TODAY is your LAST CHANCE to SAVE YOUR SUPPLEMENTS!
The Food Safety Modernization Act
(FSMA) was signed into law on January 4 of this year. Ever since then we've been sharing our concern over one of the FSMA's
mandates that eventually developed into the disastrous NDI draft guidance.
Below is a letter from Garret Wood of Advanced Bionutritionals about the FDA's latest attempts to steal your access to life saving natural medicines. TODAY IS YOUR LAST CHANCE TO STOP THIS FROM HAPPENING as the FDA comment period ends today! Please read this and ACT NOW!
I know I've sent you a lot
of emails about the new FDA rules. Sorry to keep bothering
you. But this is a critical issue. The deadline to comment
is December 2. That's today!
Some of our customers have
heard back from their Congressmen. That's good. What's not
good is that some of them are misinformed.
For example, Senator Mark
when finalized, does not create new regulations or law.
According to the FDA, the industry can use an alternative
approach if the approach is consistent with the applicable
provisions under an existing law, the Dietary Supplement
Health and Education Act of 1994 (DSHEA)."
True, it doesn't create a
new law. Frankly, that would be easier to fight! Instead
these new regulations interpret existing law to wipe out
17 years of safety and innovation.
And Senator Maria Cantwell
"In its new
guidance the FDA recommends that a manufacturer should
include information explaining the composition of the
ingredient, why the ingredient is considered new,
recommended usage by consumers, and why the ingredient is
Senator Cantwell glosses
over what kind of proof the FDA will require to consider a
"new" ingredient safe. I put "new" in quotes because these
nutrients really aren't new. They come from nature.
But under these proposed
guidelines, the FDA will consider any ingredient "new" if
a different extraction process is used, if a different
"life stage" (like ripe instead of unripe) is used, or
even if a supplement uses more of an ingredient than was
used 17 years ago.
Bear in mind, that people
have been safely taking these ingredients for years - even
Yet the FDA will require
companies to conduct prohibitively expensive studies on
every ingredient in a product and on every product a
It is true that the DSHEA of
1994 directed the FDA to define "New Dietary Ingredients."
But the FDA did nothing for 17 years. In that time,
hundreds - even thousands - of "new" ingredients have been
Now the FDA wants to ignore
nearly two decades of innovation and turn back the clock.
Dr. Robert Rowen made a good comparison. What if someone
from the government came along and replaced your current
computer with a model from 1994? Or swapped your smart
phone for a clunky early model cell phone? That's what the
FDA wants to do.
This is not hysteria. This
is not a mis-reading of the FDA's proposed guidelines.
This information comes directly from the FDA's own
If enacted, these rules will
enable the FDA to ban many of
the supplements you are now taking.
Think I'm exaggerating? Then
please listen to the full story ...
Back in the early 1990s, the
FDA tried to make many supplements illegal. Consumers were
so alarmed by the FDA's bullying that they staged a
massive revolt. The result was that
Congress passed the Dietary Supplement Health and
Education Act (DSHEA). That law protected supplements from
the FDA unless the FDA could prove a supplement wasn't
There was, however, a
loophole in the 1994 law. The FDA was given the authority
to regulate new ingredients introduced after
October 15, 1994.
So what happened? Nothing at first. For 17 years, the FDA
took no action, gave no guidance, and launched no
enforcement of these "New Dietary Ingredients."
And that's been a good
thing. Because for 17 years, the dietary supplement
industry has enjoyed tremendous innovation. These
innovations have allowed us to extract and concentrate the
most effective natural ingredients. As a result, millions
of consumers have benefitted. They've protected their
hearts and arteries ... found relief from their joint pain
... boosted their memory ... and more.
And during this time,
supplements have enjoyed a remarkable safety record.
Statistics show that supplements are safer than
prescription drugs, cosmetics, medical devices, and even
According to the Poison
Control Centers, there were zero deaths due to supplements
in 2008. In 2009, there was one.
Meanwhile, pathogens like e.
coli in food kill at least 2,000 people each year.
Acetaminophen in drugs like Tylenol kills 450 people every
year. And more powerful prescription drugs kill many more.
Even the FDA now says Vioxx likely killed over 26,000
people before they finally took it off the market!
