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FDA Advertising and Promotion Enforcement Activities: Update

Alert August 3, 2026

This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of the firm. As a result, the information presented herein does not necessarily reflect the views of the firm or any of its clients.

During the second quarter of 2026, FDA’s Office of Prescription Drug Promotion (OPDP) posted the following ten untitled letters and did not post any warning letters:

  • Untitled Letter to BioCorRx Pharmaceuticals Inc. re LUCEMYRA® (lofexidine) (March 27, 2026) (Lucemyra Untitled Letter).
  • Untitled Letter to Amneal Pharmaceuticals LLC re ALYMSYS® (bevacizumab-maly) (March 31, 2026) (Alymsys Untitled Letter).
  • Untitled Letter to Pfizer, Inc. re ADCETRIS® (brentuximab vedotin) (April 8, 2026) (Adcetris Untitled Letter).
  • Untitled Letter to Incyte Corporation re NIKTIMVO™ (axatilimab-csfr) (April 22, 2026) (Niktimvo Untitled Letter).
  • Untitled Letter to Alnylam Pharmaceuticals, Inc. re AMVUTTRA® (vutrisiran) (April 23, 2026) (Amvuttra Untitled Letter).
  • Untitled Letter to Bayer HealthCare Pharmaceuticals, Inc. re NUBEQA® (darolutamide) (April 28, 2026) (Nubeqa Untitled Letter).
  • Untitled Letter to BeOne Medicines USA, Inc. re BRUKINSA® (zanubrutinib) (May 12, 2026) (Brukinsa Untitled Letter).
  • Untitled Letter to QOL Medical, LLC. re SUCRAID® (sacrosidase) (May 26, 2026) (Sucraid Untitled Letter).
  • Untitled Letter to Pinnacle Biologics, Inc. re PHOTOFRIN® (porfimer sodium) (June 22, 2026) (Photofrin Untitled Letter).
  • Untitled Letter to Lundbeck Seattle Biopharmaceuticals, Inc. re re VYEPTI® (eptinezumab-jjmr) (June 24, 2026) (Vyepti Untitled Letter).

During the same period, the Office of Compliance and Biologics Quality (OCBQ) at the Center for Biologics Evaluation and Research (CBER) posted one warning letter:

The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) posted five warning letters relating to the advertising and promotion of medical devices.

The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) and the Office of Medical Device and Radiological Health Operations (OMDRHO) in the Office of Regulatory Affairs (ORA) did not post any warning letters relating to the advertising and promotion of medical devices during this period.

Office of Prescription Drug Promotion (OPDP)

Untitled Letter to BioCorRx Pharmaceuticals Inc. (March 27, 2026)

OPDP’s untitled letter to BioCorRx Pharmaceuticals Inc. (BioCorRx) alleges that the consumer website homepage for Lucemyra (lofexidine) misbrands the drug by making false or misleading representations. The webpage is cited as stating, “LUCEMYRA® IS THE ONLY FDA-APPROVED, NON-OPIOID MEDICINE PROVEN TO HELP WITH SYMPTOMS OF OPIOID WITHDRAWAL.” OPDP alleges that this exclusivity claim is misleading because additional FDA-approved lofexidine products are indicated for mitigating opioid withdrawal symptoms to help adults discontinue opioid use.

OPDP also alleges that the webpage presents benefit claims prominently, including statements such as “[d]emonstrated safety profile in studies” and “Lofexidine should therefore be the preferred choice for withdrawal management in an outpatient setting,” while safety disclosures are available only through a collapsible header that consumers must manually click to expand. According to the letter, this layout presents side effect information less prominently than the drug’s benefits. Therefore, the overall effect obscures key safety information and downplays the risks of using Lucemyra, and the click-to-expand format compounds the problem.

OPDP additionally notes that BioCorRx did not submit the webpage to FDA on Form FDA-2253 at the time of initial publication, as required by regulation.

