FDA Escalates Its Long War on Dietary Supplements
by Bill Sardi: FDA
May Be Getting Ready To Water-Down Your Vitamin Pills
UNBELIEVABLE NEWS HEADLINES
- Human life
found on another planet in Milky Way galaxy.
- Jesus returns
to east gate in old Jerusalem, signs autographs
government admits it seeds atmosphere with chemtrails in population
admit their wrongs and voluntarily go to police stations to surrender
and be punished.
- FDA relents
from its long-standing battle with dietary supplement companies
and allows disease-treatment/cure claims and removal of label
disclaimer that supplements do not cure disease.
FIVE IS THE LEAST LIKELY TO EVER OCCUR
The U.S. Food
& Drug Administration has a long-standing anti-dietary supplement
stance that dates back to the 1940s, an era when the first miracle
drugs like penicillin and cortisone were commercially introduced.
public was being oversold on the value of vitamin supplements, the
one so-called huckster, Adolphus Hohensee, who promoted a line
of health foods and vitamins in the 1940s. Hohensee had falsely
portrayed himself as a doctor, acquired some questionable diplomas,
and paraded a bevy of products that included lecithin, B-complex
vitamins, wheat germ oil, mineral capsules and herb laxatives. Hohensee’s
lectures would generate up to $50,000 in daily sales of his products.
The FDA took
issue with Hohensee, claiming his educational materials were part
of the labeling for his products. He incurred heavy fines. He was
assailed for "a gospel that condemned the normal American food
supply and made purchase of special supplements necessary for physical
and mental salvation."
The FDA responded
that dietary deficiency diseases did exist, but these had been eradicated
in America with fortified foods and an adequate food supply. Hohensee
accurately stated that eggs, processed grains, milk and meats of
the day were not what they were decades earlier. Crops were depleted
of nutrients. Foods were over-processed.
Hohensee’s statements were false. The soil’s quality has little
influence on the quality of the crop grown, they said, or otherwise
the crop wouldn’t grow. Hohensee claimed that garlic was good for
lowering blood pressure. Though Hohensee’s own diet was not a very
good example for others (he was caught drinking beer, fried food
and white bread by news reporters), his message rang of truth. He
and others were harassed, fined, jailed, and branded as food faddists
who peddled "nutritional nonsense." The Federal Trade
Commission and the American Medical Association also took action.
The AMA published articles of "pseudo-nutritional doctrines."
Today we know
- A significant
percentage of the American public is deficient
in essential vitamins. Without
dietary supplements many Americans are deficient in essential
- Garlic does
reduce blood pressure in some cases. Studies conducted in the
1920’s, and more than 16 modern studies conducted in the 1980’s
and 1990’s confirm that garlic
can significantly reduce blood pressure. A more
recent analysis of ten studies involving garlic and its primary
active ingredient allicin reveals that garlic reduces systolic
blood pressure by an average of 16 points and diastolic blood
pressure by 9 point compared to a placebo tablet. That is as good
as any blood pressure medication. Recognize that maybe 1 in 5
patients with high-blood pressure who take medications achieve
140/90 blood pressure. Anti-hypertensive drugs are fraught with
side effects, including the potential for inducing an excessive
drop in blood pressure during sleep that can impair circulation
to the optic nerve and result in blindness. Garlic has none of
these side effects.
- The Recommended
Daily Allowances are woefully inadequate and out-dated and do
not address the individual nutritional requirements of 50 percent
of the population (the hospitalized, smokers, pregnant females,
those taking medicines, growing children, those individuals who
exercise, anyone under emotional stress, have greater nutritional
for all of his shortcomings, was just another of the ridiculed advocates
for self-care and the nutritional approach to health maintenance.
scrutinize the relatively weak scientific citations quoted herein
in support of the claim that dietary supplements prevent, treat
or cure disease. It must be recognized the dietary supplement industry
does not generate sufficient profits to conduct long-term, placebo-controlled
human studies involving thousands of patients. The criticism that
is continually heard about dietary supplements is that they represent
unproven therapy. But in most instances drugs have already been
disproven. For example, statin cholesterol-lowering drugs and anti-cancer
drugs do not significantly reduce mortality rates, yet they are
held in high esteem as approved by the FDA. The National Institutes
of Health, which controls billions of dollars of research funds,
is remiss in sponsoring well-designed studies involving nutriceuticals.
