FDA Says Walnuts Are Illegal Drugs
By William Faloon
To the Honorable:
Please co-sponsor the Free Speech About Science Act (H.R. 1364).
This is critical because more Americans are taking charge of their personal health—determined to improve their diets and emphasize preventive care in order to stay or get healthy. Consumers are looking for reliable information backed by legitimate scientific research to assist in making informed choices.
But FDA regulations currently prohibit producers of food from referring to any scientific study documenting the potential effect of the substance on a health condition. Violation of this ban can result in the FDA declaring common foods to be “unapproved drugs,” the sale of which is subject to large fines and jail. Even cherry growers have been told by the FDA that they face jail if they link to Harvard and other studies outlining the health benefits of cherries for gout or arthritis pain. The FDA has taken these actions against walnut growers as well.
The Free Speech About Science Act of 2011 provides a limited and carefully targeted change to FDA regulations so that legitimate, peer-reviewed, scientific studies may 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 the FDA and FTC the right to take action against misleading information and against false and unsubstantiated claims.
The Free Speech About Science Act:
(1) Provides a clear definition of the types of research that may be referenced by growers and manufacturers;
(2) Ensures that referencing such research does not convert a food or dietary supplement into an “unapproved [and therefore illegal] new drug;” and
(3) Does not in any way limit FDA and FTC authority to pursue any fraudulent and misleading statements.
All of us, no matter what our party or views about healthcare, are coming to see the importance of preventive care, or preventing illnesses before they start. Diet, dietary supplements, and lifestyle play a large role in prevention. The FDA should be at the forefront of this. Instead, it is blocking producers from giving consumers truthful scientific information about healthy foods.
The FDA responds that cherries and the like should be subjected to the full FDA approval process. But this would cost as much as a billion dollars. With few exceptions, it is not possible for food producers to assume such costs for natural and therefore non-patentable products.
This is the great Catch-22 of contemporary American medicine. The FDA should find a less expensive way to “vet” natural products. Respected university research suggests that in many cases natural products are safer, more efficacious, and of course much cheaper than drugs. In the meantime, we should modify the law to at least let producers cite valid peer-reviewed science.
Please help me gain the information I need to stay healthy; co-sponsor the Free Speech About Science Act (H.R. 1364)!
1. Ros E, Nunez I, Perez-Heras A, et al. A walnut diet improves endothelial function in hypercholesterolemic subjects: a randomized crossover trial. Circulation. 2004 Apr 6;109(13):1609-14.
2. Feldman EB. The scientific evidence for a beneficial health relationship between walnuts and coronary heart disease. J Nutr. 2002 May;132(5):1062S-1101S.
3. Blomhoff R, Carlsen MH, Andersen LF, Jacobs DR Jr. Health benefits of nuts: potential role of antioxidants. Br J Nutr. 2006 Nov;96 Suppl 2:S52-60.
4. Mozaffarian D. Does alpha-linolenic acid intake reduce the risk of coronary heart disease? A review of the evidence. Altern Ther Health Med. 2005 May-Jun;11(3):24-30; quiz 31, 79.
5. Zhao G, Etherton TD, Martin KR, West SG, Gillies PJ, Kris-Etherton PM. Dietary alpha-linolenic acid reduces inflammatory and lipid cardiovascular risk factors in hypercholesterolemic men and women. J Nutr. 2004 Nov;134(11):2991-7.
6. Tapsell LC, Gillen LJ, Patch CS, Batterham M, Owen A, Baré M, Kennedy M. Including walnuts in a low-fat/modified-fat diet improves HDL cholesterol-to-total cholesterol ratios in patients with type 2 diabetes. Diabetes Care. 2004 Dec;27(12):2777-83.
7. West SG, Boseka L, Wagner P. Alpha-linolenic acid from walnuts and flax increases flow-mediated dilation of the brachial artery in a dose-dependent fashion. Poster presented at the American Heart Association’s 5th Annual Conference on Arteriosclerosis, Thrombosis, and Vascular Biology. San Francisco, CA: May 6, 2004.
