Dietary Supplement Label the FDA Doesnít Want You To See
by Bill Sardi: Western
Diet Versus Mediterranean†Diet
The US Food
& Drug Administration is playing a deadly game with the American
people, a game that protects over-priced, oftentimes ineffective
or inappropriate, and sometimes toxic or lethal drugs, while muzzling
any evidence that there are cheaper, safer and more effective and
appropriate non-prescription remedies.
The FDA does
not consider its mission to inform the American public of less problematic
alternatives, even safer drugs within the same class, nor does it
inform the public of natural remedies which have the same biological
action as Rx drugs. In fact, any natural remedy that does in fact
prevent, treat or cure a disease is declared a drug.
The FDA arrogantly
maintains prescription drugs are the high standard upon which all
other remedies must be compared. The gold standard for an FDA-approved
drug is the double-blind (doctors and patients donít know who is
taking active or inactive medicine), placebo-controlled, longitudinal
(long-term) study. A drug need only beat placebo (inactive pill)
to be approved.
outright flaw in this type of study is that it is based upon results
in groups, not individuals. We now know that the individual genetic,
environmental and family health history of patients is needed to
adequately prescribe medicines and other treatments. These factors
are generally not considered in these types of studies. As Steve
Hickey and Hilary Roberts say in their recent critique of evidence-based
Gold, The Sickness of Evidence-Based Medicine, 2011), "populations
are not people."
intentionally involve an overly large number of subjects in order
to come up with the misleading conclusion that it is ever so slightly
effective. An example would be statin cholesterol-lowering drugs
that only avert a non-mortal heart attack in 1 of 71 high-risk subjects
over a 5-year period of time. There is an even more remote chance
statin drugs will save lives when used among healthy adults who
have no risk factors for heart disease. Most statin drug users will
derive no meaningful benefit because these drugs do not prevent
mortal heart attacks.
In the era
prior to controlled studies, drugs like insulin, penicillin, aspirin,
digitalis, sulfa drugs and many vaccines came into common use because
it was obvious they worked in nearly all subjects. The same is true
for vitamins. Except for those individuals with absorption or transport
problems, vitamin C cured scurvy every time; vitamin D cured rickets
nearly every time; thiamin (vitamin B1) cured beri beri every time;
vitamin B12 cured pernicious anemia every time.
todayís FDA approved drugs may in fact be ineffective (statin drugs
donít prevent mortal heart attacks, cancer drugs donít improve survival,
antidepressants and drugs for Alzheimerís disease are no better
than a placebo pill) and may even increase the risk for death (examples:
erythropoietin prescribed for cancer-induced anemia, anti-inflammatory
drugs that may increase risk for cardiac death or from bleeding
The logic of
arguments used against dietary supplements is stupefying. While
it is often said that dietary supplements are unproven, yet many
FDA-approved drugs have already been disproven. Most antidepressants,
anti-Alzheimerís medications and anti-cancer drugs simply donít
work and should be removed from the marketplace.
drugs have become such a farce. Consider there is not one blood
pressure drug that addresses the primary cause of the disease. Diuretics
reduce fluid load by increasing excretion of urine, beta blockers
slow down the heart pump, ACE inhibitors calm a hormone produced
in the kidneys, but the primary cause of age-related hypertension
of arteries due to calcifications combined with a shortage
of nitric oxide, a transient gas that induces arteries to dilate
(widen) with physical exertion or emotional stress. Just one
magnesium pill a day will do as well as any single blood pressure
of nitric oxide is triggered by some nutrients, such as nitrites
provided in extracts from beets, or by herbal extracts from pine
bark or grapes (resveratrol, quercetin). Natural remedies more appropriately
address the primary cause of high blood pressure than any existing
FDA-approved drug, but they are shunned by modern medicine and classified
as unproven remedies.
do decrease mortality for disease but there are offsetting deaths
when all causes of drug-related mortality are considered. Drugs
can be approved (like anti-inflammatory drugs) which reduce an intended
end-point (inflammation, pain) but increase the risk for death.
is that FDA-approved drugs are allowed to be widely advertised after
gaining initial FDA approval before safety data obtained after longer-term
use is analyzed. An unsafe and deadly drug may be on the market
for years before it is recalled as the FDA relies upon pharmaceutical
companies to monitor and tabulate their own safety data.
black box warning label
The FDA has
come up with a legal out for drugs that offer benefits while producing
offsetting side effects. It is called the black-box warning label.
