Natural Medicine Associates, Inc – FDA Warning Letter, Sep 14, 2012

On March 12, 2013, the FDA issued a Warning Letter to Natural Medicine Associates, Inc. following an inspection from September 13-14, 2012. The inspection revealed that several products, including "ASTHMA H12," "COLD SORES H16," and "ECZEMA H23," are unapproved new drugs and misbranded.

The products are deemed "new drugs" because their labeling and promotional materials, such as "The Journal of Preventative & Alternative Medicine," indicate intended uses for diagnosing, curing, mitigating, treating, or preventing diseases, or affecting body structure/function, without FDA approval. These uses include treating asthma, eczema, rheumatic pain, cold sores, flu, and infections.

Although the firm markets these as homeopathic drugs, they do not meet the conditions of FDA's Compliance Policy Guide (CPG 7132.15) for homeopathic products. Specifically, their labels lack active ingredients measured in homeopathic strengths, and many ingredient names are not "Official Short Names" from the Homeopathic Pharmacopeia of the United States (HPUS).

Furthermore, these products are considered prescription drugs under section 503(b)(1) of the Act due to their intended use for conditions requiring physician diagnosis and treatment (e.g., measles, chronic ear infections, anxiety). Consequently, they are misbranded under section 503(b)(