Inspections, Compliance, Enforcement, and Criminal Investigations
Shi Feng Zhang Dba Ginseng88 11/26/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
College Park, MD 20740
NOV 26 2010
RETURN RECEIPT REQUESTED
Shi Feng Zhang
1139 Pelon Way
Monterey Park, CA 91754
Dear Shi Feng Zhang:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the internet address, www.ginseng88.com in August 2010 and has determined that the products “Cordyceps,” “Bee Propolis,” and “North Korean Red Ginseng” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the products with these claims violates the Act.
Examples of some of the claims observed on your website www.ginseng88.com include:
• Under “Quick Overview”: “Anti-virus …”
• Under “Product Description . . . Capacity and Main Treatment:”
o Curing … dysphagia . . .
o reducing … asthma”
o “Effective on chronic nephritis and kidney failure”
o “Main Treatment: erectile dysfunction”
• Under “Quick Overview” and “Product Description”
o “Curing gastric ulcer”
North Korean Red Ginseng
• Under “Quick Overview and “Product Description” “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””
Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
Furthermore, because your “Cordyceps,” “Bee Propolis” and “North Korean Red Ginseng” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1)of the Act [21 U.S.C. § 352(f)(1)].
Even if your “Cordyceps,” “Bee Propolis” and “North Korean Red Ginseng” products did not include the above claims in its labeling that cause them to be drugs, they would still be misbranded as a food under section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] because of the following statement on your website: “This product is produced by GMP factories certified by U.S.A. FDA with their quality, materials and production procedures conforming to the international safety standard." This statement is false and misleading because FDA does not certify compliance with current Good Manufacturing Practice (cGMP) regulations.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Your written response should be directed to Latasha Robinson, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, you may contact Ms. Robinson at 301-436-1890.
Office of Compliance
Center for Food Safety
and Applied Nutrition