FDA WARNING_LETTER - Dermal Source, Inc. - March 26, 2024

On March 25, 2024, the FDA issued a Warning Letter to Ms. Haake regarding the distribution of unapproved and misbranded drug products: NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, PREMIUM PRO PLUS, FIVE-STAR VASOCAINE, and MAXIMUM ZONE 1. These products, marketed as external analgesics for sensitive cosmetic procedures (e.g., tattooing, piercing), were identified through a September 2023 website review (https://dermalsource.com/).

The FDA found these products to be unapproved new drugs under section 505(a) of the FD&C Act and misbranded under section 502(ee). Violations include: - **Unapproved New Drugs**: The products are marketed without an approved application and for indications not covered by the external analgesics final administrative order (M017) under section 505G. - **Excessive Active Ingredient Concentrations**: Lidocaine HCl concentrations (5%) exceed the M017 permissible range (0.5%-4%). - **Impermissible Active Ingredient Combinations**: NEW & IMPROVED BLUE GEL, SUPERIOR SUPER JUICE, and PREMIUM PRO PLUS combine multiple "-caine" type active ingredients (e.g., lidocaine, tetracaine, benzocaine), which is not permitted by M017. - **Unapproved Indications**: Claims for pain relief during tattooing, permanent