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Testimony On Dietary Supplements Before The Senate Commerce Committee

Charles W.F. Bell, Programs Director
Consumers Union of U.S., Inc.
October 28, 2003

Good morning, Chairman McCain, Ranking Member Hollings, and other members of the Committee. Thank you for providing me the opportunity to come before you today. I am Charles Bell, Programs Director for Consumers Union(1) . Consumers Union is the nonprofit publisher of Consumer Reports magazine. Our mission at Consumers Union is to test products, inform the public, and protect consumers. Today I offer this testimony on dietary supplements as part of our consumer protection function.
The 1994 Dietary Supplement Health and Education Act of 1994 (DSHEA) opened the floodgates to thousands of untested herbal products and handcuffed the Food and Drug Administration from performing any meaningful oversight over what has since developed into a multibillion-dollar industry. The law allows anyone to launch a product with a health claim without clearance from any government agency. There’s no assurance of either safety or efficacy. And what’s on the label is sometimes not in the pill.
The contrast with regulatory standards for pharmaceutical drugs is striking. A proposed new drug can only be approved if it is deemed to be safe in multiple human studies, and companies are required to notify the FDA if consumers suffer serious side effects.
While many dietary supplements are generally safe, and many have important health benefits for consumers, there is a significant and growing number of highly questionable products that would probably not be allowed on the market if they were subject to pre-market safety testing.
In 1995, Consumer Reports magazine published a list of five supplements that according to the FDA can cause serious harm to consumers – chaparral, ephedra, comfrey, lobelia, and yohimbe. Eight years later, all five of these supplements are still being marketed and sold.
In the aftermath of DSHEA, unsafe dietary supplement products can remain on the market for many years, in the same stream of commerce as products approved by the FDA as safe and effective for their intended use. Further, new dietary supplement products can be introduced overnight that contain novel, untested ingredients and/or novel combinations of new and/or existing supplement ingredients. Health providers and public health authorities typically receive little pre-market or post-market information about how such products may affect human health, and interact with medicines that patients are already taking. Even where serious problems are documented, such as in the case of supplements like ephedra, which is discussed in detail below, it is difficult for the FDA to take prompt action to protect consumers.
Over the last several years, increasing public attention has focused in particular on the sale and marketing of herbal supplements containing ephedra or ma huang. The ephedra controversy is an important case study, in part because it has been responsible for the largest number of reported adverse events.
The U.S. Food and Drug Administration (FDA) has compelling data showing that ephedra poses serious and unreasonable health risks to consumers. Other studies, including our own analysis of the literature to date, reveal that risks from the use of ephedra far outweigh any benefits. For example, a comprehensive report appearing in the March 26, 2003 issue of The Journal of the American Medical Association, linked the use of ephedra with risks of heart, psychiatric, and gastrointestinal problems, while finding insufficient evidence to support its use to enhance athletic performance, or to promote long-term weight loss.
We believe that an outright ban of this particularly hazardous herbal supplement for both children and adults is badly needed to protect consumers from serious potential adverse health effects, including heart attacks, seizures and strokes.
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.(2) Complaints about herbal supplements containing ephedra constituted 42% of all dietary supplement complaints, and 59% of all reported deaths.(3)
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 healthcare 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 healthcare facility. 43% of reported exposures occurred in individuals over 19 years of age.(4)
In addition to the above, according to information released by Public Citizen Health Research Group, from 1997 through part of 2001, as many as 33 members of the U.S. military 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.(5)
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 cardiovascular toxic effects associated with ma Huang were not limited to massive doses.”(6)
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.
In the March 26, 2003 issue of the Journal of the American Medical Association, Shekelle and colleagues published an evidence-based review of the efficacy and safety of ephedra and ephedrine. (This review was carried out under the auspices of the RAND Institute at the request of the FDA.) According to a summary of Shekelle’s analysis of safety data from 50 clinical trials:

Evidence from controlled trials was sufficient to conclude that the use of ephedrine and/or the use of ephedra-containing dietary supplements or ephedrine plus caffeine is associated with two to three times the risk of nausea, vomiting, psychiatric symptoms such as anxiety and change in mood, autonomic hyperactivity, and palpitations.

