# FDA WARNING_LETTER - Sovereign Laboratories, LLC - April 07, 2020

Source: https://www.keypedia.com/records/warning_letter/sovereign-laboratories-llc/fa631e11-6667-4d50-988b-96701ee5d9c6

> FDA WARNING_LETTER for Sovereign Laboratories, LLC on April 07, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sovereign Laboratories, LLC
- Inspection Date: 2020-04-07
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On June 15, 2020, the FDA and FTC issued a Warning Letter to Prosov Labs and Sovereign Laboratories regarding their websites, www.prosovlabs.com and www.sovereignlaboratories.com. The FDA observed that the websites offered "PRO Vital C-LD®," "PRO Colostrum-LD®," "Vital C-LDTM," and "Colostrum-LD®" for sale, claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and are misbranded drugs under section 502 of the FD&C Act (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency and national emergency declarations related to COVID-19 as context for urgent FDA action. The company was requested to immediately cease selling these unapproved and unauthorized products for COVID-19 related claims. Examples of misleading claims from www.sovereignlaboratories.com were noted.

The

## Related Documents

- [WARNING_LETTER - 2019-02-11](https://www.keypedia.com/records/warning_letter/sovereign-laboratories-llc/f2db5645-fd7d-4ab7-ab5b-159a1a7a04c0)

## Related Officers

- [Richard A. Quaresima](https://www.keypedia.com/people/richard-a-quaresima/d0be06fa-21e5-46d0-879d-95af9663066c)
- [Director](https://www.keypedia.com/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.keypedia.com/companies/sovereign-laboratories-llc/c1da00ea-13a8-4395-8a97-6f0c197a3ac3

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