FDA WARNING_LETTER - Aquavit Pharmaceuticals, Inc - December 19, 2019

The FDA issued a Warning Letter to Aquavit Life Sciences, Inc. for marketing the AQUAGOLD® fine touch and A.S.A.P! Micro Infusion System without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. These products are deemed adulterated under section 501(f)(1)(B) because the firm lacks approved premarket approval (PMA) or investigational device exemption (IDE) applications. They are also misbranded under section 502(o) for failure to notify FDA of intent to introduce the devices into commercial distribution, as required by section 510(k).

The AQUAGOLD® fine touch, marketed for physician use, and the A.S.A.P! Micro Infusion System, for at-home use, are considered devices due to claims of delivering therapeutics into the dermis for medical purposes like stimulating collagen, wound healing, and treating conditions such as acne scars, hyperhidrosis, and alopecia. Both devices penetrate beyond the stratum corneum, affecting body structure/function. Microneedling devices for aesthetic use are Class II devices requiring 510(k) premarket notification, and no microneedling device is cleared for OTC/home use.

The firm also markets SKINWORKOUT® U.R. (Ultimate Radiance) and T.T. (Targeted Toning) serums, intended for injection for medical purposes, which