FDA WARNING_LETTER - Dr. Paul's Lab - February 09, 2021

On February 16, 2021, the FDA and FTC issued a Warning Letter to Dr. Sarah's Essentials regarding the sale of "COVID-Aid Tincture." The agencies reviewed the company's websites, http://drpaulslab.net and https://drsarahsessentials.com, on January 28 and February 9, 2021.

The FDA determined that "COVID-Aid Tincture" is an unapproved new drug, sold in violation of section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. The product is marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, which is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

The letter requires immediate action to cease the sale of all unapproved and unauthorized COVID-19 related products. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective steps, including documentation and recurrence prevention. Failure to