Cancer Pathologist Request the FDA Add Stomach Cancer to Green Tea Qualified Health Claim
TRUMBULL, Conn.–(BUSINESS WIRE)–Oct. 5, 2005–Sin Hang Lee, M.D., the cancer pathologist and founder of TeaForHealth(TM), today requested the U.S. Food and Drug Administration (FDA) add stomach cancer to the qualified health claim recently awarded to him by the FDA linking green tea to the reduction of the risk of breast and prostate cancer.
On October 7, 2005 at 3:00 p.m. PDT, Dr. Lee and TeaForHealth is also holding a press conference during the International Complementary & Natural Healthcare Expo & Conference (CAM Expo) at the Los Angeles Convention Center. TeaForHealth will introduce two new, cancer-fighting Green Tea products, based on the de facto standard strength recommended by the National Cancer Institute (NCI) in its pharmacodynamics data published in 1996, that 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 effective dose in a 70-kg (154-lb) person. Dr. Lee will speak on “The Science of Tea as Medicine” plus answer questions regarding the FDA qualified health claim for green tea. Interested persons can call 203-385-3836 for an invitation-only reservation.
Today’s requested change to the green tea qualified health claim is based on the Oct. 3, 2005, Nobel committee award to Drs. Barry Marshall and Robin Warren of Australia of the 2005 Nobel Prize in Physiology or Medicine for discovering Helicobacter pylori (H. pylori) as a causative agent for gastritis and stomach ulcer, two conditions that may lead to stomach cancer.
“This prestigious award indicates the world’s scientific community recognizes H. pylori as an agent for gastritis, a potential etiology of stomach cancer in general,” said Sin Hang Lee, M.D. “The health claim petition’s ruling clearly included the FDA statement of its continued intent to evaluate new information that becomes available. The Nobel Prize recognition is clearly the kind of new, scientifically relevant information for such evaluation.”
In his application for the green tea health claim, Dr. Lee submitted to the FDA for evaluation 18 epidemiological studies on the relationship between cancer incidence of the stomach and the habit of drinking green tea. Thirteen of the 18 studies found that drinking green tea is associated with a reduced risk of stomach cancer when compared to local controls, and the other five did not confirm such protective relationship. At the time of the decision the FDA ruled, “results of studies on the Japanese population cannot be extrapolated to reach conclusions about potential effects on the U.S. population.” In light of this new recognition that H. pylori infection is a global phenomenon, not a specifically Japanese disorder, Dr. Lee requested in a letter to Mr. Michael M. Landa of the FDA that the impact of green tea on stomach cancer now also be recognized for educational purposes.
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