Furthermore, the supplement industry cannot be blamed that its products
don’t prevent or cure disease. If supplements did that, they would
be declared drugs by the FDA! With the exception of deficiency disease
(rickets, scurvy, beri beri, pellagra, etc.) it is categorically
impossible for a dietary supplement to claim it prevents, treats
or cures any disease without facing sanctions from the FDA. This
is silly. Supplements DO prevent, treat and cure many diseases.
A muzzle has been placed over the dietary supplement industry.
To Restrict Vitamins In The 1970s
The FDA, in
league with the National Academy of Sciences Food & Nutrition
Board and other health authorities has worked to limit the intake
of essential nutrients so as to restrict their use to frank deficiency
Colman, Ph.D., President and Director of Scientific Research at
Biomed Inc. in Concord, California, a first-person observer of events
at the time, calls attention to the FDA’s effort in 1973 to make
vitamin dosages over 1.5 times the Recommended Daily Allowance available
by prescription only. Government received more mail against the
proposed 1973 vitamin regulations than it received on the Vietnam
War, says Colman.
goes on to say: "In 1973, thousands of people rallied at the
Cow Palace, a convention hall a few miles south of San Francisco,
to protest the proposed FDA regulations. I was present as
an observer. People were carrying signs saying: ‘GO
TO HEALTH, FDA.’ By a vote of something like 408 to 3, the House
of Representatives voted to take the power to regulate vitamin dosage
away from the FDA." The FDA soon dropped its plan. A
subsequent effort by FDA also failed.
To Implement Law
Hutt, former chief counsel for FDA (1971-75) and senior counsel
with the Washington, D.C., law firm of Covington & Burling LLP,
provides us with a more detailed
history of the FDA’s long war against dietary supplements. According
to Hutt, the primary thrust of the FDA’s anti-supplement efforts
has been to maintain that dietary supplements are unnecessary for
any person who eats properly, "a feeling that has continued
to persist within the agency up to this very day," says Hutt.
This is in the face of the fact that the government’s 5-A-Day program
to eat fruits and vegetables has miserably failed to reduce mortality
rates for heart disease and cancer.
the FDA applied pressure and attempted to gain greater authority
to regulate the supplement industry. This led to Congressional hearings
that finally landed in the US Court of Appeals in 1974, who overruled
parts of the regulations. Then Senator William Proxmire (D-Wis.)
pushed through Congress the Vitamin-Mineral Amendments of 1976 which
further reduced FDA flexibility in regulating dietary supplements,
says Hutt. Frustrated and bending to the will of the people, in
1979 FDA revoked all of the regulations it had propagated in 1972.
Hutt, the freedoms gained in the 1994 Dietary Supplement Health
& Education Act have FDA Commissioner David Kessler MD to thank
for them. Dr. Kessler’s arrogance prompted the supplement industry
and the public to fight back.
A year prior
to the passage of DSHEA Dr. Kessler announced he would resist approval
of any proposed disease prevention claims for dietary supplements
and would attack dietary ingredients other than essential vitamins
and minerals on the ground that they are illegal food additives
that must be removed from the market.
the Dietary Supplement Health & Education Act of 1994 was passed,
but, as Hutt explains: "Kessler was so infuriated by the enactment
of DSHEA that he ordered FDA not to enforce the new law. FDA took
virtually no enforcement action because Kessler was convinced if
the law was not enforced and the worst elements of the dietary supplement
industry were allowed to run wild, Congress would repeal the law.
