Another Victory Against FDA CensorshipJuly 2012
By William Faloon
A federal judge has again ruled the FDA violated the First Amendment to the US constitution when it tried to censor a health claim about the anti-cancer effects of a dietary supplement.
In this case, a company selling green tea leaves wanted to state on their label that “green tea may prevent prostate and breast cancer.” The FDA insisted that the claim also contain the following statement:
“The FDA does not agree that green tea may reduce the risk because there is very little scientific evidence for the claim.”1
A US District Court ruled that by forcing the company to put this negative statement on their label, the ability of this health information to be communicated was effectively negated. The judge ordered the FDA to draft an accurate disclaimer that does not nullify the cancer prevention claim altogether.
In the November 2005 issue of this magazine, I wrote an article about the FDA’s absurd position on the green tea cancer debate. My argument back then was that the FDA had misinterpreted and overlooked substantial published evidence about green tea’s cancer preventive effects. Since then, a host of new studies has shown a protective effect of green tea against common cancers.2-15 A 2009 study for example, showed that women who drank three cups of green tea a day reduced their risk of breast cancer by 37%.16
In 2011 the National Cancer Institute published a meticulous review of 13 studies that showed a trend of prostate cancer reduction in Asian green tea drinkers of 38%. The National Cancer Institute summarized their findings by stating:
“In conclusion, this meta-analysis supported that green tea but not black tea may have a protective effect on prostate cancer, especially in Asian populations.”17
A 2012 report concluded that by year 2035, the average family will face medical costs that exceed their total income.18,19 Long before this happens, Medicare will become insolvent.
Something has to drastically change to spare this nation from financial catastrophe. The encouraging news is there are more validated ways of preventing disease than ever before. The problem is that the public is kept largely in the dark because the FDA forbids companies from disseminating this information to the public.
The next part of this article is a reprint of what I wrote about the green tea debate back in 2005. At the very end is an opportunity to email your congressional representative about the need to co-sponsor a new bill that would limit the FDA’s ability to censor science-based health claims.
Life Extension Magazine November 2005
Inside the FDA’s Brain
The FDA has released a detailed report that states, “it is highly unlikely that green tea reduces the risk of prostate cancer.”20 This report is quite enlightening and we thought it appropriate to share it with Life Extension® members.
The FDA made it clear that it evaluates lots of evidence when deciding whether to allow a health claim. Most of this evidence, however, is eliminated from further review because it does not meet the agency’s standards.
While there are numerous published studies on green tea and prostate cancer, FDA determined that only two met its standards. The first study cited by the agency showed that drinking three cups of green tea a day reduced prostate cancer risk by 73%.21 The second study did not provide statistically significant data, but showed that drinking two to 10 cups of green tea daily reduced prostate cancer risk by 33%.22 According to the FDA, “both studies received high methodological quality ratings.”
Based on these two human studies, the FDA will allow the following health claim for green tea beverages:
“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.”23
Why FDA Calls These “Weak” Studies
The FDA’s gold standard is tightly controlled studies that consist of an active component and a placebo arm. The two green tea studies chosen by the FDA evaluated the effects of historical consumption of green tea beverages on prostate cancer risk.
The studies showed that the greater the consumption of green tea, the lower the prostate cancer risk. This does not, however, impress the FDA as much as a carefully designed study where half of the men would drink three to 10 cups of green tea a day while the other half drank a placebo beverage.
While the FDA admits that the study showing a 73% reduction in prostate cancer risk is significant, the agency believes the study that showed a non-statistically significant 33% risk reduction cancelled out the better study. According to the FDA, “replication of scientific findings is important in order to substantiate results.”20
The Omitted Study
While the FDA claims to have extensively reviewed the scientific literature to find the truth about green tea and prostate cancer, one important study was overlooked.
In a tightly controlled clinical setting, men with pre-malignant prostate disease were given either 600 mg/day of green tea extract or a placebo. Compared to those who received the placebo, men with this pre-malignant condition who received the green tea extract were 90% less likely to develop prostate cancer.24
Unlike the FDA’s two hand-selected green tea beverage studies, this study met the agency’s rigid design criteria and could not be classified as a “weak” study.
