3,561,596 members
12,429,752 petition signatures
$19,571,785,510 diverted from Big Pharma
Action! Dietary Supplement Labeling Act & New FDA Guidelines
Editor’s Note: Lee Bechtel, a National Health Federation lobbyist brings us important developments regarding the latest attack to our health freedoms and what we can do. We can and must fight this.
Bill S.1310, the “Dietary Supplement Labeling Act of 2011″ by Senator Dick “To Hell With Supplements” Durbin coupled with new FDA guidelines could change the face of your health and the economy forever.
In a nutshell, “This bill is nothing more than…an attempt to impose more FDA control over dietary-supplement manufacturers, their marketing, and consumer access to supplements.” The modest supplement companies don’t stand a chance under the costly regulations, paper work, off putting warning labels, and the new (dis)approval process. This will leave the competition to the mega-companies and of course, Big Pharma.
On the same day, the FDA introduced it’s own guidelines called “Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” that mimic and correlate with Durbin’s bill. Coincidence?
Basically, we can kiss any supplements developed after 1994 as well as developing vitamin companies and health food manufacturers good bye!
This is all a major part of the burgeoning attempt to give the FDA all power to regulate supplements as a drug (and keep waving unsafe drugs into the market).
Please read on and take action below – we have less than 90 days to comment on the FDA draft guidelines before it moves forward. Please contact your senators about the new bill.
HFA will continue to update on developments.
~Health Freedoms
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NEWS RELEASE
NO CLUE BILL -
NEW DURBIN BILL AND FDA GUIDANCE FOR DIETARY INGREDIENTS SPARKS REVOLT
July 08, 2011
Two dietary-supplement issues – one legislative and one FDA “guidance” – have hit Americans with a body blow recently that, if the idiots who are behind the legislation and guidance do not immediately withdraw their nonsense, will spark a political revolt in the Halls of Congress, the likes of which have not been seen since 1994! And the National Health Federation will not be alone in this revolt.
The Durbin Bill
On July 1st, Senator Dick Durbin officially introduced S.1310, the “Dietary Supplement Labeling Act of 2011.” The more correct bill name would be “Dick Durbin Knows What Is Best for Consumers.” Senator Durbin is selling this bill as his latest patent medicine that will protect consumers of dietary supplements by heaping on yet more FDA regulations. He says that this will guarantee that consumers will have the information they need to distinguish between products that are safe and others that contain potentially dangerous ingredients (i.e., not approved by the FDA). As usual, Durbin is wrong and his “solution” will only harm the industry and consumers.
This bill is nothing more than “Durbin III,” an attempt to impose more FDA control over dietary-supplement manufacturers, their marketing, and consumer access to supplements. By piling yet more costly regulations onto the backs of companies, it will also favor the mega-companies (which can afford the lawyers and specialists to deal with such useless nonsense) at the expense of the medium- and small-sized companies (which cannot). This is all part of the Durbin political agenda that pushes the “consumer safety” issue as a thin cover for pure greed and power – it is really all about protecting the drug companies’ monopoly over “cures.” We are absolutely sick of it.
On the surface, the Durbin bill tries to address the long-standing issue of the FDA not having a clear definition for “conventional foods.” This would clarify which dietary ingredients included in conventional food products are foods and should be regulated as a conventional food subject to different ingredient safety requirements, and those which are used exclusively for dietary supplements and regulated under DSHEA. This issue has been on the FDA’s docket for at least 10 years. Durbin clearly believes that the dietary-supplement industry and consumers should be on the hook for the failure of FDA bureaucrats to do their jobs.
Under current law, it is the initial choice of a manufacturer as to whether a product is classified as a food or as a dietary supplement. The distinction between dietary supplements and foods with dietary ingredient additives is not clear. This has allowed some food products, i.e., beverages and energy drinks in particular, to be marketed as dietary supplements so as to circumvent the safety standards required for conventional foods. The Durbin bill contains only one provision on this issue. The remainder of S.1310 proposes to:
- Require dietary-supplement manufactures to disclose known health risks of individual ingredients and proprietary blends of ingredients used in products;
- Display a warning on a label if the product contains a dietary ingredient that may cause a potential serious adverse reaction, drug interactions, contraindications, or potential risks based on a study conducted by the Institute of Medicine (IOM); and
- Require the submission of safety studies and related published studies, to be reviewed by bureaucrats who are typically ignorant and inexperienced when it comes to dietary supplements.
