FDA WARNING_LETTER - shi feng zhang - August 31, 2010

The FDA reviewed www.ginseng88.com in August 2010 and determined that "Cordyceps," "Bee Propolis," and "North Korean Red Ginseng" are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). Therapeutic claims on the website, such as "Anti-virus," "Curing dysphagia," "reducing asthma," "Effective on chronic nephritis and kidney failure," "Main Treatment: erectile dysfunction" for Cordyceps; "Curing gastric ulcer," "Anti-cancer" for Bee Propolis; and "Efficacy: anemia, insomnia, chronic alimentary disorder, diabetes, dysentery, asthma, disease of the respiratory organs, disease of circulating organs, disease of urinary and genital organs, disease of endocrine and metabolism" for North Korean Red Ginseng, establish their drug intent.

These products are considered "new drugs" under section 201(p) because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval, violating section 505(a). Furthermore, their labeling fails to bear adequate directions for use by a layman, as the conditions are not amenable to self-diagnosis and treatment, rendering them misbranded under section 502(f)(1).

Additionally, the statement "This product is produced by GMP factories certified by U.S