FDA WARNING_LETTER - EnerHealth Botanicals, LLC - July 12, 2013

On July 9, 10, and 12, 2013, the FDA inspected EnerHealth Botanicals, LLC's dietary supplement manufacturing facility in Longmont, Colorado. The inspection and subsequent review of product labeling, including the website, revealed serious violations.

The FDA determined that products like "Parasite Purge Herbal Remedy," "Black Walnut Extract," "Bladder Cleanse Herbal Extract," "Lung Renewal Herbal Remedy," and "Daily Immune Support" are unapproved new drugs under section 201(g)(1)(B) of the Act due to therapeutic claims. These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval. Furthermore, they are misbranded under section 502(f)(1) as they lack adequate directions for layperson use.

Even if not unapproved drugs, these products and all other manufactured dietary supplements are adulterated under section 402(g)(1) due to non-compliance with Current Good Manufacturing Practices (CGMP) (21 CFR Part 111). Specific CGMP violations include: 1. Failure to conduct identity testing for dietary ingredients (e.g., Echinacea, Osha, Milk Thistle). 2. Failure to establish specifications for component identity, finished product identity, purity, strength, composition, and packaging/labeling. 3. Failure to establish and follow written procedures for quality control operations