ON EDIT TO ADD: Mods, I find the print version less commercial and potentially less prone to being locked away as advertisement.
http://www.lef.org/LEFCMS/aspx/PrintVersionMagic.aspx?CmsID=118509Excerpt from FDA Letter
“Based on our review, we have concluded that your walnut products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).
“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.
“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)>.”