Dr. Paul's Lab

Warning LetterOpen

Paul Dettloff, DVM Dr. Paul's Lab 9559 County Road Y Mazomanie , WI 53560 United States drpaulslabllc@gmail.comIssued Feb 16, 2021Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateFeb 16, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Dr. Paul's Lab
Location: Paul Dettloff, DVM Dr. Paul's Lab 9559 County Road Y Mazomanie , WI 53560 United States drpaulslabllc@gmail.com
FEI Number: N/A
Country: United States
Issue Date: February 16, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Dr. Paul's Lab sold an unapproved new drug called "COVID-Aid Tincture" that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19 in people, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The product was also misbranded under section 502 of the FD&C Act and was distributed into interstate commerce through multiple websites including Dr. Sarah's Essentials. The FDA took this enforcement action during the global COVID-19 public health emergency to protect consumers from unauthorized products making disease claims without FDA approval.

Dr. Paul's Lab FDA Warning Letter, February 16, 2021