This puts the legal onus on the prescriber. Yes, consumers can read
these black-box warnings but often never consider them. By the FDA
shifting the risk on the prescribing doctor it is more difficult
to pursue legal remedies for avoidable harms that patients may incur.
It becomes obvious here that the FDA is in the business of shielding
pharmaceutical and vaccines makers, not the public.
immune from liability
where the public cannot by law sue manufacturers for damages from
harmful side effects or deaths. Damage claims must be submitted
to a vaccine injury board (officially the National Vaccine Injury
Since any significant
pay out from this fund would be an admission that many vaccines,
or least certain production lots of vaccines, are troublesome, the
vaccine injury board makes it nearly impossible to receive pay outs
on any claims. Again, the vaccine injury board exists to protect
and limit liability of manufacturers, not to protect the public.
speak out of two sides of their mouth here. On one side it proclaims
vaccines to be safe and the public should be vaccinated against
all manner of disease, and on the other side it says there needs
to be a vaccine injury claims board to "immunize" vaccine
makers from liability claims. If vaccines are safe, then why would
a special claims board be needed?
vaccines represent "a little bit of disease" and are inherently
problematic for children under the age of 2 years and seniors over
the age of 70 who simply donít adequately develop antibodies when
exposed to pathogenic germs. These two groups represent the at-risk
population for infectious disease mortality.
drag their feet over long-term safety data
In recent times
American pharmaceutical companies have covertly hidden or deleted
deaths or other side effects from their required safety data reports.
Penalties for doing this are weak. Some companies are tardy by many
years in reporting safety data on their products while deaths from
their product mount. Intentional obfuscation of safety data is tantamount
to hiding a murder. Fines do not adequately penalize.
are so large for some drugs (example: patentable cholesterol-lowering
statin drugs sell for $3.00-$4.00 per pill while generic
versions sell for ~10-cents), that drug companies can withstand
lawsuits and other penalties by building these costs into the price
of their products.
FDA as collector
of mafia protection money
ethical drug companies have become gangsters. In a reverse role,
the mafia-like FDA is paid off in user fees and penalties as protection
money for the crimes of these companies. Oh, a Congressional hearing
or two pretends to take these criminals to task, then business as
usual resumes. Anything short of placing drug company executives
in jail will not put a halt to their crimes.
supplements DO prevent, treat or cure disease
which certainly do prevent, treat and cure diseases, are censored
from saying that on product labels or advertising. A statement must
accompany all dietary supplement labels and advertising saying:
"These statements have not been evaluated by the Food &
Drug Administration. This product is not intended to diagnose, treat,
cure or prevent any disease."
provision in the Dietary Supplement Health & Education Act (DSHEA)
of 1994 states that dietary supplements can, in fact, make disease/cure
claims for frank nutrient deficiency diseases, such as scurvy (vitamin
C), rickets (vitamin D), beri beri (vitamin B1), or pernicious anemia
FDA effectively negates the freedom to make disease/cure claims
for dietary deficiency diseases by clarifying this law on its own
terms. The FDA says any health claims that dietary supplements prevent,
treat or cure disease have to be made in the context of what are
called structure and function claims. That is, what structure or
function in the body does a particular nutrient address? A dietary
supplement manufacturer canít really mention a disease, like scurvy,
beri beri, pellagra or rickets, is "cured" by a
here is that nutrients are like drugs and are intended to target
a disease in a specific location of the body, like gastric ulcers
or skin infections. Natural molecules have broad effects upon the
entire body and defy such a narrow description.
