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I'm not sure if all this is true ,but..........................
Senator McCain's bill is called The Dietary Supplement Safety Act
(DSSA). It would repeal key sections of the Dietary Supplement Health
and Education Act (DSHEA). DSHEA protects supplements if 1) they are
food products that have been in the food supply and not chemically
altered or 2) if they were sold as supplements prior to 1994, the year
that DSHEA was passed. If a supplement fits one of these two
descriptions, the Food and Drug Administration (FDA) cannot
arbitrarily ban it or reclassify it as a drug.
These protections are far from perfect. They discourage companies from
developing new forms of supplements. New supplements may be
arbitrarily banned by the FDA or adopted by drug companies in a way
that precludes their further sale as supplements.
McCain's bill would wipe out even the minimal protections power to
contained in DSHEA. It would give the FDA full discretion andMcCain's bill would wipe out even the minimal protections power to compile a discreet list of supplements allowed to remain on the market
while banning all others.
Everyone knows that the FDA is friendly to drug companies (which pay
its bills and provide good revolving door jobs) and hostile to
supplement companies. Under this bill, this same Agency could quite
arbitrarily ban any supplement it wished or turn it over to drug
companies to be developed as a drug and sold for multiples of its
price as a supplement.
The FDA will like this because it believes that it can more easily
control a few industry giants. But isn't it more likely that the
industry giants will eventually gain control over the FDA?
The FDA is already misusing the adverse event reporting process that
exists. Drugs rack up thousands of adverse event reports without any
action. Just recently, the FDA yanked from the market a supplement
product based on just a couple of alleged adverse event reports
without even allowing the company (an old and respected firm) to
provide any counter-evidence or counter-argument.
The bill also allows the FDA to yank a product (at the company's
expense) if there is a "reasonable probability" that it is
"adulterated" or &"misbranded" Let's
remember that "adulterated" could mean there is a minor
record keeping error on the producer's part and
"misbranded" can mean that the producer simply tells the
truth about the product. An "adulterated" and
"misbranded" supplement in Orwellian FDA speak may
actually be both completely safe and effective.
We must prevent this bill from gaining traction! Protect your access
to supplements by contacting your senators today and asking them NOT
to co-sponsor the Dietary Supplement Safety Act but rather to oppose
it.
TAKE ACTION by clicking here: Convio: ..
McCain's Dietary Supplement Safety Act (DSSA) appears to be
supported by the US Anti-Doping Agency (USADA) which is funded by
major league sports teams including baseball, football and others. The
recent suspensions of NFL and other professional sports figures is
much in the news, and the goal of the sports industry appears to be to
shift the spotlight from their players to the supplements industry. In
his comments, Senator McCain cited six NFL players recently suspended
for testing positive for banned substances and purportedly exposed to
these substances through dietary supplements.
The problem here of course is one of illegal sale and use of steroids.
So why dismantle the supplement industry in order to control already
illegal substances?
The FDA currently has complete and total authority to stop illegal
steroids and, more broadly, to regulate dietary supplements. If the
agency were doing its job, it could and would have prevented the sale
of illegal steroids. The answer to this problem is not to give FDA
more power. The Agency simply needs to do it's job.
TAKE ACTION by clicking here: Convio: ..
Why would a bill be offered to solve an illegal steroid problem that
does not really address the steroid problem but instead gives the FDA
complete and arbitrary control over all supplements? The answer is
simple.
There are a lot of vested interests which are threatened by
supplements. Drug companies do not like them because they represent a
low cost, safer, and often more effective alternative to drugs. The
FDA does not like them because supplements do not come through the FDA
approval process and therefore do not support the FDA budget.
Why not simply require that supplements be brought through the
FDA's drug approval process? Wouldn't that create a level
playing field?
That is probably the argument that Senator McCain has been sold. But
it is a completely false argument. The FDA drug approval process costs
as much as a billion dollars. It is not economically feasible to spend
such vast sums on substances that are not protected by patent, and
natural substances cannot legally be patented.
This is the great "Catch 22" of American medicine. The
FDA, which is supposed to guard and promote our health, is hostile to
the kind of natural medicine - based on diet, supplements, and
exercise - that represents the real future of healthcare. The
Agency has either been captured by drug interests or is trapped in a
catastrophically expensive, toxic, and ineffective patented-drug
model.
Senator McCain has no doubt offered this bill in good faith. But he
has been sold a bill of goods by special interests. And he has been
naïve enough not to know that he is being used.
TAKE ACTION by clicking here: Convio: ..
This exceptionally bad bill also requires the reporting of all minor
adverse events related to supplements. This is in addition to the
already existing requirement to report adverse events. This will
further stack the deck against small supplement companies by creating
new, unnecessary, even more cumbersome, and of course very expensive
administrative hurdles. The result: the consolidation of the
supplement industry into a few big companies.If passed, this bill will
likely result in the disappearance from store shelves of many
supplements currently on the market. In addition to fewer supplements,
there would likely be much lower doses available. Unbridled authority
would be handed to the FDA, an agency that needs a top to bottom
overhaul, not ever more power over our lives.
If Senator McCain's bill passes, we can look to Europe for a snapshot of
what we may be in for: EFSA, the European Food Safety Authority, has
sharply reduced the list of available supplements and is in process of
reducing potencies to ridiculous levels, such as less beta carotene
than can be found in half of a large carrot. Europeans already look to
the US to obtain their dietary supplements. If this bill passes, where
will we obtain ours?
Please take action immediately by clicking here: Convio:..
Tell your senators NOT to co- sponsor this legislation and to do
everything in their power to defeat it. Then forward this to your
friends and family and ask then to do the same!
Gretchen DuBeau
Legal Director, ANH Int.
