Petition Letter to the FDA
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 Telephone:1-888-723-3366
On July 11, 2011, President Obama issued an Executive Order that requires the FDA 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significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.
I am petitioning the FDA regarding your draft guidance on New Dietary Ingredient notifications for dietary supplements (known as Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues).
I demand that you immediately disregard all the proposals you outlined and instead consider a rational and scientific approach to regulating new dietary ingredients that will be submitted to you by the Alliance for Natural Health within the next 90 days.
Your proposed guidelines on New Dietary Ingredients will cause the price of my supplements to skyrocket and some of these life-sustaining supplements are likely to disappear altogether.
This is not acceptable, especially when there are no significant reports of adverse reactions to the supplements you plan to ban.
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 insist that you immediately put your proposed new rules on hold for a 90-day period so that the Alliance for Natural Health can draft guidelines that will protect me against unsafe ingredients without destroying my access to low-cost effective nutrients.