Agencies Respond to Potential Risks of Supplements Containing Ephedra

The Department of Health and Human Services (HHS) recently announced a number of actions designed to protect Americans from the potentially serious risks of dietary supplement products containing ephedra. The results of a RAND corporation study commissioned by the National Institutes of Health provided evidence that ephedra may be associated with health risks and found only limited evidence of health benefits resulting from the use of ephedra. The U.S. Food and Drug Administration (FDA) and HHS actions include: (1) seeking rapid public comment on the new evidence on health risks associated with ephedra to establish an up-to-date record to support new restrictions on ephedra-containing products; (2) seeking comment on whether the currently available evidence presents a “significant or unreasonable risk of illness or injury” from dietary supplements containing ephedra; (3) seeking comment on a strong new warning label on any ephedra products that continue to be marketed; and (4) immediate execution of a series of actions against ephedra products making unsubstantiated claims about sports performance enhancement. The FDA also proposed a label for all ephedra-containing dietary supplements that warns about the risks of serious adverse events, including heart attack, seizure, stroke, and death, and cautions that these risks can increase with the dose, strenuous exercise, and with the concomitant use of other stimulants such as caffeine. Ephedra is a naturally occurring substance derived from the Chinese herb ma huang, and its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. Products containing natural ephedrine have been used to promote weight loss, enhance sports performance, and increase energy.

FDA Proposal Creates Production Standards for Dietary Supplements

The FDA recently proposed a new regulation that would require current good manufacturing practices in the manufacturing, packing, and holding of dietary supplements to help consumers receive accurate labels and unadulterated products. The proposal would establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labeled to accurately reflect the active ingredients and other ingredients in the product. The proposed rule also would include requirements for designing and constructing physical plants, establishing quality control procedures, testing manufactured dietary ingredients and dietary supplements, maintaining records, and handling consumer complaints. Additional information on this proposed rule may be found on the FDA's Web site atwww.fda.gov.

HHS Proposes Smallpox Vaccination Compensation Plan

HHS Secretary Tommy G. Thompson recently proposed a plan to create a smallpox vaccination compensation program that would provide benefits to public health and medical response team members who are injured as a result of receiving the smallpox vaccine. The proposed compensation program includes four elements similar to the Public Safety Officers Benefit (PSOB) compensation program that exists for police officers and firefighters. Under the PSOB program, the federal government currently pays a $262,100 death and a $262,100 permanent and total disability benefit to police officers and firefighters. The HHS benefit package would create a benefit model based on the PSOB's compensation program for death and disability caused by the administration of the smallpox vaccine. Compensation for temporary or partial disability benefit would compensate persons for two thirds of lost wages after the fifth day of missed work, up to a maximum of $50,000. This benefit would be secondary to any workers' compensation or disability insurance benefits. HHS would also compensate individuals for their reasonable out-of-pocket medical expenses for other than minor injuries. This plan would also compensate third parties who contract vaccinia from public health and medical response team workers who have been vaccinated.

Report Shows Health Care Costs Top Americans' Economic Concerns

According to results from a health poll report conducted by the Kaiser Family Foundation, more Americans are worried about an increase in health care costs than they are about losing their job, being able to pay their rent or mortgage, or being the victim of a terrorist attack. Researchers conducted interviews with a national sample of 1,201 adults. Participants were read a list of statements and asked to respond if, over the next six months, they would be “very worried,” “somewhat worried,” “not too worried,” or “not at all worried.” The top two concerns that participants were “very worried” about were an increase in the amount they pay for health care or health insurance (38 percent), and having an income that did not keep up with inflation (37 percent). Other health care issues that were of concern to the interviewees included the quality of health care services declining (27 percent), not being able to afford the prescription drugs they need (26 percent), not being able to get the health care services they feel they need (24 percent), and the possibility of losing their health care insurance (18 percent). The complete results of this report can be found online atwww.kff.org, and clicking on “January/February Kaiser Health Poll Report.”

AAFP Adds New Resources to Bioterrorism Web Site

The American Academy of Family Physicians (AAFP) has added several new resources to its bioterrorism response Web site (www.aafp.org/btresponse.xml) that was designed to educate family physicians on preparedness and management of bioterrorism attacks and other public health threats. The new resources include links to the U.S. Department of Homeland Security's Web site, which provides detailed information on preparing for terrorist attacks, and to the American Red Cross Web site, which contains specific information in English and Spanish for individuals, families, neighborhoods, schools, and businesses. The AAFP Web site has added downloadable material, including a flyer containing key Web addresses and a copy of the Centers for Disease Control and Prevention's (CDC) Smallpox Vaccination Pocket Guide.