An additional evaluation of adverse event reports by Shekelle et al revealed 5 deaths, 4 myocardial infarctions, 11 cerebrovascular accidents, 4 seizures and 8 psychiatric cases as “sentinel events” associated with prior consumption of ephedra or ephedrine. (8)
According to an editorial article that appeared in the same issue of The Journal of the American Medical Association (JAMA):

The results of this analysis cast doubt on any claims that use of dietary supplements containing ephedra or ephedrine can help achieve long-term weight loss or weight maintenance or enhance athletic performance. The findings also strongly suggest increased risk of serious adverse effects associated with these products. Moreover, reviewing the accumulated reports of toxicity linked to these compounds, it is hard not to be impressed by the number of serious cardiovascular complications in young adults. (9)

Dietary supplements containing ephedra may interact in hard to predict ways with other prescription and over-the-counter medications that consumers are taking. For this reason, Consumers Union recommends that all consumers should consult their physicians before taking dietary supplements.
For example, combinations of ephedra products and over-the-counter cold remedies are a major issue, according to Dr. Richard Cytryn of the New Jersey Chapter of the American College of Cardiology:

Perhaps someone who has a cold does not want to interrupt a personal weight loss plan or a vigorous exercise program. He or she uses the herbal supplement and buys a sympathomemetic medication to alleviate cold symptoms. These people are actually unaware that they are taking a double dose of the drug, thereby compounding their vulnerability to its side effects. This can have potentially deadly results… Used indiscriminately, or in combination with contraindicated OTC medications, certain other herbs and even with caffeine, ephedra supplements can lead to severe physiological responses.(10)

