Supplements Face Overkill While FDA-Approved Drugs Have a License To Kill
by Bill Sardi: Movie
Itís the middle
of summer on a holiday weekend, late on Friday afternoon, and the
American public is readying themselves for another 4th
of July celebration. Itís the typical point in time, when the populace
is distracted, that government agencies often pick to release a
bombshell that wonít likely be popular with the public. And it was
The Food &
Drug Administration (FDA) had secretively, albeit belatedly, drafted
a 47-page guideline pointed at dietary supplement companies, with
a demand they prove their newly introduced products are safe. It
was written without input from industry. The rub is that the guideline
extends back 16 years to any new dietary ingredient introduced after
the Dietary Supplement Health & Education Act (DSHEA) was passed
in 1994. This includes popular dietary supplements such as resveratrol,
curcumin, hyaluronic acid, acai berry, and many others. Thousands
of new dietary ingredients have been introduced over that time,
and only a few hundred of them actually had safety data filed with
the FDA. Shame, shame.
the dead bodies and the maimed babies?
the decade-and-a-half long time gap in implementing this safety
provision in the DSHEA, no birth defects were reported for newly
introduced dietary supplements like there were for drugs such as
diethylstilbestrol and thalidomide. With a couple of exceptions
(discussed below), there were no deaths or significant side reactions
attributed to dietary supplements over this same time period. New
dietary ingredients had entered the marketplace for what was to
be the largest uncontrolled human experiment. There would be no
placebos, no eliminating criteria (stacking the deck) as with controlled
studies. The young, old, infirm and sturdy partook of dietary supplements
in presumed faith they were relatively safe. They werenít wrong
in their choice.
Over this same
time American Poison Control Centers tabulated deaths and side reactions
caused by vitamin, mineral and herbal products, and there was nary
a death attributed to these self-prescribed remedies.
loss supplement unfairly banned
Oh, the weight-loss
stimulant Ephedra (Ma Huang) was banned due to a few associated
deaths, but those were largely
attributed to overdosing on this herbal-based molecule. Oddly,
the FDA continued to allow a synthetic version, pseudoephedrine,
to be marketed in various over-the-counter cold and cough remedies,
even though it exhibited similar biological activity.
One can overdose
on aspirin, no problem. Aspirin in standard doses kills an estimated
6000 Americans every year, largely due to bleeding gastric ulcers,
but remains on store shelves. Itís those dratted dietary supplements
like Ephedra that have to be weeded away.
the only effective product to produce lean body mass in an era of
growing obesity in America, and it was yanked off the shelves via
irresponsible overuse by crash dieters whose families were looking
to sue. The news media publicized the deaths to create public doubt
over the safety of all dietary supplements. There were cries for
more regulation at the time.
was tryptophan, an amino acid supplement that was rapidly replacing
various antidepressant drugs and sleeping pills. It was found to
be a better
antidepressant than placebo pills, which cannot be said for
most of antidepressant drugs.
pharmaceutical company in Japan that made tryptophan altered their
manufacturing process, which resulted in a few reported deaths.
banned tryptophan in 1989 and lifted the ban in 2005, but by
then consumers had been frightened away from the product.
US Food & Drugged Administration chose to ban all tryptophan
supplements regardless of their origin. After all, America was about
to enter the Prozac era of psychopharmacology. This was a tip off
that the whole tryptophan fiasco was orchestrated to protect sales
of prescription pharmaceuticals, which appears to be a hidden agenda
at the FDA.
is that during this time period many FDA-approved drugs had been
recalled after they had entered into broad use and were found to
be ineffective, or even worse, result in premature death. This included
big-name drugs like Meridia, Bextra, Vioxx, and others. A long list
of FDA-approved drugs that were eventually withdrawn from the
market place can be viewed here.
Such was the
case for Vioxx and Celebrex, both approved by the FDA based upon
data from small groups of a few hundred subjects, and were allowed
to be advertised before large-group safety data had been tabulated.
This led to the premature death of thousands. Data
showing an increased mortality rate among users of Vioxx were
available 3.5 years prior to the date the drug was withdrawn by
its manufacturer. The FDA wasnít forthcoming about all this and
had to reveal the problem by flying to Britain to make the announcement.
the dietary supplement industry doesnít have such leeway. If a few
people are harmed or die from supplements, news headlines blare
across the front page of newspapers as well as on network TV news.
Network evening TV news programs are largely sponsored by pharmaceutical
advertising, so donít anticipate a fair hearing for dietary supplements
from the news media.
there is a distorted drug safety review process where attainment
of FDA approval is essentially a license to kill. If there were
no FDA and these products had to stand naked to public scrutiny
and legal liability without the imprimatur of a government agency,
the private legal system would pounce upon these drugs in rapid
manner and eliminate them via a flood of liability suits.
tracked the way the news media spun the FDA announcement of new
safety reporting guidelines for dietary supplements.
a HealthNews.com reporter said: "rigorous testing providing
safety and effectiveness data, which is required of all drugs, is
not conducted in the same way for dietary supplements. And therein
lies the problem."
