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HHS acts to reduce potential risks of dietary supplements containing ephedra

[MARCH 1, 2003]  On Friday the Department of Health and Human Services, HHS, announced a series of actions designed to protect Americans from potentially serious risks of dietary supplement products containing ephedra.

The results of a RAND Corporation study commissioned by the National Institutes of Health, as well as other recent studies, provide additional evidence that ephedra may be associated with important health risks. The RAND report also finds only limited evidence of health benefits resulting from ephedra use.

On the basis of new evidence in the medical literature and in adverse event reports, there are reasons for heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury.

To protect Americans from the potentially serious risks of these dietary supplements, HHS and the Food and Drug Administration are going to:

--Seek rapid public comment on the new evidence on health risks associated with ephedra in order to establish an up-to-date record as quickly as possible to support new restrictions on ephedra-containing products.

--Seek rapid public comment on whether the currently available evidence and medical literature present a "significant or unreasonable risk of illness or injury" from dietary supplements containing ephedra.

--Seek rapid comment on a strong new warning label on any ephedra products that continue to be marketed.

--Immediately execute a series of actions against ephedra products making unsubstantiated claims about sports performance enhancement.

In addition, the nation's top public health officials issued strong statements cautioning about the use of ephedra-containing products, especially under conditions of strenuous exercise and in combination with other stimulants, including caffeine.

"We want to caution all Americans -- particularly athletes and those who engage in strenuous activities -- about using dietary supplements that contain ephedra," said Secretary of Health and Human Services Tommy G. Thompson. "There continue to be serious questions about the risks surrounding this particular dietary supplement."

"FDA will do all we can to protect Americans from potentially dangerous dietary supplements," said Commissioner of Food and Drugs Mark B. McClellan, M.D., Ph.D. "We are particularly concerned about the risks of using products containing ephedra during heavy workouts, with caffeine and other stimulants, in a diet program that stresses the cardiovascular system, or by people under the age of 18. We are also concerned about potential stresses to the body caused by the long-term use of ephedra. The standard for regulating the safety of dietary supplements is largely untested, but we are committed to finding the right public health solution."

Ephedra is a naturally occurring substance derived from the Chinese herbal Ma Huang. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. While products containing natural ephedrine alkaloids have long been used to treat certain respiratory symptoms in traditional Chinese medicine, in recent years they been extensively promoted and used with the goals of aiding weight loss, enhancing sports performance and increasing energy.

Many of today's proposed actions involve a Federal Register notice, which went on display Friday, reopening for 30 days the comment period on a draft regulation FDA first proposed in 1997 and modified in 2000. [The notice is in Adobe Acrobat. Click here to download the Adobe Acrobat reader.]

FDA's concerns about dietary supplements containing ephedra arise in part from ephedra's mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the nervous system and heart.

In addition, evidence is accumulating about potentially serious safety problems following the use of ephedra-containing products. The RAND study has concluded that ephedra is associated with higher risks of mild to moderate side effects, such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity, such as tremor and insomnia, especially when it is taken with other stimulants.

Moreover, its review of some 16,000 adverse event reports revealed two deaths, four heart attacks, nine strokes, one seizure and five psychiatric cases involving ephedra in which the records appeared thorough and no other contributing factors were identified. RAND called such cases "sentinel events," because they may indicate a safety problem but do not prove that ephedra caused the adverse event. The study recognized that such case studies are a weak form of scientific evidence. Other unmeasured factors may have contributed, and such serious adverse events are likely to happen (albeit at very low rates) among the millions of users of ephedra anyway. The study also identified other such events potentially associated with ephedra in which other factors may have contributed to the adverse events or in which records were inadequate.

Two recent studies of ephedra's safety were published too late to be included in the RAND Corporation's review, and each raises further concerns about ephedra. One, published this month in the Annals of Internal Medicine, found that although ephedra-products make up less than one percent of all dietary supplement sales, these products account for 64 percent of adverse events associated with dietary supplements.

Another "case-control" study, published in the journal Neurology, concluded that for people who take doses above 32 milligrams a day, the rate of hemorrhagic (bleeding) strokes among ephedra users was statistically significantly higher than among nonusers. Many ephedra dietary supplement labels recommend that users take up to approximately 100 mg of ephedra daily.

