Late last week, the U.S. District Court for the Northern District of Texas ruled that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional.  Relying on the Supreme Court’s recent decision in SEC v. Jarkesy, 603 U.S. 109 (2024), the Court held that the CMP provision violates the Seventh Amendment’s right to a jury trial.

By way of background, in Jarkesy, the Supreme Court ruled that the SEC could not use its administrative authority to impose civil penalties for securities fraud through an administrative law judge proceeding on the grounds that these proceedings violate the Seventh Amendment’s right to a jury trial for all suits in common law.  We posted on the Jarkesy decision and predicted that litigants would similarly challenge the FD&C Act’s CMP provisions.  (We’ve also written about Jarkesy’s impact on DEA ALJ proceedings and the proposed Preserve Access to Affordable Generics and Biosimilars Act).

In Wulferic, LLC v. FDA, No. 4:24-cv-1183-O (N.D. Tex. Aug. 1, 2025), Plaintiff Vapor Lab—a business that makes and sells tobacco products—challenged a CMP administrative proceeding brought by FDA seeking a monetary penalty against Vapor Lab for selling e-liquid products that had not been authorized for sale by FDA.  The case was pending before an HHS ALJ, and Vapor Lab argued that the CMP provision for tobacco products was unconstitutional because the administrative proceeding violated its Seventh Amendment right to a jury trial.

The Court agreed, explaining that the Seventh Amendment’s right to a jury trial in suits at common law applies to cases traditionally decided in English law courts, as opposed to cases tried in courts of equity or admiralty.  Id. at 20.  While the Court did not find any “common law analogues” to the FD&C Act’s CMP provision for tobacco products, it noted that the remedy is the “more important” consideration.  Id. (citing Jarkesy, 603 U.S. at 123).  Here, the Court found that the CMP provision’s penalties were a type of remedy that could only be enforced in courts of law, particularly because the penalty was designed to punish and deter, included enhanced penalties for intentional violations, and was not intended to “restore the status quo” by ordering restitution to victims.  Id. at 20-21.  Thus, the Court held that the Seventh Amendment applied and that Vapor Labs had a right to a jury trial unless the public rights exception applied.  Id. at 21.

The public rights exception is a recognized departure from Article III judicial power, acknowledging that Congress may assign certain matters to an agency for decision without a jury consistent with the Seventh Amendment.  Id. at 22.  FDA argued that the public rights exception applied because the FD&C Act serves a “public-health purpose” that has been assigned to the Executive Branch.  Id. at 24-25.  The Court rejected that any such public health exception existed as a public rights exception for the federal government, reasoning instead that “the power to promote public health is a police power retained by the states, through the Tenth Amendment, and has never been a distinctive prerogative of the federal government.”  Id. at 26.

Because it found that no public rights exception existed, the Court declared the CMP provision for tobacco products—and FDA’s proceeding against Vapor Lab—to be unconstitutional.  The Court further enjoined the government to dismiss with prejudice the administrative complaint against Vapor Lab and from adjudicating civil monetary penalties against Vapor Lab in an administrative proceeding.  The Court, however, rejected Vapor Lab’s request for a nationwide injunction.

The Wulferic decision is the first case to find that the FD&C Act’s CMP provision for tobacco products is unconstitutional — but the catch is that it didn’t actually order FDA to stop carrying on as usual with respect to anybody else.  Wulferic threatens to significantly dismantle FDA’s arsenal of actions to enforce compliance with the FD&C Act’s tobacco provisions, and we expect many more similar challenges to follow if FDA stays on its current course.

Indeed, for those keeping tabs, a prior District Court challenge that we reported on was rejected for lack of subject matter jurisdiction, as was one other, Vape Central Grp., LLC v. FDA, No. 1:24-cv-3354-RDM (D.D.C. Feb. 27, 2025).  One more is awaiting a decision from a different judge in the same District, The Vaping Dragon LLC v. FDA, No. 25-cv-81-H (N.D. Tex.)).  And there’s more still: at least two other cases are looking to tee up this same issue in the Circuit Courts of Appeals right now.  In Texas Tobacco Barn, LLC v. HHS, No. 25-60200 (5th Cir.), and D and A Business Investments, LLC v. FDA, No. 25-1074 (D.C. Cir), the petitioners directly challenge FDA’s imposition of $19,000 CMPs under Jarkesy, among other things.

