FDA Issues Letters to 6 Companies for Unapproved, Misbranded OTC Analgesic Products

The FDA has issued letters to 6 companies for marketing unapproved and misbranded OTC analgesic products. The products are marketed for topical use to relieve pain before, during, or after certain cosmetic procedures, including laser hair removal, tattooing, and piercing, but the agency warns consumers not to use these products.

The FDA recommends that consumers use OTC pain relief products with no more than 4% lidocaine, not apply products over large areas of skin, or irritated or broken skin, and not wrap skin treated with the products in plastic wrap or other dressing, according to the press release.

"These products pose unacceptable risks to consumers and should not be on the market," Jill Furman, JD, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in the press release. "We are committed to using all available tools to stop the sale of these illegal high-risk products."

Some of the products included are labeled to allegedly contain ingredients, including lidocaine, at concentrations that are higher than what the FDA permits for OTC usage. The agency says that when products that contain high concentrations of lidocaine are used before or during certain cosmetic procedures, it can be applied in ways that lead to increased absorption. This can lead to serious injuries that include irregular heartbeat, seizures, difficulties breathing, or interactions with medication or dietary supplements, according to the press release. Further, when lidocaine is applied over large areas of the skin, when the skin is irritated or broken, when lidocaine is applied for long periods of time, and when the skin is covered, it can cause serious injury.

According to the agency, they are not aware of any evidence that demonstrate these products are safe and have warned about similar products over the past decade.

Products that received warning letters included: TKTX Numb Maximum Strength Pain Reliever Mirhra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40%, J-CAIN cream 29.9% (TKTX Company); NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams), NumbSkin 10.56% Lidocaine Numbing Cream (SeeNext Venture Ltd); Signature Tattoo Numbing Cream, Miracle Numb Spray (Tattoo Numbing Cream Co); Painless Tattoo Numbing Cream, Painless Tattoo Numbing Spray (Sky Bank Media LCC; Painless Tattoo Co); New and Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine, and Maximum Zone 1 (Dermal Source Inc); Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label, and Ink Eeze Numb Numbing Foam Soap (Indelicare; INKEEZE).

The FDA has given the companies 15 days to respond regarding how they will address the issue or provide their reasoning and support information as to why the products are not in violation of the law, according to the press release. Further, the FDA stated that the failure to address these violations could result in legal actions, which includes product seizure and/or a court order requiring the company to stop manufacturing and distributing these products, the press release read.

Furthermore, some of the companies have been placed on import alert by the FDA to halt their products from entering the United States and being sold to consumers, according to the press release.

Reference

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects. News release. FDA. March 26, 2024. Accessed March 26, 2024. https://prnmedia.prnewswire.com/news-releases/fda-warns-consumers-to-avoid-certain-topical-pain-relief-products-due-to-potential-for-dangerous-health-effects-302099963.html