Senator Charles J. Fuschillo, Jr., chairman of the Senate Consumer Protection Committee, recently hosted a public hearing to gather testimony on legislation to ban over-the-counter sales of ephedra in New York State. Testimony was collected from the family of a 20-year-old Northport man and the husband of a 37-year-old Huntington woman who both died after consuming a diet supplement that contained ephedra. In addition, testimony was acquired by Major League Baseball Commissioner Bud Selig, representatives from the National Football League, National Hockey League, American Heart Association, medical professionals, and the diet supplement industry.
"When it comes to weight-loss, people seek the magic bullet that promises to shed pounds fast and easy," Fuschillo said. "When they buy products that contain ephedra from over-the-counter at their local convenience or drug store, they are ingesting a product that has not been approved by the Federal Drug Administration and has a track record of costing lives of young and healthy people. This hearing will collect testimony to determine whether existing regulation of products containing ephedra provide an appropriate level of protection for consumers."
According to Fuschillo, the legislation would ban the sale of dietary supplements containing ephedra and would not apply to any drug containing ephedra sold through a prescription by a licensed physician. Some products that contain ephedra include Stacker 2, Stacker 3, Ripped Fuel and Xenadrine.
Ephedra is an herbal dietary supplement sold as a weight-loss aid and muscle-builder. Since it is classified as a dietary supplement instead of a drug, it has thus far been difficult for the Federal Drug Administration (FDA) to regulate the substance despite thousands of reports of serious side effects including seizures and heart attacks. The Dietary Supplement and Health Education Act of 1994 limited the FDA's authority to regulate dietary supplements without prior governmental review. The FDA has been calling for stricter regulations since 1997 and has been collecting evidence regarding consumer use of ephedra and has linked at least 100 deaths to the product.
In 1996, 20-year-old Peter Schlendorf of Northport took ephedra as part of a muscle building supplement. According to reports, with no recommended dosage on the label, he and his friends took several pills each. The cause of Peter's death, according to the Florida coroner: "cardiac arrhythmia caused by an herbal supplement containing the drug ephedra."
While ephedra has already been banned by the International Olympic Committee, the National Football League, National Collegiate Athletic Association and Minor League Baseball, it may be best related to the death of 23 year old Baltimore Orioles pitcher Steve Bechler on February 17, 2003. He was found to have ephedra in his system after he died of a heat stroke on an 81 degree day with only 72 percent humidity. At the time of his collapse during practice, his body temperature was 108 degrees and his organs were shutting down one by one.
Ephedra can promote heatstroke by speeding the metabolism which causes body temperature to rise while constricting blood vessels in the skin preventing the body from cooling itself efficiently and by making the user feel more energetic and less fatigued.
In his testimony, Major League Baseball Commissioner Allan H. (Bud) Selig stated, "I amended the drug policy which covers all of minor league baseball to ban the use of ephedra and to require periodic testing of all players. At the Major League level, the players are represented by a union. Under the federal labor laws, I am not free to unilaterally adopt a ban on ephedra without an agreement. I urge [Senator Fuschillo] to consider and adopt appropriate regulation which will have the effect of making it more difficult for young people, as well as professional athletes, to use dangerous products such as ephedra. I have also urged the federal government to take appropriate regulatory action."
Dr. Rudoph Leibel, an obesity researcher at Columbia University, recently told The New York Times that doses sold in the supplements often provide the equivalent of 75 to 90 milligrams of a day of ephedrine and many companies mix it with caffeine. When doctors prescribe it for weight loss, however, patients usually receive about 25 milligrams a day.
"Based on the existing medical evidence, and the ease with which ephedra can be obtained and used by the general public, the NHL does not believe that existing governmental regulation of products containing ephedra provides an appropriate level of protection for consumers," William L. Daly, executive vice president, National Hockey League, said in his statement. "The NHL, therefore, applauds and supports the New York State Legislature's inquiry into these issues, and its exploration of possible restrictions on the sale of non-medicinal ephedra products at the state level."
"This stimulant, which is often found in products advertised for weight loss and enhanced energy, has become increasingly popular among both professional and amateur athletes," said NFL Commissioner Paul Tagliabue in a statement read at the hearing. "Last December, players and clubs were alerted to the risks of ephedrine... There is growing evidence linking ephedrine to fatal heart rhythm difficulties, strokes, thermo-regulartory problems, seizures and other serious conditions." On Sept. 26, 2001, the NFL became the first professional sports league to ban the use of ephedrine and other related stimulants.
National retailer General Nutrition Centers (GNC) announced it will stop selling products containing ephedra by the end of June, 2003. GNC has more than 5,300 retail stores in the US and 26 foreign markets, including Canada and Mexico. Long Island based Twin Labs, a leading health and wellness company, announced on its web site that it will also discontinue manufacturing products with ephedra.
In a memorandum in support of Senator Fuschillo's legislation, the Medical Society of the State of New York stated "Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the nervous system and heart. The RAND (Research And Development, a non-profit organization) 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."
Fuschillo said the United States poison control centers reported 1,178 adverse reactions to ephedra dietary supplements in 2001. The American Medical Association and American Heart Association have advised people not to use ephedra because it may cause heart attack or stroke.
"The diet supplement business is a $16 billion industry that refuses to acknowledge the dangers of ephedra," Fuschillo said. "Therefore, a state law is necessary to protect the residents of New York State by prohibiting over-the-counter sales of ephedra."