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Life Extension Magazine

LE Magazine March 2006

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FDA Threatens To Raid Cherry Orchards


By William Faloon
 
by William Faloon

As Americans struggle to eat a healthier diet, the FDA has taken draconian steps to suppress information about foods that reduce disease risk.

While various agencies of the federal government encourage us to eat more fruits and vegetables, the FDA has issued an edict that precludes cherry companies from posting scientific data on their websites. This censorship of published peer-reviewed studies denies consumers access to information that could be used to make wiser food choices.

Tobacco products kill 450,000 Americans each year.1 Few people understand, however, that poor dietary habits are responsible for more deaths than tobacco. Considering the plethora of toxic foods advertised on television, it is easy to understand why so many consumers eat themselves to death. Just imagine if all you ate is what you saw advertised in the mass media.

The government stopped protecting the tobacco companies long ago, but the FDA continues to take actions that steer Americans away from certain fruits and vegetables that have proven disease-preventive effects.

FDA Intimidates Cherry Growers

There is not much profit in selling fresh fruits and vegetables. Growers of such foods cannot afford to advertise their produce in a meaningful way. Fortunately, the advent of the Internet has allowed cherry growers to enlighten the public about scientific studies showing that nutrients contained in cherries have significant health benefits.2-15 Until recently, consumers could learn of the health benefits of cherries just by logging on to a cherry company’s website. Some individuals might be impressed enough with this data to actually buy cherries at the grocery store instead of trans fat-laden snacks being advertised every second in the mass media.

On October 17, 2005, the FDA banned information about cherries’ health benefits from appearing on websites.16,17 The FDA sent warning letters to 29 companies that market cherry products. In these letters, the FDA ordered the companies to stop publicizing scientific data about cherries.18 According to the FDA, when cherry companies disseminate this information, the cherries become unapproved drugs subject to seizure. The FDA warns that if those involved in cherry trafficking continue to inform consumers about these scientific studies, criminal prosecutions will ensue.17

Why Americans Don’t Eat More Fruit

The processed food industry has earned enormous profits by loading cheap and dangerous foods with sugar, salt, preservatives, trans fats, saturated fats, and other unhealthy byproducts. Processed foods taste good to most people and are quite inexpensive compared to fresh produce. In order to convince the public to switch from toxic foods that damage the arterial wall, mutate DNA, and induce age-related disease, those who sell fresh fruits need to inform the public about the benefits scientists have discovered about plant foods.19-37

Fresh fruit can be expensive and it spoils relatively quickly. Many consumers have developed a taste addiction to processed foods, and find it challenging to switch to a healthier diet that costs more and is not as pleasing to the palate.

By censoring scientific information about cherries, the FDA is in effect shutting down an opportunity for more Americans to learn about the remarkable health benefits that have been discovered about this fruit.

Do Cherries Prevent Cancer?

In a warning letter to Friske Orchards of Ellsworth, MI, the FDA recites the following information contained on this orchard’s website:38

“Tart cherries may reduce the risk of colon cancer because of the anthocyanins and cyanidin contained in the cherry.”

The FDA goes on to say in its warning letter:

“These claims cause your product to be a drug as defined in section 201(g) . . . Because this product is not generally recognized as safe and effective when used as labeled, it is also defined as a new drug in section 201(p) . . . Under section 505 of the Act (21 USC 355), a new drug may not be legally marketed in the United States without an approved New Drug Application . . .”

As you will read in the article titled “Why Is the FDA Picking on Cherries?” we reveal the data that substantiate the cancer-preventive and other health benefits that scientists have discovered about cherries.

Interestingly, the FDA is not denying the veracity of this information. Instead, it insists that a new drug application has to be approved before the public can be informed about the scientific data supporting cherries. The FDA also asserts, without any basis, that cherries “have not been recognized as safe and effective when used as labeled.”38 According to the FDA’s interpretation of the law, cherry growers are engaged in criminal conduct by relaying findings that have been published in peer-reviewed scientific journals. Whether you or other Americans develop cancer does not appear to be a consideration of an agency whose written mission statement includes the following:

“The FDA is responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”39

As Life Extension documented many years ago, the FDA does the opposite of what it pretends to do. Instead of “helping the public get the accurate, science-based information they need to use foods to improve their health,” the FDA has gone to extreme lengths to deny American citizens the right to learn about scientific studies substantiating the health benefits discovered about cherries (and other fruits).

