Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -510

Accepted - Volume 307

Comment Record
Commentor Mr. Abe Frank Date/Time 2003-03-21 13:47:31
Organization National Collegiate Athletic Association
Category Association

Comments for FDA General
1. General Comments March 21, 2003 Dr. Mark B. McClellan Commissioner, Food and Drug Administration Dockets Management Branch (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, Maryland 20852 Dear Commissioner McClellan: The National Collegiate Athletic Association is eager to have the opportunity to comment on the proposed Food and Drug Administration (FDA) actions regarding dietary supplements containing ephedra. The NCAA shares in the concern expressed by health professionals that dietary supplements containing ephedra in its various forms may present a significant and unreasonable risk of illness and injury. We are particularly concerned about the relationship, as noted by the nation’s top public health officials, between increased risk of illness and injury, and the use of these products under conditions of strenuous exercise and in combination with other stimulants, including caffeine. The NCAA notes that its partner in sports drug testing, The National Center for Drug Free Sport (Drug Free Sport), has been reporting adverse events from dietary supplement use to the FDA through Drug Free Sport’s Resource Exchange Center (REC). The REC staff addresses questions from the NCAA membership, including student-athletes, on nutritional supplements and NCAA banned substances, and learns of these adverse events through these discussions. We believe these adverse events reports are an important step, but also know that many adverse events will go unreported, especially among a population that experiences the adverse event through use of a NCAA banned substance. We believe it important for the FDA to recognize this potential for underreporting on this issue. The NCAA was present for the United States Senate Subcommittee on Oversight of Government Management’s hearings on “Ephedra: Who is Protecting American Consumer?” conducted by Senator Richard Durbin, Illinois. Frank Uryasz, president of Drug Free Sport, spoke on behalf of the NCAA, and expressed the NCAA’s commitment to reduce the demand side of ephedrine-containing dietary supplements in sports, through education and testing. The NCAA has banned the use of ephedrine since 1997, and annually conducts drug testing of over 10,000 collegiate student-athletes for the use of this product. Mr. Uryasz made a plea for efforts to address the supply side of this issue, and to consider that an age limit of 18 does not provide relief for the 360,000 NCAA student-athletes, most of whom are over 18 years of age and have easy access to these substances. NCAA student-athletes, middle and high school athletes, their parents and coaches, are bombarded with messages touting the benefits of supplement use, including those that are stacked to contain both ephedrine and caffeine. These products attract competitive athletes through unsubstantiated claims about sports performance enhancement. The NCAA joins in the concern about significant or unreasonable risk of illness or injury from dietary supplements containing ephedra. As you recently stated in an FDA press release, “Although the overall evidence suggests that serious adverse events from ephedra appear to be infrequent, we know that such events can be very serious and possibly fatal. We believe that the current scientific evidence strongly suggests that at least some ephedra products present an unreasonable risk.” The NCAA supports steps proposed to restrict the non-prescription use of ephedrine, and urges the FDA to take the ultimate step by prohibiting the availability of ephedrine in over-the-counter dietary supplements. We thank the FDA for inviting these comments, and offer our assistance in these efforts to protect the health and safety of our constituents. Please contact Mary Wilfert, assistant director of education outreach and liaison to the Committee on Competitive Safeguards and Medical Aspects of Sports, at 317/917-6319 with questions. Sincerely, Matthew J. Mitten, chair NCAA Committee on Competitive Safeguards and Medical Aspects of Sports cc: Mr. Frank Uryasz Selected NCAA Staff Members

EC -510