| Comment Record|
Ms. Shirley Bohm ||
2003-03-31 13:33:44 |
Association of Food & Drug Officials |
| Comments for FDA General |
1. General Comments
The Association of Food and Drug Officials Board of Directors, hereinafter referred to as AFDO, is pleased to offer comments on the Food and Drug Administration's (FDA) proposed regulations for dietary supplements containing ephedrine alkaloids.
AFDO is a non-profit, professional association representing federal, state, and local regulatory officials as members, with industry representatives participating as associate members. AFDO develops and promotes uniform laws, regulations, and guidelines that result in more efficient and effective regulation along with enhanced cooperation and communication. AFDO has been a leader and active participant in many regulatory initiatives during the past many years at both state and federal levels. AFDO strongly supports FDA's desire to develop effective strategies for achieving proper regulation of the safety and labeling of dietary supplements. AFDO's membership has repeatedly provided comments to the FDA urging definitive action with regard to the public health risks associated with dietary supplement products containing ephedrine.
We believe that the proposed labeling is necessary to address the numerous health problems that have arisen from the consumption of ephedrine containing dietary supplements by the public. The warning label as proposed addresses those concerns. However, we feel that in light of the lack of mandatory adverse event reporting for dietary supplements the label should also contain the number for the FDA's MedWatch program. FDA has been seriously hampered in the last 8 years by a lack of data about serious adverse events. Only recently, in the wake of recent disclosures of information, has FDA had the volume of data necessary to draw certain conclusions about the temporal relationship between ephedrine and adverse events. The RAND study is also an example of recent efforts to obtain information. Conclusions in the study were diminished because of the lack of available data. Therefore, we strongly encourage the FDA to amend the label to include the MedWatch toll-free number. Since dietary supplements are regulated as foods, consumers assume they are safe. The necessity of a warning label at all seems to belie the underlying assumption of safety. The RAND study demonstrated that adverse events were detected in 1 in 1000 participants, in order of magnitude greater than that posed by Salmonella Enteritidis in shell eggs and that rare adverse events could not be detected at all from the available data. Therefore, an assumption of safety cannot be made and manufacturers that continue to promote their products as clinically proven safe are misleading and endangering the public.
Ephedrine from botanical sources shares the same risks for and consequences of interaction with a variety of over-the-counter and prescription drugs as those experienced with its synthetic drug counterpart. There is no difference between blood levels of ephedrine from botanical sources or ephedrine contained in over-the-counter drugs. In fact, botanical sources of ephedrine may also contain more than one pharmacologically active ephedrine alkaloid. The class of compound that ephedrine belongs to, the sympathomimetic amines, has been long known for side effects such as nausea, vomiting, psychiatric symptoms such as anxiety and change in mood, autonomic hyperactivity, and palpitations. The RAND study confirmed that there is a higher risk of these types of side effects after consumption of ephedrine containing dietary supplements.
FDA has already effectively removed phenylpropanolamine, a compound with similar pharmacological effects and a partial metabolite of ephedrine, from the market place based on recommendation of its own Advisory Committee and a Yale University School of Medicine study linking the drug to strokes. Yet since 1994, more strokes associated with ephedrine containing dietary supplements have been reported to FDA's MedWatch than for the almost 30 year period phenylpropanolamine was on the market.
Ephedrine containing products have also been promoted for increased energy and increased physical performance. The label as proposed, warns against use during physical activity and the RAND study found that no studies have been conducted to assess the long term effect of ephedrine on athletic performance. In fact, because of concerns about the safety of the product, the National Football League, the National Collegiate Athletic Association, and the International Olympic Committee have banned ephedrine containing products. In a statement issued October 8, 2002, before the Governmental Affairs Subcommittee on Oversight of Government Management, Restructuring and the District of Columbia, the president of the NCAA, Frank Uryasz stated It should be noted that the NCAA ban on ephedra is part of an overall ban on the use of stimulants. Athletes will use stimulants to increase their energy levels and to help them lose weight or body fat. The use of stimulants combined with exercise and heat can cause damaging health effects and even sudden death.
Given the significant rate of adverse events (1 in 1000) reported in the Rand report, AFDO strongly recommends that FDA ensure the label information proposed adequately conveys the significant risks, and that consumers fully understand the meaning and health implications of label information through focus group studies or other valid consumer-level initiatives.
AFDO also encourages FDA to determine a risk level for serious adverse events which would prohibit direct consumer sale of a dietary supplement containing ephedra.
Shirley B. Bohm
Association of Food & Drug Officials