FDA WARNING_LETTER - Natures Health Options LLC - July 25, 2012

The FDA issued a Warning Letter to Natures Health Options, LLC following a July 2012 inspection, identifying serious violations related to its Charantea Bitter Melon Ampalaya products (capsules and tea bags). The FDA determined that Charantea Ampalaya is promoted with therapeutic claims on the firm's website (e.g., "blood sugar-lowering properties"), causing it to be an unapproved new drug under sections 201(g)(1) and 201(p) of the Act. Furthermore, it is misbranded under section 502(f)(1) due to inadequate directions for use.

Even if not an unapproved drug, the capsule products are adulterated dietary supplements under section 402(g)(1) for failing to comply with Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111). Specific CGMP violations include the firm's failure to establish written procedures for quality control operations (21 CFR 111.103, 111.140(b)(1)), product complaints (21 CFR 111.570(b)(1)), returned dietary supplements (21 CFR 111.535(b)(1)), and holding and distributing operations (21 CFR 111.475(b)(1)). The firm's responses to these observations were deemed inadequate.

Additionally, the Charantea Ampalaya tea is misbranded under section 403(a)(1) because it is represented as a conventional food on the website, which is prohibited for dietary supplements. The FDA emphasized the firm's ultimate responsibility for CGMP compliance, even when using contract manufacturers. Natures Health Options must promptly correct all violations, submit a written response within 15 working days detailing corrective actions and documentation, and address the potential for enforcement actions, including product seizure, injunctions, and re-inspection fees.