FDA WARNING_LETTER - Apis Vida Industry and Commerce Pharmaceutical Products Ltda - March 11, 2015

On August 27, 2015, the FDA issued a Warning Letter to Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda in Brazil, following an inspection from March 9-11, 2015. While the firm's responses to the FDA 483 regarding the inspection appeared adequate, a review of product labels, the beelife.us website, and Amazon.com store revealed significant violations.

Multiple products, including Green Propolis Extract and various Compound Honeys, were deemed "unapproved new drugs" and "misbranded drugs" under Section 201(g)(1)(B) and 201(p)(1) of the Act [21 USC § 321(g)(1)(B), 321(p)(1)]. This is due to disease treatment and prevention claims (e.g., "antimicrobial," "relieve respiratory ailments," "treatment and prevention of bronchitis/asthma") made on their website and Amazon store, establishing them as drugs not generally recognized as safe and effective, and lacking FDA approval. These products are also misbranded under Section 502(f)(1) [21 U.S.C. § 352(f)(1)] for failing to bear adequate directions for use, as their intended uses are not amenable to self-diagnosis and treatment.

Additionally, the Amazonia Power Energy