- Urgent request for your help again since some of you
are having trouble signing the petition through yesterday's link. Supplements
will not just become terribly expensive but, unless you act now, many will
be gone forever.
- The FDA has had this regulation on the books for 17 years,
now they have figured out a way without any new laws to make most supplements
unavailable without millions of dollars of studies per item. This is always
in the name of protecting the public whereas the fact is there are VIRTUALLY
NO DEATHS FROM SUPPPLEMENT USE. According to the Poison Control Centers,
there were zero deaths due to supplements in 2008. In 2009, there was one.
- Please go to the bottom of the attached and complain,
as enough voices being heard by our representatives might stop the FDA
from implementing these onerous regulations.
- Garry F. Gordon MD,DO,MD(H)
- President, Gordon Research Institute
- Please find below a special message from Advanced Bionutritionals.
They have some very important information to share with you about the latest
attempt by the FDA to ban supplements.
- Read the shocking news below.
- Robert J. Rowen, MD
- Dear friend,
- 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 tomorrow!
- 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 Warner writes:
- "This guidance, 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
- 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 writes:
- "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 considered safe."
- 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 decades!
- Yet the FDA will require companies to conduct prohibitively
expensive studies on every ingredient in a product and on every product
a company sells.
- 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 introduced.
- 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
- 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
- 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 safe.
- There was, however, a loophole in the 1994 law. The FDA
was given the authority to regulate new ingredients introduced after October
- 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 food!
- 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:
- · If a supplement includes more of an ingredient
than was used 17 years ago - even something like vitamin C - it's "new."
- · If an ingredient uses a different extraction
process - like baking or fermentation - it's "new."
- · If a supplement uses an ingredient at
a different "life stage" - such as using ripe rather than non-ripe
apples - it's "new."
- · If a supplement duplicates an ingredient
in a laboratory rather than extracting it from the food - even though it's
chemically identical - it's "new."
- · And if 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 Comply
- 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 the product.
- 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 drugs!
- 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 anyway.
- 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 power.
- 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>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:
- · Hello, 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.
- · [Feel 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 like:]
- 1. 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.
- 2. 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.
- 3. 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.
- 4. 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.
- 5. 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, too.
- 6. 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.
- 7. 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.
- 8. 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?
- · I 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.
- · Thank you for your time.
- 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>http://www.usa.gov/Contact/Elected.shtml.
- Then send the same letter to President Obama. (His address
and phone number are on the website, too.)
- 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 happen here.
- 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>http://www.usa.gov/Contact/Elected.shtml.
- Garret W. Wood
- Access the FACT website: http://promed.gordonresearch.com/factforum/welcome.html