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URGENT: Stop The FDA’s Massive New Attack On Supplements!
We Need Everyone To Work Together NOW!
On August 11, 2016, the US Food and Drug Administration (FDA) issued its newly revised policy on dietary supplements.
Despite overwhelming public outcry against a previous policy proposal issued in 2011, the FDA has doubled down on its plans to:
- Eliminate tens of thousands of supplements from the market by means of unnecessary safety requirements, which include standards that The Big Drug Companies are not held to;
- Give The Big Drug Companies exclusive rights to certain supplements, probably including probiotics. This will drastically reduce their availability and make prices so high that many people will no longer be able to afford them; and
- Obstruct innovative new supplement products by requiring supplement companies to go through and pay for a new approval process for even the slightest change in manufacturing processes.
The August 11, 2016 FDA Draft Guidance will require all dietary ingredients introduced into the marketplace since October 15, 1994 to undergo drug-like safety testing prior to marketing. The tests, which are actually more onerous than those for new drugs, could cost millions of dollars per each new ingredient, and that includes each variation on those ingredients too. So what we are dealing with is whether many supplements that have been widely available since 1994 will continue to be available as a choice for all of us, and whether new supplements will be allowed on the market and made available for us to choose in the future.
The FDA knows that natural supplements aren’t on an even playing field and can’t “pay to play” in a drug-approval-style regime. Dietary supplements are natural dietary ingredients that are not patent-able drugs. A bottle of vitamin costs ten or twenty dollars, but for a pharmaceutical drug they sometimes charge thousands of dollars. If you impose this kind of a program on dietary supplements, it will result in the loss of thousands and thousands of supplements that many of us want to use every day!
The major drug companies provide much of the FDA’s budget. This is the FDA’s way of eliminating competition for Big Pharma. The FDA is working on behalf of the drug industry attempting to take as many supplements off the market as possible and prevent Americans from having access to new ones.
Much of our food supply these days is stripped of nutrients because of the impoverishment of the soil, so it’s just about impossible even if your diet is impeccable, to get the nutrients that you need to maintain a really healthy body. Therefore we all require dietary supplements in order to have a truly healthy lifestyle.
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Protect Your Access To Supplements: We All Need To Take This Seriously And Take Massive Action Right Now!
It will take a huge effort on all of our parts and we need to start IMMEDIATELY! Natural Health Choice is what many Americans want, and it can save billions of dollars in medical costs. But the federal government in the form of the FDA, working on behalf of Big Pharma, seems to want to shut it down.
It Is Up To Us, As Citizens And Consumers, To Stand Up To The FDA And Tell Them NO!
Write to Congress and the FDA to tell them why the August 11, 2016 Draft Guidance Must Be Stopped. The Alliance For Natural Health is also currently raising funds to support its lobbying effort to fight against the FDA’s new supplement policies. If the actions of the FDA continue unchecked by Congress, thousands of dietary supplements you and your family rely on every day could be eliminated. Go Here To Contribute To This Important Work
Each letter is individually addressed to your Representative and Senators and emailed. You can also have printed versions of your letter messengered to your Representative and Senators for $3 each, for a total of only $9.
FDA COMMENT DEADLINE: October 11, 2016 11:59 PM EDT Click on the Blue Button in the upper right hand corner of the page that says, “Comment Now!” This opens up a form with a box that allows up to 5000 characters for a comment. GO HERE FOR TALKING POINTS TO USE IN YOUR COMMENT
FDA Talking Points:
- Under The Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements for the last 22 years, there is supposed to be an authoritative list of “grandfathered” ingredients that do not need to submit NDI (new dietary ingredient) notifications for FDA approval. The FDA says in the August 11, 2016 Draft Guidance that it is willing to develop such a list based on “independent and verifiable data”. After 22 years, this appears to be a stalling tactic, and the FDA is likely to keep that list as short as possible.
- The August 11, 2016 FDA Draft Guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI (new dietary ingredient) notification. The FDA states that additional safety studies may be needed if the target population changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI (new dietary ingredient) notification. Are other drugs, even dangerous antipsychotics, antidepressants, and stimulants, subject to similar requirements when they are used on children? NO!!! In the FDA’s own words, “Most drugs prescribed for children have not been tested in children.” The same is true for use with elderly people. The drugs have almost never been tested on elderly people. This makes the FDA’s new position on supplements especially hypocritical. GO TO http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143565.htm
- Under current law, if an application for an investigational new drug, called an IND, is filed for an ingredient that has been in a supplement, that is, if this ingredient is being studied for use as part of a new drug, that ingredient can no longer be produced or included in a supplement if a NDI (new dietary ingredient) application has not previously been accepted by the FDA. This has already happened to pyridoxamine, a form of vitamin B6, which resulted in this valuable form of natural B6 being no longer available either as supplement or drug. The proposed FDA rules explicitly state that even when an investigational new drug or IND is rescinded or does not lead to a new drug being put onto the market, the supplement form will still be banned. This would allow drug companies to corner the market on a whole list of ingredients to keep them out of supplements forever more! Drug companies would be able to use these new rules to claim that supplements which have been around for decades are now owned by them as drugs!
- Probiotics—the “good” bacteria which our bodies, and in particular, our immune systems, absolutely depend on, could also be removed from the market. The FDA cites risks for these supplements which are purely theoretical and have never posed a problem. Is it a coincidence that Big Pharma is now very interested in producing its own versions of this product? Having probiotics subject to prescription, or costing $100 a bottle, would be a disaster for the health of Americans.
- The FDA is broadening the group of substances that must submit NDI (new dietary ingredient) applications by adopting a loose definition of what it means for a supplement to be “chemically altered.” If an ingredient has been present in the food supply and has not been chemically altered, it is supposed to be exempted from submitting a NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language ignores the fact that new and more effective ways of producing supplements have arisen in the last 22 years since The Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed. It appears that this is quite intentional. The aim is to destroy supplement innovation in the hope that this will eventually destroy the supplement companies and force all of us to use dangerarous pharmaceutical drugs instead.
- The real reason for FDA’s Draft Guidance has nothing to do with safety. It is intended to drive more supplements off the shelves, raise their prices beyond the reach of everyday Americans, and to bankrupt or drive out of business the smaller dietary-supplement companies, paving the way for Big Pharma’s use of many of the very same ingredients, to sell them as drugs at a premium. If the FDA were truly concerned about safety, it would turn away from enforcement actions on the dietary-supplement industry and focus its efforts on the industry where the real deaths occur: the pharmaceutical industry.
In The Early 1990s this dramatic public-service ad (PSA) was developed. Federal agents equipped in full Special Forces gear, converge on Mel Gibson, in this now-famous cameo, who says, in defense as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.” This call-to-action video warned consumers that the Federal government is “actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?” Near the end of the ad, as Mel Gibson’s character is being arrested, he says in desperation: “Vitamin C, you know, like in oranges?” While the video was a dramatization to be sure, it visualized a nightmarish scenario that was truly only one step away from reality at that time.
Are We Facing The Possibility Of This Becoming Reality Again?
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