Testimony Before the NY Senate Regarding Ephedra (5/30/03)

TESTIMONY OF
CONSUMERS UNION OF U.S. INC.

ON

PROPOSED NEW YORK STATE BAN
ON THE SALE OF DIETARY SUPPLEMENTS
CONTAINING EPHEDRA

BEFORE THE

NEW YORK STATE SENATE COMMITTEE ON CONSUMER PROTECTION

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

May 30, 2003

HERBAL SUPPLEMENTS CONTAINING EPHEDRA SHOULD BE BANNED IN NEW YORK STATE

Thank you for the opportunity to testify here today on behalf of Consumers Union(1). Consumers Union, the nonprofit publisher of Consumer Reports magazine and ConsumerReports.org, strongly supports New York state legislation to ban the sale of herbal supplement products containing ephedrine alkaloids and ma Huang (collectively referred to in this document as "ephedra."). We commend the New York State Senate Consumer Protection Committee for your leadership in addressing this difficult, critically important consumer issue.

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.

Prompt action by New York State to ban supplements containing ephedra will also help alert the public to this serious hidden danger in the marketplace. Unfortunately, the federal government may be unlikely to act for a protracted period, in part because of the huge lobbying muscle of the dietary supplement industry, which sells an estimated $17 billion in supplement products each year. We urge you to resist the vigorous pleadings of this special interest lobby that profits from the sale of these hazardous products.

THERE HAS BEEN NO PRE-MARKET SAFETY TESTING FOR HERBAL SUPPLEMENTS CONTAINING EPHEDRA

A huge loophole in federal regulation permits the sale of herbal supplements such as ephedra. The 1994 Dietary Supplement Health and Education Act (DSHEA) opened the floodgates to thousands of untested herbal products and handcuffed the Food and Drug Administration from performing effective oversight over what has since developed into a multibillion-dollar industry. As a result of DHSEA, herbal products are in effect deemed presumptively to be safe without any premarket safety review or testing. 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. To make matters, worse, companies are not required to report consumer complaints.

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.

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

Despite the fact that reporting for herbal supplements is only voluntary, the evidence we do have shows that ephedra has been linked to numerous deaths, heart attacks, strokes and seizures. According to the American Association of Poison Control Centers, accidental or intentional incidents involving ephedra result each year in thousands of consumers visiting emergency rooms and health care facilities for treatment.

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 health care facility. 48% of reported exposures occurred in individuals over 19 years of age.(4)

· 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.

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 cardiovascular toxic effects associated with ma Huang were not limited to massive doses." (5)

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.(6)

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.(7)

According to an editorial article that appeared in the same issue of 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.(8)

ADVERSE REACTIONS WITH OTHER MEDICATIONS IS A MAJOR SAFETY CONCERN

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.(9)

ADULT CONSUMERS ARE AT RISK, IN ADDITION TO CHILDREN

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.

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.(10) 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. (11)

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. (12)

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.

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.

· In New York, Westchester County, NY and Huntington, NY voted last year to ban the sale of supplements containing ephedra to minors. Westchester County is now considering a ban on over-the-counter sales to adults, and legislation for a comprehensive ban has also been proposed in New York City.

· In early March, Suffolk County, NY became the first county in the nation to ban the sale of herbal supplements containing ephedra to adults and kids. The Suffolk 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.

· On May 28, 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. (A copy of the Illinois "Ephedra Prohibition Act" is attached for reference.)

· 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 recent spring training death of 23 year-old Baltimore Orioles pitcher Steve Bechler has 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. (13)

· 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.

· 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.(14)

After years of controversy and rising legal claims relating to ephedra supplements, over the last few months some major manufacturers and retailers have decided to halt production and sales of herbal supplements containing ephedra.

· 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." In February, NTBY, Inc., another Long Island manufacturer, also announced that it would end sales of ephedra products.

· In January, the 7-Eleven Corp. and EAS, a major manufacturer of diet supplements, announced they would stop selling ephedra products.

· On May 3, General Nutrition Corp., a large retail chain that operates 5,300 retail stores, announced it would pull all ephedra supplements from its shelves by the end of June. (15)

HERBAL SUPPLEMENTS CONTAINING EPHEDRA SHOULD BE BANNED AT ANY LEVEL OF GOVERNMENT THAT WILL ACT TO PROTECT CONSUMERS

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.