Additional relevant evidence on whether the current system of regulating ephedra's safety is adequate comes from results under FDA's more extensive regulation of synthetic ephedrine, which is identical to the main active ingredient in ephedra. Ephedrine has long been available in some FDA-approved over-the-counter and prescription drugs. It appears that the more controlled availability of synthetic ephedrine products, which are available primarily for approved uses for respiratory symptoms and carry mandatory warning labels, has not been associated with the same kind of severe adverse events as have occurred with dietary supplements containing ephedra. This long experience with synthetic ephedrine (in over-the-counter drug products, not in dietary supplements) suggests that significant restrictions on labeling, marketing and access to ephedrine might effectively address unreasonable risks associated with certain forms of ephedra today.

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"Although the overall evidence suggests that serious adverse events from ephedra appear to be infrequent, we know that such events can be very serious and possibly fatal," said Dr. McClellan. "We believe that the current scientific evidence strongly suggests that at least some ephedra products present an unreasonable risk. We also believe that FDA's system for regulating synthetic versions of the chemicals in ephedra appears to have a much better track record of safety. To give us the strongest possible basis for further regulatory action, we are asking for quick comments on whether these dietary supplements present an unreasonable risk of harm and whether it makes sense for FDA to seek new authority in this area."

Under the Dietary Supplement Health and Education Act of 1994, FDA does not review dietary supplements for safety and effectiveness before they are marketed. Rather, the law allows FDA to prohibit sale of a dietary supplement if it "presents a significant or unreasonable risk of injury." This legal standard of "significant or unreasonable risk" implies a risk-benefit calculation based on the best available scientific evidence. It strongly suggests that the agency must determine if a product's known or supposed risks outweigh any known or suspected benefits, based on the available scientific evidence, in light of the claims the product makes and in light of the product's being sold directly to consumers without medical supervision.

In seeking comment on these issues, FDA is reopening a proposed rule entitled "Dietary Supplements Containing Ephedrine Alkaloids." That proposal would have required a warning statement for these products, as well as restrictions on their potency and composition. FDA later withdrew parts of this proposed rule because of concerns expressed by the General Accounting Office about the specific scientific evidence in the proposal.

In a broad action against potentially dangerous products, FDA sent more than two dozen warning letters on Friday to firms marketing dietary supplements that contain ephedrine alkaloids. The letters, targeted particularly at products making claims for athletic performance, explain that any claims their products make about effects on the structure and function of the human body must be truthful and not misleading. They outline FDA's view in light of the RAND report that the claims being made are not adequately substantiated by scientific data, and they direct the companies to submit any data supporting the claims within 15 days.

The letters also warn firms that they must not make claims about their products' ability to treat or cure a disease or condition such as obesity. Under the Federal Food, Drug and Cosmetic Act, unapproved products making these "disease claims" are unapproved new drugs and therefore subject to other prompt regulatory actions, including injunctions against firms and seizures of their products.

FDA will also continue to work closely with the Federal Trade Commission to ensure that dietary supplement products containing ephedra do not make false and misleading claims. "If an ad says a product is 'safe,' the advertisers must have competent and reliable evidence to prove the claim," said Timothy J. Muris, chairman of the Federal Trade Commission. "Consumers depend on advertising for information. Deceptive ad claims can put a consumer's health at risk. That's why we will pursue aggressively marketers making deceptive claims about the safety or effectiveness of products."

On Friday the FDA also proposed a warning label for all ephedra-containing dietary supplements. The proposed label warns about the risks of serious adverse events, including heart attack, seizure, stroke and death; cautions that the risk can increase with the dose, with strenuous exercise and with other stimulants such as caffeine; specifies certain groups (such as women who are pregnant or breast-feeding) who should never use these products; and lists other conditions, such as diseases and the use of certain medications, that rule out the use of ephedrine alkaloids.

"The steps being announced today demonstrate FDA's commitment to taking the most effective actions possible under current law, given the state of the scientific evidence," said Dr. McClellan. "It may be possible to use ephedra safely, in small doses, for some purposes. But in the face of continued serious adverse events following the use of ephedra, there is a problem. It is a problem we are determined to fix."

Once the 30-day comment period has ended, FDA will analyze the comments and publish its conclusions about the most appropriate approach to reducing the risk of using dietary supplement products containing ephedrine alkaloids.