Executive Director, ANH-USA
Senator McCain's bill is called The Dietary Supplement Safety Act
(DSSA). It would repeal key sections of the Dietary Supplement Health
and Education Act (DSHEA). DSHEA protects supplements if 1) they are
food products that have been in the food supply and not chemically
altered or 2) if they were sold as supplements prior to 1994, the year
that DSHEA was passed. If a supplement fits one of these two
descriptions, the Food and Drug Administration (FDA) cannot
arbitrarily ban it or reclassify it as a drug.
These protections are far from perfect. They discourage companies from
developing new forms of supplements. New supplements may be
arbitrarily banned by the FDA or adopted by drug companies in a way
that precludes their further sale as supplements.
McCain's bill would wipe out even the minimal protections power to
contained in DSHEA. It would give the FDA full discretion andMcCain's bill would wipe out even the minimal protections power to compile a discreet list of supplements allowed to remain on the market
while banning all others.
Everyone knows that the FDA is friendly to drug companies (which pay
its bills and provide good revolving door jobs) and hostile to
supplement companies. Under this bill, this same Agency could quite
arbitrarily ban any supplement it wished or turn it over to drug
companies to be developed as a drug and sold for multiples of its
price as a supplement.
The FDA will like this because it believes that it can more easily
control a few industry giants. But isn't it more likely that the
industry giants will eventually gain control over the FDA?
The FDA is already misusing the adverse event reporting process that
exists. Drugs rack up thousands of adverse event reports without any
action. Just recently, the FDA yanked from the market a supplement
product based on just a couple of alleged adverse event reports
without even allowing the company (an old and respected firm) to
provide any counter-evidence or counter-argument.
The bill also allows the FDA to yank a product (at the company's
expense) if there is a "reasonable probability" that it is
"adulterated" or &"misbranded" Let's
remember that "adulterated" could mean there is a minor
record keeping error on the producer's part and
"misbranded" can mean that the producer simply tells the
truth about the product. An "adulterated" and
"misbranded" supplement in Orwellian FDA speak may
actually be both completely safe and effective.
We must prevent this bill from gaining traction! Protect your access
to supplements by contacting your senators today and asking them NOT
to co-sponsor the Dietary Supplement Safety Act but rather to oppose
it.
TAKE ACTION by clicking here: Convio: ..
McCain's Dietary Supplement Safety Act (DSSA) appears to be
supported by the US Anti-Doping Agency (USADA) which is funded by
major league sports teams including baseball, football and others. The
recent suspensions of NFL and other professional sports figures is
much in the news, and the goal of the sports industry appears to be to
shift the spotlight from their players to the supplements industry. In
his comments, Senator McCain cited six NFL players recently suspended
for testing positive for banned substances and purportedly exposed to
these substances through dietary supplements.
The problem here of course is one of illegal sale and use of steroids.
So why dismantle the supplement industry in order to control already
illegal substances?
The FDA currently has complete and total authority to stop illegal
steroids and, more broadly, to regulate dietary supplements. If the
agency were doing its job, it could and would have prevented the sale
of illegal steroids. The answer to this problem is not to give FDA
more power. The Agency simply needs to do it's job.
TAKE ACTION by clicking here: Convio: ..
Why would a bill be offered to solve an illegal steroid problem that
does not really address the steroid problem but instead gives the FDA
complete and arbitrary control over all supplements? The answer is
simple.
There are a lot of vested interests which are threatened by
supplements. Drug companies do not like them because they represent a
low cost, safer, and often more effective alternative to drugs. The
FDA does not like them because supplements do not come through the FDA
approval process and therefore do not support the FDA budget.
Why not simply require that supplements be brought through the
FDA's drug approval process? Wouldn't that create a level
playing field?
That is probably the argument that Senator McCain has been sold. But
it is a completely false argument. The FDA drug approval process costs
as much as a billion dollars. It is not economically feasible to spend
such vast sums on substances that are not protected by patent, and
natural substances cannot legally be patented.
This is the great "Catch 22" of American medicine. The
FDA, which is supposed to guard and promote our health, is hostile to
the kind of natural medicine - based on diet, supplements, and
exercise - that represents the real future of healthcare. The
Agency has either been captured by drug interests or is trapped in a
catastrophically expensive, toxic, and ineffective patented-drug
model.
Senator McCain has no doubt offered this bill in good faith. But he
has been sold a bill of goods by special interests. And he has been
naïve enough not to know that he is being used.
TAKE ACTION by clicking here: Convio: ..
This exceptionally bad bill also requires the reporting of all minor
adverse events related to supplements. This is in addition to the
already existing requirement to report adverse events. This will
further stack the deck against small supplement companies by creating
new, unnecessary, even more cumbersome, and of course very expensive
administrative hurdles. The result: the consolidation of the
supplement industry into a few big companies.If passed, this bill will
likely result in the disappearance from store shelves of many
supplements currently on the market. In addition to fewer supplements,
there would likely be much lower doses available. Unbridled authority
would be handed to the FDA, an agency that needs a top to bottom
overhaul, not ever more power over our lives.
If Senator McCain's bill passes, we can look to Europe for a snapshot of
what we may be in for: EFSA, the European Food Safety Authority, has
sharply reduced the list of available supplements and is in process of
reducing potencies to ridiculous levels, such as less beta carotene
than can be found in half of a large carrot. Europeans already look to
the US to obtain their dietary supplements. If this bill passes, where
will we obtain ours?
Please take action immediately by clicking here: Convio:..
Tell your senators NOT to co- sponsor this legislation and to do
everything in their power to defeat it. Then forward this to your
friends and family and ask then to do the same!
Gretchen DuBeau
Legal Director, ANH Int.
Executive Director, ANH-USA
