supplement

FDA draft guidance to cripple natural products sector and health freedom, decimate supplement innovation

Thursday, August 25, 2011 by: Ethan A. Huff, staff writer
Tags: FDA, dietary ingredients, health news

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(NaturalNews) The US Food and Drug Administration (FDA) is on a mission to seize control of the dietary supplement industry, and cripple it from being able to freely innovate and market potent, effective health products to consumers.

In fact, as we reported a few weeks ago, the agency's draft guidance proposals threaten to actually ban many supplements that were introduced after the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), but that are safely and effectively used by millions of Americans today -- and YOUR help is required to stop this affront to health freedom (http://www.naturalnews.com/032924_dietary_su...).

DSHEA is perhaps the single most important piece of legislation that continues to defend Americans' freedom to innovate, manufacture, sell, and buy dietary supplements -- and it is one that millions of Americans worked very hard to get passed back in 1994. The passage of DSHEA not only opened up the door for new supplements to be developed, but it also ushered in a new era of health freedom based on innovation in nutrition rather than just in synthetic drugs.

However, the final guidance for DSHEA's "New Dietary Ingredients" (NDI), which is meant to clarify how supplement manufacturers are to notify the FDA about ingredients they use, was never properly established at the time it was passed.

And while the FDA is finally coming to task with establishing this guidance, the agency's current proposals will do more to systematically dismantle DSHEA and health freedom than they will to actually clarify them, which is what they are supposed to do.

FDA draft guidance will establish tight regulatory noose around necks of supplement manufacturers

When DSHEA was passed by Congress, it was understood that the FDA would eventually clarify how supplement manufacturers were to notify the agency about the use of "new dietary ingredients." The provisions in DSHEA clearly state that a "new dietary ingredient" is one that was not sold in the US as a "dietary ingredient" prior to October 15, 1994, when DSHEA was passed -- and many supplements on the market today contain such new dietary ingredients.

It is important to note here that this DSHEA requirement was meant to involve a simple notification process, not a convoluted ingredient approval process, which is what the FDA is actually proposing to do. In other words, the implication in DSHEA was not that the FDA would require supplement manufacturers to submit extensive applications for ingredient approval, but simply that manufacturers would notify the FDA that they are using of a new ingredient that is presumed to be safe until proven dangerous, not the other way around as the FDA is proposing.

What the FDA is right now trying to do is turn this notification requirement into a formal approval process similar to what the agency requires for new drugs -- and anyone who has been following NaturalNews for a while knows how expensive, laborious, and corrupt that whole process has become.

If the FDA's guidance proposal comes into effect, the agency will use it to control supplement manufacturers by arbitrarily restricting the ingredients they are allowed to use, and extorting them for money in order to gain ingredient approval -- and none of this, of course, was ever intended by DSHEA!

In essence, the FDA is attempting to ruin the original intent of DSHEA's dietary ingredient notification process by turning it into a control tool to over-regulate the supplement industry, and ultimately control what supplements you are allowed to take. And if the agency gets its way, many of the supplements in use today could become "illegal" overnight, and be subject to intense scrutiny by the FDA before being allowed back on the market, if they are ever even allowed back at all.

Pharmaceutical drugs responsible for at least 80 percent of poison-related fatalities, dietary supplements responsible for zero percent

The FDA's ultimate goal to rein in and regulate dietary supplements in the same way that it does pharmaceutical drugs is highly concerning, especially when considering the fact that according to statistics from the US National Poison Data System (NPDS), pharmaceutical drugs are responsible for causing at least 80 percent of all poison-related fatalities. Supplements, on the other hand, are responsible for causing basically zero percent of all deaths in the same category.

Yet the FDA continues to arrogantly treat dietary supplements as dangerous toxins, constantly alleging that it needs more power over the supplement industry to preserve "consumer safety." The truth of the matter is that the FDA already has more than enough power over the supplement industry, but has failed in many cases to enforce what is already on the books. In the rare case that a supplement is implicated in allegedly harming someone, it is often because the FDA failed to properly regulate it under current DSHEA provisions (http://naturalnews.com/032911_dietary_supple...).

FDA guidelines mirror restrictive EU 'Novel Food Regulation,' the time to oppose is NOW

If you value your freedom to freely buy nutritional and dietary supplements, as we here at NaturalNews all do, the time is NOW to oppose the FDA's new proposals. The FDA's guidelines are strangely identical to those found in the EU "Novel Food Regulation" guidelines recently passed, which have eliminated and banned a wide variety of supplements from the European market in the name of "protecting" consumers (http://www.naturalnews.com/032302_herbal_sup...).

The Alliance for Natural Health has set up a convenient Action Alert page by which you can contact Congress and express opposition to similar proposals being made by the FDA here:
https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833

And while you are at it, you can also oppose the Dietary Supplement Labeling Act, also known as the Durbin bill, which essentially corresponds with the FDA's draft guidance in that it grants more unnecessary power and control over the supplement industry to the FDA (http://naturalnews.com/032911_dietary_supple...). You can oppose the Durbin bill here:
https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=836

Sources for this story include:

http://www.anh-usa.org/fda-copies-eu-slips-i...

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