While the FDA may argue that green tea supplements differ from green tea beverages, the fact is that this placebo-controlled study existed, but was omitted from the FDA’s report. The FDA’s report concluded:
“Based on FDA’s review of the strength of the total body of publicly available scientific evidence for a claim about green tea and reduced risk of prostate cancer, FDA ranks this evidence as the lowest level for a qualified health claim. For the reasons given above, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.”23
The FDA Press Release
The FDA was so proud of its findings that it issued a press release to alert the world that green tea has little or no value in preventing cancer.25
The news media picked up on the FDA’s negative findings about green tea and echoed the agency’s claims that green tea does not prevent cancer.
Newspapers and television stations reported that consumers were wasting their money by drinking green tea. None of these media sources bothered to check the National Library of Medicine’s database to find over 600 studies relating to green tea and cancer. Even a cursory review of these studies reveals a very different story than what was contained in the FDA’s press release.
The National Library of Medicine is part of the US Department of Health and Human Services, the same parent agency as the FDA!
Consumers Need to Know the Facts
The United States faces a worsening health care crisis as aging Baby Boomers financially exhaust the nation’s medical systems.
The FDA is empowered to regulate almost every aspect of our health care, yet this federal agency continues to behave in a manner that promotes illness. An unbiased review of the published scientific literature reveals health properties attributed to green tea, but the FDA has restricted what Americans are allowed to read on the labels of green tea beverages.
If the data about green tea and prostate cancer risk turn out to be only partially accurate, the lives of millions of men could be saved and billions of dollars shaved off future health care expenditures. Yet the law still allows the FDA to censor truthful information about foods and dietary supplements.
-- End of reprint originally published in Life Extension Magazine® in November 2005. --
We Can Change the Law
The number of Americans needlessly dying because of FDA censorship is staggering!
The federal court ruling against the FDA as it relates to green tea and cancer prevention is a battle victory, but the war against governmental censorship continues.
A bill has been introduced in the US House of Representatives that would give consumers greater access to truthful, non-misleading health information.
Please contact Congress and ask your legislators to co-sponsor HR1364, the Free Speech about Science Act. If it passes, this bill has the potential to transform the healthcare field by educating the public about the science behind natural health.
For longer life,
To the Honorable:
FDA regulations prohibit reference to a scientific study by producers of food relating to the health benefits. Violation of this ban can result in FDA declaring common food to be unapproved drugs — this is censorship!
The Free Speech about Science Act provides a limited and carefully targeted change to FDA regulations so that legitimate, peer reviewed, scientific studies can be referenced by manufacturers and producers without converting a healthy food into an unapproved drug. The bill amends the appropriate sections of current law to allow the flow of legitimate scientific and educational information while still giving FDA and FTC the right to take action against misleading information and against false and unsubstantiated claims.
The Free Speech About Science Act:
The free speech about science act ensures the free flow of legitimate scientific research for consumers to make informed decisions based on all scientific information-not just limited pieces endorsed by the government.
I ask that you co-sponsor HR1364, the Free Speech About Science Act.Sincerely,
1. Available at: http://www.anh-usa.org/fda-went-too-far/. Accessed March 27, 2012.
2. Roy P, Nigam N, Singh M, et al. Tea polyphenols inhibit cyclooxygenase-2 expression and block activation of nuclear factor-kappa B and Akt in diethylnitrosoamine induced lung tumors in Swiss mice. Invest New Drugs. 2010 Aug;28(4):466-71.
3. Xu G, Ren G, Xu X, et al. Combination of curcumin and green tea catechins prevents dimethylhydrazine-induced colon carcinogenesis. Food Chem Toxicol. 2010 Jan;48(1):390-5.
4. Amin AR, Khuri FR, Chen ZG, Shin DM. Synergistic growth inhibition of squamous cell carcinoma of the head and neck by erlotinib and epigallocatechin-3-gallate: the role of p53-dependent inhibition of nuclear factor-kappaB. Cancer Prev Res (Phila). 2009 Jun;2(6):538-45.
5. Nihal M, Ahsan H, Siddiqui IA, Mukhtar H, Ahmad N, Wood GS. (-)-Epigallocatechin-3-gallate (EGCG) sensitizes melanoma cells to interferon induced growth inhibition in a mouse model of human melanoma. Cell Cycle. 2009 Jul 1;8(13):2057-63.
