FDA WARNING_LETTER - Iodine Products Inc - March 23, 2022

This FDA Warning Letter, dated March 25, 2022, addresses Iodine Products regarding the sale of unapproved and misbranded products related to COVID-19. The FDA and FTC reviewed the company's website (https://www.iodineproducts.com) and social media (YouTube, Facebook, Instagram) on March 2 and March 23, 2022.

The violations include offering "Liquid Mask Spray Anti-Viral" and "The COVID-Killer" for sale, which are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations for COVID-19 as context for urgent FDA action. The company is required to immediately cease selling these unapproved and unauthorized products. Within 48 hours, Iodine Products must email COVID-19-Task-Force-CDER@fda.hhs