The hairy line between what a food manufacturer can and cannot say about their products has landed walnut producer, Diamond Food, Inc, a number of violations that by FDA standards would classify its offerings among prescriptions drugs.
According to a letter sent last year by the FDA, Diamond violated Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR) by stating that:
• "Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses."
• "[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "
• "[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons."
These claims, says the FDA, because of their intended use to treat, prevent or cure a disease, are drugs and therefore must follow drug protocol by fulfilling an application process, must not be sold without a written prescription, and must include directions for use—none of which the manufacturer of the California walnut products has any intention of doing.
This is not the first incident where the FDA has sent warning letters to companies making "unsubstantiated claims" about the benefits of their food. A scroll through the FDA website warning letter history shows hundreds of companies, including Cheerios and POM Wonderful for claims such as "decreases high blood pressure" or "reduces cholesterol". Yet a number of products that are little more than factory extruded ersatz coming from processed food manufacturers including Frito Lay, can make claims from "heart healthy," to "boosts energy" and "promotes healthy weight."
The recently updated food pyramid (MyPlate) shows an increased emphasis on consuming fresh fruits and vegetables at every meal, and scientific findings continue to suggest the benefits of healthy foods, like walnuts, far outweigh the benefits of any fortified processed food products. Despite being loaded with healthy omega fats, Diamond's walnuts cannot be promoted for their actual benefits as part of a healthy diet approach, but rather must resort to hazy, convoluted claims, or as the FDA seems to prefer, none at all.
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