With respect to federal action to address ephedra's dangers, in the face of mounting reports of serious adverse reactions, we have repeatedly asked the FDA to ban ephedra. We are stunned and very disappointed that the FDA has not moved forward to immediately ban its use. We believe their efforts to improve labeling are likely to be grossly inadequate to protect consumers against ephedra's known hazards.

The political influence of the supplements industry appears to be a major stumbling block to federal action.

On February 20, the New York Times reported that U.S. Secretary of Health and Human Services Tommy Thompson, when asked by reporters to comment on ephedra, replied, "I wouldn't use it, would you?"

And according to a March 10 article in Business Week:

Hill sources say that Secretary Thompson has complained in the past that he couldn't take action because of White House support for the industry, which insists that ephedra supplements are safe if taken as directed. (16)

But if this is true, the White House is not necessarily the only hurdle to consumer protection, as efforts for tougher regulation may face opposition from influential members of both parties in Congress as well.

We therefore believe that it is imperative for states and local governments to act to protect consumers. This is a serious problem, and it warrants prompt, serious efforts to protect consumers against the risk of heart attacks, seizures, strokes and other adverse events. We are greatly encouraged by the leadership that has been shown by state and local government in addressing this problem, and your persistent efforts are the key for getting an effective resolution of these issues.

ALTERNATIVES TO EPHEDRA MAY ALSO POSE SERIOUS HAZARDS

There is a larger lesson from the ephedra controversy, and that is that there are serious risks to permitting untested medications in the marketplace through the DSHEA loophole. Herbal supplements can in fact act in the human body as drugs or medicines. They can have a variety of biological or health effects that are hard to predict, and are not necessarily well understood. We don't know that much about how these supplements will affect people with pre-existing health conditions, or who are taking other medications or supplements. Further, we do not have an adequate post-marketing surveillance system to warn us about potential problems that may arise.

We do have a precedent for a time when untested medicines were sold to consumers in the U.S. At the turn of the century, untested patent medicines containing various harmless and highly toxic compounds were sold to consumers, and the backlash was severe, leading to the organization of the first wave consumer movement, and shortly thereafter, the Food and Drug Administration. The idea that companies would treat consumers as test subjects for a vast uncontrolled clinical experiment on the safety and efficacy of medicines was appalling to the public.

Over the years, consumers have come to rely on regulatory agencies to ensure that products that appear on the shelves in their local retail store or pharmacy have been tested and are safe for their use. The DSHEA loophole shoots a hole in this system. It is exposing us to a variety of risks, the true scope and dimensions of which we have little idea. Further, it externalizes the responsibility and cost of research away from the profit-seeking entrepreneurs who aggressively market these products, on to the backs of consumers and government.

Herbal supplement companies are now marketing a variety of products that may pose serious risks to consumers, but we do not necessarily have the scientific information or financial resources to analyze exactly what those risks may be. 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." (17)

According to a recent article in the Minneapolis Star-Tribune:

Medical experts are particularly concerned about a common ingredient in the products that is derived from an herb called bitter orange or Citrus aurantium. The fruit of the plant, which grows wild in Asia, contains in its peel a chemical called synephrine, long used in nasal sprays that treat cold symptoms. Because it's a stimulant, it's also promoted as a way to speed metabolism and lose weight.

[Dr. William J.] Gurley [associate professor at the College of Pharmacy at the University of Arkansas for Medical Sciences] said synephrine and ephedrine, the stimulant found in ephedra, are similar compounds.

Because of this, he said, it could cause many of the same problems as ephedrine. Gurley is unaware of any medical problems linked to bitter orange's use. The U.S. Food and Drug Administration (FDA) Web site lists no medical problems caused by the herb.
However, Gurley said because the products containing it are new, problems might not be evident for some time.

"With synephrine, we're where we were six to seven years ago with ephedrine," he said.

Dr. Christine Haller, an ephedra researcher, said she believes it's "a matter of time" before medical problems are reported in people using bitter orange weight-loss products.