A Medical Atrocity!

In November 2004, Dr. David Graham, associate director for science at the FDA’s Office of Drug Safety, testified before Congress that Vioxx® had caused 88,000 to 139,000 excess cases of heart attack and stroke.40 Dr. Graham severely criticized his own employer (the FDA) for intentionally covering up information about the lethal side effects of Vioxx®.

As you will read in this month’s issue, the FDA is greatly concerned that cherry companies are disseminating scientific data showing that cherries are more effective than FDA-approved drugs in alleviating arthritis inflammation and pain.

The FDA is willing to throw cherry growers in jail for suggesting that their fruit may safely alleviate arthritis discomfort, yet the irrefutable facts are that the FDA intentionally concealed the dangers of Vioxx® for years, thereby causing the needless death of tens of thousands of Americans. Who are the real criminals here?

The FDA says it is responsible for “protecting the public health” by assuring the safety of drugs. It does not take much brainpower to see that the FDA’s purported mission is nothing more than a hoax to protect the economic interests of the pharmaceutical giants.

It would appear that the FDA is concerned that if too many arthritis sufferers discover that eating cherries could alleviate inflammation and pain, the multibillion-dollar market for anti-inflammatory drugs would be detrimentally affected. Pharmaceutical industry profits have been spared for the moment by the flagrant acts perpetrated against cherry companies by the FDA.

Congress Recognizes Problems with FDA

As this nation faces a worsening health care crisis that threatens to bankrupt corporations, aging adults, and the government itself, members of Congress are becoming incensed that the FDA is suppressing proven methods to prevent and treat disease.

On November 10, 2005, a bill was introduced in the United States House of Representatives that would prohibit the FDA from denying consumers access to truthful health information. The name of this bill is the Health Freedom Protection Act (H.R. 4282).41

The original sponsors of this bill introduced it by exposing the FDA’s inappropriate censorship of life-saving scientific information. Here is an excerpt from this historic speech:

Because of the FDA’s censorship of truthful health claims, millions of Americans may suffer with diseases and other health care problems they may have avoided by using dietary supplements. For example, the FDA prohibited consumers from learning how folic acid reduces the risk of neural tube defects for four years after the Centers for Disease Control and Prevention recommended every woman of childbearing age take folic acid supplements to reduce neural tube defects. This FDA action contributed to an estimated 10,000 cases of preventable neural tube defects!

The FDA also continues to prohibit consumers from learning about the scientific evidence that glucosamine and chondroitin sulfate are effective in the treatment of osteoarthritis; that omega-3 fatty acids may reduce the risk of sudden death heart attack; and that calcium may reduce the risk of bone fractures.

The Health Freedom Protection Act will force the FDA to at last comply with the commands of Congress, the First Amendment, and the American people by codifying the First Amendment standards adopted by the federal courts. Specifically, the Health Freedom Protection Act stops the FDA from censoring truthful claims about the curative, mitigative, or preventative effects of dietary supplements, and adopts the federal court’s suggested use of disclaimers as an alternative to censorship. The Health Freedom Protection Act also stops the FDA from prohibiting the distribution of scientific articles and publications regarding the role of nutrients in protecting against disease.42

Citizens Revolt Against Bureaucratic Corruption

When Life Extension stated in 1989 that the law had to be changed to allow scientific information about foods and supplements to be freely disseminated, everyone told us that it was impossible to beat the entrenched FDA on Capitol Hill. As we went on national television and radio shows in the early 1990s to expose the incompetence and fraud perpetrated against the public by the FDA, a growing number of health-conscious individuals began to realize the magnitude of the problem.

