|
The FDA - A Wolf in
Sheep’s Clothing
By Byron Richards, CCN
July 6, 2006
The FDA has conveniently used the
excuse of looking out for consumer safety to increase their
perverse regulatory power, undermine free speech, disrupt
commerce, and generally get in the way of helping people improve
their health. The “half-truth” of the safety issue is used as a
ploy to reduce the rights of Americans, one freedom at a time.
Once again, the FDA is seeking more police power to intimidate
supplement companies. This is one step in an overall FDA master
plan to eliminate therapeutic nutritional supplements from the
free market. Those who lose are the American public.
The newest piece of
supplement-harassing legislation is the brainchild of
vitamin-hating Senator Richard Durbin (D-IL), perennial attacker
of the supplement industry.
S 3546, Dietary Supplement and Nonprescription Drug Consumer
Protection Act, is known
as Adverse Event Reporting (AER) legislation. It was introduced
in the Senate on June 21, 2006, by Senator Orin Hatch (R-UT),
former supporter of the supplement industry now turned gutless
compromiser. It is backed by large supplement industry spin
groups like the Council for Responsible Nutrition (CRN) and the
National Nutritional Foods Association (NNFA). CRN and NNFA
have been infiltrated by Big Pharma and march to the drum of
globalization and the New World Order. Like Hatch, these groups
have placed themselves in a position of speaking for the
supplement industry. Unfortunately, they are rapidly taking on
the colors of the enemy.
The PR spin suggesting a “need” for
this legislation is to protect consumers and give consumers
confidence in the supplement industry. The only reason for any
lack of consumer confidence is due to a relentless and
fraudulent persecution of supplements by the controlled media
acting on behalf of the sickness industry. It is an attempt to
divert public attention from the real safety issue of dangerous
drugs that kill several thousand Americans per week. Big Pharma
is terrified that the American public will flock to natural
health options instead of options that have death as a side
effect.
Under the proposed legislation
supplement manufacturers and distributors would be required to
report to the FDA serious adverse reactions such as death or
inpatient hospitalization. Such requirements seem plausible to
any person with common sense; however, it is already a simple
matter to file an adverse event report for any drug, medical
device, or dietary supplement. The FDA’s MedWatch program
offers a toll free number. Forms for filing complaints are
readily available on their website. Furthermore, supplements
are so safe such reactions are very infrequent. Why is
legislation needed for a nonexistent problem?
The way the legislation is written
a person could blame vitamins for almost anything, even if they
are on multiple drugs or have pre-existing serious health
problems. While the legislation states that the need to file a
serious adverse event report is not an admission of guilt,
some feel it will lead to frivolous law suits.
If AER legislation becomes law, the
FDA will need to issue regulations. It is easy to predict that:
-
The FDA will
charge supplement companies user fees for AER functions (as
they currently do with drug companies).
-
The FDA will
use supplements as a scapegoat for adverse effects that are
caused by drugs.
-
Agreeing to
such legislation implies there is an actual need for it.
This shifts the burden of proof from government to
supplement companies, undermining free commerce, citizen’s
rights, and existing legislation that protects consumer
access to health options (DSHEA).
-
The
legislation will be a springboard for future FDA efforts to
regulate supplements as prescription drugs and implement
draconian Codex supplement guidelines, plunging alternative
health for Americans into the Dark Ages.
If all that isn’t bad enough,
tucked into the legislation is a requirement for supplement
companies to keep records of any adverse event reported to them
for the past six years. The bill says, “The term adverse
event means any health-related event associated with the use
of a dietary supplement that is adverse.” This is far different
than a serious adverse event. In another words, any symptom a
person associates with taking a vitamin that in their opinion is
improper will need to be recorded as an adverse event. Such
reports need to be open for FDA inspection at any time. This
legislation is nothing more than an FDA harassment vehicle.
As the owner of a nutritional
company,
Wellness Resources, and a clinician with twenty years of
experience working with supplements, I can tell you that such a
requirement is absolutely absurd.
The number of variables associated
with the possible cause of a symptom is staggering: the
pre-existing health and fitness of the individual, current
medications, changes in weather, emotional stress, junk food
consumption, food poisoning, a lack of sleep – the list is
almost endless. It is drugs that kill at least 100,000
Americans per year and send 1.6 million people to the hospital
with true adverse reactions. Drugs are poisons that require
physician dispensing and monitoring. Rarely do supplements
cause any type of significant adverse reaction. There is a
huge difference. Due to stringent production standards,
supplements are far safer than food!
