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Here come the regulations by Hveragerthi ..... The Truth in Medicine

Date:   10/16/2011 7:45:41 AM ( 11 years ago ago)
Hits:   2,605

I have been discussing how making up claims for alternative medicine are leading to more and more regulation.  It has already been in the works for a while, but new vague regulations are being pushed forward that can eliminate our access to many supplements.  This is why I get so upset about the heavy censorship of the facts here on Curezone.  Seems that as long as you are just making up wild claims you can post wherever you want since there are sheeple who will blindly follow.  But heaven forbid you post scientifically validated information.  Then you get banned from nearly every board.  Just remember that when all these new regulations get passed who contributed to their formation.  Those who kept promoting the proven quackery and those who censored the real facts about these quackeries and other proven medical facts.

Here is some of the newest regulations being pushed forward:


NDIs and the Burden of Proof

A Changing Burden of Proof?

Fast-forward to 2011 and the just-released draft NDI guidance. The crux of the issue is who should have the burden of proof when it comes to safety of a particular ingredient—the industry or FDA?

Here’s the breakdown:

First, the scrimmage line between new dietary ingredients and “old” ones has been moved, and industry is calling “off sides.” In the draft guidance, FDA stated the burden of proof should switch from FDA to the manufacturers of even long-time ingredients if the manufacturer changes the method of extraction, concentration or manner of production that changes the chemical composition or structure in any regard. It basically “freezes” the marketplace in time at October 1994. Any advances in technology of existing ingredients will flip the burden of proof to the other side. Likewise, use of an new dietary ingredient along with an old one will flip the burden of proof to the manufacturer to prove the safety of the old as well as the new ingredient in this new matrix.

In addition, there are apparently other issues that will remove ingredients from consideration altogether. If the ingredient has been the subject of an Investigational New Drug Application (that’s an IND, not to be confused with an NDI), that could remove it from being a dietary ingredient completely. Likewise, a synthetic version of a botanical substance cannot be a dietary ingredient either, according to the draft guidance, even if it is nature-identical to a plant material and the commercialization of the plant material is not commercially viable. No amount of safety data will escape that conundrum.

At the same time FDA’s new guidance is changing who has the burden of proof of safety, the level of that burden is shifting too—sort of like going from a preponderance of the evidence to “guilty beyond a shadow of a doubt.” The draft NDI guidance lays out what FDA expects from a manufacturer to satisfy this burden to demonstrate a reasonable expectation of safety, setting some pretty daunting standards for providing “chronic safe use” and even “intermittent safe use.” After all this time, it’s starting to look like the agency is trying to impose the food-additive burden of proof on the dietary supplement industry once again. With such high expectations from FDA to issue a “no objection” letter for an ingredient, one begins to think only the most scrupulous (or masochistic?) manufacturers will go to the trouble to file the NDI notification at all. When you set the bar too high, some folks won’t even try to jump it. That’s not an encouraging scenario for an industry whose reputation is already tarnished by companies who don’t bother to take on current regulatory burdens.

Surely this is not what Congress intended when it set up the NDI process in DSHEA 17 years ago. The differences between a reasonable “expectation” and “certainty” of safety were supposed to mean different burdens of proof for manufacturers. The dividing lines between old and new ingredients were supposed to carve out truly “new” ingredients for the higher safety substantiation, and ingredients with a history of safety were to get the benefit of the doubt. The rather remarkable safety profile of the dietary supplement industry, now evidenced over the past four years by the mandatory adverse event reporting law, demonstrates a strong safety track record in spite of whatever new concentrations, extractions and production methods have been employed since 1994. Shouldn’t that count for something in the allocation of proof?

Finally, the law sets up not one, but three ways for FDA to remove products from the market when the burden of proving safety rests with it. The scales that balance consumer access with consumer safety were pretty even before the NDI guidance came out. Now FDA seems to have tilted them too far in its direction. Maybe it’s time we put our thumb on the dish to balance them out once again. The burden of proof didn’t just change hands, it may have become insurmountable.




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