6. Sen T, Moulik S, Dutta A, et al. Multifunctional effect of epigallocatechin-3-gallate (EGCG) in downregulation of gelatinase-A (MMP-2) in human breast cancer cell line MCF-7. Life Sci. 2009 Feb 13;84(7-8):194-204.
7. Yin Z, Henry EC, Gasiewicz TA. (-)-Epigallocatechin-3-gallate is a novel Hsp90 inhibitor. Biochemistry. 2009 Jan 20;48(2):336-45.
8. Khan N, Mukhtar H. Multitargeted therapy of cancer by green tea polyphenols. Cancer Lett. 2008 Oct 8;269(2):269-80.
9. Navarro-Perán E, Cabezas-Herrera J, Sánchez-Del-Campo L, García-Cánovas F, Rodríguez-López JN. The anti-inflammatory and anti-cancer properties of epigallocatechin-3-gallate are mediated by folate cycle disruption, adenosine release and NF-kappaB suppression. Inflamm Res. 2008 Oct;57(10):472-8.
10. Siddiqui IA, Shukla Y, Adhami VM, et al. Suppression of NFkappaB and its regulated gene products by oral administration of green tea polyphenols in an autochthonous mouse prostate cancer model. Pharm Res. 2008 Sep;25(9):2135-42.
11. Chen L, Zhang HY. Cancer preventive mechanisms of the green tea polyphenol (-)-epigallocatechin-3-gallate. Molecules. 2007 May 3;12(5):946-57.
12. Bettuzzi S, Brausi M, Rizzi F, Castagnetti G, Peracchia G, Corti A. Chemoprevention of human prostate cancer by oral administration of green tea catechins in volunteers with high-grade prostate intraepithelial neoplasia: a preliminary report from a one-year proof-of-principle study. Cancer Res. 2006 Jan 15;66(2):1234-40.
13. Kuriyama S, Shimazu T, Ohmori K, et al. Green tea consumption and mortality due to cardiovascular disease, cancer, and all causes in Japan: the Ohsaki study. JAMA. 2006 Sep 13;296(10):1255-65.
14. Khan N, Afaq F, Saleem M, Ahmad N, Mukhtar H. Targeting multiple signaling pathways by green tea polyphenol (-)-epigallocatechin-3-gallate. Cancer Res. 2006 Mar 1;66(5):2500-5.
15. Laurie SA, Miller VA, Grant SC, Kris MG, Ng KK. Phase I study of green tea extract in patients with advanced lung cancer. Cancer Chemother Pharmacol. 2005 Jan;55(1):33-8.
16. Kumar, N Titus-Ernstoff L, Newcomb P, Trentham-Dietz A, Anic G, Egan K. Tea consumption and risk of breast cancer. Cancer Epidemiol Biomarkers Prev.2009 Jan(1):341-345.
17. Zheng J, Yang B, Huang T, Yu Y, Yang J, Li D. Green tea and black tea consumption and prostate cancer risk: an exploratory meta-analysis of observational studies. Nutr Cancer. 2011;63(5):663-72.
18. Available at: http://thechart.blogs.cnn.com/2012/03/14/health-care-costs-to-surpass-total-income/. Accessed March 28, 2012.
19. Young RA, DeVoe JA. Who will have health insurance in the future? An updated projection. Ann Fam Med. 2012 March/April;(10)2:156-62.
20. Available at: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm072774.htm Accessed March 28, 2012.
21. Jian L, Xie LP, Lee AH, Binns CW. Protective effect of green tea against prostate cancer: a case-control study in southeast China. Int J Cancer. 2004 Jan 1;108(1):130-5.
22. Sonoda T, Nagata Y, Mori M et al. A case-control study of diet and prostate cancer in Japan: possible protective effect of traditional Japanese diet. Cancer Sci. 2004 Mar;95(3):238-42.
23. Available at: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/ucm064923.htm. Accessed March 28, 2012.
24. Available at: http://www.aacr.org/Default.aspx?p=1066&d=432. Accessed March 28, 2012.
25. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108452.htm. Accessed March 28, 2012.