It remains unclear whether FDA will appeal the Wulferic decision under the current administration, and what it will do with its current CMP docket in light of it.  Close eyes will now go to The Vaping Dragon in particular: whether and how that case gets decided in FDA’s appeal window could make a big difference. We will be closing monitoring the fallout from this case and other challenges to FDA’s CMP statutory provisions in this post-Jarkesy world.

Since 2009, the term ultra-processed food (“UPF”) has gained recognition as there have been studies that suggest a relationship between consumption of UPFs and chronic diseases.  The term frequently focuses on processing and composition without consideration of food groups and nutritional composition.  At this time, there is great uncertainty about the explanation for the relationship between consumption of UPFs and adverse health outcomes.  A standardized definition may help shed light on the underlying causes.

In May 2025, the U.S. Food and Drug Administration (“FDA”) published its FY 2026 budget request which included $49 million to be “dedicated to combating the growing risks associated with ultra-processed foods . . . .”

On July 23, 2025, the Agency and the U.S. Department of Agriculture (“USDA”) took the first step towards addressing UPFs by jointly announcing a public request for information (“RFI”).  In the press release, U.S. Health and Human Services (“HHS”) Secretary, Robert F. Kennedy, Jr., asserted that “[u]ltra-processed foods are driving our chronic disease epidemic.”  Secretary Kennedy and his administration believe that establishing a clear federal definition is key to tackling obesity, diabetes, heart disease, cancer, and even neurological disorders.

The RFI is part of a wider effort spearheaded by Secretary Kennedy who has made food reform a central pillar of the Make America Healthy Again (“MAHA”) agenda.

Why a Clear Definition Matters

Currently, there is no single, authoritative, federally codified definition of what an UPF entails in the U.S. market.  The absence of a single clear definition generates inconsistencies in policymaking and consumer guidance and understanding.  For example, the RFI mentions several states that have proposed varying definitions for “ultra-processed” food—such disparate state efforts could lead to a patchwork regulatory scheme and consumer confusion throughout the country.  A uniform definition may:

• Enable consistent public health messaging
• Encourage more focused research
• Support clearer, more informative labeling
• Inform government programs and spending on food
• Provide a foundation for future regulation or standards

What Information is Being Requested?

Many questions need to be answered when considering a definition for UPFs and it remains to be seen whether a definition can be developed without further research.

The RFI lists many questions and requests that comments include explanations and supporting evidence.

Key questions include:

• Is the term “ultra-processed” the most apt terminology?
• What measurable factors (e.g., ingredients, processing techniques) should define an ultra-processed food?
• Should the definition consider the nutritional value of the product?
• How can such definitions be applied systematically across food products?
• What implications might this definition have for nutrition programs and labeling?

Any interested parties should submit comments by September 23, 2025 at 11:59 PM EDT.

One familiar with homeopathy might reasonably think that the practice would have a place in the Make America Healthy Again movement as an alternative to conventional pharmaceutical treatment. But after a recent court decision issued on July 15, 2025, the regulatory path for homeopathic medicine looks murkier than ever.

Homeopathy operates on the principle that “like cures like,” where practitioners use heavily diluted substances intended to cause the symptoms they are meant to treat. For decades, FDA largely ignored this $6 billion industry through a 1988 compliance policy guide (CPG) that essentially created a regulatory “safe harbor” for over-the-counter homeopathic products. Although they were unapproved new drugs, the CPG described the conditions under which FDA would allow these unapproved drugs to be on the market.

In 2015, FDA indicated that it increasingly was concerned about the safety of homeopathic drugs, and it claimed that the existence of the CPG limited its options to take enforcement action. In 2019, the agency withdrew that CPG and issued draft guidance describing its new risk-based enforcement policy to replace the CPG.  In 2022, it finalized this new enforcement guidance for homeopathic drug products.

In an effort to legitimize homeopathic drugs, the Americans for Homeopathic Choice Foundation (AHCF) submitted a petition requesting, among other things, recognition by FDA that homeopathic drugs, properly manufactured and labeled, and evaluated by appropriate standards, do not meet the legal definition of “new drugs,” and therefore were not subject to premarket review other than satisfying the requirements of current or likely inclusion in the HPUS. As we previously reported, FDA denied that petition one day before it issued the 2022 final guidance. As of that one-two punch, homeopathic remedies no longer enjoyed the benefits of FDA’s exercise of enforcement discretion from new drug approvals. As discussed in the 2022 guidance, FDA considers all homeopathic drugs to be new drugs, which can be taken off the market at any time for lack of approval. That said, enforcement actions against these unapproved drugs are generally based on safety considerations.

