Avena Botanicals, Inc. – FDA Warning Letter, May 30, 2014

The FDA issued a Warning Letter to Avena Botanicals, Inc. following a May 2014 inspection and July 2014 website review, identifying serious violations of the Federal Food, Drug and Cosmetic Act. Several products, including "Astragalus Liquid Extract" and "U.T.I. Relief," are promoted with therapeutic claims for disease treatment, making them unapproved new drugs under section 201(p). These products are also misbranded under section 502(f)(1) as they address conditions not amenable to self-diagnosis and lack adequate directions for layperson use. Furthermore, "Black Cohosh Root Liquid Extract," "Gotu Kola Liquid Extract," and "Echinacea Root Liquid Extract" were found to be adulterated dietary supplements under section 402(g)(1) due to Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111). Deficiencies included failing to establish required specifications (21 CFR 111.70(a)), not preparing or following Master Manufacturing Records (MMRs) (21 CFR 111.205(a)), incomplete Batch Production Records (BPRs) (21 CFR 111.255(b)), and inadequate identity testing for dietary ingredients (21 CFR 111.75(a)(1)(i)). The firm's responses to these CGMP issues were inadequate. These dietary supplements are also misbranded under section 403(q)(5)(F) for lacking a "Supplements Facts" panel (21 CFR 101.36). Avena Botanicals must promptly correct all violations to avoid potential enforcement actions and re-inspection fees, with a written response due within fifteen working days.