But just how
did dietary supplements, without pre-market safety reporting guidelines,
not only end up being safer than FDA-approved prescription drugs,
but also comparatively safer than aspirin, tap water, table salt
and even food itself?
reporter Brady penned her report with the headline "FDA
Attempting To Regulate Dietary Supplements,"
as if a begrudging supplement industry was dragging its feet over
the issue. Yet it was the FDA itself that was 16-years late in drafting
the safety guidelines for new dietary ingredients. Was the FDA hoping
another thalidomide-like flurry of birth defects would doom the
dietary supplement industry?
Such a news
report as Bradyís, which essentially posed the unstated question
of "why donít you want to be regulated?," was like
asking a man "when was the last time you beat your wife?"
Any answer to that type of baited question would be defensive and
self-incriminating and would not be allowed in a court of law. But
there is no judge in the court of public opinion.. The dietary supplement
industry is going to sound half-guilty any way it responds.
industry shoots itself
industry didnít help itself. Reuters News reporter Emily Stephenson,
in her article entitled "FDA
Seeks To Ease Confusion On Supplements," quoted
dietary supplement executives who literally stuck their foot in
whose legal group represents dietary supplement clients, said: "Once
everyone understands what it means to comply with it, youíll see
But that made
it sound like supplement companies were remiss in filing. Without
written guidelines in place, supplement companies were left to guess
what the FDA wanted and many New Dietary Ingredient (NDI) applications
were rejected. It also made it sound like the supplement industry
has no objection to the FDA guideline itself, when it is a doomsday
document for many small and large companies.
The newly released
guidelines spell out a long list of safety tests that may take years
to complete at great expense. Some companies may be able to skirt
around costly toxicity and birth defect studies if they can show
years of safe use, but the FDA is talking about no less than 25
years of safe use.
The FDA surely
must know that the cost of complying with the new guidelines is
beyond the capability of many small companies, and larger supplement
companies which offer hundreds of items on store shelves will have
to spend millions to prove their products are safe on paper despite
the fact they have been in common use for years without reported
for an association of retail store owners and manufacturers in the
supplement industry said her group "plans
to ask the FDA to ease up on some guidelines,"
again making it sound like the supplement industry wants to water-down
With an ear
to the ground, this writer hears the public talking about a black
market if popular dietary supplements are eventually pulled from
store shelves. But the FDA is one step ahead of this anticipated
of the FDA announcement over guidelines for new dietary supplement
ingredients, the FDA
also issued an anti-smuggling strategy. An FDA press release
says: "The FDA issued an anti-smuggling strategy developed
by the Department of Health and Human Services (HHS) in coordination
with the Department of Homeland Security (DHS) that will help to
identify and prevent smuggled foods from entering the United States
and posing a threat to national security and consumer safety."
the FDA knew that talk of a black market would arise and they took
pre-emptive action by involving a more formidable policing agency
Ė the Department of Homeland Security.
industry is clueless
Most of the
involved parties in the dietary supplement industry still donít
know what hit them. Some believe they will dutifully comply with
newly penned FDA guidelines, not recognizing this document will
doom a growing industry in a dying economy.
supplement industry holds the greatest promise for reducing the
high cost of medical care. Once existing drug patents expire and
newly introduced synthetic molecules are no better than older generic
drugs, the pharmaceutical industry may attempt to turn so-called
nutriceuticals into prescription drugs as they are in Europe.
the freedom to purchase, at least for now, natural remedies without
a doctorís prescription and at far less cost than in other countries.
For example, herbal remedies such as bilberry and Ginkgo biloba
are prescription-only remedies throughout Europe.
is closing in on a big power grab Ė and it must to save itself.
That is because modern designed drugs represent a single man-made
(patentable) molecule that narrowly targets single genes or cell
receptor sites in an attempt to quell symptoms of a sole disease.
Whereas, by definition, nutriceuticals are single natural molecules
that target hundreds of genes and therefore prevent, treat or cure
resveratrol (rez-vair-ah-trol), known as a red wine molecule, exhibits
broad biological action that could potentially address many
diseases. Resveratrol manifests biological action that counters
pain, inflammation, cholesterol, germs (bacteria, viruses and fungi),
mental depression, elevated blood sugar, the initiation, growth
and spread of cancer (something no cancer drug does), and dissipates
beta amyloid brain plaque. Resveratrol is a game changer.
must counter this threat from natural medicine if it is to survive.
It must capture nutriceuticals and make them prescription-only substances.
It must demonize dietary supplements in the short run and convince
the American public they are potentially hazardous and need to be
controlled by prescription.
supplements are not a trivial issue in America. The most letters
sent to Congress over any issue in the past two decades involved
the publicís support for the passage of the Dietary Supplement Health
& Education Act of 1994. It has been said that there are three
issues politicians dare not tamper with in America: the right to
bear arms, the privacy of the American home, and the right to directly
purchase dietary supplements unfettered by government.
travel to America to purchase a yearís supply of dietary supplements
that are far more expensive in their native country. These foreign
consumers come to America because this is a land known for free
markets and freedom to use dietary supplements. It would be an embarrassing
irony, in "the land of the free," that under the
guise of consumer protection, health freedom and the right to self-care
would be discarded.
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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