In 2024, the Alliance for Natural Health USA (ANH) and homeopathic drug distributor Meditrend , challenging the agency’s 2022 denial of the petition and arguing that FDA lacked authority to subject all homeopathic products to costly and lengthy new drug approval requirements. The CARES Act excluded homeopathic products from its reform of the OTC drug review process, and FDA and the homeopathic industry interpreted that absence from two opposing perspectives. FDA read the CARES Act exclusion to mean that Congress wanted to treat homeopathic drugs as unapproved new drugs. In contrast, the plaintiffs read the exclusion as evidence that Congress hoped to ease the path of homeopathic drugs to market.

Additionally, the plaintiffs challenged FDA’s guidance regarding enforcement priorities for (unapproved) homeopathic drugs as arbitrary and capricious.  Specifically, plaintiffs argued that the guidance violated their constitutional due process rights and was based on what the plaintiffs called “unsupported” safety concerns. Plaintiffs also claims that FDA’s concerns about safety of homeopathic drug product were insufficient reason to deny the AHCF petition.

The court dismissed most of plaintiffs’ claims outright. It found that FDA’s 2022 guidance document was not legally enforceable as final agency action and therefore could not be challenged under the Administrative Procedure Act. The court also rejected the constitutional due process claims and the statutory arguments that the plaintiffs raised about the CARES Act, ruling that Congress never intended to exempt homeopathics from standard drug approval requirements.

However, the court held open the question about whether FDA’s safety concerns about homeopathic practice were sufficient to justify the denial of the 2022 petition. It could not make a determination without a full administrative record; the “agency’s safety concerns may well be warranted. But whether they justify increased enforcement is a factual, not legal, determination. Therefore, the Court cannot reach a decision without a full record.”

For FDA, the ruling validates its revised risk based approach regarding homeopathic drugs. Plaintiffs promise to challenge FDA’s “attempt to regulate homeopathic medicines as conventional drugs” to the extent the decision allows, and the survival of the question of whether FDA had sufficient safety concerns to deny the petition keeps the door open for meaningful judicial review of that issue. We will be monitoring further developments.

Earlier this week, we posted on the retirement of DEA Chief Administrative Law Judge Judge John J. Mulrooney, II, and the lack of appointed DEA ALJs to hear DEA cases upon his retirement, effective August 1.  On a related note, HPM wants to take a moment to recognize Chief Judge Mulrooney’s tenure on the bench.  After joining OALJ in 2009, (then) Judge Mulrooney was quickly appointed as the chief judge.  In that position, he oversaw the office’s busy tribunal docket and administrative staff.  Our HPM attorneys had the privilege of appearing before him in many cases and litigated hearings over the last 16 years.  While Chief Judge Mulrooney’s well-known trial standards, fastidiousness to procedure, and expectations for preparedness could put a knot in the stomachs of experienced counsel from all over the country, litigators also knew him for his fairness, his dedication to establishing clear agency precedent, his keen wit from the bench (and in the footnotes), and his commitment to the rule of law.  And as a former law clerk, one of us can attest that there was never a better mentor or advisor who sought the best for his law clerks and who modeled dedicated public service.

Chief Judge Mulrooney’s 42-year career in public service highlights his commitment to public health and safety, spanning positions as a Navy judge advocate, an assistant district attorney, an Assistant U.S. Attorney, a DOJ trial attorney prosecuting terrorism cases, a judge on the Navy-Marine Corps Court of Criminal Appeals, an administrative law judge at the Social Security Administration, and culminating with his appointment at the OALJ where he dedicated the last sixteen years within a branch of DEA dedicated to protecting the public against the harms of diversion and drug abuse.  Thank you for your service, Chief Judge Mulrooney.  Sláinte!

On July 24, 2025, FDA released the Regulatory Accelerator, an initiative to help digital health sponsors bring their technology to market. New developers may want to bookmark this link as the initiative neatly corrals information in one place. For those who have been working in the space, most of the information is familiar.

The Regulatory Accelerator includes:

• Resource Index for Innovators, which compiles tools, engagement opportunities, and guidance throughout all phases of the total product life cycle and identifies those with associated fees,
• Medical Device Software Guidance Navigator, which represents an efficient method for identifying pertinent FDA guidance documents for medical device software development and marketing submissions, and
• Early Orientation Meetings, which are opportunities for sponsors to provide device demonstrations and/or an overview of the marketing submission and respond to questions from the FDA review team.

