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Letter to the White House

Office of Management and Budget
The White House
Washington, DC

Dear Staff:

On July 11, 2011, your office issued an Executive Order directing the FDA (and other agencies) to:

  1. Make regulatory decisions only after consideration of their costs and benefits (both quantitative and qualitative).

  2. Review significant regulations to make sure they are not excessively burdensome.

  3. Develop and release to the public a plan within 120 days under which the FDA will periodically review its existing significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.

Contradicting this Executive Order are draft guidelines issued by the FDA that affect every dietary supplement introduced after October 15, 1994. These new regulations will require extremely costly animal testing on each product the FDA asserts is a “new dietary ingredient,” even if consumers have safely been using it for decades.

If this proposed regulation is implemented, some of the most effective nutrients Americans use will be removed from the market. This includes many fish oil formulas and natural plant extracts.

These burdensome regulations are exactly what a law passed in 1994 (Dietary Supplement Health and Education Act) sought to prevent. The FDA is using its regulatory authority in direct violation of congressional intent.

In order for dietary supplements 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.

And remember, the FDA is defining a dietary supplement as being “new” if it was introduced after October 15, 1994. That means that nutrients that have been safely used for many years will be subject to the FDA’s oppressive policies that mandate costly animal testing.

The name of this draft guidance regarding so-called new dietary ingredients is the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

I ask that your office contact the FDA and order them to immediately disregard their proposed guidelines regarding new dietary ingredients as they directly contradict the Executive Order of July 11, 2011, provisions stating that regulations should be streamlined or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.

If FDA new guidelines on New Dietary Ingredients are not repealed, they will cause the price of my supplements to skyrocket, while causing some of these life-sustaining supplements to disappear altogether.

This is not acceptable, especially when there are no significant reports of adverse reactions to the supplements the FDA bureaucratically declares as “new.”

In as much as your threat to ban my access to new dietary ingredients is causing me great anxiety which is injurious to my health, I ask that you to immediately contact the FDA Office below and insist the FDA complies with your Executive Order and repeal these proposed guidelines as they will interfere with innovation, job creation and economic growth:

Corey Hilmas
Center for Food Safety and Applied Nutrition
Office of Nutrition, Labeling and Dietary Supplements
Food and Drug Administration
5100 Paint Branch Pkwy., HFS-009
College Park, MD 20740-3835

Kindly let me know the outcome of your inquiry to the FDA.


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