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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Fleminger Inc

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  College Park, MD 20740

FEB 22 2010

WARNING LETTER

VIA OVERNIGHT MAIL

Dr. Lee
Dba Dr. Lee's TeaForHealth™
Fleminger Inc.
160 Hawley Lane, Suite 205
Trwnbull, CT 06611

CFSAN-OC-10-01

Dear Dr. Lee:

This is to advise you that the Food and Drug Administration (FDA) reviewed your websites
on December 8, 2009 at the Internet addresses www.teaforhealth.com and
www.greenteahaus.com. The FDA has determined that your TeaForHealth™ green tea
products, Dr. Lee's TeaForHealth® 710EGCG™ inabottle™ Green Tea and Tea For Health®
710EGCG™ Ready-To-Drink Natural Brewed Green Tea, are promoted for conditions that
cause the products to be drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(I)],
new drugs under section 201(P) of the Act [21 USC § 321(P)], and misbranded under sections
403(a)(1), 403(r)(1)(A), 403(r)(1)(B), and 502(f)(1) of the Federal Food, Drug; and Cosmetic
Act (the Act) [21 U.S.C. §§ 343(a)(I), 343(r)(1)(A), 343(r)(1)(B), and 352(f)(1)]. The
marketing of the products with these claims violates the Act.

I. Unapproved New Drugs:

Your website, www.teaforhealth.com. redirects the consumer to another site of yours,
www.greenteahaus.com. that makes several claims and provides links to articles, brochures,
and other "educational materials." Examples of the disease claims observed on
www.greenteahaus.com include:

• "Produced according to NCI specifications*" and "Green tea of the NCI-defined
strength*" where the asterisks lead the consumer to the text: "Based on the
pharmacodynamics data published by the National Cancer Institute (NCI)...daily
consumption of 1,200 ml (40 ounces) of green tea containing 710 mcg/ml (-)epigallocatechin
gallate (EGCG).. .is equivalent to 1.5 times the lowest anticancer
effective dose in a 70-kg (154-lb.) person. Up to 10 times the lowest effective dose
can be well tolerated by cancer patients if properly administered."
• "[G]reen tea may be also useful in enhancing the anticancer effects of conventional
chemotherapeutics (chemo), even synergistically with the less toxic antineoplastic
drugs of the quinolone family, and in controlling Alzheimer's disease, Parkinson's
disease, obesity, blood thrombosis, cardiovascular diseases, diabetes ... viral
infections, liver damage ... and antibiotic-resistant bacterial infections."
• "As a COX-2 inhibitor, green tea may provide some of the benefits that Vioxx and
Celebrex had offered to patients without their toxicities."

Examples of disease claims on www.greenteahaus.com in the form of headings of categorized
"educational materials" include:

• "[A]nticancer effects of green tea and the EGCG level of the green tea used in cancer
research"
• "Green tea or its components may enhance anticancer effects of drugs and prolong
cancer patient survival"
• "Neuroprotection of green tea against Alzheimer's disease and Parkinson's disease"
• "Green tea is anti-thrombotic and may help blood circulation"
• "Antiviral effects of green tea"
• "Liver protection of green tea against hepatitis and other injuries"
• "Green tea enhances the antimicrobial effects of antibiotics, especially that against
methicillin-resistant strains of staphylococcus aureus, MRSA"

Your website, www.greenteahaus.com. links to the full text of a brochure entitled, "The Truth
in Tea." Examples of disease claims in this brochure include:

• "The anticancer activities of green tea or its components, especially the antioxidants,
for example, EGCG, are widely ranged, starting at inhibition of the formation of
exogenous carcinogens in the stomach to interference with tumor initiation, promotion
and progression."
• "The women drinking 10 Japanese cups (1200-1500 ml) or more green tea a day enjoy
an average 8.7 more cancer-free years than low volume tea drinkers do ... The result
showed a reduction of breast cancer rate in association with drinking green tea and
their dose-dependent relationship...."
• "Heavy green tea consumption was found to be associated with reduced recurrence of
breast cancer in [Stage I and Stage II breast cancer] patients ... "
• "[G]reen tea... [was] found to enhance the anticancer effects of certain
chemotherapeutic drugs, like 5- fluorouracil and doxorubicin. Thus green tea as
dietary supplement may reduce the required dosage of certain anticancer drugs and
minimize their adverse side effects."
• "Green tea...has been shown to be potentially beneficial in the fight against viral
infections through the following mechanisms:

o "Antimutagenic at the molecular level - to reduce the chance of virus mutation.
Viral mutation has been a big problem in treating SARS and HIV patients."
o "Antiviral at the cellular level (inhibit replication of viral particles, e.g., by
interfering with HIV attachment to CD4 lymphocytes).
o "Boosting the immunity of the human body (an old concept in Chinese
medicine, but quite new in western medicine) against viral and bacterial
infections."
o "Enhancing the antimicrobial activity of the antibiotics against secondary
bacterial infections reducing the chance of developing drug resistance and
working synergistically with the antibacterial drugs, such as restoring the
MRSA sensitivity to methicillin."

