November 15, 2002

The Honorable Tommy Thompson, Secretary
Department of Health and Human Services
200 Independence Avenue, SW
Washington, D.C. 20201

Dear Secretary Thompson,

For the reasons outlined below, Consumers Union, the nonprofit publisher of Consumer Reports magazine, urges the U.S. Food and Drug Administration (FDA) to immediately declare dietary supplement products containing ephedrine alkaloids and ma Huang (collectively referred to as "ephedra" in this letter) to be adulterated under Section 402 of the Federal Food Drug and Cosmetic Act ("The Act"), 21 U.S.C. §§ 342(f)(1)(A)(i) and 342(f)(1)(C). Since dietary supplement products containing ephedra have been linked to many serious adverse health events, including death, we ask you to declare such products adulterated under 21 U.S.C. 342(f)(1)(A)(i) because they "[present] a significant or unreasonable risk of illness or injury under…conditions of use recommended or suggested in labeling." In addition, we urge you to initiate proceedings to ban the production and sale of dietary supplements containing ephedra under Section 402 of the Act, 21 U.S.C. 342(f)(1)(C), because they "pose an imminent hazard to public health or safety."

We are also very alarmed by reports that major herbal supplement manufacturers have suppressed adverse event reports related to herbal supplement products. To protect consumer health and safety, we strongly urge you to seek the necessary statutory authority to require mandatory reporting of all adverse event reports received by manufacturers to the FDA, and to require additional label information for consumers to facilitate reporting of adverse reactions to FDA Medwatch.

THE FDA AND OTHER HEALTH AUTHORITIES HAVE RECEIVED MANY REPORTS OF THE HARMFUL EFFECTS OF EPHEDRA

Dietary supplement products containing ephedra provide dubious health benefits while posing serious health risks to consumers. From January 1993 through October 2000, the FDA received 1,398 reports of adverse events linked to herbal supplements containing ephedra, including 81 deaths, 32 heart attacks, 62 reports of cardiac arrhythmia, 91 reports of hypertension, 69 strokes and 70 seizures.(1) Complaints about herbal supplements containing ephedra constituted 42% of all dietary supplement complaints, and 59% of all reported deaths. (2)

As you well know, those complaints likely represent only the tip of the iceberg, because the vast majority of adverse reactions to dietary supplements or medications are never reported to the FDA, or indeed, to any health professional or agency.

The American Association of Poison Control Centers has reported a steadily increasing number of serious adverse events related to supplements containing ephedra over the last five years. Recent data released by the AAPCC indicates that in the year 2001 alone there were:

· 812 reported events relating to exposure to dietary supplements containing ephedra as a sole ingredient, including 3 deaths, 103 adverse reactions, 10 "major effects" (defined as exhibiting signs or symptoms that were life-threatening or resulted in significant residual disability) and 139 "moderate effects" (defined as exhibiting symptoms or signs that were more pronounced, more prolonged or more systemic in nature than minor symptoms -- and where usually some form of treatment is indicated). Of the 812 exposures, 440 persons (54%) were treated in a health care facility. 48% of reported exposures occurred in individuals over 19 years of age.

· 7,115 reported events linked to exposures to multi-botanical supplements containing ephedra as an ingredient, including 3 deaths, 1,075 adverse reactions, 87 "major effects" and 1,325 "moderate effects." Of the 7,115 exposures, 3,849 persons (54%) were treated in a health care facility. 43% of reported exposures occurred in individuals over 19 years of age.(3)

THERE IS COMPELLING EVIDENCE THAT EPHEDRA POSES SERIOUS RISKS TO CONSUMERS

Two recent independent studies from well-respected academic centers, reported in peer-reviewed journals, scrutinized adverse events reports filed with the FDA between 1995 and 1999. In the reports, researchers found dozens of cases of abnormal heartbeats, strokes and heart attacks that were likely related to ephedra use.

