During the third quarter of 2026, FDA’s Center for Drug Evaluation and Research (CDER) Office of Prescription Drug Promotion (OPDP) posted the following five untitled letters and did not post any warning letters:
The Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) posted three warning letters relating to the advertising and promotion of medical devices:
- Warning Letter to Nihon Kohden Digital Health Solutions, LLC re Next Generation NetKonnect software device (June 12, 2026) (NetKonnect Warning Letter).
- Warning Letter to Specialty Health Products CO, LLC re Hydro-San Colonic Irrigation System (July 7, 2026) (Hydro-San Warning Letter).
- Warning Letter to Advance-Esthetic LLC re Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro (August 25, 2026) (Zemits Warning Letter).
FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) 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 advertising and promotion during this period.
OPDP’s untitled letter to Viatris Specialty LLC (Viatris) alleges that a direct-to-consumer (DTC) video misbrands the TOBI Podhaler (tobramycin inhalation powder) by making false or misleading representations about the drug’s administration. The video features a patient and a parent describing the convenience and portability of the TOBI Podhaler, including statements such as “[t]he one thing I love about the TOBI Podhaler is when I am running late, I can do it on the way to school in the car” and “[m]y favorite things about the TOBI Podhaler are how portable it is, how quick it is to use, and how you can use it anywhere.”
OPDP alleges that these claims misleadingly suggest that patients can use the TOBI Podhaler anywhere without considering the product’s specific handling and preparation requirements. OPDP notes that the FDA-approved instructions for use include several detailed steps requiring adequate lighting and stable conditions to properly complete the preparation and administration of the product. The instructions for use also direct patients to peel back the foil from only one capsule at a time and to remove the capsule just before use because the packaging keeps the capsule dry. OPDP states that the misleading impression is concerning because incomplete emptying of the capsules or exposure of the device or capsules to moisture could cause patients to receive less medication than intended, resulting in an inadequate dose. OPDP acknowledges that the video provides some usage information but concludes that it does not correct the misleading impression.
OPDP’s untitled letter to Sanofi Vaccines US Inc. (Sanofi) alleges that two professional emails misbrand Beyfortus (nirsevimab-alip) by making false or misleading representations about the drug’s approved indication.
OPDP states in its letter that the emails include claims such as “Help Prevent RSV [Respiratory Syncytial Virus] Disease in Infants with Beyfortus® and See How You Can Affect Population Health” and “Your efforts in immunizing infants against RSV disease can impact the population health burden in your community.” OPDP asserts that these broad references imply the product is approved for general RSV disease, when the prescribing information limits the approved use to RSV lower respiratory tract disease. OPDP acknowledges that the later portion of the emails references the full approved indication, but OPDP concludes that this does not remedy the overall misleading message.
OPDP’s untitled letter to Travere Therapeutics, Inc. (Travere) alleges that a professional visual aid misbrands Filspari (sparsentan) by making false or misleading representations about the drug’s efficacy and by minimizing its risks.
OPDP alleges that repeated claims of “kidney preservation” and “kidney function preservation” are misleading because this has not been proven. According to OPDP, the prescribing information describes Filspari’s approved use as slowing “kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression,” and while the trial showed a slowing of the rate of decline, patients on the drug continued to lose kidney function.
OPDP also alleges that claims that Filspari is “[p]roven to drive 3x more patients to complete remission of proteinuria” are misleading because the complete remission analysis was exploratory, with no prespecified statistical significance threshold controlling for false-positive risk. Accordingly, OPDP states it is not possible to ascertain whether the finding is attributable to treatment with Filspari or merely due to chance. OPDP acknowledges that a footnote identifies the analysis as a “prespecified exploratory analysis” but concludes that this caveat does not adequately mitigate the misleading impression.
In addition, according to OPDP, the visual aid’s description of the drug as “well tolerated over 2 years” obscures the seriousness of its known risks, which include boxed warnings for both hepatotoxicity and embryo-fetal toxicity and a requirement that the drug be dispensed only through the Filspari Risk Evaluation and Mitigation Strategy (REMS) restricted distribution program. OPDP notes that a separate claim, “[n]o drug-induced liver injury following treatment with Filspari,” accompanied by a liver image, is inconsistent with cases of drug-induced liver injury. OPDP notes that the REMS mandates regular liver monitoring during treatment precisely because of this concern. While OPDP notes that the risks are stated throughout the visual aid, OPDP contends that this is not sufficient to mitigate the misleading impact.
