Laugh, cause what's the point in crying. FDA: "Your walnuts are being promoted as drugs."

[TalkingDog]

http://www.fda.gov/iceci/enforcementactions/warningletters/ucm202825.htm

Based on claims made on your firm's website, 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. The following are examples of the claims made on your firm's website under the heading of a web page stating "OMEGA-3s ... Every time you munch a few walnuts, you're doing your body a big favor.":


• "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."


• "mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats ... "


• "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."

• "The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States."


Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act <21 U.S.C. § 321(g)(B)>. Your walnut products are also new drugs under section 201(p) of the Act <21 U.S.C. § 321(p)> because they are not generally recognized as safe and effective for the above referenced conditions. Therefore, under section 505(a) of the Act <21 U.S.C. § 355(a)>, 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 under section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use <21 U.S.C. § 352(f)(1)>.