Of course, that did not occur. For a full decade, however, Kessler
sacrificed protection of the public health to his own personal animosity
Then the FDA
drug its feet for more than a decade before outlining Good Manufacturing
Practices for dietary supplements, all the while demeaning supplements
for not exhibiting the quality of drugs. Was the FDA again hoping
that some poorly made dietary supplement would kill or seriously
harm consumers so it could then re-launch its vendetta against the
was, after years of allegations that the supplement industry was
hiding serious side effects from regulators, an Adverse Events Reporting
rule went into effect where supplement manufacturers had to report
any adverse reactions that caused a consumer to see a doctor or
be hospitalized. However, even with this reporting requirement,
dietary supplements have proven to be comparably safer than aspirin,
tap water and table salt. Again, the FDA’s war against supplements
FDA Challenge Facing Dietary Supplements
challenge dietary supplements face is worse than any before. The
FDA now seeks to implement a new guideline that would force all
supplements dating back to the passage of the 1994 DSHEA to undergo
toxicity and birth defect studies, a requirement that would so expensive
it would quash the entire industry, require more than $50 billion
of testing which represents the entire estimated profits produced
by the industry for 20 years, a guideline that would be impossible
to administrate (56,000 supplements would have to undergo an approval
process in a short time), a guideline that would surely eliminate
thousands of products from retail store shelves and place hundreds
of thousands of Americans workers into unemployment lines. The FDA
has aimed a death blow at the industry. To find out how to oppose
this new FDA guideline, visit www.operationpushback.com
against dietary supplements by the FDA will never end till it is
relieved of its duty to oversee the supplement industry. Oversight
may be better accomplished by turning supplement regulation over
to the US Department of Agriculture. Otherwise the American public
will continue paying a steep price for the FDA’s bias of drugs over
That Vitamins Cure Disease Pre-Dates Most Drugs
The idea that
vitamins food factors that are essential for life
could cure disease was first described in the very early 1900s and
pre-dated most drugs. Subsequently various specific vitamins were
discovered and then later synthetically produced and commercialized.
a focus on profitability and patent protection, drug companies ignored
un-patentable molecules from nature such as vitamins, minerals and
amino acids to the point where only now, because of gene
analyses, are vitamins like vitamin D, folic acid (vitamin B9),
thiamin (vitamin B1) and vitamin C, along with various
herbal extracts such as resveratrol and quercetin from red wine,
curcumin from turmeric and allicin from garlic, being rediscovered
as having broader
biological activity than synthetic drugs.
political and industry pressure, as patents for older drugs expired,
the FDA has been forced into approving new drugs that are even less
effective than older drugs at an much higher consumer price. This
has been documented for diabetes
drugs, drugs to treat Parkinson’s
disease and epilepsy.
All the while, dietary supplements have been considered step-children
it may be dietary supplements that break the mold of designing individual
drugs for every disease. Instead, so-called
nutraceuticals would address many diseases, particularly chronic
diseases of aging. But trying to get these revolutionary natural
molecules past the FDA is going to be some challenge.
of the human genome and the discovery that genes are dynamic rather
than fixed in nature (genes can be switched on and off in what is
called epigenetics) now for the first time reveals natural medicines
may be superior to patent drugs. In fact, natural medicines like
ginger root, garlic, ginseng, curcumin and many others have a safety
advantage over prescription drugs. The safety of drugs is not fully
known till years after FDA approval and many thousands of patients
have taken the drug whereas natural molecules have been in use for
centuries and are in common use in the population.
now propose that epigenetic
side-effects of pharmaceuticals may be involved in the etiology
of many diseases including heart disease, cancer, nerve and
mental disorders, obesity, diabetes, leukemia, bipolar disorder,
schizophrenia, infertility, and sexual dysfunction. Pharmaceuticals
over human genes. Researchers are calling for epigenetic
screening of all existing and future pharmaceutical drugs. The
FDA actually approves drugs that worsen disease.
At some indefinite
point in time pharmacologists began to re-arrange natural molecules
into synthetics that could garner patent protection and be used
to hike up the price and profitability of medicines. Pharmacology
today largely based upon the design synthetically produced molecules
that address a particular cell receptor site or gene target.
the US Food & Drug Administration took on the role of protector
for the interests of US Drug Manufacturers and their number one
position globally in the $880 billion pharmaceutical industry. This
got to the point where, in one instance, the FDA totally relied
upon a manufacturer’s false claim that its anti-inflammatory drug
was safer (caused less gastric upset and bleeding ulcers) than other
drugs, allowed that drug to be widely promoted on television, and
led to thousands of premature deaths.
At the height
of the Vioxx scandal, where an FDA
regulator-turned-whistleblower had to actually leave the country
and break the news about the increased risk for death when taking
this drug, the FDA had the gall to send tart cherry growers in Michigan
a warning letter that their products were being advertised as drugs.
