Umbrella
FDA issued this warning letter to Brendan Mullins of Umbrella (Tucson, AZ) covering multiple product lines sold across several websites, including SARMs, kratom powders, tianeptine, and Alpha Male Plus, a product laboratory-confirmed to contain undeclared tadalafil (the active ingredient in Cialis) while labeled as a dietary supplement. The NACET Powder Nootropic was marketed with explicit claims that it would mitigate and protect against COVID-19, constituting promotion of an unapproved treatment for a serious disease. All cited products were deemed unapproved new drugs under FD&C Act sections 505(a) and 301(d), and misbranded drugs under sections 502 and 301(a), due to therapeutic and disease-treatment claims made on product pages, labels, and social media. The presence of a hidden pharmaceutical ingredient, COVID-19 treatment claims, and the breadth of unapproved drug categories across multiple storefronts compound the severity of the violations.
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