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FOR IMMEDIATE RELEASE: February 1, 2004

SCHUMER WARNS THAT NEW EPHEDRA BAN DOESN'T DO ENOUGH – 15 EPHEDRA CLONES THAT DODGE BAN ALREADY ON SALE IN NEW YORK

FDA admitted last week that dietary supplements like Bitter Orange now being marketed as ephedra substitutes may be as deadly as ephedra - but FDA ban doesn't apply to copycats

It took the NFL less than 2 months to ban ephedra while
it took the FDA over 8 years to do the same thing

Schumer asks FDA for immediate ban before ephedra copycats have similar tragic results

On Super Bowl Sunday and with the Food and Drug Administration's ban on the dietary supplement ephedra now taking effect after eight years of delay, US Senator Charles E. Schumer today released a new survey finding that New Yorkers are simply switching to 15 or more ephedra copycat products that work the same way, have similar physiological effects, and possibly pose similar risks to users. Rather than going through years of bureaucratic review while injuries and deaths mount, Schumer today asked the FDA to apply what it learned from ephedra and ban the most similar of its replacements -- Bitter Orange -- immediately along with two others it has already warned against.

"It took the FDA more than eight years to go from warning people that ephedra is dangerous to actually banning it. In that time, at least 155 people died from it," Schumer said. "Just last week they said they were going to start studying the ephedra replacement Bitter Orange. Well, that's not good enough: ephedra is a killer, and Bitter Orange is its kissing cousin. With the ephedra ban spurring an increasing number of people to start abusing Bitter Orange, we could soon see the same horrible results. We don't need studies to confim what we already know, we need action."

On December 30, the FDA announced that it would ban the weight-loss aid ephedra, saying it is unsafe and can cause heart attacks and strokes. But Schumer revealed today that the agency first warned consumers not to buy or use the supplements containing ephedra in April, 1996 – long before the controversial supplement became popular and widely used. According to the FDA, it had been investigating the supplement prior to issuing its 1996 warning. In all, it took over 8 years for the FDA to pull ephedra from the shelves -- including a year of intense pressure from Schumer and other Members of Congress.

Schumer noted that in contrast to the FDA's 8 years of study, the National Football League banned ephedra less than 2 months after the Minnesota Vikings 's Korey Stringer tragically died from it at training camp. Stringer, a Pro-Bowl right tackle, died of heatstroke on the opening day of practice in August 2001.

Last week, in a speech at the University of Mississippi, FDA Commissioner Dr. Mark B. McClellan admitted that several questionable dietary supplements are now being marketed specifically ephedra substitutes because they work in similar ways and may have similar effects. Dr. McClellan specifically cited the supplement Bitter Orange – also called citrus aurantium – that contains the chemical stimulant synephrine.

Dr. McClellan announced that his agency is planning on stepping up scrutiny of Bitter Orange specifically because consumers are now using it as an ephedra replacement. Scientists say that Bitter Orange works like ephedra does, by increasing blood pressure and constricting blood vessels. Scientists also warn that using Bitter Orange with caffeine can exacerbate these effects – ephedra users typically combined that supplement with caffeine to enhance results.

Dr. McClellan also announced that two other herbal supplements that are used in weight loss supplements – usnic acid and aristolochic acid – face new FDA scrutiny. But Schumer pointed out today that the FDA already warned against using both of these products in 2001 and questioned whether the extra delays that these studies create is necessary.

The FDA first advised consumers to stop the use of any botanical or natural products that contain aristolochic acid on April 2001, having already warned doctors about the risks of the product in May 2000. In 1999, the Canadian version of the FDA, Health Canada, warned consumers not to use products containing the herb that produces aristolochic acid without checking with a doctor. In 2001, both Canada and Australia warned against all use of the herb, and drugs using the herb have been banned in Germany since 1981.

And in November 2001, the FDA warned consumers not to use Lipokinetix, an early dietary supplement for weight loss that contained usnic acid. At the time, the agency wrote to the manufacturer, Syntrax Innovations to "strongly recommend" that the product be taken off the market following illnesses and a death in California. The company discontinued the product before the FDA could act further.

Schumer today released a new study that found 15 new dietary supplements containing Bitter Orange are now commonly available in the New York metropolitan region. These products, which are produced by 13 different dietary supplement companies, contain Bitter Orange in amounts ranging from 500 milligrams to 20 milligrams per dosage.

Schumer explained that three of these supplements contain Bitter Orange in "complexes" -- they are mixed with other substances and only the total weight of the combination is disclosed on the package label. Under federal laws and regulations, dietary supplement manufacturers are not required to list the specific amounts of individual ingredients in their products. Schumer said today that this means customers often do not know precisely how much of specific chemicals they may be ingesting if they use dietary supplements.

And Schumer also noted that every one of the Bitter Orange supplements his survey identified also contains some form of caffeine, though the amount of that caffeine is rarely disclosed. Because caffeine increases the tendency of Bitter Orange to increase blood pressure and constrict blood vessels, Schumer said that unknown amounts of Bitter Orange along with unknown amounts of caffeine can be a particularly dangerous combination.

Based on the results of his study, Schumer today asked the FDA to ban Bitter Orange, usnic acid and aristolochic acid. In a letter to Dr. McClellan, Schumer wrote, ''As people switch from ephedra to alternatives that make similar promises and work in similar ways, we must act now to prevent similarly tragic and widespread consequences. One can only hope that we learned something from our experience with ephedra. We agree that Bitter Orange use is skyrocketing, and we shouldn't have to wait for years -- or for deaths -- to act."

Schumer also noted that ephedra products were marketed to teens, and their replacements appear to be particularly popular among teen athletes. He asked Dr. McClellan to target teen populations with information campaigns about ephedra copycats, and told parents to watch out for their teens using ephedra replacement products like Bitter Orange.

"Bitter Orange may sound harmless, but evidence points to it being anything but. Ephedra was a killer, and the FDA must move much more quickly this time to protect us from dietary supplements by another name that could be just as deadly," Schumer said.

Senator Schumer was joined today by Dr. Gary Wadler, an expert on performance-enhancing drugs who is an Associate Professor of Clinical Medicine at NYU School of Medicine and a Senior Attending Physician at North Shore University in Manhasset. Dr. Wadler is Chairman and President of the Nassau County Sports Commission and Chair of the American College of Sports Medicine's Health and Science Committee. He is also a recipient of the International Olympic Committee's President's Prize for his work in the field of drugs and sports and is a member of the Board of Directors of OATH (Olympic Advocates Together Honorably), whose Policy and Advocacy Committee he co-chairs.

For a copy of Schumer's letter to Commissioner McClellan please click here.

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