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  • Whose 510(k) Is It Anyway?

    FDA recently released a draft guidance regarding the transfer or sale of a 510(k) clearance. When a 510(k) for a device is sold or transferred from one entity to another, the new 510(k) holder must list the device with the FDA.  If the device has not been significantly changed or modified, the new 510(k) holder is required to provide the original 510(k) number when creating their device listing.

    FDA notes that the sale or transfer of a 510(k) may involve changes to labeling, such as the name of the place of business and/or the device brand and model name, which likely requires a new unique device identifier (UDI) and as such will also require an update submission to FDA’s Global Unique Device Identification Database (GUDID).  Failure to register, list, or update GUDID information may render the device either adulterated, misbranded, or both. FDA has received requests from new 510(k) holders requesting that FDA update the information (e.g., establishment registration and device listings); however, this is the responsibility of the new 510(k) holder.  While it is true the new 510(k) holder can electronically update the device listing and establishment registration, unfortunately, the 510(k) database does not get updated.  This is unfortunate given that Sponsors typically search the database by applicant name or device name when searching for potential predicate devices. It would be an improvement if there was a way to update the 510(k) database with the new 510(k) holder name and new device name, or at least a way to search the registration and listing database by the 510(k) number.

    While FDA’s guidance does not address considerations beyond transfer of a 510(k), there are other items that the purchaser should be aware of when acquiring a 510(k).  For example, the purchaser should ensure that, as part of the transaction, they receive a complete copy of the 510(k), including all correspondence to and from FDA regarding the submission.  If the purchaser fails to do so, the only other way to obtain the 510(k) would be through a Freedom of Information Act (FOIA) request, which can take a significant amount of time (especially at the current FDA, which has been hit hard with cuts to FOIA staff).  In addition, Sponsors should also obtain copies of all prior “Letters to File” documenting the prior 510(k) holder’s analysis of changes implemented since receiving clearance of the 510(k) being transferred or sold.

    Finally, because FDA believes there can only be one 510(k) holder for a device at a time, the 510(k) purchaser should ensure there are appropriate representation and warranties in the acquisition documents establishing that the purchaser is the sole owner/holder of the 510(k).

    Interested parties can submit comments regarding the draft guidance until August 4, 2025.

    Categories: Medical Devices

    Color Food Beautiful: FDA Approves Gardenia Blue and Continues Push to Phase Out

    On July 14, 2025, the U.S. Food and Drug Administration (FDA) approved Gardenia Blue, a plant-based color additive, while simultaneously making clear to industry that the Agency encourages food manufacturers to accelerate their phasing out of the use of the synthetic dye FD&C Red No. 3 in food prior to the previously announced 2027 deadline.

    This dual action underscores FDA’s continued alignment with and focus on the Make America Healthy Again (MAHA) initiative, which focuses on, among other things, the removal of petroleum-based synthetic dyes from foods.

    “Natural Colors” In, Artificial Dyes Out

    FDA has long claimed that there is no such thing as a natural color, as any color additive is artificial.  Any color substance, no matter if it is nature-derived or petroleum-based, must be approved by FDA via a color additive petition (CAP).  As we reported previously, the Department of Health and Human Services Secretary, Robert F. Kennedy, Jr., has highlighted the removal of petroleum-based synthetic dyes as a focus of the MAHA campaign.  See also link.  FDA has withdrawn the approval of Red No. 3 based on evidence that it causes cancer in animals, but even though there is no evidence that they are unsafe, Secretary Kennedy has encouraged industry to also (voluntarily) remove any and all petroleum-derived dyes from foods.  To aid the industry in this effort, FDA appears to have accelerated approval of nature-derived color additives, often referred to as “natural colors.”

    Gardenia Blue, derived from the fruit of the Gardenia jasminoides plant using genipin, is the latest in a string of plant-based color additives to receive FDA approval.  It joins three others, which FDA authorized in May, two plant-based colors and one mineral-based color, reflecting a clear regulatory trend toward food colors derived from nature.  FDA determined that Gardenia Blue, meeting certain specifications, is safe for use in a variety of foods, such as sports drinks, flavored or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, and hard and soft candy.

    Although color additive approvals result from CAPs and the relevant petitions have been in the pipeline for several years, the four approvals so far under this administration appear to mark a sharp uptick from years prior.  In 2025, before President Trump took office, there was one approval for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products.  In 2024, there were zero approvals.  In 2023, there was one approval for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories, and, in 2022, there were three approvals for the safe use of spirulina (Arthrospira platensis), calcium carbonate, and Antarctic krill meal in various food products (link, link, link).  As of this writing, there are an additional four CAPs pending review.

    These approvals align with MAHA’s broader strategy to replace petroleum-based synthetic color additives with consumer-preferred alternatives—a move that also responds to public pressure.

    Red No. 3 Gets a Firm Deadline

    For decades, Red No. 3 has faced criticism due to research linking it to cancer in lab animals (see, e.g., link).  Although it was banned in cosmetics in 1990, it remained legal for use in foods—until recently.  In response to a petition from 2022, FDA revoked Red No. 3’s authorization and repealed the relevant regulation.

    FDA has set a firm deadline of January 15, 2027 for manufacturers to phase out the use of Red No. 3 in food products.  However, FDA encourages the industry to remove the color additive as soon as possible.  According to the Agency’s official announcement, this phase-out aims to “further the goal of Making America Healthy Again” and reduce health risks associated with synthetic dyes.

    FDA has pledged to offer guidance and technical support to the industry throughout the transition.  Prompt approval of alternatives to Red No. 3 and other certified colors would certainly help accelerate the phase out.  That said, every new color comes with its own challenges, and the industry will need time to adjust processing and formulation to produce the right color using a color additive.

    MAHA Agenda Continues to Gain Momentum

    This regulatory momentum is part of a wider effort spearheaded by Secretary Kennedy, who has made food reform a central pillar of the MAHA agenda.  Among other things, the initiative aims to eliminate “unsafe additives.”

    FDA’s FY 2026 budget request includes $49 million to support food chemical evaluations, safety reviews of high-risk additives like phthalates and synthetic dyes, and the development of a post-market surveillance system for food additives.

    Industry Impact and Takeaways

    As we have cautioned and discussed before (here, here), food and beverage companies should take careful note of these developments and related state-level initiatives.  With FDA setting clear deadlines and increasingly favoring plant-based alternatives, proactive adaptation will be critical.  Companies that invest in reformulation and label transparency will be better positioned to meet regulatory requirements and consumer expectations.

    HP&M Welcomes Peter Dickos to the Firm

    Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Peter “Pete” Dickos has joined the firm as Counsel.