In October 1994, by a nearly unanimous margin, Congress enacted the Dietary Supplement Health and Education Act (DSHEA), which allowed the public to learn about some of the health benefits attributed to certain nutrients.43

Despite significant losses in the federal courts regarding how DSHEA should be interpreted, the FDA is continuing to dedicate substantial resources to suppressing scientific information about how certain foods may prevent and treat disease. The FDA’s arrogance is appalling in light of the record number of prescription drugs that have been withdrawn because too many users are dying from side effects. In the case of cherries, many of the scientific studies the FDA is concerned about relate to this fruit’s anti-arthritic effect.4-6,44,45

The FDA’s flagrant disregard for the First Amendment and DSHEA is one reason why the Health Freedom Protection Act was introduced. Members of Congress and the American public are fed up with the abuse of power perpetrated by an agency whose track record shows a reckless disregard for human life.

What You Can Do to Stamp Out FDA Censorship

It is imperative that concerned citizens let their congressional representatives know how important passage of the Health Freedom Protection Act (H.R. 4282) is. I urge all Life Extension supporters to conveniently email their own representatives a new letter in support of the Health Freedom Protection Act.

Please do not settle for scientific censorship and bureaucratic fraud! Stand up for your First Amendment rights and tell Congress you want to see H.R. 4282 (Health Freedom Protection Act) enacted into law.

To find the name of your representative, visit the Legislative Action Center or call 1-202-225-3121.

For longer life,
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William Faloon

P.S. Even if the Health Freedom Protection Act does not pass, your letters to Congress will help block several other bills that would give the FDA even greater power to ban what you are allowed to read and what nutrients you are allowed to consume. So even if you are pessimistic about Congress prevailing against the FDA, it is still important that you let your representative know that you do not want the FDA to be given new draconian powers. Take Action Now!

DRUG COMPANIES CONTROL FDA

The FDA has come under fire by the media and Congress for its failure to protect consumers against dangerous drugs. Life Extension has long contended that large drug companies exert tremendous influence over the FDA. The result is that toxic drugs remain on the market while the sale of dietary supplements (and now even cherries) is impeded by FDA.

One reason doctors prescribe dangerous drugs is that pharmaceutical companies persuade the FDA to omit information concerning side effects from the drug’s label. An egregious example of the incestuous control that drug companies exert over the FDA came to light with the Vioxx® scandal.

Based on evidence showing increased heart attack rates in Vioxx® users, the FDA suggested putting a cardiovascular warning on the label. Merck, the maker of Vioxx®, vehemently objected. On November 8, 2001, when talks with the FDA were not going to Merck’s liking, the head of Merck’s research department sent an email to his top scientists stating:

“Twice in my life I have had to say to the FDA,‘That label is unacceptable, we will not under any circumstances accept it’ . . .

I assure you I will NOT sign off on any label that has a cardiac warning for Vioxx®.”46

Vioxx® was withdrawn from the market on September 30, 2004, after a clinical trial showed the risk of heart attack and stroke doubled for patients taking Vioxx® for more than 18 months.47-49 The FDA knew about the cardiovascular risks of Vioxx® years before it was withdrawn, but succumbed to drug company pressure to omit this information from the drug’s warning box. It did appear many months later on the label’s “precautions box,” which is normally too voluminous for anyone to read.

The statement by the Merck official that he would “not under any circumstances accept” a cardiovascular warning on Vioxx® provides a startling glimpse into how much control drug companies have over the FDA. Consumers are relegated to ingest toxic drugs while the FDA takes extraordinary measures to censor information showing the anti-arthritis efficacy of cherries.

References

1. Available at: http://www.cdc.gov/tobacco/factsheets/Tobacco_Related_Mortality_factsheet.htm. Accessed December 12, 2005.

2. Kang SY, Seeram NP, Nair MG, Bourquin LD. Tart cherry anthocyanins inhibit tumor development in Apc(Min) mice and reduce proliferation of human colon cancer cells. Cancer Lett. 2003 May 8;194(1):13-9.

3. Pratico D, Tillmann C, Zhang ZB, Li H, FitzGerald GA. Acceleration of atherogenesis by COX-1-dependent prostanoid formation in low density lipoprotein receptor knockout mice. Proc Natl Acad Sci USA. 2001 Mar 13;98(6):3358-63.

