Diamond Food Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Diamond Food, Inc. for violations concerning their "Diamond of California Shelled Walnuts" products, based on claims made on their website and product labels. The FDA determined that the walnut products are promoted for conditions that cause them to be unapproved new drugs, intended for the prevention, mitigation, and treatment of diseases such as lowering cholesterol, protecting against heart disease, stroke, certain cancers, easing arthritis, and fighting depression. These claims render the walnuts drugs under section 201(g)(1)(B) of the Act and new drugs under section 201(p), requiring an approved new drug application for legal marketing.

Furthermore, the products are misbranded under section 502(f)(1) because they lack adequate directions for use for self-diagnosis and treatment by laypersons. They are also misbranded under section 403(r)(1)(B) due to unauthorized health claims on the website, such as "omega-3s may lower the risk of stroke" and "increase HDL." The product label itself is misbranded under section 403(r)(1)(B) due to implied health claims from heart symbols adjacent to omega-3 information and an unauthorized health claim statement linking omega-3 in walnuts to heart health, which the FDA states lacks sufficient evidence to identify a biologically active substance.

Diamond Food, Inc. must take prompt action to correct these violations and respond in writing