Senators Give Supplements a Lifeline
January 3, 2012
Will it be enough to rein in FDA’s outrageous power grab?
ANH-USA, together with a number of supplement trade organizations, went to Capitol Hill to plead our case about the FDA’s profoundly flawed NDI (new supplement) draft guidance in the offices of two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Our visit was preceded by all the letters you have been sending to Congress, which have immeasurably increased the visibility of this issue. As you know, if this draft guidance stands, it would allow FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. Immediately after this meeting, Sens. Harkin and Hatch wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document.
The senators urged FDA to begin work on a new draft that provides needed clarification on what constitutes a New Dietary Ingredient (NDI)—but, in their words, does not undermine Congress’s desire to provide consumers with access to safe, affordable dietary supplement products. Exactly!
These senators were uniquely qualified to make such a request, since they were the principal authors of DSHEA, the Dietary Supplement Health and Education Act of 1994. “When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” they write. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”
They go on to outline the various arguments that we have been making in these pages for some time:
- The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI;
- This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure;
- The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and
- This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!
The senators requested that FDA meet with interested parties to work through all of the issues raised in our and others’ comments. Fortunately, FDA can’t just ignore the senators’ request, because the agency is required to work within legislative intent. Otherwise they would be creating new law—which legally they cannot do. This is one of the arguments we have been making all along—that FDA is in fact making new law with this draft guidance, and now Congress is calling them on it!
We would like to thank Senators Harkin and Hatch for being such stalwart champions of natural health, and for their leadership in this battle to prevent the FDA from usurping powers that they are not legally entitled to. We also want to thank every one of you for contacting Congress and the FDA and being such a vital part of this process.
We aren’t out of the woods yet—we’ll have another update soon with additional action items for you. The time may come for more specific legislative action, and we may find ourselves battling FDA in the courts as well. That’s why your continued support and activism is so terribly important. Together we can win this one, preserve your access to supplements, and keep supplements from costing as much as drugs.
I support the more conservative approach to reining in new dietary supplements. Without evidence showing their effectiveness, they may benefit the manufacturers and no one else. They may, in fact, be harmful.
I applaud Senators Hatch and Harkin for calling attention to the bureaucratic shroud the FDA has imposed on dietary supplements. Consumers would be best served if FDA spent more time enforcing the current laws rather than attempting to reinterpret and circumvent those laws in order to create a void in the dietary supplement market — to be filled by pharmaceutical companies!
Very good news for us all!!
I was sick alot, I got off of 4 medications fore asthma.
Today I am doing well , do to the help of supplements and vitamins.
My Thanks to the creators. Thank God.
Sens. Harkins & Hatch Thank you & God Bless.
The FDA is a tool of Big Pharma and the AMA. The American people want to use natural healing methods including dietary supplements. The idea that only drugs can cure disease is false, and everyone but Big Pharma and the FDA knows this fact.
The supposed guardians of our freedoms and those who look out for the “little guy” do just the opposite. This perfectly makes the case for a very limited government, which our Founding Fathers wisely encoded in the Constitution. Let’s start electing people who will govern and appoint judges who hold to a strict, literal reading of the Constitution instead of becoming dictators. Elections matter folks!!!
Thanks for the feedback as to the effect of our efforts. Keep me posted and let me know if you need any help from me. Would a request for a cash contribution from members to sustain this effort be beneficial?
Jon F. Burke, Ph.D.
Whoo Hooooo!!!
Thank you, thank you!
May our progress on these issues ever continue!
That law needs to be applied to the drug manufacturers and the fast-food gurus
instead of the dietary supplement businesses.
To the Senators’:
THANK YOU for not only being open minded, forthright, and logical but showing the population that their open does matter and can be heard.
Many people heard about the FDA’s criminal actions but REFUSED to join the fight. I hope this will motivate other to get involved on all the other serious health issues that the FDA is seeking totalitarian control over!
Thank you again!
Thank you senators for standing up & protecting our rites!!!
The FDA (Food & Death Administration) absolutely MUST be dismantled!!!!
I say *KUDOS* to Senator Harkin and Senator Hatch for going to bat for the supplement industry, and of course all the effort and hard work the ANH-USA has done and with so many accomplishments on so many health issues Americans are faced with today. I am proud to be a supplement supporter and user!
Thank You!!!!
Thank you, we are watching and know who does good in government, and we’re glad you are in there. Here’s to all our health!