4. Tall JM, Seeram NP, Zhao C, et al. Tart cherry anthocyanins suppress inflammation-induced pain behavior in rat. Behav Brain Res. 2004 Aug 12;153(1):181-8.

5. Wang H, Nair MG, Strasburg GM, et al. Cyclooxygenase active bioflavonoids from Balaton tart cherry and their structure activity relationships. Phytomedicine. 2000 Mar;7(1):15-9.

6. Seeram NP, Momin RA, Nair MG, Bourquin LD. Cyclooxygenase inhibitory and antioxidant cyanidin glycosides in cherries and berries. Phytomedicine. 2001 Sep;8(5):362-9.

7. Wang H, Nair MG, Strasburg GM, et al. Antioxidant and antiinflammatory activities of anthocyanins and their aglycon, cyanidin, from tart cherries. J Nat Prod. 1999 Feb;62(2):294-6.

8. Kolayli S, Kucuk M, Duran C, Candan F, Dincer B. Chemical and antioxidant properties of Laurocerasus officinalis Roem. (cherry laurel) fruit grown in the Black Sea region. J Agric Food Chem. 2003 Dec 3;51(25):7489-94.

9. Wakabayashi H, Fukushima H, Yamada T, et al. Inhibition of LPS-stimulated NO production in mouse macrophage-like cells by Barbados cherry, a fruit of Malpighia emarginata DC. Anticancer Res. 2003 Jul;23(4):3237-41.

10. Nagamine I, Akiyama T, Kainuma M, et al. Effect of acerola cherry extract on cell proliferation and activation of ras signal pathway at the promotion stage of lung tumorigenesis in mice. J Nutr Sci Vitaminol (Tokyo). 2002 Feb;48(1):69-72.

11. Jacob RA, Spinozzi GM, Simon VA, et al. Consumption of cherries lowers plasma urate in healthy women. J Nutr. 2003 Jun;133(6):1826-9.

12. Rimm EB, Katan MB, Ascherio A, Stampfer MJ, Willett WC. Relation between intake of flavonoids and risk for coronary heart disease in male health professionals. Ann Intern Med. 1996 Sep 1;125(5):384-9.

13. Burkhardt S, Tan DX, Manchester LC, Hardeland R, Reiter RJ. Detection and quantification of the antioxidant melatonin in Montmorency and Balaton tart cherries (Prunus cerasus). J Agric Food Chem. 2001 Oct;49(10):4898-902.

14. Available at: http://pubs.acs.org/pressrelease/jafc/release3.html. Accessed December 15, 2005.

15. Available at: http://www.wholehealthmd.com/print/view/1,1560,SU_10015,00.html. Accessed December 15, 2005.

16. Available at: http://www.wjla.com/news/stories/1005/272655.html. Accessed December 15, 2005.

17. Available at: http://www.fda.gov/bbs/topics/news/2005/new01246.html. Accessed December 15, 2005.

18. Available at: http://www.cfsan.fda.gov/~dms/chrylist.html. Accessed December 15, 2005.

19. Available at: http://aspartametruth.com/ blaylock/interaction.html. Accessed December 15, 2005.

20. Available at: http://www.inmotionmagazine.com/ geff4.html. Accessed December 15, 2005.

21. Sasso FC, Carbonara O, Nasti R, et al. Glucose metabolism and coronary heart disease in patients with normal glucose tolerance. JAMA. 2004 Apr 21;291(15):1857-63.

22. Reiser S. Effect of dietary sugars on metabolic risk factors associated with heart disease. Nutr Health. 1985;3(4):203-16.

23. Pamplona R, Bellmunt MJ, Portero M, Prat J. Mechanisms of glycation in atherogenesis. Med Hypotheses. 1993 Mar;40(3):174-81.

24. Reyes FG, Valim MF, Vercesi AE. Effect of organic synthetic food colours on mitochondrial respiration. Food Addit Contam. 1996 Jan;13(1):5-11.

