FDA WARNING_LETTER - American Global Health Group, LLC - January 31, 2021

The FDA issued a Warning Letter to American Global Health Group, LLC, regarding their AloeCure brand products (VeraFlex, Advanced Formula Capsule, Pure Aloe Vera Extract, Probiotic + Enzyme). A review of their website (www.aloecure.com) and Facebook page (www.facebook.com/aloecure) in December 2020 and January 2021 revealed claims that establish these products 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 products are deemed drugs because they are intended for the cure, mitigation, treatment, or prevention of disease, based on claims such as "Improve . . . Mobility, and Reduce Joint Discomfort" for VeraFlex, "neutralize bouts of acid reflux and heartburn" for Advanced Formula Capsule, "neutralize [stomach acid] instantly" for Pure Aloe Vera Extract, and addressing "enzyme deficiencies" for Probiotic + Enzyme. These claims, along with personal testimonials and blog posts, indicate intended drug use.

Since the 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)], requiring prior FDA