    Pete brings nearly a decade of high-level government experience to HP&M’s Enforcement and Litigation practice, with a particular focus on complex regulatory and litigation challenges involving the U.S. Food and Drug Administration (FDA). He most recently served for over six years in FDA’s Office of Chief Counsel, first as an Assistant and then as an Associate Chief Counsel. In that role, he led and supported the agency’s litigation efforts in high-stakes matters involving drug approvals, exclusivity disputes, enforcement actions, and administrative law challenges.

    Pete’s in-depth knowledge of FDA’s internal processes and priorities enhances his ability to advise pharmaceutical, biotech, and other FDA-regulated companies on regulatory compliance, product development, and enforcement risk. He also provides strategic litigation support and proactive counsel on agency engagement.

    Prior to his government service, Pete was a litigation associate at Williams & Connolly LLP and clerked for the Honorable Mark R. Hornak of the U.S. District Court for the Western District of Pennsylvania.

    “Pete was a formidable adversary during the many years we squared off in court, and I couldn’t be happier that we’re finally playing for the same team,” said HP&M Director Mike Shumsky. “With his deep experience litigating FDA-related cases, exceptional analytical instincts, and quick wit, Pete is poised to take our litigation practice to the next level and will deliver tremendous value to our clients in their most significant disputes with the government and their competitors.”

    Pete earned his J.D., cum laude, from Harvard Law School and his B.S. in Psychology, with a concentration in Neuroscience, summa cum laude, from Duke University.

    Categories: Miscellaneous

    And We’re Off: FDA Announces That the Commissioner’s National Priority Voucher Program is Open for Applications

    We blogged recently about the new Commissioner’s National Priority Voucher (“CNPV”) program, noting that we were eagerly awaiting additional details. On July 22, 2025, FDA announced some of these additional details and opened the CNPV program for applications.

    These additional details are to be found on FDA’s new webpage for the CNPV program, along with a program submission form and an updated FAQ. As a reminder, the CNPV pilot program is designed to reduce application review times to 1-2 months following final submission of an application. The voucher also entitles the company to benefits such as enhanced communication and rolling review, which would enable the shorter review time once the application is submitted.

    The new webpage provides further color on the reasons for the CNPV program. The webpage describes high rates of obesity and other health conditions among American youth and overreliance on China for active pharmaceutical ingredients and drug components as two examples of “severe threats to U.S. national security and the ability of Americans to live prosperous, healthy lives” that require FDA and the pharmaceutical industry to “act with appropriate urgency to advance transformative products and secure our critical supply chains.” The webpage also highlights the fact that the CNPV program is not limited to rare diseases and is intended to “advance the broader America First agenda by accelerating cures and meaningful treatments with historic public health impact for Americans, especially including common chronic conditions and high prevalence diseases.”

    The specific national health priorities that would qualify for a voucher have been described before, but the webpage provides more description and examples of how each could be met:

    • Addressing a U.S. public health crisis. Example: A universal flu vaccine.
    • Delivering more innovative cures for the American people. This priority focuses on “transformative impact that far outstrips the threshold for breakthrough therapy designation.” Examples: A novel immunotherapy to enable the immune system to fight multiple diseases; a novel treatment for PTSD.
    • Addressing a large unmet medical need. Examples: Drugs to treat or prevent rare diseases or addressing America’s chronic disease crisis.
    • Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency. Examples: Companies with new manufacturing establishments that shift manufacturing of “essential medicines (such as generic sterile injectables)” from foreign facilities to those within the U.S.; a “clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care.”
    • Increasing affordability. This priority was not included in the original list of priorities, but it was mentioned by Commissioner Makary in an interview on Bloomberg TV. Examples: A company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation (“MFN”) pricing; a product that reduces other downstream medical utilization to lower overall healthcare costs.

    To be eligible for a CNPV, the company must demonstrate alignment with one or more of these priorities. Vouchers can be granted for review of a specific drug or be granted to a company as an undesignated voucher, which would allow a company to use the voucher at its discretion subject to consistency with the program’s objectives.

    To request to participate in the CNPV program, a company must submit FDA’s program submission form. In completing this form, a company must select from a drop-down menu the primary national health priority the program addresses. A company must submit a brief description (350 words or fewer) of how the program aligns with the selected national health priority. This description should also include information about the disease or condition, the potential impact of the drug, the current stage of development (with relevant clinical data), any unique aspects of the company’s approach that make it particularly relevant for the chosen priority, and any specific issues for which enhanced communication is sought. This strikes us as a lot of information to squeeze into 350 words, but given the interest within industry for this program, we understand the attempt to limit the amount of work necessary to evaluate what is certain to be a flood of requests.

    At this time, a company is limited to submitting one application. The submission will be evaluated by a senior, multi-disciplinary review committee/council led by the FDA’s Office of the Chief Medical and Scientific Officer (an office held by Vinay Prasad, the Director of CBER). The council will select scientific and medical experts from relevant FDA offices and divisions for a team-based priority review. Companies should be prepared to respond promptly to any FDA inquiries regarding the submission, and FDA may contact companies directly to request an informational meeting for submissions showing initial promise as part of the selection process. A company will only be notified (by email) if additional information is needed to evaluate a submission or if a company has received a voucher. FDA has established an email address for questions (CommissionerVoucher@fda.hhs.gov) and noted that the FAQ will be updated regularly as questions arise.

    The review council intends to select no more than five pilot participants during the initial year based on the specific priorities and application readiness (e.g., companies demonstrating the ability to move forward towards a marketing application). The number of vouchers granted may be increased in future years. Vouchers will be awarded on a rolling basis. Even if not included in the initial selections, FDA may follow up with other companies that have expressed interest over time.

    As mentioned, this program has generated considerable interest within industry. Given the various national priorities that the CNPV program is trying to incentivize, many companies likely have arguments that they qualify for a voucher. Although we would encourage any company that believes it qualifies to apply for a voucher, the current limitation of one application per company means that companies should be thoughtful about how they choose to proceed, particularly because application readiness is a consideration for the selection of pilot participants, and it is not clear when a company might be allowed another shot at the CNPV.

    We would also caution companies not to forget about the existing expedited programs in the excitement of this new program. Given the likely intense competition for the first five vouchers at this early stage, the chances of selection for any individual company are slim. Even if the CNPV program were to expand, its resource demands are likely to limit the number of applications selected in the future. So don’t forget those fast track, breakthrough therapy, and RMAT designations!

    We look forward to seeing how the CNPV program progresses and which drug development programs receive vouchers, if/when they are identified.

    Upcoming Webinar on July 29: Avoiding Common Pitfalls During FDA Inspections

    As we have previously covered, FDA has long been on the receiving end of criticism about its lagging foreign inspection program.  The focus of the criticism has been that simply not enough foreign inspections are occurring at all and, when they do, they have historically been preannounced several weeks in advance.  With a preannounced inspection, the facility has time to correct known issues in advance, meaning FDA theoretically isn’t observing the true day-to-day operations of the site.  In response to this, FDA began conducting unannounced or short-notice inspections in China and India several years ago.

