FDA WARNING_LETTER - Gilroy Spice Company - July 27, 2011

The FDA conducted an inspection of Gilroy Spice Company's acidified canned food manufacturing facility from June to July 2011. The inspection and a review of the company's websites, www.gilroyspice.com and www.garliccapitalproducts.com, revealed serious violations of the Federal Food Drug and Cosmetic Act (FFDCA).

The FDA determined that Gilroy Spice Company's Garlic Capital, Gilroy Hot Stuff, Zesty Garlic Salsa, and Unique Garlic Appetizer products are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the FFDCA [21 U.S.C. 321(g)(1)(B)]. Website claims, such as "A Clove a Day Keeps Cancer at Bay" and references to "Garlic and Cancer Prevention From the Mayo Clinic," indicate the products are intended for disease prevention, mitigation, and treatment. These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and are illegally marketed without prior FDA approval. Furthermore, these products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] because they lack adequate directions for use by a layperson.

Even if the drug claims were removed, the