The Resource Index for Innovators may be of particular value to digital health innovators who are just starting their journey and learning about the different FDA submissions and programs. The index is a nicely organized visual guide identifying the available resources to innovators, all of which are accessible via active hyperlinks. Given that guidance documents and other resources have been removed from FDA’s website without warning (sometimes reinstated and sometimes not), we suggest you download any useful resources now.

While much of the Navigator organizes already existing information into an easy to find format, there was one new piece of information that caught our attention:  the introduction of Early Orientation Meetings. FDA recommends these interactions shortly after a submission has been accepted for review. The meetings are best for novel devices as they are intended to allow sponsors of marketing submissions to provide device demonstrations and/or an overview of the submission. Explanations, especially in the context of digital health products, have increasingly grown more important to demonstrate how the product will work in the intended use environment, and how, if it all, it will affect existing clinical workflows. Demonstration of software products can be a far more effective way to showcase novel features or functions as compared to still screenshots of the user interface that are included in a submission. Explaining early on how the technology works (e.g., how the device functions or achieves its intended use via inputs and outputs) to FDA reduces any gaps in knowledge that may hamper submission review,  and allows FDA to ask questions and receive clarification on any initial sticking points.

Early orientation meetings are appropriate for any traditional 510(k)s, De Novo requests, and PMAs. A sponsor can request an early orientation meeting in the cover letter of their marketing submission. However, as our recent blog post highlighted, sponsors are already experiencing delays scheduling meetings within the paradigm of existing initiatives. It is therefore unclear how FDA will be able to accommodate potentially additional requests for meetings. As FDA states on the website about early orientation meetings, it “will try to accommodate meeting requests, resources permitting.” Sponsors may want to consider their resources and return on value on these interactions if “[t]he FDA review team does not generally provide specific feedback on the submission during the meetings.” As we have opportunities to engage in these meetings in the future, we will report back on what we are seeing, and the extent to which having, or not having an early interaction meeting, has any impact on the ultimate submission review.

FDA announced earlier this month that it had updated its list of artificial intelligence (AI)-enabled medical devices and created new lists for medical devices that incorporate augmented reality or virtual reality and medical devices that incorporate sensor-based digital health technology.  The list for AI-enabled devices had not been updated since September 2024, so its lack of upkeep does not appear related to changes in the FDA workforce earlier this year.

While the information within these lists has always been available through the searchable FDA databases, having the information organized into a single location may be helpful for a number of reasons.  Developers searching for a predicate device may more easily identify devices that use technology similar to their device, or more easily determine that there is not another device with the same intended use and equivalent technological characteristics, which would indicate their device is likely appropriate for a De Novo submission.  Also, given the rapid changes in these types of technology, the information and testing being requested by FDA for review of these digital health technologies may be evolving, and being able to easily find recent submission summaries from across the review divisions may be a useful resource. At a recent conference, we heard from clinicians that it was often difficult for them to find information on the performance of medical device software that incorporates AI, so being able to easily locate devices of interest may especially be helpful for health care professionals to find summary information of the types of testing FDA reviewed and performance of the AI-models.

The lists include the date of FDA’s final decision, submission number, device name, company name, lead review panel (e.g., radiology or cardiovascular), and primary product code.  They provide a search bar to help find specific products and also include options to download the data to a CSV, Excel, or XML file.

We did some analyses of the lists and learned the following.

AI-enabled devices

There are 1,247 AI-enabled devices on the list, with the earliest approvals dating back to 1995.  As you might imagine, in the early years, there were few AI-enabled devices, with a total of 10 AI-enabled devices authorized in the first ten years.  In contrast, 253 AI-enabled devices were authorized in 2024 alone.  There have been 1,195 (96%) AI-enabled devices authorized via 510(k) clearance, 36 (3%) AI-enabled devices authorized via De Novos, and 16 (1%) AI-enabled devices authorized via premarket approval (PMA).

Of the 1,247 AI-enabled devices, 956 (77%) were authorized by the radiology panel and 116 (9%) by the cardiovascular panel.  The number of AI-enabled device submissions across the other review divisions is quite sparse with the neurology, anesthesiology, hematology, and gastroenterology-urology panels authorizing between 1% and 5% of AI-enabled devices, and the remaining panels each authorizing fewer than 1% of AI-enabled device applications.