Take the simple fact that half of
Americans have digestive problems. The overuse of antibiotics
and sugar-laden diets make us the world leaders in gas,
bloating, indigestion, and constipation. No country in the
world can beat us in antacid and laxative use.
One example is the common problem
of Candida albicans (a digestive yeast infection)
occurring after antibiotic use, especially recurring antibiotic
use. This issue is at epidemic levels in America, a problem
caused by incompetent medical care. It can ruin lives, sending
people down a path of chronic problems with digestion, sinuses,
allergies, thyroid function, autoimmune problems, depression,
and fatigue. In small children it can easily cause a life of
asthma or lead to serious learning, developmental,
immunological, or mental disorders.
Since doctors appear virtually
incapable of recognizing the problem or helping a person
recover, and they typically create the problem in the first
place, patients frequently turn to alternative health.
Thankfully for many, the proper use of vitamins and diet can
restore health and prevent what may otherwise be a lifetime of
misery.
Under current FDA repression of
free speech, we aren’t supposed to tell someone what their
problem is or how supplements can help them. Those with MDiety
syndrome deny the problem even exists! People with Candida
frequently have various symptoms that come and go and could
easily be considered adverse, both because of the problem itself
and due to the process of normal recovery (which can be likened
to pulling weeds out of a lawn, wherein the lawn is the
digestive tract).
Under the proposed legislation, if
a person gets nauseous or a headache after taking a supplement
(which is referred to as “die off” and a relatively common
occurrence), and complains about it, we would have to record it
as an adverse event. Soon, the supplements that truly help
people would be gone. Of course, individuals with Candida
get headaches and nausea from eating sugar, consuming artificial
sweeteners, or drinking alcohol. In this case, these substances
are actually making them worse. Shouldn’t the entire food
industry have to keep track of “adverse” events?
As a supplement company I will
incur costs trying to explain to people what their symptoms mean
so as to prevent having to file an adverse event report, keeping
track of symptoms in a six year file, and defending myself from
FDA harassment. The burden of proof for the safety of
supplement products will shift from the government to the
supplement companies, counter to existing law. Needless cost
will be passed on to the consumer. Much worse, truly helpful
supplements will be targeted for removal from the market so as
to eliminate competition for drugs (the true FDA intent).
Sooner or later I will be asking
myself, why should I bother trying to help anybody? And that is
exactly what the FDA would like me to think. The FDA does not
want useful supplements as a health option for the American
public. Candida albicans is one of many similar issues,
like fibromyalgia, depressed immunity, and chronic fatigue.
Tens of millions of Americans are suffering at the hands of the
inept medical care of the sickness industry. In many cases,
high quality nutrition offers a true option for a return to
health.
The pharmaceutical companies that
make garbage synthetic vitamins and seek to mass-market their
junk to the American public have nothing to worry about. Their
products are so useless they don’t produce a health effect of
any kind. It is only the companies that are truly helping
people that will be harassed. Many of the large
pharmaceutical-linked companies that comprise CRN and NNFA want
this legislation. Its costs will place all the small and
innovative nutritional companies at a serious disadvantage.
The FDA is actively engaged in a
series of steps to take away useful nutrition as a health option
for Americans. All the FDA plans to leave on the market is
watered-down trash. The useful supplements will become
prescription items of Big Pharma. I fully explain and document
this FDA plan in Fight for Your Health.
Adverse event reporting is
addressing a non-existent problem. It is seeking to shift the
legal burned of proof to supplement companies. It is targeted
to harass small and truly helpful nutritional companies. It
plays on the false need for improved safety as the excuse to
gain further regulatory control of the supplement industry. It
is a ploy by the FDA and various bought-off members of Congress
to further harass supplement companies, setting the stage for
Codex implementation and overturning U.S. law that gives
consumers access to a wide variety of supplements.
The FDA has a one-hundred year
history of promoting and protecting drug sales, while stamping
out competition. Congress should make the FDA do its real job,
that of protecting the American public from the dangerous use of
drugs and cleaning up the massive adulteration of our food
supply. Congress should quit behaving like a pawn in the
FDA/Big Pharma game. The FDA is the group in need of a total
makeover. Senator Durbin is in need of retirement (2008 if we
are lucky). Senator Hatch needs to look in a mirror and find
his soul. Our government needs to quit attacking the good guys
and impeding safe and effective health options for Americans.
Call your Senators today (202-225-3121).
Tell them no on S 3546.
Copyright © 2006 Truth In
Wellness
More Links:
Byron's Health Blog
|