The National Advisory Council for the National Center for Complementary and Alternative Medicine, part of NIH, is meeting March 17 to assess the evidence on ephedra's safety and effectiveness in order to develop a research agenda on ephedra. FDA will give that committee an opportunity to comment on Friday's notice if the committee finds it appropriate to do so.

All interested parties may send the FDA written comments on these issues involving ephedra until April 7. Comments may be sent electronically to www.fda.gov/dockets/ecomments or by regular mail to Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Additional materials about the risks of products containing ephedrine alkaloids, including a more technical FDA "white paper," may be found on FDA's website at the following addresses:

• White paper

• Fact sheet

• Sample warning letter

• List of warning letters

• Federal Register [The notice is in Adobe Acrobat. Click here to download the Adobe Acrobat reader.]

• "Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects" (RAND report)

• Summary of the RAND report on ephedra

• Additional background on ephedra

[Food and Drug Administration press release]

What you need to know about ephedra

[FEB. 22, 2003]  Ephedrine, also known as ephedra or ma huang, has injured or killed 800 users.

Products containing ephedrine

Super Cap & White Cross

Yellow Jacket

Black Beauty

What is ephedrine?

What are ephedrine, ephedra and ma huang?

These terms are used to refer to the same substance derived from the plant ephedra. Ephedrine supplements are derived from the dried branches of the plant known as ephedra. Ephedra grows primarily in Mongolia and parts of China. In the United States, ephedra and ephedrine are sold in health food stores under a variety of brand names. Ephedrine is widely used for weight loss, as an energy booster and to enhance athletic performance. These products often contain other stimulants, such as caffeine, which may have collective effects and increase the potential for adverse effects.

Ephedra contains ephedrine, a stimulant that acts on the central nervous system. It is found in products such as Metabolife, Yellow Jackets, Stacker 2, Black Beauties and other products. The FDA believes that ephedra may be related to numerous deaths. Most of the serious injuries involve high blood pressure that can cause bleeding in the brain, a stroke or a heart attack. Ephedrine alkaloids are amphetaminelike compounds used in over-the-counter and prescription drugs with potentially lethal stimulant effects on the central nervous system and heart.

Dangers

Ephedra is one of the most dangerous of the dietary supplements. People continue to believe that because herbs are "natural" they are harmless. Dietary supplements may interact with prescription, as well as over-the-counter, medications. However, many dietary remedies are dangerous, such as creatine.

There is limited research evaluating creatine's safety and usefulness. The FDA does not regulate creatine, an over-the-counter drug that has been marketed to enhance sport performance. Adverse effects associated with the use of creatine include muscle strain, stomach upsets and kidney problems.

Recent studies show that many people are seriously injured by the use of ephedrine. They are often unaware that ephedrine suppliers can make wide-ranging health claims about the product that have no scientific basis.

FDA warnings

No-Doz and Vivarin are other types of over-the-counter drugs that advertise increased alertness. These caffeine tablets can cause nausea, insomnia, tremors, irritability, depression, chest pain and dizziness.

"The FDA is warning consumers not to purchase or consume ephedrine-containing dietary supplements with labels that often portray the products as apparent alternatives to illegal street drugs such as 'ecstasy.' Possible adverse effects of ephedrine range from clinically significant effects such as heart attack, stroke, seizures, psychosis and death, to clinically less significant effects that may indicate the potential for more serious effects (for example: dizziness, headache, gastrointestinal distress, irregular heartbeat and heart palpitations). Ingredient panels on these products may list ma huang, Chinese ephedra, ma huang extract, ephedra, ephedra sinica, ephedra extract, ephedra herb powder or epitonin, all [of] which indicate a source of ephedrine."

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Dietary supplements do not need approval from the FDA before they are marketed. Also, manufacturers do not need to register themselves or their dietary supplement products with the FDA before producing or selling them.

Deceptive marketing

A law known as the Dietary Supplements Health and Education Act, which was passed in 1994, prevents the FDA from regulating these products. Prior to this act about supplements, the FDA claimed it had the power to regulate them and tried to make the manufacturers and suppliers prove their safety claims for their products.

The use of herbs in the United States has increased dramatically since the passage of the act. In 1997, 60 million Americans spent $3.24 billion on herbs for reasons such as migraines, hypertension, depression, weight loss and sexual stamina. An estimated 15 million adults are at risk for potential herb-drug interactions.

