Herbal-supplements-for-you – FDA Warning Letter, Oct 31, 2010

The FDA issued a Warning Letter after reviewing the website www.herbal-supplements-for-you.com in October 2010, identifying that products like Karela, Garlic (Lasuna), Shallaki, and Triphala are promoted for conditions that cause them to be unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act. The therapeutic claims made on the website, such as Karela for diabetes and HIV-1, Garlic as an antibiotic and for heart conditions, Shallaki for joint pain and anti-cancer properties, and Triphala for ulcerative colitis and eye diseases, establish the products as drugs intended for disease treatment, mitigation, or prevention [21 U.S.C. § 321(g)(1)(B)]. These products are considered "new drugs" [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses. Their introduction into interstate commerce without FDA-approved applications violates sections 301(d) and 505(a) of the Act. Furthermore, the products are misbranded [21 U.S.C. § 352(f)(1)] because adequate directions for use cannot be written for laypersons, as the conditions they claim to treat are not amenable to self-diagnosis. The introduction of such misbranded drugs into interstate commerce also violates section 301(a). The FDA requires prompt corrective action, including reviewing all promotional materials, and a written response within fifteen working days detailing steps taken to correct these violations and prevent recurrence, or face potential enforcement actions like product seizure or injunctions.