ASHP Urges FDA to Ban Ephedra Products
ASHP urged the Food and Drug Administration (FDA) on Friday to ban the sale of dietary supplements containing ephedra because the products pose significant risks to consumers' health. Changes that the agency has proposed to the labeling for ephedra-containing supplements will not protect the public from the dangers of these products, ASHP warned in its April 4 communication to FDA.
The ASHP Board of Directors recently approved a formal policy stating that dietary supplements containing ephedrine alkaloids should be banned from the U.S. market because of their significant, unreasonable risk of illness and injury to consumers.
April 4, 2003
RE: Docket No. 95N-0304 Dietary Supplements Containing Ephedrine Alkaloids
TO WHOM IT MAY CONCERN:
The American Society of Health-System Pharmacists (ASHP) is pleased to provide comments on the Food and Drug Administration's (FDAs) March 5, 2003, Federal Register notice requesting comments on the agencys proposed rule entitled Dietary Supplements Containing Ephedrine Alkaloids. ASHP is the 30,000-member national professional and scientific association that represents pharmacists who practice in hospitals (including outpatient services), health maintenance organizations, long-term care facilities, home care agencies, and other components of health care systems.
Among the issues that ASHP and its members have become concerned about is the widespread use of dietary supplements. This use presents substantial risks to the public health, and we recognize that pharmacists have an opportunity as well as a professional responsibility to help reduce those risks.
Specifically in regard to dietary supplements containing ephedrine alkaloids, we contacted the 10 members of ASHPs Commission on Therapeutics (COT) for their assistance and guidance. The COT is ASHPs expert therapeutic advisory body. We asked the COT whether the agencys proposed warning statement intended to appear on the principal display panel of dietary supplements containing ephedrine alkaloids would result in a reduction in the risks associated with use of these products, and whether such products present such a significant or unreasonable risk of illness or injury that they should be banned from the market.
Based on the COTs unanimous recommendation, ASHP has developed a formal policy stating that dietary supplements containing ephedrine alkaloids pose a significant and unreasonable risk of illness and injury and, therefore, should be banned. The following policy recommendation was approved by ASHPs Board of Directors:
Although labeling changes such as those proposed in the March 5 Federal Register notice may reduce somewhat the risks posed by ephedra, this reduction in risk is not adequate to protect the public from the dangers inherent in using these products. ASHP further believes that the use of ephedra represents a significant health-related expenditure for remedies of unsubstantiated value. These resources would be better directed toward interventions that are known to be safe and effective such as proven medical therapies and lifestyle changes.
The March 5 Federal Register notice solicits comments on what additional legislative authorities, if any, would be necessary or appropriate to ensure that the FDA can address the issue of health risks associated with the use of dietary supplements containing ephedrine alkaloids. ASHP believes that the FDA has sufficient current authority under the Food, Drug, and Cosmetic Act as amended by the Dietary Supplement Health and Education Act (21 USC 342(f)(1)(A)) to ban dietary supplements from the market when specific products present a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling, or if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use. ASHPs new policy supports the FDA taking such action.
While ASHP supports a ban on dietary supplements containing ephedrine alkaloids, which can be accomplished under current FDA authority, ASHPs Board of Directors has approved the following interim policy on dietary supplements that we expect will be ratified by our House of Delegates when it meets in June:
ASHP developed this policy because we strongly believe that the FDA should have strengthened authority over dietary supplements. The current regulatory framework governing dietary supplements provides neither consumers nor health care providers with sufficient information on the products safety and efficacy they need to help consumers make informed decisions. In addition, standards for product quality are currently inadequate. The widespread use of dietary supplements, combined with the absence of appropriate regulation of these products, presents the following dangers to the public health which are of deep concern to ASHPs members:
Because the publics use and perception of dietary supplements is similar to that for non-prescription drugs, ASHP believes that Congress should amend the Dietary Supplement Health and Education Act to require that these products receive FDA approval for evidence of safety and efficacy; meet manufacturing standards for identity, strength, quality, purity, packaging, and labeling; and undergo post-marketing reporting of adverse events.
Only recently has the FDA, with its publication of a proposed rule on March 13, 2003, requiring dietary supplements to meet Current Good Manufacturing Practice (CGMP) standards, begun to unambiguously address the general problem of assuring the safety and efficacy of dietary supplements. The FDA has taken almost a decade to issue its first proposed rule on CGMPs for these products. While we commend the agency for at last taking this logical first step, if past experience is a guide, without explicit statutory authority to regulate dietary supplements as nonprescription drugs, the proposed rule is more likely to spawn another decade of legal wrangling than it is to lead to the manufacture of safe and effective dietary supplements. This is the primary reason we encourage the FDA, consistent with its public health mission, to work with Congress in developing legislation to amend the Dietary Supplement Health and Education Act to provide the agency with the authority necessary to fully address the issue of health risks associated with the use of dietary supplements.
ASHP appreciates this opportunity present its comments on ephedrine alkaloids to the FDA. Feel free to contact me if you have any questions regarding our comments.
Gary C. Stein, Ph.D.