Here is the
interpretation of the DSHEA provision that permits health claims
for dietary deficiency diseases:
claims may also describe a benefit related to a nutrient deficiency
disease (like vitamin C and scurvy), as long as the statement
also tells how widespread such a disease is in the United States.
The manufacturer is responsible for ensuring the accuracy and
truthfulness of these claims; they are not pre-approved by FDA
but must be truthful and not misleading. If a dietary supplement
label includes such a claim, it must state in a "disclaimer"
that FDA has not evaluated the claim. The disclaimer must also
state that the dietary supplement product is not intended to "diagnose,
treat, cure or prevent any disease," because only a drug can
legally make such a claim.
this is double talk. How can a vitamin C supplement make a claim
it cures the common symptoms of scurvy (bleeding gums, eye hemorrhage,
skin bruising, fatigue, anemia, irritability, weakened immune response)
but not cure a disease? The disease is scurvy, the symptoms of scurvy
are those described above.
there is going to be argument with health authorities and the FDA
over just what percentage of the population is deficient in a particular
nutrient. If recognizing that humans
experienced a gene mutation many generations ago that damaged
the capacity of the liver to continually produce vitamin C internally,
then all humans are deficient by that standard and few individuals
except supplement users can adequately maintain healthy vitamin
C blood levels.
published science, roughly the following percentages of Americans
are deficient, at least throughout parts of the year, in these essential
nutrients, with the exception of dietary supplement users:
OF NUTRIENT DEFICIENCIES
B1: A strong percentage of the population are habitual consumers
of alcoholic beverages or coffee or tea, which interfere with
C: nearly 100%
D: nearly 100%
It is highly
likely that the majority of the American population experiences
symptoms related to nutrient deficiencies that are never thought
to be caused by shortages of essential vitamins and minerals. The
public runs to doctors, gets a prescription drug and is oblivious
to the fact their symptoms were caused by a nutrient imbalance.
To make matters
worse, the Food & Nutrition Board, part of the National Academy
of Science, has dialed in a certain level of disease in the population
by setting daily nutrient requirements too low. For example, the
recommended daily requirement for vitamins C and D do not even measurably
raise blood concentrations. The current recommended daily amount
of vitamin D wouldnít even cure rickets in an African American infant
nor would it measurably raise blood levels in an adult.
How many Americans
are deficient in vitamin B1 (thiamin)? All alcohol drinkers are
at risk since alcohol inhibits absorption of this essential vitamin.
Chemicals in coffee and tea called tannins
can also react with thiamine, converting it to a form that is
difficult for the body to take in.
Daily Allowance, in this instance for thiamin, by definition is
intended to prevent a nutrient deficiency disease for 98% of the
population. Many millions of US adults regularly consume alcohol
and are at risk. A standard vitamin B1 pill, generally providing
1-2 milligrams, may not prevent a shortage or overcome a state of
deficiency. A fat-soluble form of this naturally water-soluble vitamin
may even be needed enhance absorption and overcome common symptoms
of deficiency (skin problems, chronic diarrhea and mental issues,
coined as the 3Ds of B1 deficiency Ė dermatitis, diarrhea and dementia).
is, without a blood test, the public doesnít know their symptoms
are caused by a nutrient deficiency.
supplement label the FDA doesnít want you to see
Here is the
dietary supplement label the FDA doesnít want to see (below). Why?
Because this label creates true competition with dietary supplements
replacing drugs prescribed for the treatment of disease.
In a direct
letter to the FDA I have proposed different wording as a disclaimer
for dietary supplements. It reads as follows:
Proposed Disclaimer For Dietary 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 substantiate 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 controlled study.
nutrient-related disease is out there?