    On May 6, 2025, FDA announced that intends to expand the Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program “to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.”  While the details of the expanded program are vague, this is a good opportunity for stakeholders across FDA-regulated industries around the world to ensure they are inspection ready.  On July 29, 2025, ProPharma and HPM’s Kalie E. Richardson will be participating in a complimentary webinar on Avoiding Common Pitfalls During FDA Inspections to discuss common FDA inspection findings and how they can be avoided.  Please join us for the live session on July 29 at 8-9 am EDT / 2-3 pm CEST / 5:30-6:30 pm IST.

    Categories: cGMP Compliance

    Sometimes, Timing is Everything

    A recent appellate court decision vacating a Federal Trade Commission (“FTC”) rule on procedural grounds may spell the end of the effort to implement the “Negative Option Rule.”

    For any blog reader who has ever missed that cancellation deadline and found themselves saddled with another month (or year) of a streaming service or gym membership, this decision may be of personal interest, but, for regulated industry, it highlights how a procedural win can sometimes be a full victory.

    On July 8, 2025, the U.S. Court of Appeals for the Eighth Circuit delivered a major blow to the FTC’s efforts to simplify subscription cancellations, vacating the Commission’s finalized amendments to its “Negative Option Rule.”  This rule, finalized in October 2024, was designed to make it easier for consumers to cancel automatically renewing subscriptions and recurring charges—addressing widespread complaints about so-called “subscription traps.”

    This ruling emerged from multi-district litigation (“MDL”) across four federal circuit courts, brought by numerous industry associations and businesses.

    The FTC’s Now-Vacated Rule:  What Was It?

    The FTC’s updated Negative Option Rule would have:

    • Mandated a simple cancellation mechanism, such as a “click-to-cancel” button for online subscriptions,
    • Required sellers to obtain express consent for recurring charges, and
    • Obligated companies to provide clear, upfront disclosures about the terms of the deal—including the frequency and cost of recurring payments.

    The rule applied broadly across industries, from streaming services and software providers to subscription boxes (e.g., Blue Apron, Stitch Fix) and even gym memberships.

    The Court’s Rationale:  Procedural Slipup

    The court’s three-judge panel unanimously found that the FTC’s click-to-cancel rule violated the procedural requirements for a preliminary regulatory analysis, triggered by the rule’s estimated annual economic effect of $100 million or more.  The Commission’s original estimate did not meet or surpass the $100 million threshold; however, in an April 2024 recommended decision, an administrative law judge subsequently disagreed with the FTC’s estimate, finding that the economic effect would reach this threshold based on practical considerations (e.g., cost of implementation).  Despite the administrative law judge’s finding, on November 15, 2024 (i.e., after the election but before the change in administration), based on a 3-2 vote, the FTC moved forward with the final rule.

    This decision effectively nullifies the updated Negative Option Rule and sends the FTC back to the drawing board.  Considering the current makeup of the FTC commissioners, there is a very good chance that the Commission chooses to forego revising and attempting to re-implement the rule.

    Why Should Our Readers Care?

    Beyond the FTC Negative Option context, this decision highlights the importance of evaluating whether a potential procedural failure by the government is worth litigating—remember, not all procedural defects are created equal.  A company’s cost-benefit analysis may caution against pursuing litigation based on a procedural defect when, for example, the agency is able to cure the procedural defect, and, in the interim, the company would not obtain any relief.  When evaluating potential challenges to an agency action, it is critical to consider the legal and practical consequences of a “win.”  Here, because of the timing and change in administration, the petitioners were successful in seizing upon the procedural defect and upending agency rulemaking that was years in the making.

    To Meet or Not to Meet: Day 70 and Counting

    Recent communications from CDRH indicate that impacts to resources from Reductions-In-Force are causing some Offices in CDRH to delay granting a request for a pre-submission (or Q-Submission) meeting until after written feedback is provided. In a pre-submission, the Sponsor can request written feedback only, but in most cases the Sponsor requests either an in-person or teleconference meeting, both of which are preceded by written feedback. The normal process is for FDA to schedule the meeting soon after receipt of the request in order to provide adequate time to coordinate schedules. Per the Q-Submission Guidance, these meetings are usually held 70-75 days after receipt of the submission. Written feedback is generally provided around day 70, or five days before a scheduled meeting, whichever is sooner.

    We recently learned that at least one Office is responding to pre-submission requests stating that while it aims to provide written feedback within 70 days, the Office will not schedule a meeting until the Sponsor receives the written feedback and determines it would like a meeting to clarify any points in the feedback. (It is worth noting that a meeting will be automatically set at day 75 due to the database system’s programming, but this is not a real meeting date.)

    On the surface, this is reasonable. If feedback is clear, there is no need for a meeting. In fact, the guidance document specifically says the Sponsor may cancel a meeting if they are satisfied with the written feedback. It is, of course, always easier to cancel a meeting than to schedule one, and our experience has shown that even scheduling a meeting two months in advance can at times prove challenging. The reality is that if the Sponsor is not allowed to formally request a meeting until after receipt of written feedback at day 70, it is not clear how long it could be until a meeting could be scheduled, given the challenges in doing so-but it would certainly be at least three, and likely more, months from the time of submission of the Q-Sub to the meeting with FDA. This can cause a significant delay for companies who are working towards aggressive timelines and need FDA feedback to move forward with next steps. Delayed meetings could also jeopardize the ability of companies to raise capital as FDA feedback can inform investor confidence and potentially impact funding. Most companies simply cannot afford to wait that long to resolve critical matters.

    As Sponsors who have met with FDA know, meeting with the review team about its responses to a Q-Submission is incredibly helpful. For companies engaging with FDA for the first time, it allows the company and agency to begin building a relationship that will hopefully take them through a successful product authorization. Furthermore, there is always information that comes up during the course of the discussion that was not captured in the written feedback. These live interactions allow the Sponsor to better understand FDA’s position and how to work through any concerns expressed by the agency.

    Pre-submissions are the best opportunity to align with CDRH. It is the time when Sponsors intensely prepare and make the most out of their meeting, whether by showcasing their expertise on their product and the field or asking clear, objective questions. CDRH’s delays in meeting with Sponsors will call into question the predictability of the review process and potentially exacerbate the availability of novel technology.

    Categories: Medical Devices

    Blood Pressure Rising: FDA Warning Letter Takes an Aggressive Approach on General Wellness Product

    At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than a month later, on July 14, 2025, FDA issued a Warning Letter to WHOOP, Inc., (“WHOOP”), stating that its wearable product, Blood Pressure Insights (“BPI”), is adulterated and misbranded because it is a regulated medical device that is being marketed without FDA clearance or approval. WHOOP’s position is that BPI, intended to provide “daily systolic and diastolic blood pressure estimations, offering members a new way to understand how blood pressure affects their performance and well-being,” is a general wellness product consistent with FDA’s guidance, General Wellness: Policy for Low Risk Devices, and not subject to FDA’s regulatory oversight. The publication of this Warning Letter, only one day after it was issued to the company, therefore raises questions not only about how FDA will think about general wellness products moving forward, but how its thinking will align (or not) with that of the current administration.