Untitled Letter to Amneal Pharmaceuticals LLC (March 31, 2026)

OPDP’s untitled letter to Amneal Pharmaceuticals LLC (Amneal) alleges that a direct-to-consumer (DTC) patient brochure for Alymsys (bevacizumab-maly) misbrands the drug through incomplete indication disclosures, omitted risk information, and misleading safety claims. OPDP alleges that the brochure presents Alymsys’s uses in broad terms, listing general cancer types alongside promotional imagery, without disclosing the patient populations or the required combination chemotherapy regimens from the prescribing information. This omission, according to OPDP, misleadingly implies that the drug can be used in various cancers or alone, when it cannot. The misleading impression is compounded by the brochure’s layout, in which the claims about patient populations and use as a monotherapy are on the first and second pages, and the limitations of use are not until the fourth page. OPDP acknowledges that the full indications appear in the important safety information section but states that the presentation in small, simple font after other text and attention-grabbing images does not adequately mitigate the misleading impression.

OPDP alleges that the brochure omits several categories of serious risk information. The brochure describes Alymsys’s intravenous administration but does not disclose that bevacizumab products can cause infusion-related reactions, such as hypertension, oxygen desaturation, and chest pain. While the patient brochure warns patients to tell their doctor if they are pregnant or breastfeeding or plan to become pregnant or breastfeed, the brochure omits that the drug can cause harm to a fetus when administered to pregnant women, that contraception is required during treatment and for six months after the last dose, and that breastfeeding should be avoided during the same period. The brochure also fails to disclose the increased risk of ovarian failure and fertility impairment.

OPDP further notes the absence of disclosures regarding arterial thromboembolic events and other serious cardiovascular and cerebrovascular conditions. While the brochure directs patients to a page with important safety information and the full prescribing information, this does not cure the misleading omission of the risks.

OPDP alleges that the brochure’s claim that “most side effects will resolve over time” is unsupported and misleading given that Alymsys is associated with serious and occasionally deadly adverse events. OPDP notes that clinical data reflect a discontinuation rate of 8-22% due to adverse reactions, and that the brochure’s cited reference, a general American Cancer Society article on targeted therapy, does not substantiate the claim for Alymsys specifically.

According to the letter, the brochure fails to present safety information in order of severity or with prominence comparable to the effectiveness claims. Additionally, while some common adverse reactions are described in consumer-friendly language, certain risk disclosures use complicated medical terms that patients are unlikely to understand.

OPDP alleges that the cumulative effect of these omissions and minimizations misleadingly portrays Alymsys as safer and more effective than has been demonstrated by the clinical evidence and safer and more effective than the reference listed drug, Avastin (bevacizumab). OPDP notes that FDA granted biosimilar approval of Alymsys based on evidence that Alymsys and Avastin are “highly similar” with “no clinically meaningful differences in terms of safety, purity, and potency,” meaning that any implied superiority claims are unsupported.

Untitled Letter to Pfizer, Inc. (April 8, 2026)

OPDP’s untitled letter to Pfizer, Inc. (Pfizer) alleges that Facebook video advertisements for Adcetris (brentuximab vedotin) misbrand the drug by omitting material information about its approved indication and risks. The ads cited by OPDP include claims such as “ADCETRIS plus CHP is an FDA-approved option for adults with certain CD30 expressing T-cell lymphomas” and “Making a treatment decision for T-cell lymphoma?” OPDP alleges that the ads are misleading because they imply Adcetris is indicated for general treatment of T-cell lymphoma and do not specify the subtypes listed in the prescribing information. OPDP acknowledges that the full indication appears at the bottom of the ads after the important safety information but states that this does not adequately correct the misleading effect.

Additionally, OPDP alleges that the ads fail to disclose the contraindication against concurrent use with bleomycin due to pulmonary toxicity. It also states that the ads omit warnings regarding potentially fatal outcomes from serious infections, serious dermatologic reactions, and serious hyperglycemia, all of which are described in the warnings and precautions section of the prescribing information. OPDP concludes that these omissions minimize the drug’s risks and create an inaccurate perception of its safety.

Untitled Letter to Incyte Corporation (April 22, 2026)

OPDP’s untitled letter to Incyte Corporation (Incyte) alleges that the landing page and “Responses” webpage of the DTC branded website for Niktimvo (axatilimab-csfr) misbrand the drug by making false or misleading representations about its efficacy in chronic graft-versus-host disease (GVHD). As cited by OPDP, the website states that “[m]ost people achieved a response with Niktimvo” and that “75% of people (59 out of 79) experienced a response.” OPDP alleges that these claims overstate the drug’s effectiveness by implying that patients achieved complete responses, when in fact all 59 responders experienced only partial responses, and no patient had a complete response. OPDP acknowledges that definitions of “complete” and “partial” response appear on the page but states that these do not cure the overall misleading impression.