Supplements the FDA Wants to Ban
But now the FDA wants to act
like the last 17 years never happened. The agency has
drafted a proposal to regulate what it calls New Dietary
Ingredients. If this proposal is implemented, some of the
most effective nutrients you take will be pulled from the
market. Nutrients like resveratrol ... ubiquinol CoQ10 ...
bacopa ... strontium ... and more.
But that's not all. Under
these guidelines, the FDA can define almost anything
as a "new" dietary ingredient. For example:
supplement includes more of an ingredient than was used
17 years ago - even something like vitamin C - it's
ingredient uses a different extraction process - like
baking or fermentation - it's "new."
supplement uses an ingredient at a different "life
stage" - such as using ripe rather than non-ripe apples
- it's "new."
supplement duplicates an ingredient in a laboratory
rather than extracting it from the food - even though
it's chemically identical - it's "new."
a probiotic formula includes a strain of bacteria that
wasn't found in yogurt 17 years ago, it's "new."
So what would happen to all
these "new" ingredients? The manufacturers would have to
take them off the market until they could prove
the ingredients are safe - even if those ingredients have
been safely used for 17 years!
Why It's Nearly Impossible to
What kind of proof is the
FDA demanding? According to the guidelines, many companies
would have to conduct animal studies using a dosage that's
1,000 times the typical dose.
I'm not kidding you. It's
right there in black and white on the FDA's website. The
FDA wants vitamin makers to do studies for a full year, at
1,000 times the typical dose.
So a fish-oil manufacturer
would have to conduct a one-year study where animals are
force-fed the human equivalent of 240,000 milligrams of
fish oil each and every day! This outlandish dose would
injure the animals and give the FDA an excuse to outlaw
But wait, it gets even
better. If one fish-oil manufacturer performs such a study
and it passes, it doesn't mean the other fish-oil makers
can use the same data. No sir. They are still required to
go out and do their own studies before they're allowed to
sell their product.
And these studies are very
expensive. A study like the one above typically costs
about $100,000-$200,000 to perform. Multiply that by
several ingredients in several products, and you get an
idea of the cost.
Say a company carries 6
products containing 6 ingredients each. It would cost
between $3.6 and $7.2 million in studies before that
company could even offer the products for sale. For a
larger company offering 50 products or more, the costs
would be astronomical.
Few supplement makers will
be able to afford these studies, and many will be put out
of business. And the ones that remain would still be at
the mercy of the FDA's whim. That's because there are no
requirements for the FDA to approve anything. They can
approve or reject anything they want. And in the past,
they have rejected the majority of ingredients submitted
That means most of the
nutrients you buy today will be pulled from the market and
never return. Those that do return will be a lot more
expensive - or may only be available as prescription
A Blatant Abuse of Power
This is a blatant abuse of
power. What the FDA is doing here is performing an end-run
around the existing law. According to the law, the FDA has
to prove a dietary supplement is unsafe for it to be taken
off the market. These new guidelines turn that on its
head. They are clearly not what Congress intended.
Fortunately, these FDA
guidelines have not yet been finalized. All federal
agencies are required to give the public an opportunity to
comment on a draft before it is made final. In this case,
the FDA has given interested parties until December 1st to
comment on the draft. That means there's a small window of
opportunity for you to voice your disapproval.
Frankly, I wouldn't bother
commenting to the FDA. The process is cumbersome, and
those unelected bureaucrats don't care what you think
What You Can Do
The best way to defeat these
new rules is to talk to the people you do elect - your
congressman and your two U.S. senators. They have the
power to reign in the FDA - and they have done so in the
past when enough voters complained.
Back in the 1970s, the FDA
tried to require "warning labels" on vitamins. Angry
voters called and wrote letters, and Congress responded
with the Proxmire Amendments which limited the FDA's
Then in the 1990s, the FDA
went on the warpath again. When voters complained,
Congress passed the Dietary Health Supplement Education
Act, which once again limited the FDA's power.
But like a monster killed in
a horror movie, the FDA keeps coming back. And so once
again, it's time for us to step up and call the folks who
rely on our votes.