    Whether a product is a medical device has long been tied to the claims made by the marketer of the device, also referred to as the product’s “intended use.” The WHOOP Warning Letter turns this well-established precedent on its head. FDA’s position that BPI is a medical device seems to be based almost exclusively on FDA’s position that measurement or estimation of blood pressure (“BP”) is “inherently associated with the diagnosis of hypo- and hypertension and is therefore intended for use in the diagnosis of a disease or other condition, or in the cure, mitigation, treatment, or prevention of disease” (emphasis added).  FDA states not once, not twice, but five times that measurement of BP is “inherently” associated with a disease or condition, which is enough to bring the product within FDA’s jurisdiction, even in the absence of a specific medical or clinical claim.

    If an “inherent association” were enough to bring a product within FDA’s ambit, it would be the undoing of a large swath of general wellness products, many of which were on the market well before the statutory exemption for general wellness products and FDA’s guidance on general wellness even existed. FDA has long taken the position that a product with wellness claims in one context is not a regulated medical device, whereas the same product with a clinical claim would be subject to FDA’s oversight. Two clear examples of this are SpO2 and heart rate monitoring. FDA has created two product codes for “general wellness” versions of SpO2 monitors: OCH, which is defined as an oximeter intended “solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise,” and PGJ, a “pulse oximeter intended for wellness use.” The same SpO2 monitor intended for use in a hospital would be regulated as a Class II device and require a 510(k) clearance. SpO2 rates certainly are “inherently associated” with a disease or condition, namely, how well the user’s lungs are functioning. Similarly, heart rate monitors on wearable products are commonplace these days and provide alerts to users indicating when the heart rate is abnormally high or low, based upon user pre-specified settings. A high or low heart rate is also “inherently associated” with a disease, but these products have been marketed without FDA oversight for years.

    FDA stated in the Warning Letter that, in addition to being “inherently associated” with a disease or condition, BPI is not a “low risk” product because “[a]n erroneously low or high blood pressure reading can have significant consequences for the user.” The same is true of erroneously high or low SpO2 or heart rate readings. The failure of those products to correctly identify high or low SpO2 or heart rate could result in “significant consequences for the user.”

    Not only is the position taken by FDA inconsistent with decades of regulatory oversight and enforcement discretion, but it is also inconsistent with language in the general wellness guidance itself. In the guidance, FDA explicitly relies on the absence of medical or clinical claims to permit products to be deemed general wellness products. For example, FDA states that a software function “that solely monitors and records daily energy expenditure and cardiovascular workout activities to ‘allow awareness of one’s exercise activities to improve or maintain good cardiovascular health’” is not a device function because the claim that relates to a specific organ does so “only in the context of general health and does not refer to a disease or medical condition. In addition, although the monitoring or recording of exercise activities present risks (such as inaccuracy), when made in the absence of disease or medical condition claims, the technology does not pose a risk to the safety of users and other persons if specific regulatory controls are not applied.” (Emphasis added.) According to FDA’s own language, the absence of disease or medical condition claims is critical to determining whether a product is or is not a regulated medical device.

    The Warning Letter makes clear that FDA and WHOOP have been in discussions about the status of BPI for some time, throughout which WHOOP has maintained its position that the BPI is a general wellness product and does not meet the definition of a medical device. FDA, however, has repeatedly disagreed, and the Warning Letter is the escalation of that disagreement. In response to the Warning Letter, WHOOP’s CEO, Will Ahmed, calls FDA’s actions “misguided” and emphasizes that BPI is not intended to diagnose any condition and is clearly labeled for non-medical use. Indeed, the Warning Letter acknowledges that the company included disclaimers on its BPI labeling that the product is not a medical device and cannot diagnose or manage medical conditions, but concludes they are insufficient to outweigh the fact that BP monitoring is “inherently associated” with the diagnosis of a disease or condition.

    Given Secretary Kennedy’s statement specifically supporting use of WHOOP’s wearable, it is unclear how far FDA will go to try to regulate BPI. What happens next will undoubtedly be fodder for a future post, so stay tuned.

    CMS Proposals Would Raise the Bar on Bona Fide Service Fees for Average Sales Price

    The Calendar Year 2026 Medicare Physician Fee Schedule (PFS) proposed rule (here), which was issued yesterday by CMS, contained important amendments to the regulations on Medicare Part B average sales price (ASP) reporting.   One amendment would add provisions for bundled sales that are consistent with those under the Medicaid Drug Rebate Program (MDRP), with which manufacturers are familiar.  However, the other amendment, which addresses bona fide service fees (BFSFs) that are excluded from the ASP calculation, would impose substantial new obligations on manufacturers.

    By way of background, payment limits for separately payable drugs covered under Medicare Part B are calculated on a quarterly basis by CMS.  The payment limit for most Part B drugs is ASP plus 6 percent.  Manufacturers are required to report ASP to CMS quarterly and calculate ASP for each NDC in accordance with the methodology specified by statute and CMS regulations.  Essentially, ASP is calculated as a weighted average price to commercial customers in the U.S, with certain exceptions.  Among other requirements, price concessions must be deducted from the ASP calculation (thereby lowering the ASP and the payment limit).  BFSFs, on the other hand, are not deducted from the ASP calculation, and thus do not lower the ASP.  Inappropriately classifying a price concession as a BFSF, then, artificially increases the manufacturer’s ASP, which, in turn, results in Medicare overpayments and higher coinsurance amounts for Medicare beneficiaries.  According to CMS, the new proposed policies are intended to avoid inaccurate calculations of a manufacturer’s ASP and its effects on Medicare and its beneficiaries.

    Bundled Arrangements

    Bundled arrangements are one type of price concession common in the industry.   CMS proposes to add a definition of “bundled arrangement” to the existing ASP regulations at 42 C.F.R. § 414.802:

    Bundled Arrangement means an arrangement regardless of physical packaging under which the rebate, discount, or other price concession is conditioned upon the purchase of the same drug or biological or other drugs or biologicals or another product or some other performance requirement (for example, the achievement of market share, inclusion or tier placement on a formulary, purchasing patterns, prior purchases), or where the resulting discounts or other price concessions are greater than those which would have been available had the bundled drugs or biologicals been purchased separately or outside the bundled arrangement.

    This definition is familiar to drug manufacturers because it is substantially identical to the definition that has existed under the MDRP since 2007.   See 42 CFR 447.502.   To remain consistent with the MDRP, CMS also proposes to adopt the additional Medicaid language on how to allocate discounts under bundled arrangements:  “The discounts in a bundled arrangement . . . , including those discounts resulting from a contingent arrangement, are allocated proportionately to the dollar value of the units of all drugs or products sold under the bundled arrangement.”