OPDP also alleges that the website’s repeated characterization of Niktimvo as providing “fast and lasting responses” is inconsistent with the clinical evidence. Regarding speed, OPDP notes that the median time to first response was 1.5 months, with a range extending to 5.1 months. Regarding durability, the median duration of response was 1.9 months before patients progressed, died, or began new systemic therapy. OPDP acknowledges that the clinical studies section of the prescribing information shows that 60% of responders maintained their responses for at least 12 months but alleges that this figure excludes patients who progressed, thereby allegedly conflating the response measures and overstating the drug’s benefit.

According to the letter, the website displays a diagram of the human body highlighting organ-by-organ response rates under the claim “People achieved responses in multiple affected organs.” OPDP alleges that this presentation misrepresents Niktimvo’s efficacy because the drug’s effectiveness was measured as an overall response rate across all organs, not in individual organs. OPDP notes that the presentation does not account for patients who may have responded in one organ while progressing in another.

Additionally, OPDP alleges that the website’s claims such as “Niktimvo offered symptom improvement” and “44 out of 79 people who received Niktimvo (56%) reported improvement” are misleading. The webpage characterizes the outcome as a “reduction in chronic GVHD symptoms,” which, in OPDP’s view, implies fewer symptoms. However, the underlying measure, the modified Lee Symptom Scale, assesses only the overall degree of discomfort patients experience from cGVHD symptoms, not changes in the number of symptoms.

Untitled Letter to Alnylam Pharmaceuticals, Inc. (April 23, 2026)

OPDP’s untitled letter to Alnylam Pharmaceuticals, Inc. (Alnylam) alleges that the “ATTR-CM” webpage on the consumer website for Amvuttra (vutrisiran) misbrands the drug by making false or misleading claims about its effect on mortality in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM). OPDP cites the webpage as featuring the claims “Proven to help people with ATTR-CM live longer” and “People lived longer with continued treatment.” The webpage also states that “[t]he risk of death was lower over 3½ years with AMVUTTRA*,” supported by graphics showing a “36% Lower Risk” of death compared to placebo. OPDP alleges that taken together, these claims creates a misleading impression that Amvuttra has demonstrated a definitive mortality benefit over three-and-a-half years, when this has not been established.

OPDP explains that the mortality data derive from a secondary endpoint of all-cause mortality assessed at three-and-a-half years. The three-and-a-half year period included both the 36-month randomized, double-blind portion of the HELIOS-B study, in which the primary endpoint of the composite outcome of all-cause mortality and recurrent CV events was measured, and a subsequent six-month open-label extension. By three-and-a-half years, all patients originally assigned to the placebo had been unblinded and switched to Amvuttra, leaving no concurrent control group. OPDP states that the open-label design “introduces bias and confounding” and that without a concurrent comparator, it cannot be determined whether outcomes observed during the brief open-label extension resulted from ongoing treatment effects, natural disease progression, or differences in patients who chose to continue in the study. OPDP acknowledges that the webpage includes a disclaimer noting the analysis was not part of the original study plan and that other factors could have influenced the results, but concludes that these considerations are not enough to mitigate the misleading impact.

Untitled Letter to Bayer HealthCare Pharmaceuticals, Inc. (April 28, 2026)

OPDP’s untitled letter to Bayer HealthCare Pharmaceuticals, Inc. (Bayer) alleges that a DTC YouTube video and a Spanish-language broadcast advertisement for Nubeqa (darolutamide) misbrand the drug by making false or misleading representations. The letter explains that the video and TV ad state that “Nubeqa may cause serious side effects including heart disease and seizure” but do not communicate the specific consequences described in the FDA-approved Patient Information. Specifically, the Patient Information warns that “[b]lockage of the arteries in the heart (ischemic heart disease) that can lead to death has happened in some people during treatment with NUBEQA” and that patients “should avoid activities where a sudden loss of consciousness could cause serious harm to yourself or others.” OPDP alleges that excluding these details creates a misleading impression of Nubeqa’s safety.

