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At- A- Glance
•
Data from the U.S. National Poison Data System's annual report, which
tracked data from 57 U.S. poison centers and showed vitamin and mineral
supplements caused zero deaths in 2010, while pharmaceuticals caused
more than 1,100 of the total 1,366 reported fatalities
• The top categories associated with the largest number
of fatalities were ALL medications, including analgesics, sedatives,
hypnotics, cardiovascular drugs, opioids, antidepressants,
acetaminophen and antipsychotics
• Ironically, the FDA's Draft Guidance on New Dietary
Ingredients would require the supplement industry to prove the safety
of natural ingredients that, in many cases, have been on the market and
used safely for decades, using safety thresholds that are in excess of
those required by pharmaceutical drugs -- despite data showing
supplements are far safer than drugs
• You can defend your right to access safe dietary supplements by taking action today
Vitamins,
minerals and herbal supplements have a tremendously safe track record,
yet they are often singled out as being potentially dangerous by
government agencies like the U.S. Food and Drug Administration (FDA).
This - the notion that dietary supplements are unsafe --
is the premise behind the FDA's Draft Guidance on New Dietary
Ingredients, which would require the supplement industry to prove the
safety of natural ingredients that, in many cases, have been on the
market and used safely for decades.
As new research from the American Association of Poison
Control Centers' National Poison Data System reveals, there were zero
deaths linked to nutritional supplements in 2010, the most current data
available.
However,
in the FDA's new Draft Guidance, the FDA is essentially claiming that
dietary supplements are unsafe, and implying that in order to "⁞protect
consumers" the agency must place a stranglehold on the dietary
supplement industry by requesting exorbitant safety testing.
These ludicrous safety thresholds are in excess of those
required by pharmaceutical drugs -- despite extensive toxicological
data showing supplements are far safer than drugs.
The most recent data comes from the U.S. National Poison
Data System's annual report, which tracked data from 57 U.S. poison
centers and showed vitamin and mineral supplements caused zero deaths
in 2010.i
As noted by Orthomolecular Medicine News Service,
Americans easily take more than 60 billion doses of nutritional
supplements every year, and with zero related deaths this is an
outstanding safety record:
"Well over half of the U.S. population takes daily
nutritional supplements. Even if each of those people took only one
single tablet daily, that makes 165,000,000 individual doses per day,
for a total of over 60 billion doses annually. Since many persons take
far more than just one single vitamin or mineral tablet, actual
consumption is considerably higher, and the safety of nutritional
supplements is all the more remarkable.
Over 60 billion doses of vitamin and mineral supplements
per year in the USA, and not a single fatality. Not one. If vitamin and
mineral supplements are allegedly so "dangerous," as the FDA and news
media so often claim, then where are the bodies?"
In striking contrast, drugs are known to cause well over
125,000 deaths per year when taken correctly as prescribed - yet the
FDA allows "fast-track" approvals and countless new additions to the
marketplace. So why are dietary supplements on the chopping block?
Why is the FDA Attacking Dietary Supplements That Have Been Used Safely for Decades?
Back
in the early 1990s, the FDA threatened the availability of dietary
supplements to the point that consumers staged a massive revolt, which
resulted in the Dietary Supplement Health and Education Act of 1994
(DSHEA).
The law specifically protects your access to dietary
supplements by classifying them as foods, not food additives or drugs,
and it grand-fathered in dietary supplements that were already in use
as of 1994. Only novel ingredients introduced after October 15, 1994
are required to seek FDA approval.
The FDA's new proposed mandates directly contradict what
DSHEA sought to prevent, and the FDA is using its authority in direct
violation of Congressional intent. As explained in an article by
Alliance for Natural Health, the proposed regulations turn what was
clearly supposed to be a pre-market notification system into a
pre-approval system, just like that of drugs.ii
As a result, dietary supplements that have been freely
available for nearly two decades can now be forced off the market until
they receive New Dietary Ingredient (NDI) approval. And the NDI
approval process is a lengthy affair that may take months or years to
complete, and cost a small fortune. Bringing a drug from the
pre-clinical (or discovery phase) all the way to market can easily take
more than a decade and cost significantly more than $1 billion! This
despite the fact that contrary to drugs, fatalities from vitamins and
other supplements are minuscule.