OPDP further alleges that a graph captioned “[b]lood pressure remained consistent over a 2-year period and was comparable to irbesartan” is misleading because the prescribing information’s warnings and precautions section reports higher rates of hypotension-related adverse events in Filspari-treated patients compared with irbesartan-treated patients. OPDP acknowledges that hypotension risk information appears in other parts of the visual aid but concludes that this is insufficient to counteract the misleading graph and headline.
OPDP’s untitled letter to Alar Pharmaceuticals Inc. (Alar) addresses promotional materials for ALA-3000 (ketamine pamoate) injection for treating treatment-resistant depression (TRD) that were displayed at the American Psychiatric Association (APA) 2026 Annual Meeting. OPDP alleges that the exhibit booth display and brochure misbrand the product by making promotional representations of safety and efficacy for a drug that remains under investigation and has not received FDA approval. OPDP states that the claims are especially concerning because ketamine is a Schedule III drug with multiple serious risks.
OPDP states the exhibit booth and brochure claim that the investigational drug is safe and effective, including claims such as:
- “ALA-3000 Breaks Key Barriers in Ketamine Therapy for TRD.”
- “No sedation, dissociation, psychosis-like effects, or commonly ketamine-reported AEs (e.g., blood pressure elevation, urinary toxicity).”
- “No abuse signals.”
OPDP alleges that these claims make conclusory statements that ALA-3000 is safe and effective for the treatment of TRD, despite the fact that ALA-3000 has not been approved and, based on the brochure, appears to have been studied only in Phase 1 clinical trials.
OPDP states that the claims are particularly concerning from a public health perspective because ketamine, the active ingredient of ALA-3000, is a Schedule III controlled substance associated with serious risks, including sedation, dissociation, respiratory depression, hemodynamic instability, and abuse and misuse. OPDP further alleges that the promotional materials’ representation that ALA-3000 is better than approved therapies for treating TRD is especially concerning given these risks.
Additionally, OPDP alleges that the booth display lacked any statement identifying ALA-3000 as an investigational new drug not approved for commercial distribution in the United States, and that the ALA-3000 booth was situated in the exhibit hall close to booths for approved products.
OPDP’s untitled letter to Evolus, Inc. (Evolus) alleges that an Instagram post for Jeuveau (prabotulinumtoxinA-xvfs), published on both the “evolus” and “jeuveaubyevolus” accounts, misbrands the drug by overstating its efficacy and minimizing its risks. OPDP notes that FDA’s Bad Ad Program also received a complaint about the post. The agency describes the violations as a public health concern because Jeuveau carries serious and potentially life-threatening risks, including a boxed warning for distant spread of toxin effects. OPDP notes that advisory comments it sent to Evolus in November 2019 covered similar issues and expresses concern that Evolus continues to present the drug’s benefits in a misleading manner.
The post contains an Instagram reel featuring a patient who says she is “excited about getting rid of my lines” and, in voiceover during before-and-after clips from day 0 and day 2, remarks that she is “really surprised at how quickly it’s kicking in” and that she feels like the line between her eyebrows is “gone.” The accompanying caption states “Lines today. Blurred in as little as 2 days,” refers to Jeuveau’s “iconic fast-acting results,” and states that most patients “achieve complete results by day 30.” OPDP alleges that this content suggests Jeuveau eliminates frown lines permanently and delivers complete results, which is inconsistent with an approved indication limited to the “temporary improvement in the appearance of moderate to severe glabellar lines.” According to OPDP, efficacy was established using a composite endpoint requiring at least a two-point improvement on the Glabellar Line Scale at Day 30. Evaluation of a score of “none” was exploratory in the pivotal trials, and no statistical analysis was performed. OPDP acknowledges that the full indication appears in the post, but only at the end of the testimonial or lower in the caption, and concludes that this placement does not mitigate the misleading impression.
OPDP also alleges that the post overstates how quickly Jeuveau works by implying meaningful results by day 2. According to OPDP, the day 2 data derive from an exploratory, hypothesis-generating endpoint without multiplicity adjustment, so it cannot be determined whether the observed effect resulted from treatment or chance. In OPDP’s view, presenting the day 2 data in conjunction with the primary endpoint at day 30 conflates different levels of clinical response and statistical analysis in a way viewers are unlikely to distinguish. OPDP acknowledges that the testimonial may reflect the patient’s actual experience and that the video displays the statement “[i]ndividual results may vary,” but it concludes that neither point cures the misleading impression.
