| Public Health Service Food and Drug Administration |
San Francisco District |
Department of Health and Human Services
WARNING LETTER
May 6, 2011
VIA UPS, Signature required
Letitia Y. Lii, Manager
Ten Tea
419 Eccles Avenue
South San Francisco, CA 94080-1902
Dear Ms. Lii:
The U.S. Food and Drug Administration (FDA) conducted an inspection on December 30, 2010 through January 17, 2011 of your tea distribution and repacking facility located at 419 Eccles Avenue, South San Francisco, CA. During the inspection, our investigator photographed the label for your Green Tea product FDA also reviewed your website at the Internet address www.tentea.com in April 2011. Based on our review of the label and your website, we have determined that your Green Tea, Dragon Well Green Tea, Ginseng Green Tea, Pu-Erh Tea, White Tea, and Kung Ding Cha products are promoted for conditions that cause them to be drugs within the meaning of 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 product labels and 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 these products with these claims violates the Act Furthermore, your product labeling fails to bear adequate directions for the products' intended uses, causing the products to be misbranded under section 502(t)(I) of the Act [21 U.S.C. § 352(t)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331 (a)]. You may find the Act and FDA regulations through links at FDA's home page at http://www.fda.gov.
Examples of some of the claims observed on your product labeling include:
With respect to green tea products in general:
• "The following are the possible health benefits of green tea: reduces blood pressure, decreases the risk fur heart attacks, stroke, and cancer, reduces total cholesterol and LDL (bad cholesterol) ..."
Green Tea:
• "Green Tea has been reported to contain ... among teas, the highest concentration of catechins which has been reported ... to help prevent cancer."
Dragon Well Green Tea:
• "Green Tea has been reported to contain ... among teas, the highest concentration of catechins which has been reported ... to help prevent cancer."
Ginseng Green Tea:
• "Green Tea is reported to contain among teas, the highest concentration of catechins which has been reported to help prevent cancer."
Pu-ErbTea:
• "Some scientific studies have suggested the possibility that Pu-Erh tea reduces cholesterol. ..."
White Tea:
• " ...White tea ... may have the strongest anti-cancer potential of all teas."
Ku Ding Cha:
• 'This Chinese Tea [Ku Ding Cha] is known for its medicinal properties including ... reducing cholesterol."
The claims listed above establish that your products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)], because they are intended for use in the cure, mitigation, treatment, or prevention of disease. Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" as defined by section 201(P) of the Act [21 U.S.C. § 321(p)]. A new drug may not be legally marketed in the United States 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 products Green Tea, Dragon Well Green Tea, Ginseng Green Tea, Pu-Erb Tea, White Tea, and Kung Ding Cha are being 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 these products safely for their intended uses. Thus, your product labeling fails to bear adequate directions for the products' intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. §§ 331(a)].
Unauthorized Health Claim
An unauthorized health claim observed on your product labeling states: "The following are the possible health benefits of green tea. .. decreases the risk for heart attacks, stroke, and cancer ....
This claim causes your product to be misbranded under section 403(r)(1)(B) of the Act [21 U.S.C. § 343(r)(1)(B)] in that it is a health claim that has not been authorized by regulation or the Act. In a letter issued to industry on February 24, 2011 (Docket No. FDA-2004-Q-0427), FDA articulated one qualified health claim for green tea for which FDA intended to consider exercising enforcement discretion:
• "Drinking green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce that risk because there is very little scientific evidence for the claim."
The claim presented on your website is not consistent with this qualified health claim.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all 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 or 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 ensure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If all corrective actions cannot be completed within fifteen working days, please state the reason for the delay and the time within which the corrections will be completed.
Your written response should be directed to Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issue in this letter, please contact Russell A. Campbell, Compliance Officer at 510-337-6861.
Sincerely,
/S/
Barbara J. Cassens
Director
San Francisco District
U.S. Food and Drug Administration
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