FDA WARNING_LETTER - Precision Herbs, LLC - December 01, 2011

The FDA issued a Warning Letter to Precision Herbs, LLC following a review of its website, www.precisionherbs.com, which revealed the marketing of ten products, including "Chi Max Protectors" and "Harmonic Combo," without proper marketing clearance or approval. The FDA determined these products are "devices" under section 201(h) of the Federal Food, Drug, and Cosmetic Act. Consequently, these devices are adulterated under section 501(f)(1)(B) because the firm lacks approved premarket approval (PMA) applications (section 515(a)) or investigational device exemptions (section 520(g)). Additionally, the devices are misbranded under section 502(o) as the firm failed to provide the required 510(k) notification of intent to introduce them into commercial distribution. Precision Herbs must promptly correct these violations and submit a written response within fifteen business days, detailing specific corrective and preventive actions, including documentation and a timetable if necessary. Failure to comply could lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts or Certificates to Foreign Governments. The letter emphasizes the firm's responsibility for ensuring overall compliance with applicable laws and regulations.