    Recognizing the range of potential structures of bundled arrangements, which may vary based on, inter alia, the number and type of products included in the arrangement and the timing of the price concessions, CMS is soliciting comments on methods of allocating discounts for bundled sales containing both Part B-covered and non-covered products.  CMS is also soliciting comments regarding how discounts associated with sales that may be considered bundled across time periods (e.g., outcomes-based arrangements or value-based purchasing arrangements) could be accounted for in ASP calculations.

    BFSFs

    Under the existing four-prong test in 42 C.F.R. § 414.802, BFSFs are defined as fees paid by a manufacturer to an entity that:

    1. represent fair market value
    2. for bona fide, itemized services actually performed on behalf of the manufacturer,
    3. that the manufacturer would otherwise perform (or contract for) in the absence of the service arrangement, and
    4. that are not passed on in whole or in part to a client or customer of an entity, whether or not the entity takes title to the drug.

    The fee must meet all four criteria to be considered a BFSF rather than a price concession that is deducted from ASP.   In the proposed rule, CMS makes significant changes to criteria 1 (fair market value) and 4 (“not passed on”).

    Fair Market Value

    CMS has historically taken a hands-off approach to manufacturers’ determinations of fair market value, consistently declining to define the term.  For example, in 2016, CMS explained that, “[g]iven the continually changing pharmaceutical marketplace, we will  continue to allow manufacturers the flexibility to determine the fair market value of a  service when evaluating whether the service fee is bona fide or not.”  81 Fed. Reg. 5170, 5179 (Feb. 1, 2026).  Now, CMS proposes much more oversight.  To ensure that BFSFs are correctly identified and that the manufacturer’s ASP is not manipulated, the proposed rule would revise the definition of BFSFs to add the following requirements to the existing four-prong test in § 414.802:

    1. For fees paid by a manufacturer to an entity that do not vary directly with the amount of drug sold or the price of a manufacturer’s drug, CMS would require the fair market value to be determined either based on comparable market transactions that generally reflect current market conditions or the cost of the service plus a reasonable markup to the total cost; and
    2. For fees paid by a manufacturer to an entity that vary directly with the amount of drug sold or price of a manufacturer’s drug, CMS would require:
      • The fair market value to be determined by using the cost of the service and adding a reasonable markup to the total cost (or if any material portion of cost data is unavailable, by using a market-based approach based on verifiable market data until sufficient cost data are available), and
      • The fair market value assessment to be conducted by an independent third-party valuator and documented with a description of the methodology used.

    The manufacturer’s documentation  of the methodology used to determine fair market value would have to be submitted, along with other reasonable assumptions, to CMS each quarter.

    Service fees based on a percentage of sales are ubiquitous in the industry.  Wholesaler distribution fees are one common example.  Under the proposed rule, in order to exclude distribution service fees paid to a wholesaler, it would no longer be sufficient to compare one wholesaler’s fee percentage to other wholesalers’ fee percentages for similar services.  Instead, a manufacturer would have to use a cost-plus-markup approach to evaluate the fees paid to one wholesaler, even if other wholesalers charged the identical percentage of sales.  Further, a manufacturer must pay the expense of retaining an independent evaluator to conduct this analysis.  The more familiar and simpler market comparison approach may be used if cost data are unavailable, but cost data will typically be available from the third-party consulting firms that must be used.  In short, in order to exclude a wholesale distribution fee from ASP as a BFSF, a manufacturer would have to (1) retain an independent consulting firm; (2) have them determine fair market value using a cost-plus-markup approach; and (3) submit the resulting documentation to CMS.

    In addition, CMS would require manufacturers to conduct periodic updates of any fair market value analyses for service arrangements that are ongoing, at a frequency no less than the renewal frequency of the arrangement.

    “Not passed on”

    Recognizing that manufacturers may not know whether fees they pay to a service provider are passed through to another entity, CMS has, since 2007, permitted manufacturers to assume that service fees are not passed on, absent evidence to the contrary.  Under the proposed rule, that assumption would no longer be permitted.  Instead, manufacturers would be required to obtain from each service provider whose fees are treated as a BFSF a certification or warranty that the fees are not passed on in whole or in part to a client, customer, or affiliate of the service provider, whether or not the entity takes title to the drug.  Beginning with the April 30, 2026 quarterly ASP submission for 1Q 2026, these certification letters must be submitted to CMS every quarter, along with the documentation of fair market value described above and other reasonable assumptions.

    CMS’s list of examples

    Lastly, CMS offers guidance in the form of four examples of fees that are not, or may not be, BFSFs:

    1. Arrangements whereby drug manufacturers make payments to drug distributors to subsidize credit card processing fees that would ordinarily be borne by the distributors’ customers are not BFSFs.
    2. Any payment by a manufacturer to an entity for tissue procurement is not a BFSF.
    3. Fees paid for data about the product may exceed fair market value for the service or may not be for bona fide services because the data is required for legal compliance and audit purposes under the service agreement (for example, data to validate that a rebate has been earned or is not duplicative ).  Therefore, data fees, like other service fees, should be assessed for fair market value and a certification obtained that the fees are not passed through.
    4. Fees paid for distribution services should be assessed for fair market value.

    The proposed BFSF amendments would reverse CMS’s decades-old approach to fair market value and passed through fees, and impose a significant new cost and time burden on manufacturers.  Another troubling problem is how the proposed ASP amendments would interact with inconsistent MDRP regulation on BFSFs, which CMS is not proposing to revise as yet.  For example, the proposed regulation would not change the rule that transactions excluded from Medicaid Rebate best price are exempt from ASP.   See 42 CFR 414.804(a)(4)(i).  BFSFs (as defined under the MDRP) are excluded from best price.  Unless the MDRP definition of BFSF is amended, the question arises whether, to be excluded from ASP, a fee must meet the MDRP definition or the new, more exacting ASP definition of a BFSF.

    The proposed rule will be published in the Federal Register of July 16, and comments may be submitted here until September 12, 2025.

    ACI’s Annual Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products – West Coast Edition

    The American Conference Institute’s 3rd Annual West Coast Forum on Legal, Regulatory, and Compliance for Cosmetics & Personal Care Products is scheduled to take place from October 8-9, 2025 in Santa Monica, California.  The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, new FTC advertising guidelines, and FDA leadership changes.  Whether you’re navigating the impact of delayed MoCRA implementation or responding to increased scrutiny on marketing practices, this conference is your one-stop shop for industry perspectives and actionable compliance tools.

