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.
During the fourth quarter of 2024 FDA’s Office of Prescription Drug Promotion (OPDP) posted one Untitled Letter.
- Untitled Letter to Merz Pharmaceuticals GmbH re E: BLA 125360 XEOMIN (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use (October 31, 2024) (Xeomin Untitled Letter).
During the same period, the Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH) posted one warning letter relating to the advertising and promotion of medical devices.[i]
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. FDA’s Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) has not posted any enforcement letters since 2018.
This alert merely summarizes the allegations contained in FDA’s letters. It does not contain any analyses, opinions, characterizations, or conclusions by or of Covington & Burling LLP. As a result, the information presented herein does not necessarily reflect the views of Covington & Burling LLP or any of its clients.
Office of Prescription Drug Promotion (OPDP)
Xeomin Untitled Letter (October 2024)
OPDP’s untitled letter to Merz Pharmaceuticals GmbH (“Merz”) alleges that an Instagram post made by both Merz, on the Xeomin Aesthetics Instagram account, and Nate Berkus on his personal Instagram account in “[p]aid partnership with xeominaesthetic” makes “false or misleading representations and suggestions about the risks and efficacy of Xeomin.” Specifically, OPDP expresses concerns that the post does not present the “benefits and serious risks of the drug in a truthful and non-misleading manner”.
Xeomin is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity, and it carries a boxed warning regarding the distant spread of toxin effect. Xeomin is contraindicated in patients with a known hypersensitivity to any botulinum toxin product or to any components of Xeomin and in patients with an infection at the proposed injection site. The packaging lists a series of warnings and precautions regarding the product.
OPDP notes that it had twice previously provided advisory comments to Merz. Although the substance of those comments is redacted, OPDP states, “We are concerned that Merz is not presenting the benefits and serious risks of the drug in a truthful and non-misleading manner, despite concerns previously expressed by OPDP.”
False or Misleading Risk Presentation
OPDP alleges that the post “undermines the communication of important risk information and thereby misleadingly minimizes the risks associated with the use of Xeomin.” In the post, Berkus invites viewers to “[c]ome with me as I get ready for a big night out” and includes voiceover claims regarding Xeomin, including that it “is a ‘smart tox,’ and that it ‘smoothes [sic] the look of frown lines’ and further implies that it will keep him ‘looking fresh’”. OPDP alleges that the post displays the indication and use statement as static, onscreen text throughout the presentation, while risk information is “presented only at the end of the reel,” after a viewer may believe the video to be over, and as “onscreen text, using fast-paced, scrolling font that is small and difficult to read, which is unlikely to draw the viewer’s attention.” OPDP acknowledges that risk information is also included in the caption of the post, but states that “it can only be accessed if the viewer manually scrolls down, past additional benefit claims and other unrelated information” and therefore that it “does not mitigate the post’s overall misleading minimization of the risk.”
False or Misleading Benefit Presentation
OPDP also alleges that the post is “false or misleading with respect to benefits.” Specifically, OPDP alleges that “the claims and presentations in the post (reel and caption)[] suggest that after a ‘surprise appearance’ of frown lines during preparation for a same-day event, treatment with Xeomin is a ‘secret weapon for looking fresh’ and ‘smoothes [sic] the look of frown lines’, which can result in achievement of clinical effects in time for a ‘big night out’, when this has not been demonstrated.” The efficacy of Xeomin was evaluated based on a composite endpoint where treatment success was defined as a 2-grade improvement for both the investigator and patient assessment per the 4-point Facial Wrinkle Scale compared to baseline on Day 30. Efficacy data was also collected at other time points besides the primary endpoint at Day 30, but composite endpoint treatment success was not evaluated before day 7. OPDP notes that it is not aware of data to support the suggestion the Xeomin can provide successful treatment as rapidly as suggested in the post. Additionally, OPDP alleges that claim that Xeomin is “a double filtered smart tox that smooths the looks of frown lines with the only ingredients that you need for treatment” and the use of the hashtag “#SmartTox” “misleadingly suggest[s] that due to its manufacturing process and formulation, Xeomin offers benefits over other botulinum toxin products, when this has not been demonstrated.” OPDP acknowledges that the PI states that the active neurotoxin of Xeomin is “without accessory proteins,” but it is not aware of any head-to-head studies of comparing Xeomin to other botulinum toxin products approved for the same indication.
Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH)
Anne’s Daye Ltd dba Tampon Innovations Warning Letter (December 2024)
FDA’s warning letter to Anne’s Daye Ltd dba Tampon Innovations (Anne’s Daye) arose out of a facility inspection and review of the firm’s website. FDA alleges the Anne’s Daye is marketing Cannabinoid (CBD) Coated Daye Tampons and Vaginal Microbiome Screening Kits as unapproved medical devices.
CBD Coated Daye Tampon
FDA alleges that the Anne’s Daye is marketing the CBD Coated Daye Tampons for a new intended use without necessary premarket approval. According to FDA, the Daye Tampon product was cleared with an indication “for insertion into the vagina to absorb menstrual discharge”; however, the firm’s labeling and promotion of the CBD Coated Daye Tampon “provides evidence that the device is intended for relief of period related pain, which would constitute a major change or modification to its intended use, for which [the] firm lacks clearance or approval.” FDA flags example statements, including “CBD is known for its soothing and anti-inflammatory properties, which makes it your period’s perfect partner in crime”; “featuring a special comfort coating that ensures a mellow period experience”; and “Fully-sustainable organic tampons with a no-shed protective sleeve and a CBD coating for the days when period pain is cramping your style.”
FDA’s letter also alleges that “FDA has repeatedly identified [the firm’s] product as being marketed without the necessary premarket authorization.” Specifically, FDA states that it sent an “It Has Come to Our Attention (IHCTOA) Letter” on April 5, 2024, explaining that “the CBD coating raises significant concerns regarding the safety and effectiveness of [the firm’s] device.” FDA also explains that it notified the company in written feedback to the firm’s pre-submission that “the inclusion of a drug product (CBD) as part of the subject device (tampon) represents a different technological characteristic and raises different questions of safety and effectiveness as compared to the proposed predicate devices and other previously cleared tampons. Therefore, the 510(k) pathway is not appropriate for [the firm’s] product.”
Vaginal Microbiome Screening Kit
FDA alleges that statements regarding the Anne’s Daye’s Vaginal Microbiome Screening Kit indicate that it is intended for “indications for which [the] firm lacks clearance or approval”, specifically “diagnosing yeast infections, BV, STIs, fertility implications, and other gynecological health complications.” FDA cites claims from the Anne’s Daye’s website, Trustpilot website, and Amazon website. FDA alleges that the firm has been “importing and distributing Vaginal Microbiome Screening Kits into interstate commerce under” the clearance for Daye tampons, “which did not include a clearance for diagnostic purposes.” FDA also claims that the agency denied clearance for the screening kit as a “general wellness device” because the “firm markets the device with diagnostic claims that are outside the scope of a general wellness device as described in the FDA guidance document ‘General Wellness: Policy for Low Risk Devices’.”
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
[i] The Anne’s Daye Warning Letter also includes allegations that the firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. These allegations are omitted from the discussion in this alert.
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