Food Consumer, IL
02-04-07
FDA asked to rescind health claims on soy, whole grains
By news release
Citizen Petition Calls For FDA To Rescind Cholesterol-Related Health Claims for
Soy Protein and Whole Grains and Recognize A Bran Molecule As The Primary
Antidote To Arterial Disease
A citizen petition, submitted to the Food & Drug Administration today, pleads with
the agency to rescind health claims for soy protein, barley and whole grains
which was based on their assumed ability to reduce cholesterol-related heart
risks, and to recognize an overlooked substance in bran as a major dietary
component that improves cardiovascular health. The petition, filed by health
journalist Bill Sardi, president of Knowledge of Health, Inc. [
www.knowledgeofhealth.com ] also pleads with the FDA to review the way it
determines health claims for foods.
San Dimas, CA- Based upon emerging scientific studies which show that dietary
and drug measures used to lower cholesterol do not lower cardiovascular
mortality rates, a petition filed with the Federal Food & Drug Administration today
pleads with the FDA to rescind its prior adoption of cardiovascular health claims
for soy protein, barley and whole grains, and to recognize IP6 phytate, a
component of bran in these same foods, as a major substance that may help
maintain cardiovascular health.
The citizen petition, submitted by Bill Sardi, president of Knowledge of Health,
Inc, of San Dimas, California, cites over 150 scientific references representing
over 2000 pages of materials that were submitted to the FDA along with the 64page petition.
Sardi says stronger cholesterol-lowering drugs, which typically lower cholesterol
by 20-30 percent, have not been shown to lower cardiovascular risks in healthy
populations, so soy protein, which only lowers cholesterol by a meager 3%,
would produce vanishing health benefits.
Sardi says the American Heart Association also recently concluded that there
were no meaningful cholesterol-related health benefits derived from soy protein
consumption, especially since the FDA suggested an intake level (25 grams per
day) that simply cannot be achieved by most people.
"The FDA health claim did not involve any pharmacological action produced by
soy protein, but solely relied upon its bulk consumption to replace other fatty or
sugary foods. Even sawdust could have met this health claim, the way it was
written," says Sardi.
When the FDA approved health claims for these plant foods it could not identify
the substance in these foods that produced cardiovascular health benefits.
Recently researchers at Iowa State University identified IP6 phytate as the
substance in soy that reduces non-cholesterol cardiovascular disease risk factors
(C-reactive protein, homocysteine, iron levels) in adults.
Soy protein and whole grains are still very healthy, not because they lower
cholesterol, but because they contain IP6 phytate that prevents arterial
calcifications and controls iron overload, says Sardi. While IP6 phytate, a known
mineral chelator (binder) is a major component of soy, barley and whole grains,
for unexplained reasons food producers and FDA reviewers overlooked the
obvious benefits afforded by IP6 phytate, says Sardi.
The petition also asks the FDA to consider identifying foods by their
appropriateness for the stage of life of consumers. Iron and calcium-rich foods
are more appropriate for growing children and child-bearing females, but not for
full-grown males and non-menstruating females who detrimentally accumulate
these minerals with advancing age.
The petition also takes the FDA to task for the way it evaluates health claims, the
way the FDA presents statistics (using relative rather than hard numbers to
misleadingly magnify the alleged benefits of foods and drugs it approves), and
the inconsistent and unscientific manner in which it employs "scientific
consensus" before it will evaluate any food-related health claim.
Scientific consensus, as practiced, may delay the implementation of life-saving
health measures while prolonging outdated and disproven practices, says
Sardi. He cites the example of hand washing, which was shown to save lives in
1847, but modern medicine still had not adopted the practice 17 years later at the
death of its major advocate, Dr. Ignaz Semmelweis.
Sardi says modern medicine has undergone two major paradigm reversals in the
past two decades and is now facing a third. One was the discovery that gastric
ulcers are caused by a bacterium, not excessive stomach acid, and the second
was the realization that hormone replacement therapy, which may relieve
menopausal symptoms, should not be taken for health reasons.
The third paradigm reversal is now upon us, the revelation that cholesterol is not
a valid marker of cardiovascular disease, says Sardi. He says modern medicine
waited for the patent to expire on a popular antacid drug before it began to
prescribe antibiotics to treat ulcers, and he hopes that the FDA doesn't allow the
same thing to happen with cholesterol-lowering drugs, which now are deemed to
be ineffective for healthy Americans. We currently have popular consensus
among medical practitioners that cholesterol reduction is beneficial, but no
science to back that belief, says Sardi. A recently published study by Harvard
professor John Abramson confirms there is no evidence of any benefit derived
from efforts to lower cholesterol among healthy populations.
The petition points to age-related accumulation of calcium and iron, not
cholesterol, as the primary cause of heart disease. The petition cites evidence
that in countries which consume the least calcium (200-400 milligrams per day),
cardiovascular disease is non-existent and blood pressure does not rise with
advancing age. In countries that consume more than 800 milligrams of calcium
per day (USA, Ireland, New Zealand, Scandinavian countries), cardiovascular
disease is the leading cause of mortality. The petition cites a study showing only
3% of arterial plaque is cholesterol and 50% is calcium.
The FDA has 90 days to respond to the petition which can be viewed at
www.knowledgeofhealth.com