8. Iwamoto M, Imaizumi K, Sato M, Hirooka Y, Sakai K, Takeshita A, Kono M. Serum lipid profiles in Japanese women and men during consumption of walnuts. Eur JClin Nutr. 2002 Jul;56(7):629-37.
9. Morgan JM, Horton K, Reese D, et al. Effects of walnut consumption as part of a low-fat, low-cholesterol diet on serum cardiovascular risk factors. Int J Vit Nutr Research. 2002 Oct;72(5):341-7.
10. Hu FB, Stampfer MJ, Manson JE, et al. Frequent nut consumption and risk of coronary heart disease in women: prospective cohort study. BMJ. 1998 Nov 14;317(7169):1341-5.
11. Chisholm A, Mann J, Skeaff M, et al. A diet rich in walnuts favourably influences plasma fatty acid profile in moderately hyperlipidaemic subjects. Eur J Clin Nutr. 1998 Jan;52(1):12-6.
12. de Lorgeril M, Renaud S, Mamelle N, et al. Mediterranean alpha-linolenic acid-rich diet in secondary prevention of coronary heart disease. Lancet. 1994 Jun 11;343(8911):1454-9.
13. Maguire LS, O’Sullivan SM, Galvin K, O’Connor TP, O’Brien NM. Fatty acid profile, tocopherol, squalene and phytosterol content of walnuts, almonds, peanuts, hazelnuts and the macadamia nut. Int J Food Sci Nutr. 2004 May;55(3):171-8.
14. Sabate J, Fraser GE, Burke K, Knutsen SF, Bennett H, Lindsted KD. Effects of walnuts on serum lipid levels and blood pressure in normal men. N Engl J Med. 1993 Mar 4;328(9):603-7.
15. Zambon D, Sabate J, Munoz S, et al. Substituting walnuts for monounsaturated fat improves the serum lipid profile of hypercholesterolemic men and women. A randomized crossover trial. Ann Intern Med. 2000 Apr 4;132(7):538-46.
16. Iwamoto M, Imaizumi K, Sato M, et al. Serum lipid profiles in Japanese women and men during consumption of walnuts. Eur J Clin Nutr. 2002 Jul;56(7):629-37.
17. Simopoulos AP. Essential fatty acids in health and chronic disease. Am J Clin Nutr. 1999 Sep;70(3 Suppl):560S-569S.
18. Hu FB, Stampfer MJ. Nut consumption and risk of coronary heart disease: a review of epidemiologic evidence. Curr Atheroscler Rep. 1999 Nov;1(3):204-9.
19. Zibaeenezhad MJ, Rezaiezadeh M, Mowla A, Ayatollahi SM, Panjehshahin MR. Antihypertriglyceridemic effect of walnut oil. Angiology. 2003 Jul-Aug;54(4):411-4.
20. Almario RU, Vonghavaravat V, Wong R, Kasim-Karakas SE. Effects of walnut consumption on plasma fatty acids and lipoproteins in combined hyperlipidemia. Am J Clin Nutr. 2001 Jul;74(1):72-9.
21. Anderson KJ, Teuber SS, Gobeille A, Cremin P, Waterhouse AL, Steinberg FM. Walnut polyphenolics inhibit in vitro human plasma and LDL oxidation. J Nutr. 2001 Nov;131(11):2837-42.
22. Singh I, Turner AH, Sinclair AJ, Li D, Hawley JA. Effects of gamma-tocopherol supplementation on thrombotic risk factors. Asia Pac J Clin Nutr. 2007;16(3):422-8.
23. McCarty MF. Gamma-tocopherol may promote effective no synthase function by protecting tetrahydrobiopterin from peroxynitrite. Med Hypotheses. 2007;69(6):1367-70.
24. Park SK, Page GP, Kim K, et al. alpha- and gamma-Tocopherol prevent age-related transcriptional alterations in the heart and brain of mice. J Nutr. 2008 Jun;138(6):1010-8.
25. Cortés B, Núñez I, Cofán M, et al. Acute effects of high-fat meals enriched with walnuts or olive oil on postprandial endothelial function. J Am Coll Cardiol. 2006 Oct 17;48(8):1666-71.