Augmented reality/virtual reality devices

FDA’s website defines augmented reality as “a real-world augmented experience with overlaying or mixing simulated digital imagery with the real world as seen through a camera or display, such as a smartphone or head-mounted or heads-up display (HUD). Digital imagery may be able to interact with real surroundings (often controlled by users). This is sometimes referred to as mixed or merged reality.” Virtual reality is defined as “a virtual world immersive experience that may require a headset to completely replace a user’s surrounding view with a simulated, immersive, and interactive virtual environment.”

There are 92 augmented reality/virtual reality devices on the list, with the earliest submission cleared in 2015.  The radiology panel also topped review of these device types with 34 devices on the list (37%).  The orthopedic review panel authorized 25 submissions (27%), with neurology coming in third with 17 authorizations (18%).  Cardiovascular, ear, nose, and throat, general and plastic surgery, ophthalmic, and physical medicine review panels have each reviewed a small number of these device types.

Devices that incorporate sensor-based digital health technology

Sensor-based medical devices have been around for many years, but this list focuses on sensor-based digital health technology devices that are non- or minimally invasive, wearable, designed for continuous or spot check monitoring of an individual’s health parameters, and that can be used in non-clinical settings, such as the home.  As such, the list includes technologies authorized beginning in 2015.

There are 215 sensor-based digital health technology devices on the list.  Over half of these submissions (111 or 51%) were reviewed by the cardiovascular review panel.  The neurology, clinical chemistry, and anesthesiology review panels reviewed 18%, 17%, and 12%, respectively, with the ophthalmic and ear, nose, and throat review panels constituting only 1%.

The lists were updated on July 10, 2025, and do not appear to be updated daily as new devices are cleared.  We will watch to see if FDA updates the lists regularly (e.g., monthly when summary documents are added to the 510(k) database), or if it will be another nine months before the next update is made.

FDA notes that the lists may not be comprehensive, as they were generated based on the use of related terms in the summary descriptions of marketing authorization documents or the device’s classification.  FDA notes that it will explore methods to identify and tag medical devices that incorporate these technologies in the future.  Until then, users should be cautious and check other sources if the information being searched for is not found on the list.

Last week, DEA registrants and applicants with pending actions before DEA’s Office of Administrative Law Judges (OALJ) received an order from Chief Administrative Law Judge John J. Mulrooney, II, staying the hearing proceedings in those cases.  In those orders, Chief Judge Mulrooney announced that he was retiring from the bench effective August 1, 2025, and that, in the absence of any other DEA ALJs, all proceedings and hearing dates are postponed indefinitely.

The OALJ, which historically has maintained a heavy yet efficient workflow of complex diversion and drug scheduling cases, had a total of three ALJs in January prior to the change in administration in January 2025.  Since then, the number of ALJs quickly declined, leaving as of this summer Chief Judge Mulrooney as the sole tribunal overseeing a busy docket that typically requires multiple ALJs.

As a reminder, the OALJ is responsible for not only presiding over orders to show cause against DEA registrants, but also actions related to DEA decisions on imports, exports, drug scheduling, and issuing quotas.  Where does this leave DEA and all of the DEA registrants with pending or contemplated administrative actions?  It’s a bit too early to tell, but it is unlikely that the pending show cause matters will be resolved anytime soon; and, although less frequent, it creates a void for registrants who would want to challenge the other types of decisions identified above.  Under the Controlled Substances Act and DEA’s implementing regulations, proceedings to deny, revoke, or suspend a DEA registration must be conducted pursuant to the hearing procedures delineated in the Administrative Procedure Act as set forth in 5 U.S.C. §§ 551-559.  See 21 U.S.C. 824(c)(4); 21 C.F.R. § 1316.41.  And DEA’s implementing regulations require that a “presiding officer,” defined as an administrative law judge qualified and appointed as provided in 5 U.S.C. § 556, must conduct administrative enforcement hearings.  21 C.F.R. §§ 1316.42(f); 1316.52.

DEA must either (1) hire and appoint new ALJs to fill the vacant bench, or (2) appoint ALJs from other federal agencies to hear these cases.  But both options take time, and we believe that litigants facing orders to show cause or immediate suspension orders (ISOs) may not obtain relief for a period of time.  This, of course, can impact the due process rights of the parties, particularly recipients of an ISO and applicants for new DEA registrations which have been denied.  Individuals or entities facing pending administrative actions with the DEA should consider and evaluate with experienced counsel the impact that an “indefinite” stay may have on their cases as well as potential recourse.

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.

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.

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.

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.

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.

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.

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.

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.