Deceptive marketing occurs when the supplement industry selects brand names or uses wording on labels such as "fat burner" or "detoxifies" or "natural ecstasy" to suggest the impossible.

Contact the FDA

If you think you, or someone you know, have suffered a serious harmful effect or illness from a product the FDA regulates, including dietary supplements, the first thing you should do is contact or see your health care provider immediately. Then you and your health care provider are encouraged to report this problem to the FDA. You, or anyone, may report a serious adverse event or illness directly to the FDA, by calling 1 (800) FDA-1088 or by fax to 1 (800) FDA-0178. The identity of the reporter or patient is kept confidential.

If you, or someone you know, is addicted to any drug, contact Logan-Mason Mental Health for treatment options.

[Logan-Mason Mental Health]

This pamphlet material was developed by Kristi Lessen, N.I.S., Logan-Mason Mental Health substance abuse prevention specialist, in collaboration with Richard Alexander, M.D., medical director of Mental Health Centers of Central Illinois and medical director of Memorial Behavioral Health Group. The pamphlet is paid for in part by the Illinois Department of Human Services.

Logan-Mason Mental Health

(A division of Mental Health Centers of Central Illinois)

304 Eighth St.

Lincoln, IL 62656

(217) 735-2272

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CICBC blood drives monthly at paramedics' building

Schedule for 2003 announced

Blood supplies across the nation are critical. In some areas, there is less than a one-day supply. Fortunately, thanks to the dedicated donors in central Illinois, these tremendous shortages have not yet touched our hospitals. However, the blood supply is a resource that must be renewed. Every three seconds someone needs a blood transfusion of some kind. To accommodate this constant usage, community members must continually help replenish the supply. Since a donor can donate whole blood only every eight weeks, Central Illinois Community Blood Center needs community members to come forward and help with this lifesaving effort.

Central Illinois Community Blood Center provides all of the blood and blood products for 12 area hospitals, including those in Lincoln, Hopedale and Springfield. No other organization provides blood in these hospitals. CICBC is a community-based blood center whose mission is to provide a safe and adequate blood supply for patients in local hospitals in a cost-effective manner.

When you donate blood through CICBC, you help to keep a safe and adequate blood supply for your community. You also help keep local medical costs under control. Regularly scheduled blood drives are on the first Monday of each month (except Labor Day) at the Logan County Paramedics Association building, 1300 N. Postville Road. (See 2003 schedule below.) Please help by donating blood.

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CICBC will also bring its automated double red cell machine, and if donors are interested in platelet apheresis, information will be available. If there is enough interest, CICBC will bring apheresis machines to Lincoln.

CICBC also provides other services for the communities served, such as therapeutic phlebotomy at no charge for patients with hereditary hemochromatosis.

For more information, call Terry Bell at 753-1530.

[CICBC press release]

• March 3, noon-6 p.m., at Logan County Paramedics Association building

• March 12, hours and location to be announced

• April 7, noon-6 p.m., at Logan County Paramedics Association building

• April 11, at Lincoln Community High School

• May 5, noon-6 p.m., at Logan County Paramedics Association building

• May 14, hours and location to be announced

• June 2, noon-6 p.m., at Logan County Paramedics Association building

• July 7, noon-6 p.m., at Logan County Paramedics Association building

• July 15, hours and location to be announced

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• Aug. 4, noon-6 p.m., at Logan County Paramedics Association building

• Sept. 8, noon-6 p.m., at Logan County Paramedics Association building

• Sept. 24, hours and location to be announced

• Oct. 6, noon-6 p.m., at Logan County Paramedics Association building

• Nov. 3, noon-6 p.m., at Logan County Paramedics Association building

• Nov. 12, hours and location to be announced

• Dec. 1, noon-6 p.m., at Logan County Paramedics Association building

The Rural Health Partnership has announced the schedule for its mobile health unit for 2002.

For more information on the mobile health unit schedule and services, contact Dayle Eldredge at (217) 732-2161, Ext. 409.

Community resource list

This family resource list to save and use is provided by the Healthy Communities Partnership and the Healthy Families Task Force, 732-2161, Ext. 409.         

(updated 2-15-02)

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