Cancer Pathologist Ignites the First Green Tea Health Claim Discussion with FDA; Sin Hang Lee, M.D. Advocates Quality Green Tea Standard for Health Benefits
After evaluating the report, Dr. Lee noted that the FDA response did not comment specifically on qualitative properties and the periodic quantitative intake of the green tea. The qualified health claim, originally filed by Dr. Lee, cited a National Cancer Institute (NCI) recommendation that daily consumption of 40 ounces of typical green tea containing 710(mu)g/mL natural (-)-epigallocatechin gallate (EGCG) comprise the criterion for evaluation of possible risk reduction of certain forms of cancer. The NCI standard, published in 1996, is based on the traditional green tea drink consumed by the residents living near tea plantations in China and Japan. Dr. Lee continues to request the Administration set the equivalent standard for green tea when related to health protection.
“to consider exercising its enforcement discretion for”
Following a systematic evaluation, the FDA yesterday indicated its intent "to consider exercising its enforcement discretion for" qualified health claims for breast and prostate cancer. In a letter to Dr. Lee, the agency said, "The FDA concludes that there is very limited credible evidence for qualified health claims specifically for green tea and breast cancer and for green tea and prostate cancer, provided that the qualified claims are appropriately worded so as to not mislead consumers." The FDA cited two negative cohort studies, however Dr. Lee noted the "lack of ready access likely prevented the studies from utilizing the standard recommended by both the NCI and our efforts for evaluating health benefits of green tea." The FDA concluded that current evidence does not support qualified health claims regarding any other type of cancer, however, the FDA also stated its continued intent to evaluate new information that becomes available.
"Cancer has become the Number One killer of Americans below the age of 85," said Sin Hang Lee, M.D. "Prevention of cancer occurrence, or prevention of cancer recurrence after its surgical removal, through scientific evidence-based, integrative healthy diet and lifestyle programs is the best approach to combat cancer. I am pleased the FDA is taking a look at this important issue."
Dr. Lee submitted an application under FDA Docket No. 2004Q-0083, requesting the FDA approve a green tea health claim food label to increase awareness of the natural EGCG levels required in the tea drinks for the fight against cancer. Dr. Lee and his company, Fleminger, Inc., maintain an educational website at www.greenteahaus.com to disseminate evidence-based information to the public about the health benefits of green tea, and assert the use of green tea as a conventional food to help fight other disorders associated with aging, such as Parkinson's and Alzheimer's disease and obesity. A high natural-EGCG green tea is available to consumers under the brand name of Dr. Lee's TeaForHealth(TM). Interested readers may visit www.teaforhealth.com for more information regarding the art and technology of drinking tea for health, or for the virtual tea shop that provides high natural-EGCG green tea to health-conscious consumers.