These therapeutic claims on your website establish that the products are drugs under section
201(g)(1) of the Act, because they are intended for use in the cure, mitigation, treatment, or
prevention of disease. Your products are also "new drugs" under section 201 (P) of the Act,
because they are not generally recognized as safe and effective for the above referenced
conditions. 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. In addition, your products are offered for conditions that are not amenable
to self-diagnosis and treatment by individuals who are not medical practitioners; therefore,
adequate directions for use cannot be written so that a layperson can use these drugs safely for
their intended purposes. Thus, your products are misbranded under section 502(f)(1) of the
Act, in that their labeling fails to bear adequate directions for use.

II. Unauthorized Health Claims:

Examples of health claims observed on www.teaforhealth.com include:

• "Green tea may reduce the risk of breast and prostate cancers. The FDA has concluded
that there is credible evidence supporting this claim although the evidence is limited."

Examples of health claims on www.greenteahaus.com in the form of headings of categorized
"educational materials" include:

• "Epidemiological and clinical studies on the relationship between cancer risk and the
consumption of green tea..."

Examples of health claims in "The Truth in Tea" include:

• "[H]igh consumption of green tea [is] associated with reduced cancer rates of the
breast, esophagus, stomach, colon, rectum, pancreas, urinary bladder, prostate, lung,
liver, and ovary... "
• "Recent medical research has provided evidence that drinking green tea may reduce
the risk of fatal heart attack, stroke, Alzheimer's disease, Parkinson's disease, help
reduce body fat and help fight viral infection."

These claims cause your products to be misbranded under section 403(r)(1)(B) of the Act in
that they are health claims that have not been authorized by regulation or the Act. In a letter
issued to you on June 30, 2005 ("the June 2005 letter"), FDA articulated two health claims for
green tea for which FDA intended to consider exercising enforcement discretion:

1. "Two studies do not show that drinking green tea reduces the risk of breast cancer in
women, but one weaker, more limited study suggests that drinking green tea may
reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that
green tea reduces the risk of breast cancer."
2. "One weak and limited study does not show that drinking green tea reduces the risk of
prostate cancer, but another weak and limited study suggest that drinking green tea
may reduce this risks. Based on these studies, FDA concludes that it is highly
unlikely that green tea reduces the risk of prostate cancer."

The claims presented on your websites are not consistent with either of these qualified health claims.

III. Unauthorized Nutrient Content Claims:

Examples of unauthorized nutrient content claims on www.teaforhealth.com include:

• "Drink high antioxidant green tea -- for your health!"

Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which
is of the type required to be in the labeling of the food must be made in accordance with a
regulation promulgated by the Secretary (and, by delegation, FDA) authorizing the use of
such a claim. The use of a term, not defined by regulation, in food labeling to characterize the
level of a nutrient misbrands the product under section 403(r)(1)(A) of the Act.

Nutrient content claims using the term "antioxidant" must also comply with the requirements
listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a
claim, an RDI must have been established for each of the nutrients that are the subject of the
claim (21 CFR 101.54(g)(1)), and these nutrients must have recognized antioxidant activity
(21 CFR 101.54(g)(2)). The level of each nutrient that is the subject of the claim must also be
sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e) (21 CFR 101.54(g)(3)).
For example, to bear the claim "high in antioxidant vitamin C," the product must contain 20
percent or more of the RDI for vitamin C under 21 CFR 101.54(b)). Such a claim must also
include the names of the nutrients that are the subject of the claim as part of the claim or,
alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g ..
asterisk) that refers to the same symbol that appears elsewhere on the same panel of the
product label, followed by the name or names of the nutrients with recognized antioxidan'
activity (21 CFR 101.54(g)(4)). The use of a nutrient content claim that uses the term
"antioxidant" but does not comply with the requirements of 21 CFR 101.54(g) misbrands a 
product under section 403(r)(2)(A) of the Act.

Your claim, "Drink high antioxidant green tea," is an unauthorized nutrient content claim.
The term "high" is defined in 21 CFR 101.54(b) and may be used to characterize the level of
antioxidant nutrients (21 CFR 101.54(g)(3)). However, this claim does not comply with 21
CFR 101.54(g)(4) because it does not include the nutrients that are the subject of the claim or
use a symbol to link the term "antioxidant" to those nutrients. Thus, this claim is
unauthorized and causes your product to be misbranded under section 403(r)(2)(A) of the Act.

