FDA WARNING_LETTER - AG Essence, Inc. - January 22, 2024

The FDA issued a Warning Letter to Belkis Wingfield, manufacturer and distributor of Banda-SiL Silver Wound Care Gel and Banda-Sil Silver Liquid Gel Spray, following an inspection from January 9-22, 2024. This letter follows prior communications and inspections in 2019 and 2020, where the FDA informed the firm that their products require premarket review. Despite a February 2021 letter from the firm stating they would cease marketing without a 510(k) submission, no such submission has been made, and the firm continues to market the products.

The FDA determined the products are adulterated under 21 U.S.C. § 351(f)(1)(B) and misbranded under 21 U.S.C. § 352(o) because they lack required premarket approval (PMA) or 510(k) notification. The products also appear to make claims (e.g., "prevents infection, stimulates wound healing, and promotes skin matrix repair") that may classify them as drugs requiring an approved new drug application.

Additionally, the products are misbranded due to non-compliance with Unique Device Identifier (UDI) labeling requirements (21 CFR 801.20(a)), failure to submit required information to the Global Unique Device Identification Database (GUDID) (21 CFR