Thank you Senators HATCH and HARKIN for standing up for the American people and protecting our freedom to utilize the dietary supplements of our choice! Congressmen WAXMAN and Senator DURBIN who have both worked steadfastly to kill the availability of supplements need to take lessons from you guys. Perhaps they got confused and thought they were elected to represent BIG PHARMA.
Last but not least, Kudos to ANH for taking action to stop this threat to our health and our freedom of choice! Good work!
This renews my faith in humanity ( a little more), but of course, the jury is still out.
This news renews my faith in humanity ( a little), but the jury is still out.
This is awesome!!
Thank you fight for our health freedom, we need more freedom
Good work. Next I ask you this… supplements in the form of plants have been used for thousands of years. There should be no hinderances placed on putting them in bottles or mixing them in a variety of combinations. This would basically be illegalizing food/nourishment. Additionally, the nutritional field is young, much is not known, so the bill now limits new discoveries, this has never been placed on any other industry (though many industries/products should have been regulated per they destroy the environment which provides life, liberty and the pursuit of happiness, in trade of INC profit and payola by lobbyists). Thanks for all your efforts to protect our food, bottled or otherwise.
I applaude all of those in the forefront, including the senators in question, fighting this battle for the health of America. God bless America
Way to go Sens Harkin/Hatch and ANH!!! I know we’ll win this battle and war. May 2012 be
the year of awakening for everybody, so they realize the benefits of natural supplements, vitamins and organic foods.
WOW AMAZING. 2 useful senators. Thank God ! Seriously. The thugs at the FDA need a reality check. Glad OUR representatives made the call.
I would like to see someone look into Commissioner Hamburg’s motivation behind this and other activities. It is clear there is a war on supplements. Does someone just wake up one day and decide they are bad? What recourse do citizens have to call into question what motivators come into play with actions like this. It appears reform is needed at the FDA to return it to an unbiased position.
Great job folks! Its these little victories against “Big Pharma” that makes all the emailing, phone calls and letter writing worth while. Each success is a march in the diection of liberty.
LImit government intrusion in my life. I am able to make decisions that affect my life. Let me choose, either right or wrong, but let it be my choice.
thank you ANH so much for all that you do! You are so important and so good….
Thank you Hatch and Harkin! We so much appreciate your humanely-oriented work in this matter!
Why the need to re-evaluate wording? Why any need to review NDIs at all? Herbs and foods have been around for milennia and have already stood the test of time. Clinical testing is already being done a-plenty on herbs and supplements. there is no need for further controls.
I suggest that we won’t have our freedom back unless some of us in the public run for public office to challenge congressional seats. When we get enough good people in office, and we legislate campaign finance reform….then and only then will we have OUR America back.
Short of that, I can foresee a lot of upcoming battles….prune back the branches and the tree grows all the more strongly. We need to dig the tree up by the roots.
Excellent. A bipartisan effort to control an over reaching governmental agency. Thank you, Senators.
Hats off to the Senators supporting supplements.
Yeah!!! Yes, I know we are not out of the woods yet, but it is so good to know that all of our emails and faxes to congress is making a dent and that SOMEONE is finally listening to us! After so many losses I was beginning to feel that all our emails and faxes were useless. But obviously we are making a dent. ANH-USA THANK YOU for tirelessly working on our behalf for health freedom! I am proud to be a member of The Alliance for Natural Health-USA!!!
It is another sad commentary on our govt. thinking that it can run our lives better than we can. I am so fed up.
Well done to these forward thinking Senators, there are still some folks in politics with principles. Also conratulations to ANH-USA for persistence.
Thank you Senators Harkin & Hatch for acting on behalf of the people. We need voices like yours to keep our health. From all of us who believe in preventive care, and leading healthy, happy lives as is our right, my husband and I thank you.
I believe that Gary Null said that he and several others have already filed a lawsuit against the FDA on this issue. I think he mentioned Durk Pearson and Julian Whitaker.
Since the guidance is still in its draft phase, a lawsuit is not yet possible until the guidance has been finalized and a party with standing can show in court that they have been harmed by the guidance. ANH is working with Jonathan Emord and others to prepare a lawsuit against the FDA at such time as it is legally possible.
I am a Utah resident (Senator Hatch’s state) and my three sons are third generation chiropractors. Supplements have always been an important part of our life and health, and the issue of natural health is of prime importance to me. Senator Hatch’s son in law is also a chiropractor in California and it pleases me no end to see him take on the giants of the opposition and effectively do what few could. Thank you to those whose voice made a difference and may we continue to fight to protect our right to natural healing.
