No Response from FDA:
Soy Petition by WAPF
It’s been more than two years now and the Food and Drug Administration (FDA) is still sitting on a 65-page petition from the Weston A. Price Foundation requesting retraction of a health claim for soy protein and heart disease that has been used by manufacturers to market soy foods as “heart healthy” since October 1999. View the petition here.
A retraction would represent a major setback for the soy industry given that the soy/heart health claim gave soy a “healthy” image and quickly boosted sales from under one billion per year to more than $4 billion per year. Given that there has never been a sound basis for a soy health claim, the heavy marketing of soy as a 'miracle food' has put American men, women and children at risk.
I was the lead author of the petition and it was filed Sally Fallon Morell, president of the Weston A. Price Foundation. Other signers included Kilmer S. McCully, MD, father of the homocysteine theory of heart disease, author of more than 70 papers in peer reviewed journals and author of two popular books The Homocysteine Revolution and The Heart Revolution; Mary G. Enig, PhD, a world renowned biochemist and nutritionist who exposed the dangers of trans fats in the late 1970s; and Galen D. Knight, PhD, a biochemist who has extensively researched the role of vitalethine in humoral immunity and cancer prevention.
The petition persuasively and comprehensively argues why the FDA is mandated by law to retract the soy/heart disease health claim. Five key points are:
- Soy protein isolate and other modern soy protein products are not safe substances with a long history in the food supply.
- The scientific evidence on soy protein and heart disease is contradictory and inconsistent.
- Studies published since 1999 undermine the credibility of -- and conclusions drawn -- from key studies evaluated by the FDA when it approved the health claim in 1999.
- Recent studies show that soy can contribute to or cause heart disease, including endothelial damage (especially in women), heart arrhythmias and cardiomyopathy, an increasingly prevalent condition that affects 1 in 500 Americans.
- The mechanism by which soy might lower cholesterol could cause endocrine disruption, diminished humoral immunity and cancer development.
Even the American Heart Association has informed the FDA in a publicly available letter that its soy/heart health claim is unwarranted and should be revoked. In January 2006, the AHA announced in its journal Circulation that the soy has little effect on cholesterol and is unlikely to prevent heart disease. Earlier, the US Agency for Healthcare Research and Quality published a 245-page report stating that nearly all the research carried out on soy is “inconclusive,” that soy products appear to exert “a small benefit on LDL cholesterol and triglycerides” but that those effects are of “small clinical effect in individuals.”
The Weston A. Price Foundation has been a leader in alerting the public to the fact that soy protein and soy oil in the food supply have been linked to digestive distress, thyroid damage, reproductive problems, infertility, ADD/ADHD, dementia, heart disease and cancer.
In 2005, the Weston A. Price Foundation protested a soy-prevents cancer health claim filed by the Solae Company with the FDA. Solae withdrew their petition in the face of massive evidence that soy can cause, contribute to and accelerate the growth of cancer, particularly breast cancer.
Clearly soy is not the solution for people at risk for heart disease. Worse, possible benefits are far outweighed by proven risks to the thyroid, reproductive and immune systems.
The time has come for the Food and Drug Administration to stop procrastinating on this important issue, act to protect the public and retract the spurious 1999 soy and heart disease health claim.
Dr. Kaayla T. Daniel, PhD, CCN
earned her PhD in Nutritional Sciences and Anti-Aging Therapies from the Union Institute and University in Cincinnati, is board certified as a clinical nutritionist (CCN) by the International and American Association of Clinical Nutritionists in Dallas and is a member of the Board of Directors of the Weston A. Price Foundation and Farm-to-Consumer Legal Defense Fund. As a clinical nutritionist, she specializes in digestive disorders, women's reproductive health issues, infertility, and recovery from vegetarian and soy-based diets.
Dr. Daniel is the author of The Whole Soy Story: The Dark Side of America's Favorite Health Food (New Trends, March 2005), which has been endorsed by leading health professionals, including Kilmer McCully, MD, Doris J. Rapp, MD, Jonathan V. Wright, MD, Russell Blaylock, MD, Larrian Gillespie, MD, Joseph Mercola, OD, Debra Lynn Dadd and others. Larry Dossey, MD, called it "science writing at its best" and William Campbell Douglass, II,MD called it "the most important nutritional book of the decade."
Dr. Daniel has been extensively quoted in major newspapers and magazines, including the San Francisco Chronicle, Washington Post, Toronto Globe & Mail, Glamour, Oxygen and Alternative Medicine, and has appeared as a guest on NPR's People's Pharmacy, the Discovery Channel's Medical Hotseat and ABC's View from the Bay. Online her book has been featured prominently on www.mercola.com, the world's leading natural health and dietary website. She has also appeared as an expert witness before the California Public Safety Committee and the National Institute for Environmental Health Sciences.