EDITORIAL

New FDA Directive to Outlaw Most Supplements

I n early July, the FDA issued a proposed ruling that would have a devastating effect on our health by making virtually all dietary supplements unapproved new drugs. Under the guise of establishing new guidelines for qualifying new dietary ingredients (NDIs), and in the interest of “safety,”* nearly everything that has come onto the market since 1994 would be required to be withdrawn, until the FDA gives explicit approval if ever. This is true whether the supplement is a formulation or a single-ingredient product, and even if it had once been qualified as a so-called “grandfathered” supplement.


* The heavily-regulated drug industry—the model for the FDA safety standards—turns out to be a lot less safe than the supplement business, by a significant magnitude. An examination of US National Poison Data System figures reveals that, for the last two years for which data is available, pharmaceutical drugs caused 80% and 81% of fatalities, respectively. Supplements, on the other hand, have not had one single undisputable death. Night and day! And the FDA’s rationale for advancing its NDI progress is safety. Heaven help us!


The FDA Wants to Reverse the Burden of Proof

Make no mistake. This is the greatest threat to our health freedoms since the FDA attempted to turn nutrients into prescription drugs back in the early 1990s, and possibly more perverse because now the burden of proof is reversed. In an extreme example of what is known as the “precautionary principle”—requiring proof that a supplement does not cause any toxicity and that it is perfectly safe—the FDA “guidelines” would mandate the reverse of the premise, “innocent until proven guilty,” upon which our legal system is based. Henceforth, all supplements would be guilty until proven safe, just the opposite of the intention of the legislation passed by Congress in 1994, the Dietary Supplement Health and Education Act (DSHEA).

Shocked into Responsiveness

Consumers were so shocked by FDA threats of wrongfully exercising authority that they staged a colossal revolt. This typhoon of consumer response became the most intense lobbying effort that Washington has witnessed since the public’s response to the Vietnam War. Consequently, Congress passed DSHEA prohibiting the FDA from banning popular nutrients (as the agency had threatened to do).

Although 17 years have passed, the FDA’s unwarranted and severe proposals to regulate NDIs are diabolical and fully on par with what shocked us so in the 1990s. If implemented, the most effective nutrients you are taking will be removed from the market.

It is Time to Revolt Again

Now is the time to empower ourselves once more … to speak out and revolt just as we did back in 1994, the result of which was a glorious victory over FDA tyranny! So if you have not done so already, please send your message to Congress through the Action Alerts at the Alliance for Natural Health Website (www.anh-usa.org ) in opposition to the FDA’s NDI proposed ruling. And while you’re at it, read up on the other Hydra Head of regulatory excesses known as the Durbin bill and take action also. Both these issues are enormously important if you want to maintain your right to access supplements and your freedom to choose.

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