SeeNext Venture, Ltd. – FDA Warning Letter, Mar 25, 2024

On March 25, 2024, the FDA issued a Warning Letter to Jung Woo Shin regarding the distribution of NumbSkin 5% Lidocaine Numbing Cream (15g and 30g) and NumbSkin 10.56% Lidocaine Numbing Cream. An October 2023 website review (numbskin.com) revealed these products are marketed as external analgesics for sensitive cosmetic procedures (e.g., tattooing, piercing, laser hair removal) and anorectal use.

The FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act and misbranded under section 502(ee). Violations stem from marketing without an approved application and for indications not covered by the external analgesics final administrative order (M017) or anorectal monograph (M015). The lidocaine concentrations (5% and 10.56%) exceed the 0.5% to 4% range permitted by M017. Furthermore, claims for tattooing, piercing, and other pain-sensitive procedures are not included in M017 or M015.

The FDA expressed safety concerns due to potential increased absorption of active ingredients through irritated or broken skin, especially when used without professional supervision, which could lead to serious injury. The letter requires a written response within 15 working days detailing corrective actions and prevention