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FDA ON WARPATH
Call your Congressman now! 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 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!
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.
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. 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. 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!
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:
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. 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.
Robert J. Rowen, MD