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U.S. Department of Health and Human Services

Food

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Alliance for Natural Health v. Sebelius, Case No. 09-1546 (D.D.C.)

May 17, 2012

Jonathan W. Emord
Christopher K. Niederhauser
Emord & Associates, P.C.
1050 Seventh Street, N.W.
Suite 600
Washington, DC 20036

Re: Alliance for Natural Health v. Sebelius, Case No. 09 1546 (D.D.C.)

Mr. Emord and Mr. Niederhauser:

Pursuant to Judge Howell’s opinion and order in the above-captioned case, the Food and Drug Administration (FDA or the agency), on remand, has drafted additional qualified health claims as to an association between vitamin C and a reduced risk of gastric cancer, and vitamin E and a reduced risk of bladder cancer. FDA has also drafted additional qualified health claims for the remaining two qualified health claims from your April 9, 2008 petition that were not at issue in the Court’s opinion (the claims concerning the association between vitamin E and the reduced risk of colorectal and renal cancer), in order to avoid further litigation on those claims. FDA intends to consider exercising enforcement discretion for either iteration of each the following qualified health claims, which include appropriate qualifying language:

Vitamin C and Gastric Cancer:

  1. Vitamin C may reduce the risk of gastric cancer although the FDA has concluded that there is very little scientific evidence for this claim.
  2. Vitamin C may reduce the risk of gastric cancer. FDA has concluded that there is very little scientific evidence for this claim.

Vitamin E and Bladder Cancer:

  1. Vitamin E may reduce the risk of bladder cancer although the FDA has concluded that there is very little scientific evidence for this claim.
  2. Vitamin E may reduce the risk of bladder cancer. FDA has concluded that there is very little scientific evidence for this claim.

Vitamin E and Colorectal Cancer:

  1. Vitamin E may reduce the risk of colorectal cancer although the FDA has concluded that there is very little scientific evidence for this claim.
  2. Vitamin E may reduce the risk of colorectal cancer. FDA has concluded that there is very little scientific evidence for this claim.

Vitamin E and Renal Cancer:

  1. Vitamin E may reduce the risk of renal cancer although the FDA has concluded that there is very little scientific evidence for this claim.
  2. Vitamin E may reduce the risk of renal cancer. FDA has concluded that there is very little scientific evidence for this claim.

FDA intends to consider exercising enforcement discretion for the claims set forth above, as well as the qualified health claims set forth in FDA’s June 19, 2009 petition response.

Please refer to the agency’s June 19, 2009 response to your April 9, 2008 health claim petition for FDA’s analysis of the scientific evidence and consideration of disclaimers or other qualifying language.

Please note that scientific information is subject to change, as are consumer consumption patterns. FDA intends to evaluate new information that becomes available to determine whether it necessitates a change in the agency’s consideration of enforcement discretion. For example, scientific evidence may become available that will support significant scientific agreement, that will support a qualified health claim for the claims that have been denied, that will no longer support the use of the above qualified health claims, or that raises safety concerns about the substance that is the subject of the claim.

Sincerely,

/s/

Barbara O. Schneeman, Ph.D.
Director
Office of Nutrition, Labeling, and Dietary Supplements
Center for Food Safety and Applied Nutrition

cc: Shoshana Hutchinson, OCC