    Key highlights for 2025 include:

    • Litigation Trends
    • FDA and FTC Enforcement Priorities
    • Packaging and EPR laws
    • Greenwashing Risks and Advertising Claims
    • Global Trade and Tariff Concerns
    • ESG and Clean Beauty Compliance
    • IP and Privacy Protections
    • Multi-state Regulatory Challenges
    • Legal Hurdles in Scaling from Indie to Mid-size brands

    Hyman, Phelps & McNamara, P.C.’s Riëtte van Laack will speak at a session titled “Cosmeceuticals, Medspas & Professional Products: Navigating the Legal Gray Zone,” where she will examine the unique regulatory and contractual considerations that arise when professional-use cosmetics and skincare products are marketed, labeled, and sold into medspas, massage clinics, and other treatment environments.

    FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA26.  You can access the conference brochure and sign up for the event here.  We’ll see you at the conference!

    Categories: Cosmetics

    Federal Hiring Shake-Up (Again): What the Latest Executive Action and Supreme Court Decision Mean for Industry

    On July 7, 2025, President Trump, via Executive Order (“EO”), issued a presidential memorandum and accompanying fact sheet directing major changes in federal civilian hiring, including extending the federal civilian hiring freeze through October 15, 2025.  Under the titular theme “Ensuring Accountability and Prioritizing Public Safety in Federal Hiring,” the EO aims to align staffing decisions more closely with agency oversight, performance goals, and legal exemptions.

    Broad Hiring Freeze with Specific Exemptions

    • Most notably, a hiring freeze is in effect through October 15, 2025, prohibiting federal agencies from filling vacant positions or creating new roles without written approval from presidential appointees like FDA Commissioner Martin Makary—unless exempted.
    • Exempted roles include those that support national security, immigration enforcement, public safety—clearly, and likely intentionally, vague buckets for the first and third categories.  Specifically, the EO exempts roles including but not limited to military personnel, firefighters, air traffic controllers, Veteran Affairs medical staff, National Weather Source employees, and food inspectors.  The last exemption for food inspectors may be related to this administration’s focus on the Make America Healthy Again (“MAHA”) agenda as spearheaded by the Department of Health and Human Services (“HHS”) Secretary Robert F. Kennedy.  Granted, the fact sheet also does not specify whether “food inspectors” refers to FDA personnel who inspect food facilities and farms, and/or members of the U.S. Department of Agriculture Food Safety and Inspection Service who are responsible for inspecting meat, poultry, and eggs products, as well as (certain) fish.
    • The provision of Social Security, Medicare, or veteran’s healthcare or benefits are also not to be “adversely impact[ed]” by the EO, although no further specificity is provided.
    • The EO makes clear that it does not apply to the Executive Office of the President or its components.

    Role of Presidential Leadership in Hiring Approval

    • Agencies must now secure explicit sign-off from leaders appointed by the president—such as department heads or chiefs of staff—before initiating hires.
    • Approved hires proceed one business day after the Office of Personnel Management (“OPM”) receives confirmation, ensuring direct presidential oversight.

    Aligning with the Merit Hiring Plan

    • All hiring must adhere to the May 29, 2025 Merit Hiring Plan, which emphasizes competency-based hiring and aims to curb bureaucratic inefficiencies.

    Fiscal Discipline & Deregulation

    • Framed as a strategy to enhance fiscal accountability, the initiative is part of the administration’s purported broader goals to control taxpayer spending, streamline government, and reverse the last administration’s federal job growth.
    • This is consistent with the Trump Administration’s 10-to-1 deregulation policy, voluntary attrition programs (see link), and ongoing restructuring efforts.
    • Echoes the hiring restrictions enacted by EOs 14173 and EO 14151 in January, which also eliminated certain Diversity, Equity, and Inclusion (“DEI”) programs.

    Supreme Court Clears Path for RIF Actions

    Coinciding with the July 7th EO, the U.S. Supreme Court issued a decision permitting the federal government to proceed with its Reduction-in-Force (“RIF”) terminations even while legal challenges continue to wind through the courts.  For FDA, this means that thousands of employees previously marked for RIF may soon be officially removed from their positions.

    This decision removes a key procedural barrier that had protected federal employees while litigation played out.  As of now, neither Secretary Kennedy nor Commissioner Makary has commented publicly on the Agency’s response or whether other injunctions will continue to prevent terminations in the short term.

    What This Means for Industry

    For FDA-regulated sectors—including pharmaceuticals, medical devices, food safety, and cosmetics—this convergence of executive and judicial action could have immediate and longer-term consequences such as regulatory delays or disruptions.

    This large-scale personnel reduction at FDA could slow review timelines for applications, and already has in the case of one new drug application, and guidance issuance.

    The FDA’s silence so far has left stakeholders uncertain about how quickly these changes will take effect or how they will be managed.  Industry should stay closely attuned to updates from HHS and FDA leadership, prepare contingency plans for potential regulatory disruptions or delays, and consider deepening their engagement with government affairs teams to monitor and respond to unfolding developments.

    Final Thoughts

    This federal hiring overhaul heralds a new era of presidential oversight, tighter budget constraints, and a shift in prioritization toward “public safety” roles, although it is not entirely clear what this last piece encompasses or means.  Opponents of these presidential initiatives will argue that the administration’s moves centralize authority and politicize the civil service, while supporters will extoll the virtues of a streamlined government, efficiency, and accountability.  Regardless, industry stakeholders should remain vigilant for further updates as well as build in contingencies and temper expectations about predictability with respect to FDA decisions and guidance, including transparency thereinto.

    Interestingly, as of July 11, USAJOBS—the online platform providing access to federal employment opportunities—continues to list 14 open and currently hiring positions at FDA.

    Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

    In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database.  These particular CRLs were issued in response to original and supplemental drug and biological product applications submitted to the Agency between 2020 and 2024 that ultimately gained approval. However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. While the announcement states that FDA is planning to publish additional CRLs from its archives, it is not clear if those CRLs will also be for approved products for which the action packages are already available or products that have not been approved.

    Commissioner Makary linked this initiative to his broader effort to enhance public trust through transparency, stating “[d]rug developers and capital markets alike want predictability. Greater transparency into our decisions will help align expectations and foster better communication among stakeholders.” The announcement goes on to say that, due to the historical practice of “refrain[ing] from publishing CRLs for pending applications, sponsors often misrepresent the rationale behind FDA’s decision to their stakeholders and the public” (emphasis added). The announcement references a 2015 analysis conducted by FDA of 61 CRLs issued between 2008 and 2013 (48 for New Drug Application [NDAs] and 13 for Biologics License Application [BLAs]) attempting to compare the reasons identified in those CRLs for not approving a product with the respective applicants’ public statements regarding the CRL (which we blogged about here; the FDA’s full analysis is available here). This latest initiative suggests FDA’s concerns regarding sponsors’ disclosure of the substance of CRLs persists.    However, it is difficult to see how releasing CRLs to the openFDA database that are already available as part of a product’s action package at Drugs@FDA mitigates these concerns.