OPDP also alleges that both materials are misleading because they do not present the major statement using both audio and text simultaneously (dual modality) and that “attention-grabbing visuals” shown during the major statement interfere with the viewer’s understanding of the major statement.

Untitled Letter to BeOne Medicines USA, Inc. (May 12, 2026)

OPDP’s untitled letter to BeOne Medicines USA, Inc. (BeOne) alleges that a DTC broadcast advertisement for Brukinsa (zanubrutinib) misbrands the drug by making false or misleading representations about its efficacy and safety. According to OPDP, the TV ad depicts an older woman navigating concerns about her treatment, as she prepares to cross a narrow bridge. The video is accompanied by the voiceover, “There’s a lot to consider when finding the best CLL [chronic lymphocytic leukemia] treatment for you. Brukinsa brings clarity to your path ahead.” The ad concludes with the woman smiling from a mountaintop as the voiceover states, “See your future clearly again.”

OPDP alleges that the totality of these claims and visuals misleadingly suggests that Brukinsa will improve patients’ emotional and physical quality of life, when this has not been shown. OPDP notes that although the pivotal trials collected patient-reported outcome data, these results are potentially biased due to the open-label study design, “were not analyzed based on a prespecified hypothesis, were not controlled for multiplicity,” and are only descriptive.

The ad also claims that Brukinsa is “the only BTKi [Bruton’s tyrosine kinase inhibitor] proven superior to both another BTKi and to chemotherapy” and presents comparative cardiovascular event data, including atrial fibrillation rates, suggesting a safety advantage over ibrutinib. OPDP alleges that these presentations collectively convey that Brukinsa is safer, particularly regarding cardiac risk, when this has not been established. While OPDP recognizes that the atrial fibrillation data met prespecified significance criteria in Brukinsa’s favor, OPDP emphasizes that the ALPINE trial lacked sufficient statistical power to establish a clinically meaningful difference in atrial fibrillation or flutter rates between the treatment groups.

OPDP also alleges that both materials are misleading because they do not present the major statement using both audio and text simultaneously (dual modality). OPDP alleges that the major statement is shown at the most emotional part of the story, during which the woman is shown confidently crossing the bridge, having fun with her friend, browsing in a gift shop, and posing at a mountaintop overlook. OPDP states that these “compelling and attention-grabbing visuals” interfere with comprehension of the major statement.

Untitled Letter to QOL Medical, LLC. (May 26, 2026)

OPDP’s untitled letter to QOL Medical, LLC (QOL Medical) alleges that two promotional emails for Sucraid (sacrosidase) Oral Solution misbrand the drug by making false or misleading representations about its approved indication and by omitting material risk information. The emails contain the following claims:

  • “Do you have patients suffering with unresolved IBS-like symptoms, including gas, bloating, diarrhea, and/or nausea?”
  • “Learn more about the only FDA-approved enzyme replacement therapy for the treatment of CSID [Congenital Sucrase-Isomaltase Deficiency] ...”

OPDP alleges that by presenting Sucraid through the lens of irritable bowel syndrome (IBS) and discussing symptom overlap, the emails misleadingly imply the drug can be used to treat IBS, when it is not approved for that purpose. OPDP further alleges that the emails imply Sucraid treats all aspects of CSID, when the approved indication is limited to treating sucrase deficiency in adults and children over five months. OPDP acknowledges that the full indication appears alongside the important safety information at the bottom of the emails, but OPDP notes it is presented in small font after other text and eye-catching visuals, which OPDP states is not enough to correct the misleading impression.

OPDP alleges that the emails omit material risk information from the prescribing information such as severe hypersensitivity reactions (including wheezing, rash, and pruritus) and a precaution that Sucraid may increase blood glucose concentrations in patients with diabetes mellitus, requiring monitoring and dietary adjustment. Additionally, the emails allegedly fail to communicate that Sucraid does not replace isomaltase and that patients may continue to experience CSID symptoms, potentially requiring dietary starch restriction. OPDP also alleges that the risk information that is shared in the emails appears in an improper order, with adverse reactions disclosed before the precautions (such as increased blood glucose in diabetic patients), misleadingly minimizing the risks.