Here's what you need to do:
Go to http://www.usa.gov/Contact/Elected.shtml
and look up the phone numbers of your U.S. Senators and
your Representative (congressman). Then give them a call.
Don't be shy and don't
worry. No one is going to bite you, no one is going to
argue with you, and no one is going to quiz you to see how
well you know the issues. The job of the staffers who
answer is to listen politely and to relay what you say to
their boss. So please do call. And please be polite and
respectful of the staffers' time.
Here are some talking points
to use when you call:
my name is [name] and I am a constituent of [name of
Senator or Representative].
- I am
very concerned about the new FDA draft guidance on
dietary supplements and new dietary ingredients.
free to tell them about the supplements you take and/or
the benefits you get from those supplements. Then feel
free to make as many of the following points as you
- Supplements have an unrivaled safety
record. Statistics show they're safer than drugs, safer
than medical devices, safer than cosmetics, and even
safer than food.
- The FDA cannot define New Dietary
Ingredients so broadly. According to these guidelines,
almost everything is a New Dietary Ingredient. This will
strangle innovation and deprive consumers of the
supplements they depend on for their health.
- The FDA did nothing about new
dietary ingredients for 17 years. Now they want to wipe
out 17 years' worth of innovation and 17 years' worth of
benefits to the consumer.
- When the Dietary Health Supplement
Education Act was passed, Congress intended a simple
notification process for new dietary ingredients. The
FDA is turning this into a pre-approval scheme, which
goes against the intent of the law.
- The FDA already has ample regulatory
authority to take action against a product if it's
unsafe. They don't need to have this pre-approval power,
- These could be disastrous to public
health. At a time when preventative measures are even
more important to health care costs, the FDA is limiting
access to preventative health care.
- The cost of complying with these
guidelines would be astronomical. Experts estimate that
the studies required would cost between $100,000 and
$200,000 per ingredient notification. That adds up to
millions of dollars per supplement company. Smaller
companies would not be able to afford this and would go
out of business.
The economy is already hurting and we have high
unemployment. Experts estimate that this could cost the
economy tens of billions of dollars and result in the
loss of tens of thousands of jobs.
- The government's resources are
already stretched. We have record budget deficits and
record debt. Why enact more regulations when there are
no safety issues here?
request that Congress direct the FDA to carefully review
their draft guidance. If they do not amend the guidance
to reflect my concerns, I request that Congress call
hearings at the end of the review process. I also call
on Congress to write legislation that would
"grandfather" all supplements currently on the market.
After the phone call, send a
letter to your senators and reps, making the same points.
Make sure the letter is in your own words (form letters
tend not to work as well). You can find the e-mail and
physical addresses at the same website, http://www.usa.gov/Contact/Elected.shtml.
Then send the same letter to
President Obama. (His address and phone number are on the
Please, please, please don't
make the mistake of thinking that the FDA won't take your
supplements away. Similar regulations were passed in other
countries, and the result was disastrous. Many supplements
were taken off the market forever. In some instances, the
entire supplement industry was decimated. Don't let that
Take action now! You only
have a small window of opportunity to make your voice
heard. Get started by going to http://www.usa.gov/Contact/Elected.shtml.
Garret W. Wood
Besides emailing your
senators and congressperson (which you should continue
to to periodically, until the FDA guidance is modified
or overruled by Congress), it's important to file your
comments with the FDA itself, which will appear in
the Federal Register and hopefully add to the voices of
others and help save our supplements; otherwise, the FDA
will claim that no one objected. The link below will take
you to where you can Submit a Comment. In one of the
mandatory fields, it asks you the name of your
organization: you can enter Citizens for Health in this
(they're one of the organizations leading our fight to
save our supplements). Feel free to customize your message
and tell the FDA why access to supplements is important to
you. The Comment form only allows a few words, so you
might want to just put a short summary in it and save a
more detailed message in a text (.txt) file, which it
allows you to attach.
Please note that, due to many requests from people who
would be harmed by their loss of supplements, the FDA has
granted an extension for us to file our comments -- but
we must submit them quickly, as the FDA will not
consider any submitted after December 2, 2011 (although
you can continue contacting Congress and the Senate
after this date).
Link to where you can Submit Your Comments:
In the box asking for your Organization, you can put:
Citizens for Health