26. Ros E, Mataix J. Fatty acid composition of nuts—implications for cardiovascular health. Br J Nutr. 2006 Nov;96 Suppl 2:S29-35.
27. Ma Y, Njike VY, Millet J, et al. Effects of walnut consumption on endothelial function in type 2 diabetic subjects: a randomized controlled crossover trial. Diabetes Care. 2010 Feb;33(2):227-32.
28. Le Brocq M, Leslie SJ, Milliken P, Megson IL. Endothelial dysfunction: from molecular mechanisms to measurement, clinical implications, and therapeutic opportunities. Antioxid Redox Signal. 2008 Sep;10(9):1631-74.
29. Ros E. Nuts and novel biomarkers of cardiovascular disease. Am J Clin Nutr. 2009 May;89(5):1649S-56S.
30. Feldman EB. The scientific evidence for a beneficial health relationship between walnuts and coronary heart disease. J Nutr. 2002 May;132(5):1062S-1101S.
31. Ristic-Medic D, Ristic G, Tepsic V. Alpha-linolenic acid and cardiovascular diseases. Med Pregl. 2003;56 Suppl 1:19-25.
32. Available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202825.htm. Accessed March 26, 2010.
33. Aviram M, Rosenblat M, Gaitini D, et al. Pomegranate juice consumption for 3 years by patients with carotid artery stenosis reduces common carotid intima-media thickness, blood pressure and LDL oxidation. Clin Nutr. 2004 Jun;23(3):423-33.
34. Oyama J, Maeda T, Kouzuma K, et al. Green tea catechins improve human forearm endothelial dysfunction and have antiatherosclerotic effects in smokers. Circ J. 2010 Mar;74(3):578-88.
35. Available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202785.htm. Accessed April 11, 2011.
36. Available at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm224509.htm. Accessed April 11, 2011.
37. Available at: http://www.fritolay.com/your-health/whats-in-our-snacks.html. Accessed March 25, 2010.
38. Available at: http://www.fritolay.com/about-us/press-release-20060503.html. March 25, 2010.
39. Jakobsen MU, O’Reilly EJ, Heitmann BL, et al. Major types of dietary fat and risk of coronary heart disease: a pooled analysis of 11 cohort studies. Am J Clin Nutr. 2009 May;89(5):1425-32.
40. Scherr C, Ribeiro JP. Fat content of dairy products, eggs, margarines and oils: implications for atherosclerosis. Arq Bras Cardiol. 2010 Jul;95(1):55-60.
41. Available at: http://www.kedu.us/Ask%20the%20Doctor/omega%203%20cardiovascular.pdf. Accessed March 29, 2010.
42. Simopoulos AP. The importance of the omega-6/omega-3 fatty acid ratio in cardiovascular disease and other chronic diseases. Exp Biol Med (Maywood). 2008 Jun;233(6):674-88.
43. Okuyama H, Kobayashi T, Watanabe S. Dietary fatty acids--the N-6/N-3 balance and chronic elderly diseases. Excess linoleic acid and relative N-3 deficiency syndrome seen in Japan. Prog Lipid Res. 1996 Dec;35(4):409-57.
44. Kiecolt-Glaser JK, Belury MA, Porter K, et al. Depressive symptoms, omega-6:omega-3 fatty acids, and inflammation in older adults. Psychosom Med. 2007 Apr;69(3):217-24.
45. Guebre-Egziabher F, Rabasa-Lhoret R, Bonnet F, et al. Nutritional intervention to reduce the n-6/n-3 fatty acid ratio increases adiponectin concentration and fatty acid oxidation in healthy subjects. Eur J Clin Nutr. 2008 Nov;62(11):1287-93.
46. Jackson LS, Al-Taher F. Effects of consumer food preparation on acrylamide formation. Adv Exp Med Biol. 2005 561:447-65.
47. Available at: http://www.cancer.gov/cancertopics/factsheet/Risk/Fs3_96.pdf. Accessed April 11, 2010.
48. Available at: http://www.fda.gov/food/foodsafety/foodcontaminantsadulteration/chemicalcontaminants/acrylamide/ucm053569.htm. Accessed April 11, 2011.