FDA WARNING_LETTER - river hills harvest - January 24, 2014

The FDA conducted an inspection of River Hills Harvest dba Elderberrylife from November 18, 2013, to January 24, 2014, and collected labels for "100% Pure Premium Elderberry Juice." The FDA determined the product's labeling promotes it for conditions that classify it as an unapproved new drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

Examples of drug claims include treating common cold, flu, Herpes, diabetes, some cancers, high cholesterol, and alleviating joint/muscle pain. Since the product is not generally recognized as safe and effective for these uses, it is a "new drug" under section 201(p) of the Act [21 U.S.C. § 321(p)] and requires prior FDA approval. Furthermore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because it lacks adequate directions for use by a layperson for conditions not amenable to self-diagnosis.

Even if not classified as a drug, the product is misbranded under section 403 [21 U.S.C. § 3