FDA WARNING_LETTER - SafaLab, Inc. - February 08, 2021

On February 18, 2021, the FDA and FTC issued a Warning Letter to Safalab, Inc. and Weeksmd.com after reviewing their websites on February 8, 2021. The FDA found that www.safalab.com offered "The Prevention 12 Pak" (also called "Coronavirus Prevention 12 Pak"), consisting of 12 products, for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. The website www.weeksmd.com directed consumers to www.safalab.com for this product.

The FDA determined "The Prevention 12 Pak" is 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). Its introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter cited specific claims from both websites, including statements about the product's ability to protect against COVID-19 and the anti-viral properties of its components (e.g., Melatonin, Selenium, Iodine, Vitamin D3, Glutathione, Vitamin A, Zinc).