Untitled Letter to Pinnacle Biologics, Inc. (June 22, 2026)

OPDP’s untitled letter to Pinnacle Biologics, Inc. (Pinnacle) alleges that two promotional videos for Photofrin (porfimer sodium) misbrand the drug by making false or misleading representations about its approved indications, its risks, and its efficacy. OPDP alleges that the videos introduce Photofrin for the treatment of esophageal cancer and high-grade dysplasia in Barrett’s esophagus (“esophageal cancer video”) and endobronchial non-small-cell lung cancer (NSCLC) (“NSCLC video”) without disclosing the specific patient populations and limitations set out in the prescribing information. OPDP acknowledges that the full indications appear in an “INDICATIONS FOR USE” section at the end of each video, but it notes that this presentation is insufficient because the indications are shown in small, plain font for about five seconds alongside competing risk information, making it difficult for health care providers to understand them.

OPDP alleges that the videos promote Photofrin’s benefits while omitting serious risk information from the prescribing information. The videos do not communicate the contraindications, including that Photofrin is contraindicated in patients with porphyria and that photodynamic therapy (PDT) “is contraindicated in patients with tumors eroding into a major blood vessel.” OPDP further alleges that the esophageal cancer video minimizes contraindication-related risks by claiming that the therapy “selectively destroys the cancer cells with . . . a diameter of up to 1.2cm,” when the prescribing information states that “PDT is not suitable for patients with esophageal or gastric varices, or patients with esophageal ulcers >1 cm in diameter.”

The letter continues that the videos omit warnings and precautions regarding gastroesophageal fistula and perforation, pulmonary and gastroesophageal hemorrhage, photosensitivity, airway obstruction and respiratory distress, and embryo-fetal toxicity. While OPDP acknowledges that the videos briefly reference treatment-induced inflammation and photosensitivity, it states that this roughly ten-second presentation does not convey that all patients will be photosensitive or that inflammation may lead to airway obstruction, and therefore does not cure the misleading impact.

OPDP states that the videos fail to present risk information in a prominent and readable manner compared to the benefit claims. The serious warnings and precautions appear as still text in small font for about five seconds at the end of each video, alongside the indications and common adverse reactions, while benefit claims are displayed in large text with “colorful animated” visuals. OPDP further notes that the videos provide no sign alerting watchers that important risk information follows the benefit portion, which undermines the communication of that risk information.

According to OPDP, the NSCLC video minimizes risk by suggesting that debridement is optional because the voiceover states “[d]ebridement may be performed if residual tumor remains.” OPDP states that this contradicts the prescribing information, which refers to a “mandatory debridement bronchoscopy” and directs that debridement be performed two to three days “after each light administration to minimize the potential for obstruction caused by necrotic debris.”

Additionally, OPDP alleges that the following claims are misleading:

  • “Photodynamic therapy is proven to boost anti-tumor immunity and improves tumor cell immunogenicity” (emphasis in original)
  • “The energy transfer generates reactive singlet oxygen which selectively destroys the cancer cells with … a diameter of up to 1.2cm.”

OPDP alleges that that the cited review article only generally describes immunogenic tumor cell death and anti-tumor responses induced by PDT in animal models, and does not address Photofrin; therefore, the “proven” characterization is misleading. Additionally, the 1.2 cm claim misleadingly suggests a definite and quantifiable benefit that has not been demonstrated and for which no supporting data are cited.

Untitled Letter to Lundbeck Seattle Biopharmaceuticals, Inc. (June 24, 2026)

OPDP’s untitled letter to Lundbeck Seattle Biopharmaceuticals, Inc. (Lundbeck) alleges that two webpages on the health care provider branded website for Vyepti (eptinezumab-jjmr), titled “Efficacy and 2-year patient outcomes” and “Real VYEPTI experience,” misbrand the drug by making false or misleading claims about its efficacy. As cited by OPDP, the “Efficacy and 2-year patient outcomes” webpage includes claims such as “40% of patients treated with VYEPTI 300 mg were 100% migraine free for a month or more vs 22% with placebo” and “Give your patients the chance for 100% migraine freedom for a month or more,” presented alongside a prominent graphic of a woman standing in front of a large “100%” image. OPDP alleges that these claims create the misleading impression that patients treated with Vyepti will achieve complete migraine freedom for a month or longer, when this has not been established. OPDP explains that the claims are based on a post-hoc analysis of data from the PROMISE-1 and PROMISE-2 trials, which lacked a prespecified statistical procedure controlling for false positive error rate. Therefore, OPDP states that it cannot be determined whether the findings resulted from Vyepti treatment or occurred by chance. OPDP acknowledges that “Post hoc analysis” appears as a footnote to these claims but states this does not cure the misleading message.