    Taking a step back, a CRL is a letter sent to an applicant at the end of FDA’s review cycle of an NDA or BLA when the Agency concludes that the application cannot be approved in its current form. The CRL outlines the specific deficiencies preventing approval or licensure, which often relate to safety or efficacy concerns, problems with manufacturing processes, or, in the case of generics, failures to demonstrate bioequivalence. The letter provides detailed descriptions of the deficiency(ies) and often includes FDA’s suggestions or requirements for resolving them. After receiving a CRL, the applicant must decide whether to address the deficiencies noted in the CRL or, if addressing the deficiencies are too burdensome, withdraw the application entirely. If a drug is approved, section 916 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (codified at 21 U.S.C. § 355(l)) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e., where no active moiety for a drug or no active ingredient for a biological product has been approved in any other application) be posted online within 30 calendar days of approval or within 30 days of the third Freedom of Information Act (FOIA) request for that package.

    FOIA is a federal law that gives the public the right to request access to records from any federal agency, including FDA. The goal of FOIA is to promote transparency and accountability in government by allowing the public to obtain information about agency operations, decisions and communications. However, FOIA has exemptions, which are categories of information that agencies are allowed or are required to withhold. Relevant here, FOIA Exemption 4 protects trade secrets and confidential commercial information. As such, any information in an approval package, including a CRL, must be redacted prior to public disclosure to protect this information and these redactions may be substantial, particularly in cases involving manufacturing processes, formulation details, or future development plans.

    Commissioner Makary’s announcement, made the same day as his statement touting his accomplishments in his first 100 days leading FDA, raises questions about whether this effort is truly “radical transparency” or just a repackaging of existing requirements. The key difference may lie in timing and ease of access; despite the statutory requirement under FDAAA, action packages are often slow to appear on FDA’s website, especially following staffing disruptions at FDA. For example, the FDA staff responsible for posting action packages and responding to FOIA requests were subject to the FDA’s Reduction in Force earlier this year (which we blogged about here). This disruption led to a backlog in public postings of approval materials and responses to FOIA requests. Even as some FOIA staff have returned to the Agency, a backlog continues to persist and some approval packages have yet to appear on FDA’s website.

    It is currently unclear whether FDA intends to publish CRLs close in time to their issuance or for applications that are not subsequently approved. (Query how FDA would make this determination and when – only after a sponsor withdraws their application?) The prospect of publication of such CRLs would likely be of great concern to many applicants and of great interest to their competitors. Regardless, we will be watching to see how this radical transparency initiative unfolds.

    State-Led Food Transparency: Texas and Louisiana Lead the Charge

    Two southern states are taking bold steps to change the way they approach food labeling—and they’re not mincing words.  In a growing movement aligned with the “Make America Healthy Again” (MAHA) agenda, Texas and Louisiana have each passed sweeping new laws requiring clearer warnings and disclosures for food additives and seed oils.

    Together, these laws signal a significant shift in how state governments may begin to challenge the status quo on food transparency, consumer rights, and ingredient safety.  Here’s what industry needs to know.

    Texas Goes BIG on Food Warnings

    Beginning on January 1, 2027, Texans may notice new warning labels on some food products sold in their fair state.  On June 22, 2025, Texas Governor Greg Abbott signed into law SB 25—nicknamed the “Make Texas Healthy Again” law—requiring, among other things, that any food or beverage containing one of 44 specified “ingredients” must carry a prominent warning label if FDA “requires the ingredient to be named on a food label.”  The law applies to all foods, even if produced outside of the state.  This labeling requirement will apply to packages “developed or copyrighted” from January 1, 2027 onward.

    The labels of such products must clearly state:

    WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United Kingdom.

    Thus, the warning requirement is predicated on the regulatory status of the listed substances in the foreign jurisdictions of Australia, Canada, the European Union (EU), or the United Kingdom.

    The warning must “be placed in a prominent and reasonably visible location” and “have sufficiently high contrast with the immediate background to ensure the warning is likely to be seen and understood by the ordinary individual under customary conditions of purchase and use.”  It also must be provided on manufacturers and retailers’ websites that offer the product for sale, or otherwise communicated to consumers.

    What Made the List?

    The law covers 44 substances—from azodicarbonamide (ADA) to bleached flour, titanium dioxide, and synthetic dyes like yellow 5 and 6 and red 3, 4, and 40.  The law includes a federal preemption clause for laws and regulations promulgated by FDA or the U.S. Department of Agriculture (USDA) that:  (1) prohibit the use of the ingredient; (2) impose conditions on the use of the ingredient, including requiring a warning or disclosure statement; or (3) determine that the ingredient or class of ingredients are safe for human consumption.  Some of the substances included on the list—such as partially hydrogenated oils and red 3—are already prohibited in the United States.  Others, such as yellow 5, are already the subject of regulations that impose conditions on their use.  It is not clear to us what exactly the drafters of the law had in mind, but the preemption provision seems to significantly reduce the possible impact of this law.

    Louisiana Follows Suit—with a Twist

    Just days earlier, on June 20, Louisiana Governor Jeff Landry signed SB 14 into law, delivering what may be an even more comprehensive MAHA-aligned measure.  The Louisiana law completely bans certain food and color additives from school meals, requires a warning for certain food ingredients for foods sold in the state, and becomes the first law in the nation to require restaurant disclosures of seed oil use.

    Major Elements of the Louisiana Law:

    • Bans 15 additives in public school, or nonpublic schools receiving state funds, meals (food and beverage) starting in the 2027–2028 school year, including:
      • Artificial sweeteners like aspartame and saccharin.
      • Preservatives such as BHA and BHT.
      • Synthetic dyes.
    • Requires food manufacturers to provide QR codes that will redirect consumers to a webpage that must include a disclosure about the presence of 44 additives.  The disclosure must be accompanied by the statement:  “NOTICE: This product contains [insert ingredient here].  For more information about this ingredient, including FDA approvals, click HERE.”  The QR codes and digital disclosures must be included on the outer product packaging by January 1, 2028.  Notably, this is less of a “warning” than the Texas law’s provision.  Another notable difference between the Louisiana and Texas law is that the Louisiana bill does not include a preemption provision.
    • Requires seed oil disclosures be displayed on restaurant menus or in-store signage for items prepared with oils such as canola, soybean, sunflower, or cottonseed.

    While the Louisiana law stops short of requiring on-package printed warnings like Texas, its QR-code-based digital notice system aims to balance transparency with practicality.  The approach, lawmakers say, is modeled on international labeling practices but tailored for local implementation.

    Industry Implications

    It remains to be seen how industry will respond to the Texas and Louisiana laws.  Reformulation to avoid the warning requirements might seem the least “painful.”  However, if that is not an option, will there be two warnings/disclosures on the label?  And what if a third state requires yet another warning/disclosure?  The options are bad enough that the possibility of a judicial challenge to one or both of the laws cannot be excluded.

