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

Source: https://www.keypedia.com/records/warning_letter/safalab-inc/8978af15-5db7-4d25-a38a-bb91e1ec0b30

> FDA WARNING_LETTER for SafaLab, Inc. on February 08, 2021. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SafaLab, Inc.
- Inspection Date: 2021-02-08
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: 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).

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)
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Company: https://www.keypedia.com/companies/safalab-inc/3442c4f3-a4bb-42bd-9ce6-72d1355e2106

Office: https://www.keypedia.com/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2