FDA admonishes companies for marketing unauthorized products, making misleading claims
The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices without authorization, including devices for eyelid cleaning and an infection control system. Additionally, the agency sent an untitled letter to a company regarding misleading promotional communications for a prescription migraine drug.
These letters were posted on the agency’s website on 7 July. FDA also issued 15 warning letters to companies selling unapproved ketamine online, citing concerns regarding the safety of the medication.
BlephEx, LLC
FDA issued a warning letter to BlephEx, LLC in Brentwood, TN for marketing its powered eyelid cleaning devices for unapproved uses, as well as for good manufacturing practice (GMP) and Global Unique Device Identification Database (GUDID) submission failures. These devices include its BlephEx Powered Eyelid Cleaning Sponge, the OptiVize Ophthalmic Battery-Powered Electrolysis Unit, and the OptiVize Ophthalmic Forceps.
The agency said the company is marketing these products to vulnerable populations, such as those who suffer from dry eye, blepharitis, pre-cataract, and pre-LASIK patients.
FDA said the company’s cleaning sponge is adulterated “because your firm does not have an approved application for premarket approval (PMA) in effect” for the product or an approved application for an investigational device exemption (IDE).
The sponge is also misbranded because the product is “intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 878.4820 without submitting a premarket notification to FDA.”
In a video, the company president is shown recommending the eyelid cleaning sponge for “dry eye and blepharitis patients” and further states that the device is used for “opening up the meibomian glands.”
FDA said that “your firm appears to be marketing the BlephEx Powered Eyelid Cleaning Sponge device for use on specific vulnerable populations, including those with dry eye, blepharitis, pre-cataract, and pre-LASIK patients. Expanding the device's indications to these specific groups introduces significant, unverified safety concerns.’
FDA inspectors also uncovered GMP violations at the site, such as inadequate handling of complaints. The agency said none of the 177-plus complaints listed in its complaint log have been reviewed, evaluated, investigated, or kept in a separate file for MDR reporting.
Additionally, the firm received a reprimand for insufficient training of its personnel. The company’s vice president of operations confirmed that there was no training procedure in place. He stated that, before the inspection, he was unaware of the company’s quality system, which includes the complaint handling procedure, the corrective and preventive action (CAPA) procedure, and other quality system requirements, even though he had been responsible for overseeing the quality system since August 2023.
Skytron, LLC
FDA warned Skytron in Grand Rapids, MI for illegally marketing several devices that are designed as infection control systems, including the 140 Sentry, 2280 Syndicate, 3200 Max and UV Smart D25 in the US without proper marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act.
The agency assessed the firm’s webpage and found that the systems are adulterated because the company lacks an approved PMA or an approved IDE.
FDA further noted that the company’s UV Smart D25 device “fails to qualify for 510(k) exemption under 21 CFR 880.6992 because the device’s technology includes neither a mechanical cleaning nor disinfection step, which is different than medical washer-disinfector devices identified in 21 CFR 880.6992 under which you registered the device.”
In March 2024, the company informed the FDA that it would remove these claims, but they have still not been removed.
Untitled letter
FDA issued an untitled letter to Lundbeck Seattle Biopharmaceuticals over its promotional communications for Vyepti (eptinezumab-jjmr) injection for intravenous use which is used to prevent migraines. At issue are the company’s efficacy claims for the drug on its webpage.
The webpage claims that in a 6-month chronic migraine study, 40% of patients treated with VYEPTI 300 mg were 100% migraine-free for a month or more, compared to 22% with a placebo. It also touted the results of an observational study, which showed that 35% of patients treated with VYPETI 100 mg were 100% migraine free for a month or more vs 22% with a placebo.
FDA said that “these claims and presentations create the misleading impression that patients treated with Vyepti will be 100% migraine-free for a month or more, when this has not been demonstrated. The webpage cites the post-hoc analysis of the data from PROMISE-1 and PROMISE-2 in support of these claims. However, because these analyses were conducted post hoc and there was no prespecified statistical procedure controlling for type 1 error rate (false positive rate), it is not possible to ascertain whether the findings were attributable to treatment with Vyepti, or merely due to chance.”
Ketamine retailers
FDA also issued warning letters to 15 companies that were selling illegal ketamine products to consumers through their websites. This action is part of the agency’s increased efforts to enforce regulations against the illicit sale of ketamine, which is a Schedule III controlled substance. All the companies, except for one, were based in the US; the remaining company is located in the Netherlands.
In its warning letter to the Pure Arylycyclohexylamine Store, FDA said that it “has identified significant risks associated with unapproved ketamine products, especially in the absence of appropriate medical supervision. Given the increased interest in the use of ketamine products, the easy availability of unapproved and misbranded ketamine products via the internet puts U.S. consumers at risk for serious adverse events.” FDA sent similar warning letters to all 15 companies.
Ketamine was approved as a general anesthetic by FDA in 1970 and more recently, the agency approved Spravato (esketamine), a ketamine derivative nasal spray used to treat adults with treatment-resistant depression and those with depressive symptoms with major depressive disorder with acute suicidal ideation or behavior alongside an oral antidepressant.
