Seen any walnuts in your medicine cabinet lately? According to the Food and Drug Administration, that is precisely where you should find them. Because Diamond Foods made truthful claims about the health benefits of consuming walnuts that the FDA didn’t approve, it sent the company a letter declaring, “Your walnut products are drugs” — and “new drugs” at that — and, therefore, “they may not legally be marketed … in the United States without an approved new drug application.” The agency even threatened Diamond with “seizure” if it failed to comply.
The FDA’s letter continues: “We have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.” Furthermore, the products are also “misbranded” because they “are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes.” Who knew you had to have directions to eat walnuts?
Because Diamond Food dared to let consumers know that natural substances in a natural food may offer some health benefits and protections, the FDA views this as a new drug. In their eyes, only FDA-approved drugs are capable of offering such protections …
“Because of these intended uses, your walnut products are drugs… Your walnut products are also new drugs … because they are not generally recognized as safe and effective for the above referenced conditions. Therefore … they may not be legally marketed with the above claims in the United States without an approved new drug application.
Additionally, your walnut products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your walnut products are also misbranded… in that the labeling for these drugs fails to bear adequate directions for use… “
The FDA’s current position is that foods such as walnuts, cherries, broccoli, turmeric, green tea and the like should be subjected to the full FDA approval process. But obtaining a new drug application, as the FDA suggested, can cost billions of dollars. And let’s face it — walnut growers cannot come close to affording that!