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then we've been sharing our concern over one of the FSMA's mandates that eventually developed into the disastrous NDI draft guidance.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 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 (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 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 own website.
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 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 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 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 here 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.
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 here.
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
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