Few herbs have generated more controversy than ephedra. This ancient and unpretentious-looking plant (it resembles a stubby broom) contains a class of chemicals called alkaloids, which are among nature’s most potent and useful medicines. Morphine, quinine, and caffeine are other well-known alkaloids (look for the -ine suffix to identify an alkaloid), as is ephedrine, the key substance that gives ephedra its “kick”.
Before ephedra reached its current popularity in the United States, Chinese healers understood that ma-huang, the classical Chinese name for various Ephedra species, “releases the exterior and disperses cold” and “facilitates the movement of lung chi (or life’s energy) and controls wheezing,” according to D. Bensky and A. Gamble, authors of Chinese Herbal Medicine: Materia Medica (Eastland, 1993). The Chinese also used ephedra to treat asthma, colds, congestion, and coughs. They carefully controlled ephedra’s use, however, because they knew that ephedra could not only clear the bronchial passages, but also stimulate the central nervous system.
Such properties have made ephedra one of the top-selling herbs in the United States. Some estimates put sales of ephedra products at $750 million in 1995.
For some people, ephedra is truly a lifesaver, providing sufferers of chronic asthma and allergies with blessed relief when nothing else helps. For others, ephedra has become a symbol of the irresponsible use of herbs and a reason to clamp down on the herb industry.
Ephedrine was first isolated from ephedra in 1887 by Japanese chemist N. Nagai. In 1924, K. Chen of the Eli Lily Company recognized it as a useful bronchodilator—it relaxes the bronchial muscles so that airways can expand. Many drugs coming onto the market then contained ephedrine and became increasingly popular over time. The U.S. Food and Drug Administration (FDA) monograph for ephedrine was published on September 9, 1976. It is still sold as an active ingredient in many well-known pharmaceuticals, such as Primatene and Sudafed, but the ephedrine in these drugs is now synthetically made and known as ephedrine hydrochloride or pseudoephedrine hydrochloride. However, people with certain health conditions, such as heart or thyroid disease, hypertension, and diabetes, shouldn’t use products containing ephedrine because it increases the heart rate and systolic and diastolic blood pressure.
Too many of these pills will give the average person a memorable buzz because of its stimulant nature. It not only excites the central nervous system and raises blood pressure, but, according to some, also promotes thermogenesis, a heat-producing physiological process that can lead to weight loss and reduction of body fat.
During the early 1990s, several herbal formulators believed that a combination of ephedrine, caffeine, and aspirin would help burn body fat. These herbal formulas became a huge success and were quickly copied. Hundreds of products were sold containing ingredients such as extracts of ephedra (ephedrine), kola nut, green tea, guarana, caffeine, white willow bark (which contains salicylic acid, a precursor to aspirin), and chromium picolinate (a blood sugar regulator).
Testimonials of astonishing weight loss and increased energy fueled sales to new heights. The market for ephedrine products expanded to include not only those who wanted to lose weight, but also body builders looking for a pre-workout boost, college and high school athletes hoping for a competitive edge, and members of the “X” generation searching for a zing at concerts and raves. Names such as Herbal Ecstasy, Cloud 9, Exphoria, Fat Burner, and Thermoslim began appearing on market shelves.
Meanwhile, the dietary supplement industry launched a legislative campaign to curb what its members saw as the FDA’s unfair and punitive regulation of herbs and other dietary supplements. When Congress passed the Dietary Supplement Health and Education Act (DSHEA) in October 1994, the industry considered it an enormous victory. Not only did the law establish a new regulatory framework for all dietary supplements, including ephedra, it also required the FDA to demonstrate that a dietary supplement was unsafe before it could order its removal from store shelves.
Ephedra’s increasing popularity and the change in the FDA’s enforcement authority happened at about the same time, leading some ephedra promoters to become even bolder in promoting their products. In addition, the U.S. Drug Enforcement Agency (DEA) stepped in, claiming that ephedra extracts were used to make methamphetamine (illegal street speed), so they should be strictly monitored or controlled. Some states, including Ohio, New York, Texas, and Florida, took independent action and banned or limited the sale of ephedra. FDA officials even began questioning whether ephedrine should be used in over-the-counter asthma treatments.
Meanwhile, the FDA began receiving reports, as many as 600 of them by August 1995, that products containing ephedra were causing adverse reactions ranging from sleeplessness to heart attacks. While the majority of these complaints were traced back to a product called Formula One, FDA officials believed that the real problem was ephedra itself, which by now was an ingredient in hundreds of products and generating hundreds of millions of dollars in sales. Recognizing the political sensitivity of the issue, the FDA organized a committee of about twenty people with wide-ranging backgrounds, including myself, to review the adverse reaction reports, to listen to public testimony about how ephedra affected humans, and to seek advice about its future regulation. After two spirited days of discussion, committee members concluded that ephedra should not be removed from the market, but that stricter labeling standards and control of ephedrine levels in dietary supplements were warranted.
The FDA took no apparent steps to act on this advice. But when a college student died in Florida in 1996 after using an ephedra product, the FDA convened another expert advisory panel. This time, the FDA sought more specific advice about removing ephedra from the marketplace or at least drastically limiting its availability.
After another highly spirited two-day meeting in 1996—which then FDA Commissioner David Kessler attended—committee members again recommended that the amount of ephedrine available to the public be strictly limited, that labeling be strictly controlled, and that combining ephedra with herbs containing caffeine be avoided. As of this writing, the FDA has yet to take any action on this proposal.
In an open society, consumers are largely free to make choices about personal health and well-being. Underlying this freedom is an expectation that products being offered to consumers are what they say they are (meaning they are honestly labeled and can be consumed or used without unexpected risks or hidden dangers). The regulation of herbs generally, and ephedra specifically, offers a fascinating example of how the availability of products and information must go together. If the government wishes to ban something it believes to be harmful, it should first determine whether such products can be safely used and under which circumstances, and whether consumers can be properly informed about the risks and benefits. When the government blocks access to products, often the underlying demand for such goods will create a black market where there are few controls and remedies if things go wrong. Conversely, the FDA, until recently, seemed loathe to acknowledge that herbs have a useful and important role in our society, and it has resisted being part of a thoughtful process to give due respect to and find a proper place in society for these products.
Today the millions of consumers who have taken ephedra and the hundreds of companies who have used it in the manufacture of their products are part of a greater experiment, one which tests the underpinnings of a democratic society. How do you allow people to govern themselves, yet regulate or control unacceptable risks in the name of protecting the vulnerable and weak among us?
The final chapter to this story has yet to be written, but I hope that the question of ephedra regulation will lead us to higher ground, one where the industry is eager and willing to protect the health and interest of its customers, and where the government is willing to recognize that banning products and limiting free speech only serves to demean, not protect. There are likely to be other “ephedras” under the microscope of the FDA. That will give us yet more chances to ask how we shall govern ourselves—a question that government, industry, and consumers must ask themselves time and again.
So, from the scrubby little ephedra plant arises one of life’s great questions. Who would have thought?
Loren Israelsen is president of the LDI Group, a consulting firm that deals exclusively with dietary supplement and phytomedicine issues. He is the former president of Nature’s Way, a manufacturer of herbal supplements based in Utah.
Israelsen served as general counsel and vice president to the American Herbal Products Association and as industry liaison to the FDA’s expert advisory committee on ephedra. Here, he offers his view of where this controversial herb has been and where it may go.