The webpage also includes claims such as:

  • “Meaningful improvement in migraine severity”
  • “>70% of patients on VYEPTI 300 mg reported their migraine symptoms were MUCH IMPROVED or VERY MUCH IMPROVED through 2 years”
  • “Patients saw improvement in disability from first dose through 2 years, which resulted in more engagement at home, work, and in their social life”

OPDP alleges that these claims create a false perception that Vyepti has shown long-term benefits on patient-reported outcomes (PROs) such as migraine severity, migraine-associated disability, and health-related quality of life, when this has not been established.

OPDP identifies several limitations with the underlying PREVAIL study, including that PREVAIL was an open-label, single-arm trial with no alpha-allocation to the PRO endpoints, meaning these data are considered exploratory, and it cannot be determined whether the outcomes were due to chance. OPDP’s view is that because PREVAIL lacked a control arm, the study could not establish that any PRO improvements were attributable to the drug. Additionally, OPDP cites methodological concerns with the PRO instruments used: the Headache Impact Test was developed for general headache patients rather than migraine patients specifically and lacks a standard recall period; the Migraine Disability Assessment utilizes a three-month recall period which is prone to recall bias; and the Patient Global Impression of Change requires patients to compare their current state to a baseline months or years earlier, which may disproportionately reflect recent occurrences.

The “Real VYEPTI experience” webpage presents claims such as:

  • “~70% of patients reported increased satisfaction with their ability TO PLAN, BE PRODUCTIVE, AND PARTICIPATE in their daily lives”
  • “After starting VYEPTI, patients reported >2x THE AMOUNT OF MONTHLY GOOD DAYS”
  • “Of the 74 patients who stated they experience brain fog, 86% REPORTED IMPROVEMENT IN BRAIN FOG”

OPDP alleges that these claims, presented alongside colorful graphics and charts, misleadingly suggest that Vyepti has demonstrated benefits on outcomes such as daily living satisfaction, more “good days,” and improved “brain fog,” when this has not been established.

OPDP identifies several limitations with the REVIEW study, an observational, single-arm trial. The study required patients to have completed at least two consecutive Vyepti infusion cycles (at least six months of exposure) before enrollment, which OPDP states may have created a favorable selection bias by excluding patients who stopped treatment due to lack of efficacy or negative reactions. OPDP further notes that the study’s endpoints of “good days,” “brain fog,” and patient satisfaction lack standardized definitions and objective correlates, raising concerns about consistency of patient reports. Additionally, OPDP explains that without an active control arm, it cannot be established whether improvements were because of Vyepti or due to other factors such as patient expectations. OPDP also raises concerns that the REVIEW study required patients to remember symptoms from up to 15 months before and that differences in data collection practices across sites introduced further variability.

Office of Compliance and Biologics Quality (OCBQ) at the Center for Biologics Evaluation and Research (CBER)

Warning Letter to Estar Technologies Ltd. (April 22, 2026)

OCBQ’s warning letter to Estar Technologies Ltd. (Estar) alleges that Estar is marketing multiple platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) device kits in the United States without marketing clearance or approval. OCBQ notes that while the Tropocells® PRP kit was 510(k)-cleared for a narrow indication, specifically the “safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of blood at the patient point of care” to be “mixed with autograft and/or allograft bone prior to application to a bony defect for improving handling characteristics,” the company’s website promotes the device for substantially different uses. As cited in the letter, the website states that Tropocells® PRP can be used for “musculoskeletal injuries, joint and osteoarthritis treatment, sports injuries, wound healing, ophthalmology, dentistry and oral surgery, and post-surgical recovery.” OCBQ alleges that these are major changes to the device’s intended use that could significantly impact its safety or effectiveness, requiring a new 510(k) premarket notification.

Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH)

Warning Letter to Happiest Baby, Inc. (June 15, 2026)

CDRH’s warning letter to Happiest Baby, Inc. (Happiest Baby) arose out of a July 2025 inspection of the company. Among other violations, CDRH alleges that the SNOO Smart Sleeper Bassinet (SNOO) is authorized for home use, but statements on the company’s website suggest that Happiest Baby is marketing the SNOO for use in hospitals as part of a SNOO Hospital Bundle without clearance or approval. The Hospital Bundle includes, among other components, the bassinet, mobility cart, and reuseable mattress. CDRH alleges that this positioning constitutes a major change in the intended use of the device given differences between hospital and home environments, including varying levels of cleaning protocols, which could cause degradation of the bassinette, and the possibility of infants with medical conditions. Additionally, CDRH alleges that adding a mobility cart creates new safety risks such as tipping.

CDRH states that it reviewed Happiest Baby’s earlier responses arguing why the SNOO is not a medical device when used in a hospital because it is marketed “exclusively as a soothing tool to calm infant fussing, improve sleep, and reduce caregiver stress and workload.” CDRH explains that its evaluation of the SNOO Hospital Bundle as a device is based on its intended use to “facilitate a supine position during sleep” and claims such as “to keep babies safely in the supine position, as recommended by the American Academy of Pediatrics.”

Additionally, CDRH points to the design of the SNOO Hospital Bundle as including the same products as authorized for home use. CDRH also alleges that Happiest Baby significantly changed the SNOO Smart Sleeper by creating two new SNOO Sleep Sack sizes.

Warning Letter to Skytron, LLC (May 19, 2026)

CDRH’s warning letter to Skytron, LLC (Skytron) arose out of a review of the company’s website. Among other violations, CDRH alleges that Skytron is marketing four UVC disinfection devices, the 1140 Sentry, 2280 Syndicate, 3200 Max, and UV Smart D25, in the United States without marketing clearance or approval.

CDRH states that although the company listed the UV Smart D25 device under the 510(k)-exempt device type of a medical washer-disinfector device (21 CFR § 880.6992, product code MEC), the device does not fall within this exemption because that exemption requires a mechanical cleaning step followed by thermal or chemical disinfection. CDRH notes that the UV Smart D25 instead relies on non-ionizing UV-C radiation with no mechanical cleaning component, which CDRH states falls outside the scope of the exemption.

CDRH cites various website and brochure statements promoting the devices for health care-related disinfection uses, including claims of specific log-reduction rates against microorganisms, whole-room disinfection capability, and use in disinfecting patient care equipment such as infusion pumps, thermometers, and monitoring equipment. CDRH states that Skytron has not provided any evidence to support the safety and effectiveness of the devices for these uses. CDRH identifies public health concerns, including potential skin, eye, and respiratory harm from UV or chemical byproduct exposure, hazard of patient cross-contamination from insufficient disinfection, and potential compromise of the material integrity of other medical devices in the space.

Additionally, CDRH describes a series of communications with Skytron dating back to February 2022, when FDA first issued an “It Has Come to Our Attention” letter regarding similar marketing concerns. CDRH states that Skytron represented on multiple occasions, including in 2024, that it would remove health care-related claims and images from its website, but that as of CDRH’s May 11, 2026, review, Skytron’s marketing materials continued to include the statements noted above.

In addition, CDRH alleges the UV Smart D25 is misbranded because brochure statements referencing the device’s registration and listing with FDA create a misleading impression of FDA approval or endorsement.

Warning Letter to 3B Medical, Inc. dba Reach Health, Inc. (May 20, 2026)

CDRH’s warning letter to 3B Medical, Inc. dba Reach Health, Inc. (Reach Health) arose out of a December 2025 inspection of the company. Among other violations, CDRH alleges that Reach Health is marketing auto-adjusting positive airway pressure (APAP) ventilator devices, with significant changes following its 510(k) clearance without submitting a new premarket notification.