These provisions may look good on initial reading but are really serious flaws that are intended to give the FDA the authority to regulate supplements like drugs. This will eliminate many safe products already on the market, increase dramatically the retail costs of others, and yet not advance consumer safety one iota. Already, supplements are amongst the safest consumer products on the market – far safer than conventional foods, drugs, doctors, and hospitals, all of which are much more regulated.
Keep in mind, too, that with regard to serious adverse events, the 2007 Dietary Supplement Adverse Event Reporting law has been in place, but the number of reports filed have not provided enough historical evidence on individual ingredients or proprietary blends of ingredients used in products to establish a fair and balanced evaluation by FDA bureaucrats. It is no secret based upon past history that the IOM and its anti-supplement pool of scientists think that healthy foods and supplements should be regulated like drugs. Finally, the FDA-issued industry Guidance for New Dietary Ingredients contains requirements that, if finalized, would mirror these Durbin requirements. Is Senator Durbin seeking to codify into law this new Guidance and its requirements or were he and his staff out of the loop on what the FDA was doing? In all probability, this is not likely; Durbin must have been coordinating with the FDA.
The FDA Guidance on New Dietary Ingredients
By coincidence, on the same day, July 1st, as Durbin launched his legislative initiative, the FDA issued its own notice for its draft “Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” This is a proposed guidance for supplement manufacturers and not a regulation that mandates industry compliance. Again, it is another left-over DSHEA issue from seventeen years ago not addressed by FDA bureaucrats. (For FDA Guidance, go to:http://www.thenhf.com/files/pdf/Draft_Guidance_New_NDI.pdf. )
On its own face, the draft Guidance raises many health-freedom and supplement manufacturer issues. Under current regulatory language, companies are already required to file pre-marketing notification with the FDA for supplements and their ingredients with a new dietary ingredient (NDI). The product may be marketed after a 45-day FDA review period, even if the FDA does not do an internal review. So, who is not doing their job on this point? Certainly not the manufacturers. The draft Guidance does not specifically set industry standards for requiring drug-like clinical testing, but it does without doubt, interject this into the FDA’s review and approval process. The NDI Notifications Section (VI), subpart (B) lists 43 types of safety evidence that can be submitted to substantiate the safety of a new dietary supplement ingredient used in a product. These NDIs are products marketed after October 15, 1994, the date set by compromise when DSHEA was passed. There are other provisions dealing with the use of conventional food dietary ingredients in supplements, pre- and post-DSHEA.
The NHF has been aware of and tracking both of these developments. After close analysis of the Durbin bill and the draft Guidance, the NHF believes that the Durbin bill is redundant in all of its measures and should be opposed, as stated above and because it is a back-door “Durbinesk” move to repeal the protections granted under the DSHEA law. The outline of S.1310 and the powers being granted to the FDA have all of the hallmarks of the FDA’s ban on ephedrine alkaloid containing supplements.
This may also be why it has no other Senate sponsors, to date. It is crystal clear, in our view, that the draft Guidance for industry goes far beyond the original Congressional intent behind the DSHEA law of 1994. For example, the Guidance says it will consider 25 years of widespread use to be the minimum to establish a history of safe use for a supplement. So only a dietary supplement sold before 1986 would meet this standard. Products on the market before 1994 were deemed to be covered by DSHEA without the necessity of meeting its requirements. The Guidance contains guidelines for when additional animal or human safety studies are needed, and has recommendations for a Safety Testing Matrix for individual ingredients. In other words, the FDA’s fantasy of applying expensive and totally unnecessary drug-like safety and clinical studies to new supplement products is being expressed in this Guidance.
For these reasons, and many more, the NHF opposes S.1310 and the FDA’s draft Guidance for Dietary Supplement New Dietary Ingredients. The NHF will be submitting written comments to the FDA within the 90-day window for doing so and we encourage all reading this to do the same. Moreover, please send an email to your Senators opposing S.1310.
S.1310 Bill text – [Click Here] S.1310 Sample letter [Click Here]
Submit electronic comments to http://www.regulations.gov
This is the dockets management/regulations page for the FDA
Enter 2011-D-0376-0001 into Key Word/Document ID space
The notice for Draft Guidance for Industry: DietarySupplements: New Dietary Ingredient Notifications and Related Issues will appear in the box.
Click on Submit comment button and fill in the requested information that follows.
For individuals, this is a public comment filing.
People have 20 minutes to submit their comments.
*********
Submit written comments – re: ATT Docket # 2011-D-0376-001
Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Rm.1061
Rockville, MD 20852
*********
Submit fax comments re: ATT Docket # 2011-D-0376-001 to FAX # 301 436-2639
For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2375.