Samenuk and others at the New England Medical Center in Boston analyzed almost 1,000 cases of possible ephedra toxicity submitted to the FDA. They reported in a recent issue of Mayo Clinic Proceedings that untoward events were clearly related to immediate prior use of the drug in 37 people, and that 36 of these 37 victims had taken the product according to the manufacturer's directions. Sixteen suffered a stroke; 10 had a heart attack; and 11 died. The study concluded that "ma Huang use is temporally related to stroke, myocardial infarction, and sudden death; (2) underlying heart or vascular disease is not a prerequisite for ma Huang-related adverse events; and (3) the cardio-vascular toxic effects associated with ma Huang were not limited to massive doses." (4)

In the December 21, 2000 issue of The New England Journal of Medicine, Haller and Benowitz from the University of California in San Francisco analyzed 140 cases of alleged ephedra toxicity that were reported to the FDA from 1997 to 1999. Abnormal heart rhythms, increases in blood pressure, stroke, sudden death, and heart attack led the list. Of those reactions, 62 percent were thought to be "definitely or probably" or "possibly" due to ephedra. Eight of the 10 deaths were attributed to ephedra, including that of a 15-year-old girl.

The few clinical studies that have been done to date are short-term and have used small numbers of subjects. Adverse reactions included elevated blood pressure, palpitations, chest pain, and extreme irritability. Dropout rates were high in the ephedra-using volunteers.

MANUFACTURERS HAVE SUPPRESSED INFORMATION REGARDING EPHEDRA-RELATED ADVERSE EVENTS

Strong evidence has now emerged that manufacturers of dietary supplements containing ephedra have been concealing substantial numbers of consumer complaints regarding their products:

· On August 15, 2002, the Justice Department disclosed that it was investigating whether Metabolife (a major manufacturer and distributor of ephedra products), had made false statements to the FDA regarding the existence of consumer complaints about its products. On the same day, Metabolife announced that it would turn over 13,000 consumer health complaints or "adverse event reports" to the FDA.(5) After analyzing the Metabolife adverse events reports, the special investigations division of the House Committee on Government Reform concluded that 2,000 of the 13,000 reports were "significant" effects, including three deaths, 20 heart attacks, 24 strokes, 40 seizures, 465 episodes of chest pains and 966 reports of heart rhythm disturbances. (6)

· Two years ago, depositions in a lawsuit in San Francisco against E'ola (a Utah-based multilevel-marketing firm) regarding a death allegedly linked to ephedra revealed that the company had received 3,500 customer complaints about one of its ephedra weight-loss products. According to the San Francisco Chronicle, none of the complaints were ever disclosed to the FDA.(7)

While it isn't clear how many other manufacturers and sellers of ephedra products may be suppressing information regarding potential health effects, those examples do not inspire confidence that serious health impacts arising from the use of herbal supplements will be promptly reported to responsible health authorities under a voluntary reporting system. This also underscores the dangers of allowing herbal medicines in the marketplace without premarket safety testing and a rigorous post-marketing surveillance system. Those are very serious problems that badly need to be addressed by the Congress and the FDA without additional delay.

OTHER PUBLIC AND PRIVATE ENTITIES ARE ALARMED BY EPHEDRA'S DANGERS, AND ARE TAKING ACTION TO PROTECT CONSUMERS

While the FDA has thus far failed to act to protect the public health from these dangerous products, other entities from Canada and Western Europe, to states and localities across the United States, are working to protect the public from injury and death.

· Canada, the United Kingdom and Germany all prohibit sales of ephedra, while other European countries allow the sale of ephedra products only by prescription. At least ten U.S. states, and several local governments have imposed various restrictions on ephedra sales, such as requiring a prescription, outlawing sales to minors, or limiting the maximum dose.

· The American Medical Association has called for the FDA to remove products containing ephedra from the marketplace.

· The National Collegiate Athletic Association, the International Olympic Committee, and the National Football League have already banned the use of ephedra-containing products.

