FDA WARNING_LETTER - Fleminger Inc

The FDA issued a Warning Letter to Dr. Lee Dba Dr. Lee's TeaForHealth? Fleminger Inc. on December 8, 2009, following a review of their websites, www.teaforhealth.com and www.greenteahaus.com. The FDA determined that the company's green tea products, "Dr. Lee's TeaForHealth? 710EGCG? inabottle? Green Tea" and "Tea For Health? 710EGCG? Ready-To-Drink Natural Brewed Green Tea," were promoted with claims that cause them to be unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (the Act).

The violations include:

1. **Unapproved New Drugs:** The websites made numerous therapeutic claims, such as preventing or treating cancer, Alzheimer's, Parkinson's, obesity, cardiovascular diseases, diabetes, viral infections, and enhancing chemotherapy effects. These claims establish the products as drugs under section 201(g)(1) of the Act, and "new drugs" under section 201(P) because they are not generally recognized as safe and effective. Marketing new drugs without FDA approval violates section 505(a). Additionally, the products are misbranded under section 502(f)(1) as they lack adequate directions for layperson use for conditions not amenable to self-diagnosis.