*******
National Health Federation: Established in 1955, the National Health Federation is a consumer-education, health-freedom organization working to protect individuals’ rights to choose to consume healthy food, take supplements and use alternative therapies without unnecessary government restrictions. The NHF is the only such organization with recognized observer-delegate status at Codex meetings.
Lee Betchel, NHF Lobbyist
Source:
http://www.thenhf.com/article.php?id=2936
Dear Senator: Regard bill S-1310 it is certainly going to cause a lot of extra work for makers of supplements. As far as I know, we don’t have any problem with supplements. They don’t seem to be killing anyone or harming anyone’s health.
I’m primarily concerned that we get to keep our right to our own health care, including supplements. So I am much against your signing any bill that could open the door to that direction.
Sincerely, Patricia Krenik
Note that there is a 2000 character limit to the comments section, so comments need to be brief and succinct. I suggest typing a letter and uploading it, which allows you all the space you need!!!
Dear Senator Durbin,
This S 1310 bill is not only ridiculous, controlling and illogical, but will increase health costs in the future. We the public – remember, we’re the ones who hire, fire and pay YOU – we want supplements easily and readily available.
If you want to “Protect the Public”, why don’t you go after licensed medications that kill over 100,000 people a year? Or do you accept donations from Big Pharma??
The American people will fight you on this. You have no right, nor are you acting out of caring for us. STOP IT RIGHT NOW.
Sincerely and disgusted,
Barb Thomas
[...] lot of major news happens when we are celebrating and resting up over the holidays. Witness the sneak attack on all supplements and now the Monsanto [...]
I am a Ph.D. in nutritonal science and I have been educating people for over 17 years on the life changing effects of natural supplementation. I have witness these various supplements have a postive life changing effect on 1000s and 1000s of people, myself included.
If Senator Durbin Bill S-1310 became law he will have harmed millions of people who find great benefit from these supplements, myself included. I am sure that is not his wish but if you are not up on the science of nutritional it would be easy to be fooled by the Lobbying from Pharmaceutical Companies that want to take over this growing industry and I sure their money applied to re-election campaign is seductive as well but we need Senator Durbin and the Senate to do the right thing and not pass this Senater Bill 1310 or tremendous harm will be done.
Sincerely
Dan Solloway Ph.D.
You make this sooo difficult to submit a comment! Please expedite and simplify with form letters, I do not have the time in my schedule to write this stuff out by hand. I appreciate that you’re trying to have intelligent activism, but come on! If I am not willing to do this, who is? Very few people are going to take the time to use such an arcane and manual approach, I imagine!
We the people want and need to be the deciders of which supplements we want and need to take for our collective health needs. We all vary in our health needs and need to be able to personally calibrate the impact of any supplements we take, whether we are in good or poor health. Many of us have health conditions that are treated with supplements. This proposed legislation and “guidance” will overburden the supplements industry and cause medical harm to us the users in denying us access to supplements. We are not interested in either S.1310 nor the proposed FDA guidance.
Senator Durbin:
The S1310 bill should not be passed. I want the freedom to use the
green herbs that God gave us as I feel I need it. That may be in the
form of fresh herbs or in supplement form. Do not take this freedom
from us. The FDA is there for people that are served by it. Keep the
supplements there for those of us who choose to use them. Allow us
the FREEDOM to make our own choice!
Sincerely,
Susan Rickett
As an adult, I reserve the right to choose my own medical providers, including doctors, medications, insurance, and yes, even organic foods, supplements (vitamins, iron, etc.) without outside intrvention-including federal government. Please… DO NOT signBill S.1310, the “Dietary Supplement Labeling Act of 2011. Thank you!
Please be sure that this is the strategy you would really want for your own loved ones. As far as I am concerned, supplements have been much more instrumental for my health and those I care about. Why would you promote something so useless without any real dangers like the prescription medication that do cause dangers? It makes me wonder what is in it for you…… What is your motivation? Will you be able to honestly face your higher power when reviewed and tell him you did this solely for the people. The way I see it, many people will lose their ability to maintain their health. Western medicine and prescription is not the only way. Please think carefully, and dig deep into your soul. Does your spirit really want to be the one behind such a damaging bill? Do you really want your name on such a destructive and unreasonable bill? At the end of the day we are all trying to survive the toxic pollutants the FDA has already approved. Sad for all involved. I will pray for anyone behind this very bad idea and hope that someone reasonable will intervene.
