By Garret Wood
Advanced Bionutritionals
The FDA has issued new rules that, if enacted, will enable them 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 safe.
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 benefited. 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 to them.
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 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:]
- 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, too.
- 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?
- 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,
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.