While much of the discussion of the ephedra problem focuses on persons under 18, the hazards of ephedra are by no means limited to minors. Consumers Union’s chief medical adviser Dr. Marvin Lipman, a physician and emeritus professor of medicine at New York Medical College, is 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. Further, adult consumers may turn to herbal supplements containing ephedra after many years of physical inactivity, without consulting physicians. As noted above, the AAPCC data indicates that roughly half of all adverse event reports received by poison control centers involve adult consumers.
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.(11) 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. (12)
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. (13)
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.
Despite the large number of deaths and serious adverse events linked to ephedra use, and repeated requests from consumer and public health organizations, the FDA has failed to ban dietary supplements containing ephedra. We believe this is because the FDA has been hampered in its regulatory efforts by the restrictions placed on the Agency’s regulatory authority under DSHEA.
A broad range of health and sporting organizations have spoken out regarding ephedra’s hazards:
• The American Medical Association has called for the FDA to remove products containing ephedra from the marketplace.
• The American Heart Association issued a statement in early April stating that supplements containing ephedra “do more harm than good and should be removed from the market.”
• The 2003 spring training death of 23 year-old Baltimore Orioles pitcher Steve Bechler prompted Major League Baseball to ban ephedra use by minor league baseball, and open talks with the MLB Players Association regarding these issues.
• The National Football League, the National Collegiate Athletic Association and the International Olympic Committee have also banned Ephedra supplements. The deaths of three other prominent athletes, all football players — Korey Stringer of the Minnesota Viking, Rashidi Wheeler of Northwestern University, and DeVaughn Williams of Florida State University — have also been linked to herbal supplements containing ephedra. The NFL has joined with the Blue Cross Blue Shield Association and other sporting organizations to press for stronger federal regulation of anabolic steroids and ephedra products. (14)
• The American Council on Exercise, America’s Authority on Fitness and “workout watchdog” issued a statement in April 2003 urging Americans to avoid use of supplements containing ephedra and to consult their physicians before taking any dietary supplement.
Concerned about the delay in federal action to ban ephedra, state and local governments are enacting legislation to address the ephedra problem directly. However, most government officials we have talked to have clearly stated that they do not have sufficient resources to address public health problems caused by ephedra, and that they would prefer for the FDA to address the hazards posed by ephedra and other supplements.
• 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.
• In 2002, California passed legislation prohibiting the sale of products containing ephedra to minors. The bill also required clear and conspicuous labels that warn consumers of specific potential health risks such as heart attack, stroke and death; indicate that sales to persons under 18 are prohibited; and provide the toll free number for FDA Medwatch to report adverse events.
• In March 2003, Suffolk County, New York became the first county in the nation to ban the sale of herbal supplements containing ephedra to adults and kids. The Suffolk County bill was strongly supported by Karen and Tom Schlendorf of Northport, Long Island, whose son Peter died in 1998 after taking supplements containing ephedra while on spring break in Florida; and Doug Hanson, of Huntington, Long Island, whose wife passed away while working out in a gym after taking ephedra supplements in 1998.
• In May 2003, the state of Illinois banned the sale of dietary supplements containing ephedra. Persons who sell supplements containing ephedra in Illinois can now be charged with a Class A misdemeanor, punishable by imprisonment for less than one year and/or a fine of not more than $5,000 for a first offense.
• In July 2003, Westchester County, New York banned the sale of ephedra to adults, amending a recently passed law that prohibited sales to persons under 18.
• In August 2003, New York state banned the sale of dietary supplements containing ephedra.
• This month, California enacted legislation banning the sale, manufacture, and distribution of ephedra, which takes effect on January 1, 2004.
Over the last two years, several major national retail chains, including CVS, GNC, Eckerd and 7-Eleven have announced that they will no longer stock dietary supplement products containing ephedra. Several major manufacturers, including TwinLab, Nature’s Bounty, and Cytodyne, have also announced that they will no longer make and distribute supplements containing ephedra.
Consumer Reports and Consumer Reports on Health have published various articles regarding ephedra and other herbal supplements, and we continuing to investigate these issues. Our ongoing research suggests that:
• Herbal supplements containing ephedra are still widely available at lower-profile retail sites such as independent pharmacies, gas stations and truck stops, and convenience and health food stores.
• Ephedra is present not just in weight-loss supplements, the best known use, but also in supplements marketed as energy boosters or alternatives to street drugs such as ectasy and speed.
• Ephedra akaloids are turning up in supplements under names that consumers may not recognize: epitonin, Ma Huang, sida cordifolia and sinica.
• Labels listing ingredients are often in small print, and hard to decipher. Labels do not necessarily provide appropriate warning of potential hazards, or indicate how many milligrams of each substance are present.
• Many ephedra supplements contain caffeine and/or other herbal compounds that contain caffeine, such as guarana, kola nut, paulina cupana, and mate, as well as green and black tea. Some products appear to far exceed the recommended daily intake for caffeine of 300 milligrams.
• Consumers can’t necessarily rely on pharmacy or retail employees for accurate information about whether products contain ephedra or not.
It is important to realize that if and when ephedra is banned at the national level, we may see a variety of other dangerous, untested, unregulated herbal medicines drive right through the huge DSHEA loophole. There are certainly other herbal medicines that cause dangerous interactions that are also on the market today. While they have achieved less visibility, they are nevertheless of great concern to many medical professionals, researchers and patients. We have a serious concern that a variety of serious adverse events involving supplements that are less frequently taken will be overlooked, unless FDA and FTC are given adequate resources to investigate and take prompt enforcement actions.
To take just one example, herbal supplement companies are rushing to market with a variety of compounds to create “ephedra-free” herbal supplements. But as Dr. Paul Coates of the National Institutes of Health’s Office of Dietary Supplements has warned, “The fact that a dietary supplement is ephedra-free is not a indication of its safety.” (15)
