Will New FDA Rules Force Dietary Supplement Makers And Sellers Out Of Business?
Legislative and Regulatory News Update by Nurse Mark
July 29 UPDATE:
You may be forgiven if you feel we are becoming tiresome with continual warnings about these threats to our freedom to choose nutritional supplements – after all, we have been writing about such threats, from one source or another, for almost a decade. If it is not some piece of legislation being proposed by senators or congressmen who are in the pockets of Big Pharma, it is the FDA seeking to expand it’s powers with newly expanded regulations.
So far your voices have, for the most part, been heard in Washington and the worst of the attempts to crush your freedoms have been turned away.
You could be forgiven for thinking that it will always be so – that someone’s voice will always be heard.
But that will only be the case if it is YOUR voice that is heard – you must not ever think that you can relax your vigilance and “let someone else handle this one” – for when you do we will all lose.
These threats will keep coming up in one form or another, until Big Pharma and the FDA finally get what they want: total control over what you are allowed to choose for your health.
They are relying on you to grow weary of hearing us tell you about this or that latest threat to your health freedom.
They are relying on you finally deciding that we have cried “wolf” once too often.
When you finally get tired of our warnings, when you decide that we are “just crying wolf” they will have won – and we will all lose.
Please don’t let that happen! Stand firm, remain vigilant, continue to hold their feet to the fore and demand your health freedoms continue to be respected!
New Regulations To Expand FDA Powers:
The FDA is once again up to it’s old tricks, proving just how tightly wedded they are to their masters in Big Pharma. This report is provided to us by Alliance for Natural Health USA - we provide a brief excerpt here and encourage you to visit their website here for the full article and a link that will allow you to contact the FDA and voice your opinion about these proposed rules.
Visit the Alliance for Natural Health USA website here: http://www.anh-usa.org/fda-new-sneak-attack-on-supplements/
Just before the July 4 holiday weekend, hoping to limit media attention, the FDA dropped a bomb on dietary supplements. Don’t let them get away with it! A new Action Alert.
On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). Ever since DSHEA was enacted in 1994, supplement manufacturers have had very little guidance on what counts as an NDI and when or how to send an NDI notification. The government has arbitrarily ignored or enforced this section of DSHEA, doing as it liked, without spelling out the rules.
Why does this matter? Because when you hear New Dietary Ingredient (NDI), substitute “New Supplement” in your mind. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements—and if so, under what rules.
Now, seventeen years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIs—that is, on new supplements. They had to do this because it was mandated by the recent Food Safety Modernization Act.
We have reviewed the very complicated new regulations in detail. In the hands of an agency charged with regulating supplements fairly—one not hostile to supplements the way FDA is—they might be made to work. But in the hands of the FDA, which wants everything, supplements and drugs alike, to go through the vastly expensive new drug approval process, we fear the new rules will be used to forbid the development or sale of any new supplements—where “new” means anything after 1994, when DSHEA was passed.
Folks, if these rules are allowed to go into effect you will no longer be able to buy vitamins, minerals, dietary supplements, or even “medicinal spices” like turmeric or cinnamon from anyone – because
- No-one in their right mind will jump through the flaming hoops of complex and capricious (not to mention expensive) paperwork that these new rules require, and,
- No-one in their right mind will allow themselves to be put into the position of legal and physical risk that comes with the possibility (more like certainty) of making an error in any of this paperwork – or worse, failing to obtain the correct “approval” for something.
It has become clear that the FDA is an agency out of control – an agency that fancies itself every bit as powerful as the FBI or DEA or even the military – as is evidenced by their eagerness to conduct heavily armed, SWAT-style raids based upon the flimsiest of evidence and the most absurd of regulatory pretenses.
“Did you really think we want those laws observed?” said Dr. Ferris. “We want them to be broken. You’d better get it straight that it’s not a bunch of boy scouts you’re up against… We’re after power and we mean it… There’s no way to rule innocent men. The only power any government has is the power to crack down on criminals. Well, when there aren’t enough criminals one makes them. One declares so many things to be a crime that it becomes impossible for men to live without breaking laws. Who wants a nation of law-abiding citizens? What’s there in that for anyone? But just pass the kind of laws that can neither be observed nor enforced or objectively interpreted – and you create a nation of law-breakers – and then you cash in on guilt. Now that’s the system, Mr. Reardon, that’s the game, and once you understand it, you’ll be much easier to deal with.”
(Ayn Rand, ‘Atlas Shrugged’ 1957)
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