FDA WARNING_LETTER - Matrixx Initiatives Inc

The FDA issued a Warning Letter to Matrixx Initiatives, Inc. after reviewing their website and labeling for "Zicam Cold Remedy RapidMelts with Vitamin C & Echinacea" and "Zicam Cold Remedy RapidMelts with Vitamin C" products. The Agency determined these products are unapproved new drugs, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act), as they are intended to reduce cold duration and severity but lack FDA approval. Vitamin C, an active ingredient, is not generally recognized as safe and effective for this use.

Furthermore, the products are misbranded under section 502 of the Act. Specifically, their labels fail to identify vitamin C and echinacea (in the respective product) as active drug ingredients and omit quantity statements, violating section 502(e)(1)(A)(ii) and 21 CFR §§ 201.10, 201.66(c)(2). The products are also falsely labeled as homeopathic under section 502(a) because vitamin C is not a recognized homeopathic ingredient.

Additionally, inspections revealed Matrixx failed to submit certain serious adverse event reports as required by section 760 of the Act. While the firm's corrective action plan for adverse event reporting was acknowledged, a regulatory meeting was recommended for further clarification. Matrixx must respond within 15 business days with corrective actions and documentation, or a timeline for completion, to avoid potential legal action.