Dangerous loopholes in DSHEA and the Controlled Substances Act that permit manufacturers to aggressively market and sell untested, unregulated steroid equivalents to the public, including persons under 18. A national survey conducted for the Blue Cross Blue Shield Association in 1999 found that 6 percent of youths ages 15 to 16 and 8 percent of 17- and 18-year-olds had taken a sports supplement. Yet as we noted in Consumer Reports magazine in June 2001, sports-medicine researchers have only tested products like androstenedione and creatine in adults.(16) There has been no systematic testing of these drugs in minors, and for ethical reasons, such tests probably will not be conducted. Because of serious safety concerns, numerous sporting and medical organizations, including the AMA and the American Academy of Pediatrics, believe that steroid precursors should be classified as Controlled Substances.
In April 2001, the Office of Inspector General at the Department of Health and Human Services concluded that FDA’s adverse event reporting system was “an inadequate safety valve” because of inadequate authority and organizational capacity to collect and take action on adverse event reports. (17) The report noted that in contrast to requirements for monograph drugs and new drug application (NDA) drugs, manufacturers of dietary supplements are not required to register their companies or their products with the FDA. As a result, the FDA does not have a list of supplement products and ingredients when it receives an adverse event report. The Inspector General found that FDA was unable to determine the ingredients for 32 percent of products mentioned in adverse event reports (AERs). It also lacked product labels for 77 percent of the products mentioned in the AERs, and product samples for 69 percent of products that it requested. For products referenced in the AERs, FDA was unable to determine the manufacturer for 32 percent of the products, and the city and state for 71 percent of manufacturers. (18)
1) The FDA should ban the sale of ephedra and untested steroid equivalents for both minors and adults. If the FDA believes additional legal authority is needed to act on these matters, we strongly urge the Congress to provide that authority.
At a minimum, we would support the provisions in the “Dietary Supplement Safety Act of 2003” (S. 722) that would require stimulants to be approved as new drugs, would declare foods containing unapproved stimulants to be adulterated, and prohibits the introduction into interstate commerce of a supplement containing a stimulant unless it is approved by the Secretary. These provisions would also be extremely helpful for addressing the hazards posed by herbal heart stimulants such as ephedra and steroid precursors.
2) Pre-market safety testing should be required for dietary supplements, particularly for stimulants deemed to be of special concern by FDA and other health authorities.
Many consumers are surprised to learn the government does not currently evaluate the safety of dietary supplements before they are sold.(19) This situation poses a serious risk to public health, and amounts to a vast, uncontrolled clinical trial on an unsuspecting public. Even Joseph Levitt, Esq., Director of the FDA’s Center for Food Safety and Applied Nutrition, testified in Congress in March 2001 that the current “regulation of dietary supplements is, for the most part, a post-marketing program.” (20)
We support the provisions in S. 722 that would authorize the Secretary of the Department of Health and Human Services (DHHS) to require the manufacturers of dietary supplements, or any ingredient in a dietary supplement to submit data demonstrating that the dietary supplement is safe. The Secretary would then be authorized to review the data and issue a determination that either the ingredient is safe and that continued marketing is approved, or that continued marketing is disapproved because either it is unsafe, or it has not been shown to be safe.
3) Dietary supplement manufacturers should be required to report adverse events to the FDA.
The current voluntary reporting system provides insufficient information for public health authorities to take prompt action regarding harmful products that put consumers at serious risk. We strongly support provisions in S. 722 that would require manufacturers, packers and distributors of dietary supplement products to collect, review, and report serious adverse events suffered by consumers using their products to the Secretary of the Department of Health and Human Services (DHHS), within 15 days of receiving notice of the event. In addition, the bill would require dietary supplement manufacturers to report on all adverse events to DHHS annually.
4) Post-marketing surveillance for dietary supplements should be improved.
We believe that the FDA must be given additional resources and a resounding mandate from the Congress to strengthen post-marketing surveillance of dietary supplements. As a first step, we support the provisions if S. 722 that would authorize the Secretary of DHHS to require manufacturers of dietary supplements to conduct postmarket surveillance if the Secretary determines that consumer use of a manufactured dietary supplement may result in serious adverse events.
Once again, I thank Chairman McCain, and Ranking Member Hollings and the Committee for the opportunity to testify, and I look forward your questions.
(1) Consumers Union is a nonprofit membership organization chartered in 1936 under the laws of the State of New York to provide consumers with information, education and counsel about goods, services, health, and personal finance. Consumers Union’s income is solely derived from the sale of Consumer Reports, its other publications and from noncommercial contributions, grants and fees. In addition to reports on Consumers Union’s own product testing, Consumer Reports with approximately 4million paid circulation, regularly carries articles on health, product safety, marketplace economics and legislative, judicial and regulatory actions that affect consumer welfare. Consumers Union’s publications carry no advertising and receive no commercial support.
(2) 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).
(3) Ibid.
(4) 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
(5) 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.
(6) Samuenk, D. et al. Adverse cardiovascular events temporally associated with Ma Huang, an herbal source of ephedrine. Mayo Clin Proc. 2002;77:12-16.
(7) Shekelle, P.G., Hardy, M.L. Morton, S.C. et al. Efficacy and safety of ephedra and ephedrine for weight loss and athletic performance: a meta-analysis. JAMA 2003; 289: 1537-1545. March 23, 2003
(8) Ibid.
(9) Fontanarosa, P., Rennie, D., DeAngelis, C.D. The Need for Regulation of Dietary Supplements—Lessons from Ephedra, JAMA 2003: 289: 1568-1570 March 23, 2003
(10) Cytryn, R. “Weight Loss Aids, Energy Boosters Potentially Hazardous,” PR Newswire, January 24, 2002.
(11) Neergaard, L. Feds investigate top ephedra seller, Associated Press, August 15, 2002.
(12) Crabtree, P. Metabolife understated danger: firm glossed over complaints about herb ephedra, panel told. San Diego Union Tribune, October 9, 2002.
(13) 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.
(14) Associated Press, “NFL supports supplement regulation laws,” May 2, 2003.
(15) Jill Burcum, “Your Health: Ephedra-free products loaded with new herbs of concern,” Minneapolis Star Tribune, April 29, 2003.
(16) “Sports Supplement Dangers,” Consumer Reports, June 2001, p. 40.
(17) Office of Inspector General, Department of Health and Human Services, “Adverse Event Reporting For Dietary Supplements: An Inadequate Safety Valve,” April 2001, OEI-01-00-00180.
(18) Ibid, p. ii.
(19) For example, see “Widespread Ignorance of Regulation and Labeling of Vitamins, Minerals and Food Supplements,” Healthcare News, Harris Interactive, December, 2002; and Blendon, R. et al., “Americans’ Views on the Use and Regulation of Dietary Supplements,” Arch. Intern. Med., Vol 161, March 26, 2001, p. 805-810.
(20) Statement by Joseph Levitt, Esq., Director, CFSAN/FDA, before the Committee on Government Reform, March 20, 2001, available on the Web at http://www.fda.gov/ola/2001/dietary.html