In February, the FDA sent a Warning Letter to the president and CEO of Diamond Foods claiming the company’s walnuts are drug products in violation of the Federal Food, Drug, and Cosmetic Act. The FDA came to this conclusion because the company suggests walnuts are beneficial to human health.
Excerpt from the FDA’s Warning Letter:
Michael J Mendes, President and Chief Executive
Diamond Food, Inc.
1050 S. Diamond St.
Stockton, California 95201
Dear Mr. Mendes:
The Food and Drug Administration (FDA) has reviewed the label for your “Diamond of California Shelled Walnuts” products and your website at www.diamondnuts.com. Based on our review, we have concluded that your walnut products are in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You can find copies of the Act and these regulations through links in FDA’s home page at http://www.fda.gov.
Based on claims made on your firm’s website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease. The following are examples of the claims made on your firm’s website under the heading of a web page stating “OMEGA-3s … Every time you munch a few walnuts, you’re doing your body a big favor.”:
• “Studies indicate that the omega-3 fatty acids found in walnuts may help lower cholesterol; protect against heart disease, stroke and some cancers; ease arthritis and other inflammatory diseases; and even fight depression and other mental illnesses.”
• “[O]mega-3 fatty acids inhibit the tumor growth that is promoted by the acids found in other fats … ”
• “[I]n treating major depression, for example, omega-3s seem to work by making it easier for brain cell receptors to process mood-related signals from neighboring neurons.”
• “The omega-3s found in fish oil are thought to be responsible for the significantly lower incidence of breast cancer in Japanese women as compared to women in the United States.”
Because of these intended uses, your walnut products are drugs within the meaning of section 201 (g)(1)(B) of the Act [21 U.S.C. § 321(g)(B)].
As the Alliance For Natural Health (ANA) points out, the National Library of Medicine database contains no fewer than thirty-five peer-reviewed published papers supporting the claim that walnuts improves vascular health and may reduce heart attack risk.
The ANH also adds that Life Extension magazine has published at least fifty-seven articles that describe the health benefits of walnuts — each supported with voluminous scientific references.
* There is a sharply reduced incidence of heart disease in those who consume walnuts.
* Walnuts provide a unique blend of polyunsaturated fatty acids (including omega-3s), along with nutrients like gamma tocopherol that have demonstrated heart health benefits.
* Even moderate consumption of walnuts offers significant reductions in dangerous LDL cholesterol and improvement in the lipoprotein profile.
* Walnuts protect against coronary artery disease and atherosclerosis because they contain key nutrients like arginine, polyphenols, and omega-3 fatty acids.
Yet, writes the ANA, the FDA says the walnuts “are not generally recognized as safe and effective,” that the manufacturer’s “unauthorized health claims” have caused the walnuts to become “misbranded,” which makes them subject to government “seizure or injunction”!
Even we have reported on the benefits of walnuts derived from various reputable scientific studies.
In a study at Marshall University of Medicine in Huntington, West Virginia, researchers concluded walnuts provide Omega-3 fatty acids, antioxidants, and phytosteros that may reduce the risk of breast cancer. The study results were included along with other various anti-cancer food studies presented at the 100th annual meeting in Denver of the American Association for Cancer Research.
It’s a well-known fact walnuts are high in Omega-3 fatty acids. In a report published in the Journal of the American Medical Association, researchers concluded that omega-3 fatty acids may slow biological aging in heart disease patients.
And in a western diets where processed foods are prevalent, omega-6 fatty acids outnumber omega-3 fatty acids 20:1. This dietary imbalance is responsible for the rise of such diseases as asthma, coronary heart disease, many forms of cancer, autoimmunity and neurodegenerative diseases, all of which are believed to stem from inflammation. According to Andrew Weil, M.D., the imbalance between omega-3 and omega-6 fatty contributes to obesity, depression, dyslexia, hyperactivity and even a tendency toward violence.
Bill Faloon of the Life Extension Foundation claims the “FDA has issued waves of warning letters to companies making foods (pomegranate juice, green tea, and walnuts) that protect against atherosclerosis.”
Earlier, the FDA attacked cherry growers for citing scientific research from “places like Harvard indicating that cherries reduce inflammation and pain. The FDA sent an injunction letter threatening the usual legal penalties—including jail—if this truthful dissemination of scientific research did not stop immediately.”
Two Things The Alliance for Natural Health Says You Can Do
As our regular newsletter readers are aware, on March 23 a bipartisan bill was introduced into the House of Representatives called the Free Speech about Science Act (HR 4913). This landmark legislation, promoted by ANH-USA, protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.