Little research has been done to determine whether bitter orange is safe or effective in helping people lose weight, she said. Federal law does not require dietary supplement manufacturers to meet the same safety guidelines that drug manufacturers must.

"Consumers really are guinea pigs," said Haller, an assistant professor at the University of California, San Francisco.

Adding to the problem, said Haller and other experts, is that bitter orange often is mixed with many herbs. Dexatrim Results, for example, contains bitter orange along with several naturally occurring sources of caffeine, kelp, licorice root and yohimbe bark, which contains a potent stimulant called yohimbine that the FDA says is linked to kidney failure, heart problems and even death.

"I'm especially alarmed that yohimbe is in the mix in some of these products," Haller said. "I hadn't been aware of that."

Another product, Phen-Free, mixes bitter orange with yohimbe bark, cayenne pepper powder, caffeine and an herbal antidepressant called Saint-John's-wort, among others. (18)

So while ephedra supplements have been the marquee feature at the theater, there may be more horror films of this genre, and many sequels to follow. As soon as ephedra is banned, 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.
While it is tempting to treat the ephedra issue in isolation - and for the sake of the public's welfare, ephedra must immediately be banned - we also need to bear in mind that the system that created ephedra also puts us at serious, continuing risk. We will also have to promptly tackle the larger question of how dietary supplements can be effectively regulated.

As one modest but essential measure toward that goal, Consumers Union believes that companies that sell herbal supplements should be required to report adverse event complaints received from doctors and consumers to public health authorities. As the Office of Inspector General at the Department of Health and Human Services has documented, we do not have an adequate post-marketing surveillance system for herbal supplements.(19)

We are outraged by the apparent suppression of serious adverse event complaints by herbal supplement companies that sold ephedra products described above. This situation cries out for government intervention. If the federal government fails to act, we certainly hope that states will act to address this serious situation. If we do not know where the problems are, we cannot possibly begin to craft effective public health interventions.

For example, in California, the proposed Senate Bill 779 would require a manufacturer or distributor of a dietary supplements to send to the state health department 4 times a year a copy of all adverse event reports and consumer health complaints that they receive about their products. The bill would authorize the department to charge a fee to cover the cost of reviewing these materials.

Along with pre-market safety testing, mandatory reporting of adverse events involving herbal supplements, which is already required for pharmaceutical drugs and many over-the-counter products, is an essential first step for adequately policing the marketplace for herbal supplement products.

Thank you very much for the opportunity to testify here today. We look forward to your prompt action to ban ephedra for children and adults in New York State.

_____

Notes:

(1) Consumers Union, publisher of Consumer Reports magazine and ConsumerReports.org, is an independent nonprofit testing, educational and information organization serving only the consumer. We are a comprehensive source of unbiased advice about products and services, personal finance, health, nutrition and other consumer concerns. Since 1936, our mission has been to test products, inform the public and protect consumers.

(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) Samuenk, D. et al. Adverse cardiovascular events temporally associated with Ma Huang, an herbal source of ephedrine. Mayo Clin Proc . 2002;77:12-16.

(6) 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

(7) Ibid.

(8) 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

(9) Cytryn, R. "Weight Loss Aids, Energy Boosters Potentially Hazardous," PR Newswire, January 24, 2002.

(10) Neergaard, L. Feds investigate top ephedra seller, Associated Press, August 15, 2002.

(11) Crabtree, P. Metabolife understated danger: firm glossed over complaints about herb ephedra, panel told. San Diego Union Tribune, October 9, 2002.

(12) 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.

(13) Associated Press, "NFL supports supplement regulation laws," May 2, 2003.

(14) 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.

(15) Crabtree, Penni. "GNC to pull all ephedra items from shelves," Copley News Service, May 3, 2003.

(16) Carey, John. "The Feds May Lower the Boom on Ephedra," Business Week, March 10, 2003.

(17) Jill Burcum, "Your Health: Ephedra-free products loaded with new herbs of concern," Minneapolis Star Tribune, April 29, 2003.

(18) Ibid.

(19) Office of Inspector General, Department of Health and Human Services. "Adverse Event Reporting for Dietary Supplements: An Inadequate Safety Valve, April 2001.

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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