OPDP describes the person interviewed as “lively and engaging,” “fashion-forward,” and “beauty-focused.” OPDP takes issue with caption language promoting a “Blur The Lines Masterclass” with the cosmetic service IPSY and describing an effort to “blur[] the lines between what’s found in your beauty bag and what happens in the treatment room,” accompanied by syringe and lipstick icons. OPDP alleges that this presentation, together with the video’s upbeat, fashion-focused styling, equates a prescription injectable administered by a healthcare provider with an ordinary beauty product and simplifies its dosage and administration requirements. The agency points to prescribing information language stating that safe and effective use “depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques,” and to the product’s boxed warning, contraindications, and warnings and precautions.
OPDP further alleges that the post does not present risk information with emphasis and readability comparable to its benefit claims. The risk information appears only after the testimonial ends with the tagline “Jeuveau, you see me,” which is displayed against a dark backdrop for a few seconds in a manner that signals the close of the video. A brief narrated statement follows, along with fast-scrolling, unnarrated risk text, and OPDP notes that nothing in the reel alerts viewers that important risk information will appear after the testimonial. OPDP acknowledges that the caption discloses prescription status and limited risk information, but viewers can reach that content only by scrolling past additional benefit claims, and this format minimizes Jeuveau’s risks.
CDRH’s warning letter to Nihon Kohden Digital Health Solutions, LLC (Nihon Kohden) arose out of a February 2026 inspection of the company. CDRH alleges that the company’s Next Generation NetKonnect (NGNK) software, a class II arrhythmia detector and alarm device, is adulterated and misbranded because it has been marketed for uses beyond the scope of that clearance without a new premarket submission.
CDRH alleges that the device’s labeling describes NGNK as offering “device-agnostic compatibility,” referring to the software’s ability to run on any brand of commercial computer and to accept input from non-Nihon Kohden devices. However, the device was cleared only to support inputs from other Nihon Kohden devices, and it concludes that the expanded compatibility claim represents a major change in intended use requiring a new 510(k). The agency explains that pairing the software with input devices that have not been validated for interoperability could produce incorrect vital sign readings or loss of monitoring, which may delay diagnosis or lead to misdiagnosis.
CDRH’s warning letter to Specialty Health Products CO, LLC (Specialty Health Products) arose out of a December 2025 inspection of the company and a review of its website, user guide, product catalog, and written orders. Among other violations, CDRH alleges that the Hydro-San Colonic Irrigation System is adulterated and misbranded because the company is marketing it for an intended use that falls outside its original 510(k) clearance.
CDRH notes that the Hydro-San Colonic Irrigation System was cleared for use “when colonic irrigation is indicated.” The agency alleges, however, that the company’s promotional materials show the device is distributed for colon hydrotherapy, an alternative wellness practice typically promoted to boost energy and detoxify the body rather than for medical purposes. As examples, CDRH cites a product catalog describing the company as a “leading manufacturer of professional colon hydro-therapy systems,” a webpage stating that the company’s mission is to “be the premier service provider of professional Colon Hydrotherapy devices,” and website claims that colon hydrotherapy can improve digestive health, relieve constipation, lower cancer risk, and improve the body’s retention of vitamins and nutrients. CDRH also points to written orders allegedly indicating that the device was sold to wellness centers for colon hydrotherapy. CDRH explains that colonic irrigation systems are class II devices only when intended for medically indicated colon cleansing, such as before radiological or endoscopic examinations, and are class III devices when intended for other uses, including routine colon cleansing for general well-being.
CDRH’s warning letter to Advance-Esthetic LLC (Advance-Esthetic) arose out of an October to November 2025 inspection of the company. CDRH alleges that the company’s Zemits CrystalFrax Pro, Zemits Abigon Pro, and Zemits Bionexis Lite Pro devices are adulterated and misbranded because they are marketed as 510(k) exempt devices but with intended uses that fall outside the exemption.
CDRH notes that the company listed the three devices under the 510(k) exempt product code for therapeutic massagers, a device type that is exempt from premarket notification when used for medical purposes such as relieving minor muscle aches and pains.
CDRH alleges that the company’s marketing shows the devices are intended for uses different from those of exempt therapeutic massagers and therefore that the devices fall outside the scope of the 510(k) exemption. The agency cites website claims that the Zemits Bionexis Lite Pro can “reduce cellulite appearance,” “decrease appearance of stretch marks,” and “reduce edema and puffiness,” as well as a statement that the Zemits CrystalFrax Pro “stimulates collagen production.” CDRH further points to a video linked on the company’s website stating that the Zemits Abigon Pro can “stimulate collagen regeneration [and] increase the production of elastin and hyaluronic acid.”
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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