    A Growing MAHA Movement

    Both laws appear to be part of a broader effort to advance the MAHA agenda.  The Department of Health and Human Services Secretary Robert F. Kennedy Jr., a vocal opponent of seed oils and food additives, praised the state laws as essential tools to fight chronic disease and reduce national healthcare costs.  Pat McMath, a Louisiana Senator, emphasized that the Louisiana bill would give federal regulators and reform-minded lawmakers the leverage to “force the food companies to the table to change and alter the ingredients that are all making us sick.”

    Governor Landry echoed this sentiment, citing Louisiana’s dismal health rankings and declaring that the new law marked “the beginning of a healthy transformation for Louisiana.”  See, e.g., link.

    A Sign of Things to Come?

    This may foreshadow future legislative action at the state level. The size of Louisiana and Texas’s markets, as well as their economic influence, could and likely will have ripple effects throughout the country.

    With Virginia, West Virginia (see our previous blog post here), Utah, and Arizona having adopted similar, though narrower, measures—especially targeting school meals—Texas and Louisiana are shaping what may become a template for future state (and possibly federal) action.

    We will monitor the Texas and Louisiana laws’ implementation, enforcement, and broader impact on national food-labeling practices.

    FDA Softens August 2025 NDSRI Deadline—Progress Reports Now Accepted

    Recently, FDA announced a deadline shift, although the Agency did so quietly.  On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently marketed products.  The Agency confirmed that it will now accept progress reports in lieu of full compliance by August 1, 2025, and has explicitly asked sponsors to detail their mitigation efforts in their upcoming annual or amended annual reports.  21 C.F.R. § 314.81(b)(2).

    What does this mean?

    • Confirmatory testing remains due by August 1, 2025, but FDA has now acknowledged that full implementation of mitigation strategies—such as reformulation or the addition of new specifications—may take longer.
    • For firms unable to meet the deadline, progress updates must be submitted by August 1, 2025.
    • These updates should be included under a new section titled “NDSRI Update” in the Log of Outstanding Regulatory Business (eCTD 1.13.14) within the annual report—or submitted as an amendment if the company’s annual report for the year has already been filed.

    What should be included in the progress report?

    FDA has provided a clear checklist for the updates, which must address:

    1. Whether NDSRIs can form under forced degradation;
    2. The specific NDSRIs detected;
    3. Nitrosamine test method(s) with validation information;
    4. Product batch(es) analyzed, with dates relative to manufacture;
    5. Confirmatory test results (in ng/day or ppm);
    6. Root cause of impurity (if known);
    7. Mitigation strategies undertaken; and
    8. Estimated timeline for completing mitigation.

    Per FDA’s update, non-application products without annual report requirements should prepare similar documentation and retain it for FDA inspection requests.

    Why FDA changed course

    During the April 2025 Generic Drugs Forum (beginning at the 2:38 mark), FDA officials reasserted the August 1 deadline—but also hinted at flexibility in cases of product shortages or technical challenges.  The June 23rd decision to extend the deadline reflects FDA’s recognition that nitrosamine mitigation strategies vary widely and can demand extensive time and supply‑chain adjustments.  Further, determining the root cause of the nitrosamine source/contamination as well as gathering stability data for reformulation can be difficult and lengthy undertakings.  In addition, the sponsor or manufacturer will need data on nitrosamine buildup over at least part of the dating period to assess whether the levels (ng/day) are problematic.  All of these efforts require much time and many resources.

    So, what does this update mean?

    • FDA committed to reviewing all progress reports submitted by August 1 and stated that it may issue revised target timelines based on these reports.
    • The Agency continued to emphasize that confirmatory nitrosamine testing should be completed even if mitigation lags behind.
    • FDA pledged to update its online guidance periodically with new timelines, methods, and scientific insights.

    The bigger picture

    FDA’s updated approach toes a careful line—enforcing public safety by mandating confirmatory tests and acceptable intake standards, while also avoiding drug shortages by allowing more time for companies to adjust and adapt.  For example, if FDA were to take action now, many generic drugs products could be taken off the market given that the cancer risk is assessed over a 70 year-period.  See FDA, Guidance, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs) at 4 (Aug. 2023); FDA, Guidance, Control of Nitrosamine Impurities in Human Drugs at 12 (Sept. 2024).

    Such action would provide little public benefit.  Rather, FDA’s update aligns with the Agency’s ongoing nitrosamine strategy since 2018, which has tackled contaminants in APIs such as ranitidine, metformin, and valsartan.  Coupled with the aforementioned August 2023 NDSRI guidance on acceptable intake limits, testing, and mitigation frameworks and the September 2024 guidance on the control of NDSRIs, this update offers a pragmatic pathway forward for manufacturers.

    What should industry do?

    • By August 1, 2025:
      • Complete confirmatory testing for at-risk products.
      • Submit the required changes to drug applications via a Prior Approval Supplement or a detailed progress report in your annual report or amended annual report if you have already submitted an annual report for this yearly cycle.
    • Continue to move forward on developing and implementing mitigation plans.
    • Monitor FDA communications, including the aforementioned webpage, as the Agency may put forth revised timelines and new/revised guidance based on submissions.

    Food for thought

    FDA’s decision to accept progress reports offers crucial and practical relief for manufacturers and sponsors racing against this looming deadline.  However, this flexibility comes with responsibility:  companies must maintain transparency, complete rigorous testing, and accelerate root cause investigations and mitigation strategies to protect patient health.

    We recommend a proactive approach—prioritize preparing now for both documentation and real-world process changes that can help you remain compliant and competitive—and HPM is here to help.

    HPM’s Larry Houck Speaking at Opioid and Fentanyl Abuse Management Summit

    The diversion of controlled substances intended for patients by physicians, pharmacists, nurses and other trusted healthcare employees is a significant issue facing hospitals and healthcare facilities.

    Controlled substances are a necessary component of medical care for patients, and recent employee diversion incidents illustrate the continued vulnerability of hospitals.  Hospitals that fail to fulfill their obligations under the federal Controlled Substances Act and DEA regulations pose serious risks to their patients for undertreatment and worse, and to their employees for overdose and death.  Employee diversion of significant controlled substance quantities from hospitals has also resulted in large civil monetary settlements, some in the millions of dollars, costly compliance remediation programs, and in unwanted local and national publicity.

    HPM Director Larry Houck is presenting “Hospital/Healthcare Facility Controlled Substance Diversion: Recent Case Studies,” focusing on this timely topic, at the World Conference Forum’s 2025 Opioid & Fentanyl Abuse Management Summit in Chicago on July 17th-18th.

    Attendees will learn:

    • How employees in some high-profile cases were able to divert significant controlled substance quantities;
    • Red flags that hospitals missed;
    • Safeguards to minimize internal diversion risks; and
    • Best practices for maximizing diversion detection.

    Click here to learn more about WCF’s Opioid & Abuse Management Summit.