3,561,596 members
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DSPA: NHF’s Pre-emptive Strike on the FDA Draft Guidance The FDA’s Attack on Supplements Can be Stopped
Important action item from our friends at the National Health Federation
~Health Freedoms
In an end-run worthy of an NFL halfback, the National Health Federation is spearheading the introduction of legislation to counter the FDA’s infamous new Draft Guidance on New Dietary Ingredients (NDIs). The Guidance, if finalized and acted upon, would result in the loss of access to countless safe natural health products Americans consume daily. The Guidance would require perfectly safe dietary-supplement ingredients to undergo very expensive, burdensome, and unnecessary testing and FDA approval or else be removed from the market.
Since the passage of the Dietary Supplement Health and Education Act of 1994, the United States has enjoyed excellent access to essential nutrients, but more recently we have watched as the FDA increasingly squeezes the life out of that law with new and onerous rules and regulations. Now, the FDA wants to enforce even more rigorous “safety” standards on products that have never caused harm, but which entered the marketplace after the year DSHEA became law, 1994.
The Dietary Supplement Protection Act (DSPA), which has not yet been issued a bill number, is the brainchild of the Federation and is being introduced by health-freedom advocate Rep. Dan Burton (R-IN). (For more information on Rep. Burton, visit the website http://indianadan.com.) Simply but powerfully, DSPA amends DSHEA by moving forward the grandfathering date to 2007, from 1994, thereby putting many thousands of safe, time-tested products immediately out of range of the NDI Draft Guidance.
The logic of the DSPA is clear, given that the safety standards of the entire industry have undergone an overhaul since DSHEA, with much more stringent manufacturing practice standards in place; the current regulatory environment is vastly different from what it was 17 years ago. As a consequence, the innovative formulators and manufacturers of some 26,000 products added since 1994 have jumped through increasingly smaller flaming hoops to bring their products to market, meeting tougher and tougher standards.
To provide a perspective of just how many of our products the NDI guidance could ultimately affect, consider that prior to DSHEA, there were only 4,000 products on the market, and now there are 30,000: that’s a staggering 87% of our supplements that might be considered “novel” under the existing grandfathering date, and hence potentially “unsafe.” The FDA calls this “Subject to evaluation,” the NHF calls it a strip search.
Scott Tips, president of the National Health Federation, asks, “Where are the dead bodies from these new dietary ingredients? There are none, and the FDA knows this simple fact yet wants to push these safe supplements off the market or price them beyond the reach of most consumers through expensive and useless regulations camouflaged as ‘protecting the public.’ We must preempt the FDA, to push the goal posts far enough forward as is politically feasible so as to ensure that no matter the outcome of the Draft Guidance, the natural health industry, and the millions upon millions of consumers who use its products, are saved from the FDA’s immediate stranglehold on health freedom. We are very appreciative of Representative Dan Burton for introducing this bill.“
The NHF takes very seriously its role as a watchdog over the machinations of the FDA, and has pressed Congress to take a more aggressive stance on the FDA’s misinterpretation of the spirit and intent of DSHEA. In fact, the Draft Guidance on NDIs is contemptuous of the intent of Congress when it passed DSHEA, because instead of ensuring access to a full range of products, it obstructs their path to the marketplace.
With the Dietary Supplement Protection Act, the NHF is attempting to establish a bulkhead against further restrictions of the healthy choices of Americans, and in the coming weeks will be pushing hard for its passage. DSPA can score a touchdown for consumers and the industry alike, and NHF will continue to seek support for its earliest possible enactment into law.
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This is what we need because without something to stop the FDA thugs, we may as well all eat from the corrupted food chain and become emaciated versions of our former selves.
I can’t understand why our Congressmen have not been more pro-active to protect dietary supplements because over the years along with other people, I have sent my share of faxes and letters to my representatives. The trouble is, they don’t see the big picture of what’s on the horizon……OR, they don’t care and actually would prefer us all to be sickly and unhealthy in order to protect the medical and pharmaceutical industries.
Anyway, it’s good news to learn about Rep. Dan Burton’s bill and hopefully it will get the sponsorship it needs.
Good article…..I intend to pass it on.
Hooray for Sen. Burton!!! Where is Sen. Hatch on this? I wore myself out working on the passage of the DSHEA, along with millions of other people. At that time the stores and manufacturers were behind us. Now they are strangely silent, maybe afraid after all the raids before? However, their lack of participation means that fewer people know about this. We need to spread the word to everyone we know. Without the supplements I need, I literally will surely die. Is that what they want? And aside from the effect on the general public, can you imagine the number of jobs lost if they get their way? It all stems from corrupt government agencies that need to be investigated top to bottom. Let’s all stand together guys, and help Ben. Burton fix this.
The FDA needs to be purged from the top. Corruption is one reason we use supplements and if they endanger our health we may have to ‘Occupy’ them.
You have children, parents, sisters, brothers, realtives? Do you care of their well being and yourselves? Better think @ that!
Good work! A pre-emptive strike is exactly what’s needed right now.
I only want the FDA involved if I will be able to purchase all of my supplements using my Health Insurance Rx coverage that I never get to use because I do not take regular prescriptions.
I have an Auto-Immune disease that prevents me from absorbing my nutrients & I have food allergies that make it impossible to obtain all of my required vitamins & minerals.
I spend more money monthly on my dietary supplements than I do on my Health Insurance, and I can not afford for the prices to rise in order to meet new tougher guidelines.
Plus, can the Federal Government REALLY afford to enact tougher regulation that they do not have the money to enforce??????
“Plus, can the Federal Government REALLY afford to enact tougher regulation that they do not have the money to enforce?”
Oh there is plenty of money when there is death and destruction involved. The TOTAL costs for the Iraq and Afghanistan slaughters could run to 10 trillion dollars.
Taking away our supplements may not be as good as a war but it is certainly in the death and destruction vein.