--HEALTH FREEDOM / FDA Breaks Its Promise
-From: Whole Health Insider / Vitamin Research Products
-Date: July 2012

In the past, we've informed you about the FDA's draft New Dietary Ingredients (NDI) guidance. The FDA promised that until it finishes reviewing comments and releases the final guidance, it would enforce only the Dietary Supplement Health and Education Act (DSHEA)--not the draft guidance. Now the agency has gone back on its word and is enforcing one of the provisons of the draft guidance.

There's a lot of opposition to the draft NDI guidance because it steps outside the bounds of DSHEA and opposes Congressional intent. It's creating new law, which the FDA isn't allowed to do. If made final its current form, the NDI draft guidance will make nuturtional supplements less available and more expensive.

The NDI draft guidance provision that the FDA has decided to enforce? It's the one that says synthetic botanical constitutents can no longer be considered Dietary Ingredients and must never be sold as supplements--only as drugs.

Recently, the FDA sent warning letters to 10 companies who sell supplements containing dimethylamylamine (DMAA), reportedly derived from the Asian geranium. The FDA warned that DMAA supplements are classed as "adulterated" because:

1)DMAA hasn't gone through the NDI notification process, and

2) It's a synthetically produced botanical ingredient, which, by definition, isn't an NDI.

DSHEA itself does not prohibit synthetic compounds that are equivalent to naturally sourced ingrdients in and of themselves from being considered dietary ingredients. This distinction comes form the NDI draft guidance and gives drug companies a monopoly on synthetics.

DMAA, is controversial. Last year, two soldiers who happened to be taking DMAA-containing supplements died after having heart attacks during fitness exercises. However, at press time, DMAA hasn't been conclusively linked to the deaths.

If DMAA is proven unsafe, it should be removed--we're not arguing that point. But it's not illegal simply on the basis of being a synthetic compound--that simply isn't a DSHEA requirement.

Another problem? The FDA hasn't addressed the thousands of papers in public comments submitted on the synthetic botanicals question, making it seem as if the FDA doesn't care about the concerns.

I urge you to contact your Congressional representatives to encourage them to push back on the FDA's attempts to create its own laws.

-Irfan Qureshi, ND
-VRP Chief Regulatory Officer
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