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Old 07-01-2005, 03:24 AM   #1
Rhonda4
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FDA News
FOR IMMEDIATE RELEASE
P05-36
June 30, 2005
Media Inquiries:
Kimberly Rawlings, 301-827-6242
Consumer Inquiries:
888-INFO-FDA



FDA Issues Information for Consumers about Claims for Green Tea and Certain Cancers
Under the Food and Drug Administration's (FDA) "Consumer Health for Better Nutrition Initiative," the Agency is announcing the results of a review of qualified health claims that green tea may reduce the risk of certain types of cancer. Based on a systematic evaluation of the available scientific data, the FDA intends to consider exercising its enforcement discretion for the following qualified health claims for breast and prostate cancer:

"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"; and

"One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and 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 prostate cancer."

The FDA also concluded that existing evidence does not support qualified health claims for green tea consumption and a reduced risk of any other type of cancer.

Guidance on qualified health claims for conventional foods and dietary supplements was issued by the FDA in July 2003. FDA will continue to evaluate new information that becomes available to determine whether changes in these claims, or in the decision, are necessary.

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Old 07-05-2005, 01:39 AM   #2
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These data are, like many other in research studies, not yet conclusive. Additionally, the FDA information seems to speak of PREVENTION, with no mention of any therapeutic effect on existing breast cancers in humans. I guess I will simply state what I have in other posts. The apparent mechanism of action of the polyphenol EGCG found in green tea, is that of tyrosine kinase inhibition. Tyrosine kinase signalling is the method by which the malignant HER2 cell communicates the signal to grow, across the cell membrane. The experimental drug lapatinib, uses tyrosine kinase receptor inhibition, as one of it's mechanisms of action against the HER2 breast cancer cell.
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Old 07-05-2005, 07:54 AM   #3
Christine MH
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Interestingly enough, there was a recent randomised, controlled study of green tea extract and prostate cancer that seems to have been highly successful, although the numbers of participants was small.
See "Green Tea Prevents Prostate Cancer" at American Association of Cancer Research website:
http://www.aacr.org/Default.aspx?p=1066&d=432

Also, the epidemiological evidence for green tea and breast cancer generally indicates that it works against recurrence, not the initiation of cancer, although there are some problems (the benefit does not seem to go up with increased consumption).

I guess that the FDA doesn't want merchants hawking green tea based on weak scientific evidence, but I personally figure that if it even might have an effect it is worthwhile as a chemopreventative (preventing more chemo!).

The U.S. National Cancer Institute is carrying out tests on these things in large properly conducted trials that should settle this once in for all, but I suppose that nothing will be approvable until then.
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Old 07-05-2005, 08:52 PM   #4
al from canada
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Don't forget that the FDA has a political agenda and mandate to fulfill.

This announcement contradicts every study I've read about green tea and cancer, (and that is a lot of studies!)

Just goes to show you the truth in the saying, "Hello, I'm from the government and I'm here to help you".

Need I say more?

Al
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Old 07-06-2005, 10:11 AM   #5
Rhonda4
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After I posted that, I got to thinking about the source and I SO agree with you. Yesterday, I even saw in the news where there are DOCTORS disputing the FDA's findings. I will continue to drink it along w/ following the rest of my phytochemical diet...ANYTHING to keep this from coming back. Take care.

Rhonda
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Old 07-11-2005, 07:19 AM   #6
anne
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Anne,

I have to agree with Al. US News recently did an article on B.C. and along with olive oil, green tea (3 cups a day) fight's HER2 apprently according to some top researchers. You can't trust FDA and any added bonus to fight this disease without side effects is worth it.
Anne
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Old 07-23-2005, 09:44 PM   #7
S. H. Lee, F.R.C.P.(C)
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My Webpage
Please read this open letter to Mr. Michael M. Landa who wrote the legal brief on the FDA green tea decision. Science will eventually prevail. The current cancer patients and the potential future cancer patients that include all of us should educate ourselves to manage our own health.
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Old 07-24-2005, 04:12 AM   #8
Rhonda4
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Dr. Lee, I read your response to the FDA and want to thank you for clarifying their response. Also, after reading your biography, I want to thank you for all your work, especially in the area of breast cancer.
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