SafaLab, Inc.

Warning LetterOpen

Dr. Bradford Weeks SafaLab, Inc. 317 Cascade Ave. Langley , WA 98260 United States info@safalab.com laura@safalab.comIssued Feb 18, 2021Center for Food Safety and Applied Nutrition (CFSAN)

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

Letter Details

Firm: SafaLab, Inc.
Location: Dr. Bradford Weeks SafaLab, Inc. 317 Cascade Ave. Langley , WA 98260 United States info@safalab.com laura@safalab.com
FEI Number: N/A
Country: United States
Issue Date: February 18, 2021
Issuing Office: Center for Food Safety and Applied Nutrition (CFSAN)
Product Type: Drugs
Status: Open

Summary

SafaLab, Inc. was cited for selling an unapproved new drug called "The Prevention 12 Pak" (also marketed as the "Coronavirus Prevention 12 Pak"), a combination product containing 12 ingredients including vitamins, minerals, and supplements, which violated section 505(a) of the Federal Food, Drug, and Cosmetic Act by lacking FDA approval. The company made disease claims on its websites (safalab.com and weeksmd.com) that the product could mitigate, prevent, treat, diagnose, or cure COVID-19, rendering it both an unapproved drug and a misbranded drug under section 502 of the FD&C Act. The FDA took action during the COVID-19 public health emergency period to prevent distribution of the unapproved product into interstate commerce in violation of sections 301(a) and (d) of the FD&C Act.