Dear Mr. Durbin,
PLEASE,PLEASE LISTEN TO US(WE THE PEOPLE), Those of us who are in big favor of taking supplements & herbals do not want our health freedoms taken away from us, we feel it is our freedom & privilege to take natural supplement whenever we want and need to. We have been doing so for a number of years now and don’t feel this is the time for you and big FDA to take them away from us now. WHO ARE YOU TO STOP US FROM TAKING THEM AWAY!!!!! If you don’t like them and don’t want to take them, that is your choice, but don’t take that privilege away from those of us who wish to take them. After all they are far safer than taking prescriptions drugs that make one sick from side effects.
*Also, supplements manufacturers and companies bring major profits and business to the economy, they help bring a big boost to our economy, and in bad times like these, our economy could use a big boost, and if the supplement manufacturers, companies and health food stores and online supplement stores, are shut down, so will our economy and our country, SO THINK ABOUT THAT BEFORE YOU SIGN THAT BIG STUPID BILL OF YOURS.
PLEASE FOR OUR COUNTRY SAKE AND THE SAKE OF HEALTH FREEDOMS, DO NOT SIGN YOUR BILL. WE THE PEOPLE PLEAD WITH YOU TO NOT DO IT.
Sincerely,
Michelle r. Taylor
Getting tired of these Law Makers who have an agenda to take down the supplements. They obviously are in the back pockets of the “BIG PHARMA”. I’d say that 80% of the people I know are into supplements, and natural healing. Even though they are getting the big bucks from “BIG PHARMA” they need to realize that there are a (LOT) of people out here who depend on supplements just AS MUCH as drugs. They might be losing their job, if they go against the people.
And so the war between the FDA and its regulating bodies and the dietary supplement industry continues… As a Registered Dietitian, I am a proponent of whole food nutrition with the inclusion of some dietary supplements being appropriate only in certain cases. I’m also a fan of science and absolutely believe in the efficacy of taking a nutritional ingredient shall certain benefits being proven and safety established in replicated clinical research. I do think the public should have the right to purchased and take dietary supplements but not at the expense of their safety. Too many dietary supplements on the market make outlandish claims regarding health and performance and furthermore, there is also a crop of dietary supplements out there that are impure (do not contain what their label states them to). Not too long ago, an investigation of 60 nutritional supplements discovered that a quarter contained illegal steroids not included on the supplement label. Furthermore, I think most remember what detriments (including death in several cases) were seen with ephedra before the FDA was finally able to take it off the market. In my mind, the safety of the consumer needs to be #1 and I think this is where the FDA and Durbin would like to intervene. I understand the supplement industry’s predicament but better regulatory procedures that ensure the safety and purity of the ingredient needs to be established. If that means going through independent testing/clinical trials prior to being released to the marketplace, so be it. The focus of nutritional healing should be whole food-based anyways.
when the fda start caring about anything but their pocket books. they release drugs that haven’t been tested properly and when they start killing people then they recall them the fda should be defunded.
The FDA’s attempted new guidelines is a low-blow attempt to undermine health freedom in the US, and to sabotage the health industry so pharmaceutical and medical, and food companies, such as Monsanto, can gain a monopoly on the market. It is the opposite of American health and safety – and to use such words on their bills and drafts is bold-faced lie. We need to fight for our rights to choose and support, as private individuals, the health and vitamin and dietary supplements we need to combat things like GMO foods, irradiated foods, depleted soils, toxic vaccines, etc. with which we are bombarded daily. Our freedom is our freedom to choose. FDA is corruptly trying to remove our power of choice and our ability to keep ourselves healthy. Please join in the fight.
Very disgusted by all of this. I guess the bible is turning out correct, when it speaks about the government taking away all of our freedom. It is due to the fact of more money for them, greed and power, and most of all control over everything! I can’t believe they would even be thinking of passing this. We the people will never let this down, how ludicrous is all of this. Its our health!
Maybe we should all be contacting lawyers, to draw up cases against the millions of pharmaceutical drug companies & drugs, the FDA let slide by, and turning into 1000s, 1000s, deaths, and hospitalized side effects caused from the medications. Or, let’s talk about how they pass out Oxy Cotton, morphine, and other major harmful/insanely addictive drugs like candy, and watch our family, friends, relatives, strangers, etc. lose their lives. How is this not a CONCERN to our government.
So for sake of argument, and lets just assume the governments response to my comments above would be “It is the consumers responsibility to consume as directed”. Is that not the same for supplement products, or basically anything out in the market; Alcohol, “toothpaste”, skin care, and the list goes on.
Very concerned for the future of our country.