Thank you to Senators Harkin and Hatch and all involved. Your efforts are so very much appreciated.
We need idiots like this (fda) out of our lives and replaced by responsible, sympathetic human beings.. We should’t have had to write petitions concerning this matter as in it’s very nature was corruption and big pharma friendly. Let us therefore keep a big eye open so these ‘noids won’t go behind our backs and pass it behind closed doors next time.
Keep up the good fight to keep our freedoms. Supplements saved my life. I have the smarts to pick and choose, learn and decide which products are the best for me. No Gov. intervention thank you.!!
The FDA and our government needs to stay out
Of natural products. It is another way of taxing and
Interfering with American’s business. They have
for years inforced man made medicine that has
Harmful side effects making people illl. Now they
want to restrict Natural Products for their own greed.
This must be stopped!!
Thank You Senators for fighting this battle for us. Let’s hope we will be able to decide about our health and our children
Good news but in reality means nothing. The onslaught will continue. The FDA is owned lock,stock and barrel by big Pharma and they will keep coming back at this. The benefits of the citizens are never taken into account anymore, these “representatives” are not there for the people as they were originally meant to be. My guess is that eventually they will win as the apathy in this nation has gone way beyond the tipping point ( thanks to fluoride in the water ).
We need to stop this insanity. The big food company’s are well in the way to poisoning us all, and wiping out natural foods The FDA works for them and must be eliminated, GMO’s must be outlawed worldwide, The US government needs to be reined in, lobbyist outlawed Lawmakers held accountable
Evil stalkes the earth destroying at will. Attempting to control the worlds food supply is VERY BAD and must be stopped!
It’s about time the FDA tested the drugs they’re providing pharmacists that are truly killing and destroying many seniors and properly educating people about over the counter sleep aids that
have brought on an epidemic of Altzheimer’s disease instead of testing clinically the nutritional supplements people require for amnesty from their lapses in processing healthy food!
I take suppliments all the time and have avoided a heart operation because of them. I think the FDA wants to kill us so they won’t have to pay social security. Or maybe it is because the Big Drug companys depend on Seniors taking so many drugs it keeps them in business. My Doctor is amazed that I don’t take ANY drugs and am in good health. Hope to be able to continue taking my suppliments. Norma
Thank you for telling us about this information about dietary supplements. I need 43 vitamins/good oils daily to be ok with my MS/Celiac. Most of America is Celiac…but they don’t know it…tests may not work to diagnose it and doctors may not be trained it. Most people need vitamins/good oils or America will be very sick…and be a weak nation. Thanks for your awesome help!
Why don’t they rein in the BIG drug companies? they kill far more of us and sicken us than otc supplements can ever do.
keep up good work,we need more freedom, jimmy mack
Kudos to Harkins and Hatch. It should be about our right to choose.
Way to go, ANH-USA!!
Very Happy to hear this…
YAHOO!! WHAT A BIRTHDAY (JAN 3RD) PRESENT!!! KUDOS TO HATCH AND HARKIN!! IT’S GOOD TO KNOW SOMEONE IN THE GOVERNMENT IS ON OUR SIDE. THIS HAS BEEN A BATTLE WITH THE FDA FOR YEARS.
If there is any way to add my note of thanks to Senators Orin Hatch and Tom Harkin for their intervention action I would be pleased to be informed about how to do this. Thank you for your vigilance. Yes my prayers will be supporting this journey of vigilance int he days ahead.
Thank you Hatch and Harkin. Looks like we will once again take-up the fight for our health freedom!
it is refreshing to see some senetors understand the importance of supplements. hope this helps us all.
It would seem that haviing a larger number of our Washintin friends push together, might help show the FDA there really is a force working to protect the peolple against the FDA. Why don’t we have more than just two on our side. Ron Paul would definitly be there and I feel certain that others could be found and that doing so would be worthwhile
This good news , I wil continue to do all I can to see this through for our healths sake and our personal health choices.
Good News . . . and many Thanks to Senators Harkin and Hatch . . .
The FDA has too much power over our health. They are in a way telling us, you do it our way or not at all. People of today know how much health care cost and are finding easier ways to keep healthy without the high prescription cost. Even health lab cost is outrageous. A lot of us are trying to get away from chemicals. We are already getting enough in our system.