All that the tart cherry growers were doing is linking their websites
to a US Department of Agriculture report showing tart
cherry is as effective an anti-inflammatory agent as ibuprofen.
Tart cherry doesn’t cause gastric ulcers as does Vioxx and the many
other COX-2 inhibitor drugs that are still on the market. In fact,
there is still no safe prescription or non-prescription pain reliever
on the market to day.
The FDA does
not consider it has the assigned duty to notify and educate the
public that the biological action of many drugs, like tart cherry,
can be duplicated with dietary supplements at far less cost and
fewer side effects. The FDA’s job has morphed into protecting the
pharmaceutical industry rather than public health. FDA employees
might as well wear hats and T-shirts emblazoned with the names of
major pharmaceutical companies on them like race car drivers and
their crews wear Pennzoil caps and shirts.
it has been documented for decades that vitamin
C acts as a potent statin drug that can eliminate cholesterol from
the arteries via increased bile flow. It was authoritatively
documented that chondroitin
sulfate, a molecule naturally made in the body, when consumed
orally can eliminate angina chest pain and reduce mortality from
heart disease, working in a superior manner to an array of prescription
The FDA also
chooses not to compare new drugs against existing medicines, but
gives pharmaceutical companies an easy passage to approval by only
having to show new drugs are better than an inactive placebo tablet.
Whereas the first drugs like penicillin and insulin worked in most
patients, today medicines like statin drugs are approved by the
FDA when they
only work in 1 in 71 subjects (3%) over a 5-year period in averting
a non-mortal heart attack. Essentially the FDA has given license
to pharmaceutical companies to treat all chronic diseases as if
they are drug deficiencies when in fact many are rooted in nutrient
overloads or deficiencies. In this scenario, patients will never
dereliction of duty is the FDA does not require drugs to be labeled
that they deplete essential nutrients. For example, statin cholesterol-lowering
drugs deplete coenzyme-Q10
work if vitamin D levels are low. The FDA doesn’t even want
the public discovering dietary supplements help prevent drug side
Is The FDA?
There is a
litany of anti-dietary supplement policies and practices attributed
to the FDA over the years. Here are some of the most atrocious fiascos
the FDA has been responsible for:
- After over
a decade of wrangling over whether to fortify foods with folic
acid to prevent birth defects (spina bifida, anencephaly), the
FDA finalized a ruling on this subject in 1996. Many thousands
of birth defects could have been prevented, but the FDA was reluctant
to take action despite science that obviously pointed to this
B vitamin as a preventive nutrient. The reason why the FDA was
so slow in approving food fortification to prevent birth defects
is because, as one government scientific expert indicates, this
destroy the scientific basis for RDA’s in this country."
The FDA didn’t want even one nutrient to be used and allowed to
claim it prevented a disease. The FDA has the shame of all those
birth defects on its hands. The folic
acid food fortification program went into effect and silenced
- In the mid-1990s
the FDA took
a multi-herbal dietary supplement out of the hands of dying prostate
cancer patients because it was mislabeled, even though it
was saving their lives. True, it was spiked with two drug molecules
(a blood thinner and a hormone), but men were living in extended
remission from their disease. Over 100 studies were published
showing this herbal product was extending terminal prostate cancer
patients’ lives indefinitely. Instead of allowing this herbal
drug to continue to be used on a compassionate life-saving basis,
it chose to literally take these pills out of the hands of otherwise
- The FDA
has become a shill for pharmaceutical manufacturers, even going
so far as to hide a startling downturn in the life expectancy
of Americans in 1993 that was caused by a toxic flu vaccine. Since
the Spanish Flu in 1918 the life expectancy of Americans progressively
rose, year after year. This investigator tracked down the cause
of this sudden
drop in life expectancy and found it was linked to a late flu
season vaccination program in nursing homes that year. The
FDA and other public health agencies said nothing about this.
