FDA WARNING_LETTER - CAMA Wellness Center/IodoRios Company, LLC - March 02, 2021

The FDA and FTC issued a Warning Letter to IodoRios, LLC on March 5, 2021, regarding the sale of unapproved and misbranded products related to COVID-19. The agencies reviewed the company's websites, www.cp.camacenter.com and www.facebook.com/IoWipe, on February 8 and March 2, 2021, respectively.

The FDA observed that IodoRios, LLC offers a hand wipe product for sale in the United States, claiming it mitigates, prevents, treats, diagnoses, or cures COVID-19. This product is deemed an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 (21 U.S.C. § 352). The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations for COVID-19, emphasizing FDA's urgent measures to protect consumers from unauthorized products. IodoRios, LLC is required to immediately cease selling all unapproved and unauthorized products for COVID-