Garlic Rx – FDA Warning Letter, Oct 10, 2012

On October 10, 2012, the FDA issued a Warning Letter to Garlic Wise regarding their Alli-C product. The FDA reviewed the product's labeling, including a tri-fold brochure, and determined that Alli-C is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims in the labeling establish the product as a drug intended for the cure, mitigation, treatment, or prevention of disease. Examples of these claims include preventing and treating viral infections (e.g., common cold, herpes simplex), killing bacterial infections (e.g., MRSA, C. difficile, E. coli, Salmonella), and combating conditions like fibromyalgia, arthritis, candida, colds, and flu.

The FDA states that Alli-C is not generally recognized as safe and effective for these uses, making it a "new drug" under section 201(p) of the Act. New drugs require prior FDA approval based on scientific data demonstrating safety and effectiveness, which Alli-C lacks.

Furthermore, the product is considered misbranded under section 502(f)(1) of the Act because it is offered for conditions not amenable to self-diagnosis and treatment by laypersons, meaning adequate directions for safe use cannot be provided. The introduction of a misbranded drug into interstate commerce violates section 301