ASHP Urges Ban of Ephedra Products
The American Society of Health-System Pharmacists (ASHP) has urged the Food and Drug Administration (FDA) to ban the sale of dietary supplements containing ephedra because of significant risks to public health. Labeling changes proposed by the FDA will not protect the public from the dangers of these products, ASHP warned.
ASHPs call to ban products containing ephedra is based on formal policy recently approved by its Board of Directors. In its communication to the FDA on April 4, 2003, ASHP supported a ban on ephedra products because:
- Ephedrine alkaloids pose a significant risk of illness and injury;
- Changes in product labeling will not protect the public from these dangers;
- Using these products represents significant expenditures for a remedy of unsubstantiated value; and
- Other safe and effective interventions are available for all common uses of these products.
In its letter to the FDA, ASHP also encouraged the agency to work with Congress to amend the Dietary Supplement Health Education Act to require that dietary supplements must at least meet the same legal requirements as nonprescription drugs.
Many consumers think of dietary supplements in the same way they perceive nonprescription drugs, but these supplements are not subject to any of the rigorous safety regulations that nonprescription drugs undergo, said Henri R. Manasse, Jr., PhD, ScD, ASHP executive vice president and CEO. To protect consumers, ASHP policy advises Congress 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.
ASHP is the 30,000-member national professional association that represents pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. ASHP, which has a long history of medication-error prevention efforts, believes that the mission of pharmacists is to help people make the best use of medicines. Assisting pharmacists in fulfilling this mission is ASHP's primary objective. The Society has extensive publishing and educational programs designed to help members improve their professional practice, and it is the national accrediting organization for pharmacy residency and pharmacy technician training programs. For more information, visit www.ashp.org or www.safemedication.com.