CDRH stated that the APAP devices’ 510(k) clearance covered only “single-patient use,” yet the company’s current user manuals describe the devices as intended for “single-patient re-use” or “multi-patient re-use,” which constitutes a major change to the intended use that requires a new 510(k) clearance. According to CDRH, this modification could affect safety and effectiveness because multi-patient use introduces cross-contamination and infection transmission risks that were not evaluated under the original clearance. The device’s existing labeling and reprocessing instructions do not address the decontamination protocols necessary to safely support reuse.

Warning Letter to BlephEx, LLC (June 3, 2026)

CDRH’s warning letter to BlephEx, LLC. (BlephEx) arose out of a November 2025 inspection of the company and its website. Among other violations, CDRH alleges that the BlephEx Powered Eyelid Cleaning Sponge, OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and OptiVize Ophthalmic Forceps are adulterated and misbranded because they are marketed for uses outside of the 510(k) exemptions. According to CDRH, in 2017 the BlephEx Powered Eyelid Cleaning Sponge was classified under 21 CFR § 878.4820 as a class I device exempt from 510(k) notification, based on BlephEx’s representation that the device was intended only for general eyelid cleaning and hygiene, not for treating any disease or condition. CDRH alleges that BlephEx is now marketing the device for treating blepharitis and dry eye disease and for use in pre-cataract and pre-LASIK patients, including through testimonial and procedure videos on its website. CDRH states that this represents a use different from the generic device type under 21 CFR § 878.4820, which covers general surgical instrument motors and eyelid margin cleaning by health care professionals, and that expanding use to these vulnerable patient populations introduces unverified risks of tissue injury, infection, and complications with surgical wounds. CDRH concludes that the device therefore exceeds the limitations on exemption in 21 CFR § 878.9(a) and requires premarket notification.

Additionally, CDRH alleges that the OptiVize Ophthalmic Battery-Powered Electrolysis Unit is marketed for a different intended use and with different technology than the ophthalmic electrolysis units classified under 21 CFR § 886.4250, which are “intended to destroy ocular hair follicles by applying a galvanic electrical current.” CDRH cites website claims describing the device being marketed for a different use, with examples such as: “destruction of biofilm within ocular hair follicles” and “completely vaporize biofilm lurking in any structure within the eyelid.” CDRH also notes that the company is marketing the device using “different fundamental scientific technology.” Therefore, these differences cause the device to exceed the exemption limitations in 21 CFR § 886.9(a) and (b).

CDRH also alleges that the OptiVize Ophthalmic Forceps is marketed for a use different from manual ophthalmic surgical instruments classified under 21 CFR § 886.4350, which are nonpowered handheld devices used to aid ophthalmic surgical procedures. CDRH cites website claims describing the device’s use of heated, vibratory expression to clear meibomian glands, and states that this heat- and vibration-based mode of action differs from that of a manual surgical instrument, causing the device to exceed the exemption limitations in 21 CFR § 886.9(a).

Warning Letter to AseptiKits, LLC (June 4, 2026)

CDRH’s warning letter to AseptiKits, LLC (AseptiKits) alleges that the PALA YourTears models (8, 12, 14), ALAdrop, SyrilKit, and VitrALA devices are adulterated and misbranded because Aseptikits has not obtained required marketing authorization, and that the company’s website makes false and misleading claims regarding the devices’ regulatory status. CDRH notes that AseptiKits stated that the devices are exempt under 21 § CFR 880.5440(b), but according to CDRH, this exemption applies only to pharmacy compounding systems themselves and “does not encompass the ancillary devices that make up the delivery and container system,” including “fluid transfer sets, metering chambers, I.V. bags, connectors, or other components that provide a fluid contact surface.” Based on the products’ actual composition and function as described on AseptiKits’ website (closed-system bags, syringes, and filters used for sterile preparation, measurement, or priming of drug products), CDRH states that the devices instead fall under separate, non-exempt class II product codes and therefore require 510(k) clearance.

Separately, CDRH states that AseptiKits makes claims on its website asserting that its products “are 510(k) approved” and “meet FDA requirements,” including a “Key Differentiators” statement that the products “meet or exceed FDA regulations.” CDRH alleges that these representations are false and misleading because the devices at issue have not, in fact, been cleared or approved by FDA.

If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device practice.

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