- #1
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FDA Denies Petition on Health Claims of Green Tea
Click For Summary
Discussion Overview
The discussion centers around the FDA's recent denial of a petition regarding health claims associated with green tea and its extract, particularly in relation to cardiovascular disease (CVD). Participants explore the implications of this decision, the nature of the evidence reviewed by the FDA, and the existence of independent studies on green tea.
Discussion Character
- Debate/contested
- Technical explanation
- Exploratory
Main Points Raised
- Some participants express skepticism about the FDA's conclusion, suggesting that the petitioner may regret seeking official validation of health claims.
- One participant questions the credibility of the FDA and seeks independent studies on green tea, asserting that there are indeed studies available.
- Another participant clarifies that the FDA does not conduct studies but reviews evidence provided by petitioners, indicating that the rejection was due to insufficient evidence for the specific claim regarding CVD.
- This participant also notes that the rejection does not negate other potential health benefits of green tea, which could be filed as separate claims.
- Concerns are raised about the effectiveness of green tea at typical consumption levels, emphasizing the need to demonstrate both safety and efficacy for any health claims.
- One participant shares their positive experience with the FDA's review process, contrasting with the negative perceptions often discussed.
Areas of Agreement / Disagreement
Participants express differing views on the credibility of the FDA and the implications of its decision. There is no consensus on the validity of the health claims related to green tea, and multiple competing perspectives remain regarding the adequacy of the evidence and the nature of independent studies.
Contextual Notes
Limitations include the specific focus on cardiovascular disease claims and the distinction between the FDA's role in evidence review versus the generation of independent research. The discussion does not resolve the effectiveness of green tea at typical consumption levels or the existence of other health benefits.
- #2
Moonbear
Staff Emeritus
Science Advisor
Gold Member
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Considering this has been plastered all over the internet today, I'm thinking the petitioner is likely sorry they asked. Better to let rumors run around that there might be a health benefit than a news story all over the internet informing your customers that it's a bunch of bunk. 
At least they didn't come out with some finding that it's unhealthy or harmful, so if you like it, no reason to stop drinking it.
At least they didn't come out with some finding that it's unhealthy or harmful, so if you like it, no reason to stop drinking it.- #3
Chris J.
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I have one question to pose: Has there been an independent study of Green Tea (Camellia sinesis) and/or its extract? One that is NOT done by the FDA (which is full of crap)? And I will answer my own question: Yes; here are the studies: http://www.google.com/search?hl=en&...=Research+Independent+Study+Green+Tea&spell=1
- #4
Moonbear
Staff Emeritus
Science Advisor
Gold Member
- 11,959
- 54
The FDA doesn't do the studies, they only review the evidence provided by the person filing for the claim. This means that the person who wanted to make the health claim couldn't provide enough evidence to support their own claim. It seems to be in vogue to cast aspersions on the FDA, but I've actually been involved in research conducted for an FDA application, and part of the application process, and while there is certainly a lot of paperwork, and they are very nitpicky, I thought their nitpicking was well-placed and ensured the experiments and analysis were done meticulously enough that you could trust the results and conclusions drawn. It's not the vast conspiracy people like to claim it is.
Also, note that this rejection is specifically for the claim of benefits in protecting against cardiovascular disease. It does not support or deny any other claims of health benefits, which may or may not actually exist, and may or may not be filed as separate claims. You wouldn't file them all in one application, but as separate applications.
Also, even if specific compounds in green tea, when extracted and concentrated, can provide some sort of health benefit or have a medicinal property, that doesn't mean it would be in any way effective in the doses you'd get from a cup of tea, which would have to be demonstrated to the FDA if you wanted to claim health benefits of green tea. You have to show that your claims hold up at the doses you are providing of whatever compound you're testing. You have to demonstrate both safety AND efficacy to FDA to get approval. Just one or the other is not sufficient.
Also, note that this rejection is specifically for the claim of benefits in protecting against cardiovascular disease. It does not support or deny any other claims of health benefits, which may or may not actually exist, and may or may not be filed as separate claims. You wouldn't file them all in one application, but as separate applications.
Also, even if specific compounds in green tea, when extracted and concentrated, can provide some sort of health benefit or have a medicinal property, that doesn't mean it would be in any way effective in the doses you'd get from a cup of tea, which would have to be demonstrated to the FDA if you wanted to claim health benefits of green tea. You have to show that your claims hold up at the doses you are providing of whatever compound you're testing. You have to demonstrate both safety AND efficacy to FDA to get approval. Just one or the other is not sufficient.
- #5
zoobyshoe
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It's interesting to hear your take on this, Moonbear, from your having participated in an FDA investigation. I've pretty much only heard negative things when I hear them at all.