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

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.

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