God only knows
how much nutrient deficiency disease is overlooked or misdiagnosed
and inappropriately treated with drugs today. The average 75-year
old American is over-medicated (taking 5 prescription drugs) despite
the fact nutrient absorption and deficiency problems are rampant
in this age group. The drugs themselves deplete essential nutrients
yet the FDA does not require this fact to be included in product
is left to their own self-guided use of dietary supplements knowing
their doctors are poorly trained on the subject and that doctors
typically roll their eyes when they hear their patients talk about
vitamin pills. There isnít a disease on the planet that cannot be
aided by vitamins and mineral supplements, yet first-line treatment
A retiree can
walk into a doctorís office, present complaints about short-term
memory loss, burning feet, fatigue and backache and received prescriptions
for a number of drugs when all of these symptoms emanate from a
single dietary deficiency Ė vitamin B12. Furthermore, a blood test
that reveals vitamin B12 levels are within the normal reference
range does not mean the patient has healthy B12 levels. The only
way to conclusively know is to conduct a therapeutic challenge and
provide supplemental B12 to see if symptoms subside.
has received four inquiries in the past month about chronic diarrhea.
Upon further questioning it was found that three of these diarrhea
sufferers were regular beer drinkers and one regularly drank wine.
Alcohol depletes vitamin B1 and induces chronic diarrhea. A short
course of fat-soluble vitamin B1 resolved symptoms in all of these
cases, but had these people gone to the doctor they would have likely
been worked up with a battery of tests for irritable bowel syndrome
and given a drug (lomotil) to slow down motility (passage) of waste
material in the digestive tract, a drug that makes a person sleepy,
may interfere with driving and produces other side effects.
If the label
on vitamin B1 pills were permitted to say "resolves symptoms
of chronic diarrhea associated with overconsumption of alcohol"
this could eliminate costly visits to the doctor and help consumers
find a more appropriate therapy. Oh, doctors will protest, saying
the patient may have other health problems that need a doctorís
attention, but the problem is doctors are inadequately trained to
detect nutrient deficiency diseases. The patient will never get
well on drugs.
that has been suggested is to fortify
alcoholic beverages with vitamin B1. However, this would eliminate
a great deal of doctoring and inappropriate medical care, and furthermore,
health authorities claim vitamin fortification would give license
for over-imbibers to continue drinking. So we allow health problems
emanating from alcohol-induced nutrient deficiencies to arise and
then treat them as they occur rather than prevent them altogether.
As an aside, alcohol also induces nutrient deficiencies for zinc
I recall spending
the days of my youth with periodic bleeding gums, green plaque on
my teeth, fatigue and irritability, all signs of vitamin C deficiency.
Not a word was uttered by my dentist about my need for more vitamin
In a drug-oriented
health delivery and disease treatment system, just how will the
many millions of Americans find their way out of symptoms caused
by widespread nutrient deficiencies?
takeover of the dietary supplement industry
supplement industry has withstood two prior attempts by the FDA
to turn their products into drugs, one assault that led to the Senator
Proxmire hearings in the 1970s and the 1994 attack that backfired
and resulted in passage of the Dietary Supplement Health & Freedom
Act of 1994. But now the FDA is ready to take the freedoms gained
in 1994 away.
The FDA, knowing
that patents on many blockbuster prescription drugs are expiring
and most newly approved drugs donít work better than earlier off-patent
drugs, and that so-called drug research and development pipelines
are empty, is now ready to turn all dietary supplements into drugs
by declaration they must submit to onerous safety testing or be
removed from retail store shelves.
force dietary supplement manufacturers to spend 20 years of all
their profits to complete the required testing. This new requirement
emanates from a piece of legislation signed into law by President
Obama, the Food Safety Act of January of 2011. If this sounds preposterous,
it is. This outlaw agency, the FDA, will stop at nothing, not even
written law (DSHEA). You can read about this battle for dietary
supplement freedom at www.operationpushback.com
are poised to bring down the high cost of medicines, reduce avoidable
side effects and improve the health of Americans, even reduce the
overall mortality rate, but to do so there must be freedom to label
supplements truthfully Ė that they do in fact prevent, treat and
cure diseases, that their biological actions mimic or exceed those
of prescription drugs and would improve measurable health parameters
for most Americans at less cost.
