. In addition, many botulism victims never recover entirely and may have lifelong symptoms.

The uniquely vulnerable nature of the ByHeart formula’s consumers made this a high-profile recall, and the agency appears to have taken advantage of those circumstances to reiterate supply chain participants’ legal obligations. Specifically, FDA:

• conducted thousands of effectiveness checks directly and through state partners to determine whether the recalled products remained on store shelves;
• issued warning letters to four national retailers for continuing to receive, distribute, and offer for sale ByHeart’s recalled products for weeks after the firm’s recall initiation notices were sent; and
• published an open letter to all food industry leaders calling on them to “strengthen recall compliance and ensure recall effectiveness.”

Why it matters: FDA’s expectations for recalled products, especially those with a high risk of causing “serious adverse health consequences or death,” are clear — they must be removed from the marketplace to prevent consumer harm — and the letter to industry serves as a roadmap of general requirements. But every entity receiving, holding, distributing, or selling FDA-regulated products should be familiar with all applicable requirements and ensure they are ready to comply in the event of a recall. Recall readiness and effective implementation are key to protecting not only consumers from potentially harmful products but also the business, its board members, and its investors from future allegations associated with either failing to act entirely or taking insufficient actions.

Who may be affected: All retailers and distributors of FDA-regulated consumer products (not only foods and supplements but also cosmetics and medical products) should heed these reminders and take this opportunity to revisit their internal policies, procedures, and communication plans for responding to a manufacturer-initiated recall. Businesses should also update training materials and offer any necessary refresher or new training sessions to employees. Relevant personnel within every business should understand their specific roles as well as the need to move quickly to implement recall instructions upon receipt. And as part of their oversight duties, company management teams, board members, and hands-on investors should encourage proactive compliance programs be implemented by these regulated business entities.

Advisory Committee Meetings for Individual Drug Products Plummet; Long-Term Effect on Agency Decision-Making Remains to Be Seen

What is happening: As FDA stakeholders look back on 2025, one striking statistic is that the agency convened only seven advisory committee meetings to discuss pending drug and biological product applications over the course of the year. By comparison, there were 12, 18, and 10 such meetings in each of the previous three years, respectively. Advisory committee deliberations are open to the public and meeting agendas typically include a public comment session that allows additional perspectives and information to be shared with committee members and the agency.

Why it matters: Public discussion and debate around newly emerging medical technologies, including consideration of different opinions or dissenting views of complex non-linear issues such as how much residual risk is acceptable when considering a product’s clinical benefits, has been a hallmark of credible regulatory decision-making for much of FDA’s history. An agency webpage explaining the role of advisory committees to consumers (last updated in 2016 and still available here) says it well: “The primary role of an advisory committee is to provide independent advice that will contribute to the quality of the agency’s regulatory decision-making and lend credibility to the product review process. In this way, the FDA can make sound decisions about new medical products and other public health issues.” Reducing the use of advisory committees may lead to a decrease in the quality of the agency’s drug-specific risk/benefit analyses, as well as potentially result in “blind spots” on narrow issues for which FDA may not have relevant internal expertise.

Who may be affected: Consumers, patient advocacy groups, public health researchers, and drug developers alike may lose from an apparent FDA decision to stop soliciting input from independent external advisors on challenging clinical data or other difficult questions related to medical product innovations. The agency itself will also lose important sources of additional information, which may over time create less robust analytical documentation supporting individual product decisions. Public discussion of emerging regulatory issues has an educational effect as well, providing other inventors and investors with critical input on how FDA and key opinion leaders in a particular discipline are evaluating new areas or are considering risk.

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