IV. False or Misleading Labeling:

Your website, www.teaforhealth.com. makes false or misleading statements regarding FDA's
conclusions on the relationship between green tea consumption and cancer risk, including:

• "Green tea may reduce the risk of breast and prostate cancers. The FDA has concluded
that there is credible evidence supporting this claim although the evidence is limited."
• "Green tea happens to be one of the components in our diet whose anticancer effects
have been supported by solid scientific evidence. The consumers are entitled to the
whole truth....The fully disclosed accurate language of the [FDA] granted health claims
should read as follows (with my clarifying notes added in parentheses):

1. 'Two studies (which were conducted among Japanese living in the
northern rural Miyagi prefecture where no tea plantations are in
existence)
do not show that drinking green tea reduces the risk of breast cancer
in women, but one weaker, more limited study (which was conducted among
green tea drinking Asian women living in Los Angeles, CA, U.S.A.)

suggests that drinking green tea may reduce this risk. Based on these studies,
FDA concludes that it is highly unlikely that green tea reduces the risk of
breast cancer (if a green tea similar to those marketed in northern rural
Japan is consumed)
.'

2. 'One weak and limited study (which was conducted among Japanese living
in the northernmost island of Hokkaido where no tea trees can survive)

does not show that drinking green tea reduces the risk of prostate cancer, but
another weak and limited study (which was conducted among the local
residents of Hangzhou, the traditional green tea plantation and
production capital of China)
suggests that drinking green tea may reduce this
risk. Based on these studies, FDA concludes that it is highly unlikely that
green tea reduces the risk of prostate cancer (if a green tea similar to those
marketed in Hokkaido of Japan is consumed)
.",1

In the June 2005 letter, FDA informed you of the results of our review of the scientific
evidence and other information submitted as part of the petition filed under docket 2004Q-0083
regarding green tea and various cancers. We advised you of our conclusions that there
is very limited credible evidence for qualified health claims regarding the consumption of
green tea and a reduced risk of prostrate cancer and the consumption of green tea and a
reduced risk of breast cancer. We also advised you of our conclusion that there is not credible
evidence to support a claim with respect to all other types of cancer. The June 2005 letter
articulated FDA's intent to consider exercising enforcement discretion for the two qualified
health claims cited in section II above.

FDA worded the conclusions and qualified health claims in the June 2005 letter to reflect our
careful evaluation and ranking of the level of scientific evidence linking green tea
consumption and the risk of various cancers.2 Your statement, "FDA has concluded that there
is credible evidence supporting this claim although the evidence is limited," mischaracterizes
FDA's conclusions about the level of evidence suggesting green tea reduces the risk of breast
and prostate cancers. Moreover, your edits to FDA's conclusions in the qualified health
claims' language and your assertions that your edits make the qualified health claims "fully
disclosed" and "accurate" suggest that your rendition of FDA's qualified health claims more
accurately reflects and more fully discloses FDA's conclusions than FDA's non-embellished
version. These statements alter the meaning of FDA's language and misrepresent FDA's
conclusions. Thus, these statements cause your products to be misbranded under section
403(a)(1) of the Act.

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 products marketed by your firm
comply with the Act and its implementing regulations. We urge you to review your websites,
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. The Act
authorizes the seizure of illegal products and injunctions against manufacturers and
distributors of those products [21 §§ U.S.C. 332 and 334]. You should take prompt action to
correct these deviations and prevent their future recurrence. Failure to do so may result in
enforcement action without further notice.

Please respond in writing within fifteen (15) working days from your receipt of this letter.
Your response should include each step that has been or will be taken to completely correct
the labeling violations and to prevent the recurrence of similar violations, the time within
which correction will be completed, and any documentation necessary to show that the
correction has been achieved. If applicable, please include a copy of your revised label. If
corrective actions cannot be completed within fifteen (15) working days, state the reason for
the delay and the time within which the corrections will be completed.

If you need additional information or have questions concerning any products distributed
through your web site, please contact FDA. You may respond in writing to Felicia B.
Williams, Compliance Officer, Division of Enforcement, Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD
20740.


Sincerely,
/S/

Roberta Wagner
Director
Office of Compliance
Center for Food Safety and
Applied Nutrition


cc: New England District

________________________________________

1 http://www.teaforhealth.comIPR/2006/082806.htm

2 For more information on this process generally, see FOOD & DRUG ADMIN., Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data (July 2003), available at http://www.fda.gov/OHRMS/DOCKETS/98fr/03N-0069-gdl0001.pdf.