According to the 2001 report of the American Association
of Poison Control Centers (AAPCC), of the substances implicated in
fatal poisonings in 2001, 84.6 percent were pharmaceutical drugs, with
analgesics being implicated as the primary cause of death in 32 percent
of fatalities or 341 deaths. This compares with 0.8 percent for all
dietary supplements combined, even including substances such as
dinitrophenol, a dangerous (and illegal) substance banned in 1938, as
well as the central nervous system stimulant Ma Huang (Ephedra).
Interestingly, the anti-asthma drug theophylline alone was responsible
for 15 deaths, 66 percent more than all the available dietary
supplements combined.
What might make an "old" ingredient "new," under the new regulation?
The
methods of production and extraction, for example … As bizarre as that
sounds, the mere fact that a product is being extracted or produced by
improved means compared to methods used in the past, could reclassify
any grandfathered nutrient as an NDI that would now have to undergo the
same type of safety testing and approval process as a drug.
In
some cases, the FDA will require manufacturers to conduct outrageously
expensive studies using absurdly high doses, in some situations
multiplied by a "safety factor" up to 2,000-times the recommended
dosage on a per product basis. Further, the FDA proposes that new
dietary supplement ingredients should adhere to aggressive safety
margins, which are typically reserved for chemical compounds known to
be dangerous in all but the most miniscule concentrations.
Since food additives or preservatives such as aspartame,
monosodium glutamate, and sodium nitrate are known to cause cancer or
other severe health problems, the FDA has implemented safety guidelines
that limit allowable concentrations of these food additives to levels
that are supposed to be physiologically inert.
The fact that the FDA is trying to impose the same limits
upon dietary supplements seems to be arbitrary and completely
unfounded. In fact, when someone takes a dietary supplement, their
intent is to positively affect the structure or function of their
bodies in some way -- limiting dosages of dietary supplements to
physiologically inert levels defeats the entire purpose of
supplementation with health-sustaining nutrients.
And, since supplements are not patented drugs, virtually
no supplement manufacturers will be able to afford these "safety"
studies, which means that many of the nutrients you now purchase at low
prices will convert into high-priced drugs, or simply disappear from
the market entirely.
While
the U.S. National Poison Data System's annual report showed zero deaths
from nutritional supplements, this was not the case for prescription
and over-the-counter drugs. The top categories associated with the
largest number of fatalities were ALL medications, including:
1. Analgesics, sedatives, hypnotics, and antipsychotics
2. Cardiovascular drugs
3. Opioids
4. Acetaminophen combinations
5. Antidepressants
Slightly
lower down on the list were more drugs, including muscle relaxants,
anti-inflammatory drugs, hormones, antacids, anticoagulants,
antihistamines and more. Out of a total 1,366 reported fatalities,
pharmaceuticals were involved in over 1,100 of these deaths (again,
compared to zero for supplements). Keep in mind that this is not an
estimate of all the deaths attributed to pharmaceuticals in the U.S.,
only those reported to 57 poison control centers. The total figure is
closer to 125,000 deaths from pharmaceuticals per year. iii
If you extrapolate this number out over 30 years this is
well in excess of 3 million people who died from taking appropriately
prescribed legal drugs. It is simply incomprehensible that any rational
approach would seek to vilify supplements over drugs when the data in
no way, shape or form supports it. The most likely motive for this
position is financial greed that can put your life in jeopardy.
No
one can sit on the sidelines with an emergency of this magnitude about
to befall everyone who depends on dietary supplements. As citizens, we
have the constitutional right to petition the government to redress our
grievances. In this case, the FDA NDI proposals pose a direct threat to
our health and longevity by threatening free access to dietary
supplements with exemplary safety records.
We therefore have to take extraordinary measures to defend
our right to continue using supplements that our very lives depend on,
and to gain access to new natural ingredients that demonstrate efficacy
in scientific studies. I ask each one of you to contact your
representatives by following this link:
https://secure3.convio.net/aahf/site/Advocacy?alertId=911&pg=makeACall
