The American Herbal Products Association (AHPA) filed a friend of the court brief1,2 in the U.S. Court of Appeals for the District of Columbia Circuit in support of Julian Whitaker, M.D., and others who have filed for a health claim from FDA for saw palmetto (Serenoa repens) and its relationship to the symptoms of benign prostatic hyperplasia (BPH).3 The brief was filed May 28, 2003, on behalf of AHPA by its General Counsel, Anthony L. Young, a partner at Kleinfeld, Kaplan and Becker, LLP.
According to AHPA, FDA refused to evaluate the merits of Dr. Whitaker's health claim petition on the basis that it describes how saw palmetto "treats" the symptoms of BPH. Such claims, according to FDA, may only be made for drugs and the health claim provision of the Nutrition Labeling and Education Act (NLEA) of 1990 does not authorize health claims concerning a nutrient's ability to treat diseases or their symptoms.4 FDA prevailed with these arguments in the lower court and Dr. Whitaker appealed. (See accompanying article.)
AHPA's friend of the court brief pointed out that NLEA requires FDA to consider any claim regarding the relationship between a nutrient and disease and that FDA never took the "no treatment claims" position in regulations promulgated under NLEA.5 AHPA also pointed out that the District Court's rationale for determining that the health claim provision of NLEA is ambiguous is flawed because the statute clearly permits treatment claims to be made as health claims.4
AHPA also countered FDA's long-held position that allowing a treatment claim for saw palmetto would discourage men from seeking proper medical evaluation and noted that AHPA recommends that the following or similar language appear on the label of any products containing saw palmetto:
"Notice: The National Institute on Aging recommends that men get regular medical checkups with a thorough prostate exam. You should inform your health care practitioner that you are using this product."
AHPA's brief said:
"In the final analysis, there is no reason to believe that men will improperly use dietary supplements containing saw palmetto if they are marketed with the proposed health claim. Indeed, approving the saw palmetto health claim with accompanying language concerning the need for routine prostate exams would benefit, not harm, the public health. If approved, the labels of most saw palmetto products will likely bear the health claim along with any additional language regarding the need for regular prostate exams required by FDA. Thus, approval of the proposed health claim would likely result in a wider dissemination of the National Institute on Aging's important recommendation for regular prostate exams.
"We are pleased to support Julian Whitaker and his allies in seeking reversal of FDA's position which seeks to rewrite the NLEA's health claims provision.
"FDA's refusal to look at Dr. Whitaker's proposed BPH claim on the merits needs to be brought up short. FDA must be open to receiving and reviewing health claims for foods and supplements on their merits so that the claims may be properly qualified and consumers can receive information about these products. Information was the abiding goal of both NLEA and DSHEA and FDA has simply lost sight of that goal."2
Reference:
1. American Herbal Products Association. AHPA Files Friend of Court Brief on Health Claim for Saw Palmetto. AHPA Update. May 28, 2003.
2. Amicus Curiae Brief of the American Herbal Products Association, Whitaker v. Thompson,, No. 03-5020, D.C. Cir. Friend of the court briefs, called briefs amicus curiae, are permitted in all courts with the permission of the litigants and the court. They are often used by trade associations (e.g., AHPA) and other interest groups (e.g., the Sierra Club) to present points of view of interest to their members and to the Court.
3. Brief of the Appellants, Whitaker v. Thompson,, No. 03-5020, D.C. Cir.
4. 21 U.S.C. §343(r)(6).
5. 21 C.F.R. Part 101, Subpart E.