The FDA, in
league with a Medicare prescription drug program that does not pay
for dietary supplements (if Medicare did pay for supplements you
can be sure they would only pay for watered-down doses of vitamins
and minerals), and co-payments for medicines are far lower than
the cost of supplements. Retirees on limited incomes are forced
to use drugs to control age-related diseases rather than supplements,
which are often more desired by Medicare enrollees.
is being held at bay by a cabal involving drug manufacturers, physicians
groups, health insurance funds and government research establishments.
This is a form of government-involved racketeering, politically
extending beyond crony capitalism to fascism, where industry owns
government and exerts its influence under authority of law.
be those seniors who say: "get this war over with, let supplements
become drugs, and let government insurance plans pay for vitamin,
mineral and herbal pills without argument."
Yes, but at
what cost may we ask? With what assurance will natural products
be prescribed rather than shelved? With what assurance that the
public treasure chest wonít be gouged as it now is by overly-priced
drugs, like 10-cent
cholesterol-lowering statin pills that are billed to Medicare
at $3.00-$4.00 per pill?
program faces a $60 trillion shortfall, so how can we continue
to allow this crime to continue? With Congress in the hip pocket
of the drug industry, who is there to launch a complaint to? It
appears only an act of God is big enough to put a stop to all of
branded dietary supplement today, with over $1 billion in sales,
is masquerading as a drug sold under the brand name Lovaza. This
Rx fish oil concentrate is prescribed to lower a type of blood fat
called triglycerides and sells for $240/month suggested retail price
but only costs Medicare patients a $25 insurance copayment. An equivalent
fish oil pill that IS a dietary supplement sells for around $130/month,
but of course, insurance plans donít pay for it. This is how the
FDA, working in league with other self-interested parties, drives
up the cost of healthcare.
clockwise: FDA = government agency whose purpose is largely
to promote drugs over dietary supplements; NIH = National Institutes
of Health, Office of Dietary Supplements, which is now threatening
to declare all supplements are drugs; Adverse Event Reporting Hotline
= phone number to call if dietary supplements cause a serious side
effect; CODEX = comprised of representatives from different countries
for the purpose of "harmonizing" the dose of dietary supplements
worldwide; Food & Nutrition Board = government-appointed committee
that establishes daily nutrient needs for the population; Big Pharma
= pharmaceutical industry ($883 billion in sales) that dwarfs sales
of dietary supplements ($20 billion); US Dept Agriculture = plays
peripheral role in making recommendations for nutrients in the population;
Physician Groups (AMA) = physicians receive little training about
dietary supplements but somehow know all the side effects posed
by vitamin pills; Health & Human Services Food Stamp Program
= which does not pay for dietary supplements for the group that
is most needy in the population; Federal Trade Commission = sanctions
and fines companies who make untruthful claims about their products;
News Media = largely controlled by Big Pharma which sponsors most
evening network TV news programs; Health Freedom Organizations (Citizens
for Health, Natural Solutions Foundation, National Health Federation,
etc) = groups that pretend to oppose restrictions on health freedoms
and access to dietary supplements who tend to be alarmist and constantly
seek donations; National Health Federation is only group that has
standing at CODEX; National Sanitation Foundation, US Pharmacopeia
= independent organizations that certify the quality of dietary
supplements; Health insurance and Medicare = pools of insurance
money that do not reimburse for dietary supplements because they
are "unproven"; Quackwatch = anti-dietary supplement website
that somehow has high ranking on the internet, declared two-time
Nobel Prize winner Linus Pauling a health quack; Council for Responsible
Nutrition = industry group that represents dietary supplement manufacturers;
Natural Products Association = industry group that represents supplement
makers and retail stores; Consumerlab.com = organization that is
a shill for the FDA comprised of former FDA personnel who expose
improperly labeled 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.
This article has been written exclusively for www.LewRockwell.com
and other parties who wish to refer to it should link rather than
post at other URLs.†
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