FDA Set to Ban Your Supplements

September 13 2011

Story at-a-glance

The FDA’s new Draft Guidance on New Dietary Ingredients threatens to remove some of your most commonly used supplements from the market Manufacturers of supplements will be forced to conduct expensive safety studies using absurdly high doses, which will force many out of business—effectively eliminating competition to high-priced pharmaceuticals The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives, which is in direct violation of DSHEA, which classifies dietary supplements as foods, not food additives, in order to protect consumer access to dietary supplements Defend your right to continue using supplements by taking action now!

The FDA has issued a proposed mandate that represents the greatest threat to dietary supplements since 1994. Back in the early 1990s, consumers were so alarmed by FDA bullying that they staged a massive revolt. The result was that Congress passed a law prohibiting the FDA from banning popular nutrients (as the agency had threatened to do).

There was, however, a loophole in the 1994 law. The FDA was given authority to regulate ingredients introduced after October 15, 1994.

It has been 17 years, but the FDA just issued draconian proposals as to how it intends to regulate what it now calls "new dietary ingredients". You can find the FDA Draft Guidance on New Dietary Ingredients (NDI's) here. If implemented, some of the most effective nutrients you are taking will be removed from the market. This includes many fish oil formulas and natural plant extracts. A detailed analysis of the FDA Draft Guidance is available here.

These oppressive rules are exactly what the 1994 law (DSHEA) sought to prevent. The FDA is using its authority in direct violation of Congressional intent.

In order for these ingredients you are using today to return to the market, the FDA will require manufacturers to conduct outrageously expensive studies using absurdly high doses, in some situations multiplied by a "safety factor" up to 2,000-times the recommended dosage on a per product basis.

The FDA defines dietary supplements as being "new" if they were introduced after October 15, 1994. That means that even certain nutrients that have been safely used over the course of three decades will be subject to the FDA's oppressive policies that mandate costly animal testing...

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