FDA WARNING_LETTER - Sovereign Laboratories, LLC - February 11, 2019

The FDA issued a Warning Letter to Sovereign Laboratories, LLC, on February 5, 2019, following a review of their websites (www.sovereignlaboratories.com and www.soverignhealthinitiative.org) in October 2018. The FDA determined that the products Colostrum-LD®, Viralox®, and Curcumin-LD® are marketed with claims establishing them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The violations stem from numerous claims on their websites, promotional literature, and Facebook page that indicate the products are intended for the cure, mitigation, treatment, or prevention of disease. Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and lack the required FDA approval for interstate commerce, violating sections 301(d) and 505(a) [21 U.S.C. §§ 331(d), 355(a)].

Furthermore, the products are deemed misbranded under section 502(f)(1) of the Act [2