25. Jagerstad M, Skog K. Genotoxicity of heat-processed foods. Mutat Res. 2005 Jul 1;574(1-2):156-72.

26. Sasaki YF, Kawaguchi S, Kamaya A, et al. The comet assay with 8 mouse organs: results with 39 currently used food additives. Mutat Res. 2002 Aug 26;519(1-2): 103-19.

27. Tsuda S, Murakami M, Matsusaka N, et al. DNA damage induced by red food dyes orally administered to pregnant and male mice. Toxicol Sci. 2001 May;61(1):92-9.

28. Ashida H, Hashimoto T, Tsuji S, Kanazawa K, Danno G. Synergistic effects of food colors on the toxicity of 3-amino-1,4-dimethyl-5H-pyrido[4,3-b]indole (Trp-P-1) in primary cultured rat hepatocytes. J Nutr Sci Vitaminol (Tokyo). 2000 Jun;46(3):130-6.

29. Tjaderhane L, Larmas M. A high sucrose diet decreases the mechanical strength of bones in growing rats. J Nutr. 1998 Oct;128(10):1807-10.

30. Veromann S, Sunter A, Tasa G, et al. Dietary sugar and salt represent real risk factors for cataract development. Ophthalmologica. 2003 Jul;217(4):302-7.

31. Michaud DS, Liu S, Giovannucci E, et al. Dietary sugar, glycemic load, and pancreatic cancer risk in a prospective study. J Natl Cancer Inst. 2002 Sep 4;94(17):1293-300.

32. Molteni R, Barnard RJ, Ying Z, Roberts CK, Gomez-Pinilla F. A high-fat, refined sugar diet reduces hippocampal brain-derived neurotrophic factor, neuronal plasticity, and learning. Neuroscience. 2002;112(4):803-14.

33. Blacklock NJ. Sucrose and idiopathic renal stone. Nutr Health. 1987;5(1-2):9-17.

34. Moerman CJ, Bueno de Mesquita HB, Runia S. Dietary sugar intake in the aetiology of biliary tract cancer. Int J Epidemiol. 1993 Apr;22(2):207-14.

35. Kruis W, Forstmaier G, Scheurlen C, Stellaard F. Effect of diets low and high in refined sugars on gut transit, bile acid metabolism, and bacterial fermentation. Gut. 1991 Apr;32(4):367-71.

36. Yudkin J, Eisa O. Dietary sucrose and oestradiol concentration in young men. Ann Nutr Metab. 1988;32(2):53-5.

37. De Stefani E, Deneo-Pellegrini H, Mendilaharsu M, Ronco A, Carzoglio JC. Dietary sugar and lung cancer: a case-control study in Uruguay. Nutr Cancer. 1998;31(2):132-7.

38. Available at: http://www.fda.gov/foi/warning_letters/g5531d.htm. Accessed December 15, 2005.

39. Available at: http://www.fda.gov/opacom/morechoices/mission.html. Accessed December 15, 2005.

40. Available at: http://www.finance.senate.gov/ sitepages/hearing111804.htm. Accessed December 15, 2005.

41. Available at: http://thomas.loc.gov/. Accessed December 15, 2005.

42. Available at: http://www.house.gov/ paul/congrec/congrec2005/cr111005.htm. Accessed December 15, 2005.

43. Available at: http://www.fda.gov/opacom/laws/dshea.html. Accessed December 15, 2005.

44. Available at: http://www.arthritis.org/ resources/arthritistoday/2002_archives/2002_09_10_OnCall.asp. Accessed December 15, 2005.

45. Blando F, Gerardi C, Nicoletti I. Sour cherry (Prunus cerasus L) anthocyanins as ingredients for functional foods. J Biomed Biotechnol. 2004;2004(5):253-8.

46. Martinez B. Novartis fights eczema drug’s cancer warning. Wall Street Journal. April 8, 2005.

47. Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med. 2005 Mar 17;352(11):1092-102.

48. Topol EJ. Failing the public healthrofecoxib, Merck, and the FDA. N Engl J Med. 2004 Oct 21;351(17):1707-9.

49. Martinez B. Merck documents shed light on Vioxx legal battles. Wall Street Journal. February 7, 2005.