Had a news report reached the public that a killer flu vaccine
a vaccine that was FDA-approved was responsible
for the greatest downturn in American life expectancy in eight
decades, it would have caused the nation’s annual flu vaccination
program to implode and who knows what would have happened to the
- In 2002
the Food & Drug Administration (FDA) issued
a warning, asking physicians to report adverse reactions associated
with kava kava supplements, an anti-anxiety herbal product. Based
upon reports from European pharmaceutical companies, the public
was also warned to report any side effects and the FDA warning
was published in newspapers and on TV news reports. Later, published
studies cleared kava kava from any suspicion, but the damage
had been done. The public backed away from kava supplements based
upon the bulletin issued by the FDA, and this forced kava farmers
in the South Pacific to plow over their fields. A $25 million
crop-based industry was destroyed by FDA rumor spreading.
FDA Have Another Vioxx In-The-Making?
pharmaceutical company in the world faces expiration of many of
its blockbuster multi-billion dollar drugs. Make it an unstated
assignment for the FDA to do what it can to help out a pharmaceutical
company that faces such a falloff in revenues.
Just such an
example is the recently approved blood-thinning drug ticagrelor
(Brilinta), which an FDA
panel initially declined in December, 2010 by a 7-to-1 vote.
Keep in mind that the patent for the reigning blockbuster anti-clotting
drug clopidogrel (Plavix) expires next year.
The maker of
ticagrelor (Brilinta) appealed and re-submitted data from European
trials to gain
FDA approval on July 20, 2011. But comparative studies in the
US showed that clopidogrel (Plavix) produced fewer deaths (3.2%
death rate for clopidogrel versus 3.8% for ticagrelor). Larger studies
confirm the lower 3.2% death rate for Plavix. So how did Brilinta
suddenly exhibit a 16% lower death rate than Plavix? Simple: the
drug manufacturer monitored its own trials in Europe, but not in
researchers said: "Since the ‘play of chance’ cannot explain
these discrepancies due to excess death rates, and considering that
study sponsor self-monitored sites in most countries, but not in
the USA, the mortality data are questionable, and should be independently
verified…. The future practice of self monitoring in pivotal indication-seeking
clinical trials should be completely banned."
Do we have
another Vioxx in the making here? Similarly, the FDA relied upon
drug manufacturer data for Vioxx, a drug that was later recalled.
Meanwhile, dietary supplements safely thin the blood, such as fish
oil, magnesium, garlic and resveratrol, and can be taken in combination
without side effect or over-thinning of the blood as occurs with
drugs. You will never learn about this from the FDA.
DO prevent and treat disease
the FDA says dietary supplements DO effectively prevent, treat and
even cure diseases, though every dietary supplement must include
the following disclaimer statement on its label: "This
statement has not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure, or prevent any disease."
Imagine an FDA that wasn’t anti-dietary supplement. The FDA disclaimer
might say something like this:
supplements make a significant contribution to daily
nutrient needs. Consumers are urged to carefully examine
the level of scientific evidence (lab dish, animal, human studies)
that substantiates whether a supplement prevents, treats or
cures disease, and whether that science pertains to a
particular product or its ingredients in general
and provides the same dosage and form of nutrient
used in a published study.
is the FDA’s legacy:
deaths from use of Vioxx while tart cherry growers were muzzled;
- Babies with
preventable birth defects in their spinal cord and backbone as
a result of foot-dragging over inclusion of folic acid into fortified
- Men prematurely
dying of prostate cancer for lack of an herbal product forced
off the market;
heart disease patients mistakenly relying upon cholesterol-lowering
statin drugs to save their lives and spare them from a mortal
heart attack while other natural
remedies that may actually avert sudden-death heart attacks
All this is
part of the legacy of the FDA in the aftermath of its tyranny against
nutritional therapy and dietary supplements. If needless deaths
haven’t reformed the FDA, what will?
The U.S. Food
& Drug Administration is above the law, ignores court orders,
persistently denigrates dietary supplements, protects the financial
interests of pharmaceutical companies above those of the public’s
health, and its actions have needlessly killed many thousands of
Americans. It is a derelict organization whose pronouncements should
be disregarded and watched with caution by the public. The FDA’s
inherent conflict in protecting the nation’s pharmaceutical trade
suggests it should, once and for all, be removed from oversight
of dietary supplements.
him mail] is a frequent writer on health and political
topics. His health writings can be found at www.naturalhealthlibrarian.com.
latest book is Downsizing
© 2011 Bill Sardi Word of Knowledge Agency, San Dimas, California.
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