FDA WARNING_LETTER - Jonathan's Sprouts Inc. - October 13, 2010

On March 24, 2011, the FDA issued a Warning Letter to Jonathan's Sprouts Inc. following an inspection from September 27 to October 13, 2010. The inspection and subsequent review of the company's website (jonathansorganic.com), which is considered labeling, revealed that their Organic Mung Bean Sprouts, Organic Alfalfa Sprouts, Organic Clover Sprouts, and Organic Broccoli Sprouts were promoted with therapeutic claims, causing them to be classified as unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act).

Examples of violative claims included statements about preventing cancer, lowering cholesterol, treating arteriosclerosis, cardiovascular disease, osteoporosis, and fibrocystic breast tumors, and fighting ulcers and stomach cancer. These products are also misbranded under section 502(f)(1) of the Act due to inadequate directions for use for self-treatment.

Additionally, the products were misbranded due to unauthorized health claims (e.g., phytoestrogens reducing breast cancer risk) under section 403(r)(1)(B) and unauthorized nutrient content claims under section 403(r)(1)(A). Specific nutrient content claim violations included non-compliant "antioxidant" claims, "high" or "rich in" claims for