· According to information recently released by Public Citizen Health Research Group, from 1997 through part of 2001, as many as 33 members of the U.S. military have died in ephedra-related deaths. Those who died were between their early 20s and early 40s and were reportedly in good health. As a result, the Army and Air Force military exchanges have removed such products from military commissary shelves worldwide. (8)

· On November 11, Twinlab Corporation, a major herbal supplement manufacturer based in Hauppauge, NY, announced in would stop all sales of products containing ephedra as of March 2003, because of "escalating insurance costs and regulatory uncertainties."

While we believe that other manufacturers should follow Twinlab's lead -- and voluntarily remove ephedra products from the marketplace -- it's clear that consumers need more than just voluntary action, or even state and local legislation, to be adequately protected. Although some U.S. states and localities, such as California, Westchester County, NY and the Huntington, NY have banned the sale of ephedra to under-age purchasers, its hazards are by no means limited to minors. We are particularly concerned about the potential risks to adults who may have known or unknown conditions such as cardiovascular disease, diabetes and hypertension, or who may combine their intake of ephedra with caffeine, other herbal supplements and/or other medications. We are also concerned about the risks to consumers caused by further delay and inaction by the federal government.

As a national consumer organization, our position is clear. We believe consumers should immediately stop using products containing ephedra, and educate themselves and others about the serious dangers of these products. Further, we believe consumers should discuss the use of any herbal supplement with their physician prior to taking it, and promptly report any adverse reactions such products to their physician and to the FDA Medwatch database.

We also believe that the federal government must now act to protect consumers against the known and widely acknowledged hazards of ephedra. Compared to the adverse event data that have accumulated for products containing ephedra, certain prescription drugs have been withdrawn from the market for much less adverse events.

We are very concerned that delay by the FDA in addressing this serious public health hazard continually subjects consumers to unnecessary risk, and undermines public confidence in the government institutions that are charged with protecting consumer health and safety.

It is for the foregoing reasons that we petition the FDA to declare dietary supplements containing ephedrine alkaloids and ma Huang to be adulterated, and to initiate a proceeding to ban the manufacture, sale, introduction, or delivery for introduction into interstate commerce of all such products immediately. We also urge you to seek the necessary statutory authority to require mandatory reporting of all adverse event reports received by manufacturers to the FDA, and to require that all herbal supplement products include label information that directs consumers to report any adverse health effects to their doctor and to FDA's Medwatch.

Sincerely,

______

(1) FDA Special Nutritional Adverse Event Monitoring System (SN/AEMS), FDA Analysis of FDA Data 1/93 - 2/01, Attachment 1 to 9/5/01 Petition by Public Citizen Health Research Group, available at http://www.fda.gov/ohrms/dockets/dailys/01/Sep01/091001/cp00001.pdf (no period).
(2) Id..
(3) American Association of Poison Control Centers, 2001 Annual Report of AAPCC Toxic Exposure Surveillance System, also reported in American Journal of Emergency Medicine, Vol. 20, No. 5, September 2002, p. 439. Available at: http://www.aapcc.org/Annual%20Reports/01report/2001%20TESS%20tables%2022ab.pdf
(4) Samuenk, D. et al. Adverse cardiovascular events temporally associated with Ma Huang, an herbal source of ephedrine. Mayo Clin Proc . 2002;77:12-16.
(5) Neergaard, L. Feds investigate top ephedra seller, Associated Press, August 15, 2002.
(6) Crabtree, P. Metabolife understated danger: firm glossed over complaints about herb ephedra, panel told. San Diego Union Tribune, October 9, 2002.
(7) Howe, K. FDA Stops Tracking Herbal Remedies: Agency says it doesn't have the funding to assess adverse reactions, San Francisco Chronicle, February 14, 2000, p. A1.
(8) Testimony of Sidney M. Wolfe, MD, Director, Public Citizen Health Research Group, Before Senate Governmental Affairs Committee, Subcommittee on Oversight of Government Management Hearing on Dangers of Ephedra, October 8, 2002.

View Files Sorted By Office: Consumers Union OPI, New York - Washington DC Office
West Coast Regional Office - Southwest Regional Office - Consumer Policy Institute

  
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