1999-10-06
Metabolife Maker Targets ABC News
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1) The maker of a dietary supplement is launching a pre-emptive strike against ABC News in advance of a ``20/20'' segment it believes will show the company in a negative light.
2) Metabolife International Inc. is posting on the Internet a videotape of an interview that its CEO, Michael Ellis, conducted with ABC News and is spending at least $1.5 million in advertising to call attention to it.
3) A full-page ad directing people to a Web site with the interview ran in today's edition of The New York Times.
4) ``What I'm concerned about is that the whole story won't be out there,'' Metabolife's CEO, Michael Ellis, said today. ```20/20' may, and I'm not saying they will, have a different agenda on how they want this story to go.''
5) An ABC spokeswoman confirmed ``20/20'' is working on a story that examines health claims made by Metabolife for its products. It has no scheduled air date.
6) ``They clearly think this is as important an issue as we do, or else they wouldn't have been devoting all these resources to rebutting a piece that they haven't seen yet,'' said Eileen Murphy, ABC News spokeswoman. ``It seems curious to us.''
7) Ellis said a ``20/20'' representative called to talk to Metabolife 10 days after the company filed a defamation lawsuit against WCBV-TV, an ABC affiliate in Boston, for a story it ran about potential harmful side effects to its products.
8) Metabolife fears the ``20/20'' story may be in retaliation for the lawsuit, Ellis said.
9) Murphy said WCBV's story was one of the reports that persuaded ABC to take its own look into Metabolife. But, she said, it was ``completely and utterly false'' that the assignment was made out of retaliation.
10) ABC's interview with Ellis was conducted in an auditorium before more than 300 Metabolife employees and their guests, and was videotaped by Metabolife. Ellis said this was done because he had so many requests from employees to see the interview, and was not an attempt to intimidate ABC.
11) Murphy said ABC agreed to conduct the interview before an audience because the network believed it was important to get Metabolife's side of the story.
1999-10-07
2000-04-17
2000-11-06
Herbal Stimulant May Be Deadly
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1) Ephedra, an herbal stimulant used by millions of Americans for bodybuilding and weight loss, can cause heart attacks, stroke, seizures and death in otherwise healthy young people, researchers say.
2) At least 54 deaths and about 1,000 reports of complications have been linked to ephedra since the mid-1990s.
3) The researchers concluded that the dietary supplement, also known as ma huang, poses a risk that far outweighs any benefits it might have.
4) ``They're uncommon events, but they're serious,'' said Dr. Neal L. Benowitz, chief of clinical pharmacology at the University of California at San Francisco. ``The substance is unreasonably hazardous as marketed.''
5) The research, commissioned by the Food and Drug Administration, appears in the New England Journal of Medicine, which moved up release of the study from Dec. 21 to Monday because of the importance of the finding.
6) Benowitz and colleague Dr. Christine A. Haller noted that most of the cases they studied involved healthy young people. Some had been taking ephedra for just days or weeks, and two women who became pregnant while taking it lost their babies.
7) Ephedra (pronounced eh-FED-ruh) products are often sold in health food stores under such names as Ripped Fuel _ used by bodybuilders hoping to increase muscle and energy _ as well as Metabolife and Diet-Phen for dieters. There are hundreds of unregulated ephedra products on the market.
8) Benowitz estimated 12 million people in the United States used ephedra products last year.
9) Joseph Levitt, director of FDA's food safety center, said the agency will decide by the end of the year whether to impose restrictions on ephedra or commission further research.
10) Also Monday, the FDA warned Americans not to use over-the-counter cold remedies or appetite suppressants with an ingredient called phenylpropanolamine, or PPA, because it can cause strokes. The FDA said it is taking steps to ban PPA, which is a chemical cousin of the types of ephedra the California researchers studied.
11) In the study released Monday, the researchers reviewed records from 140 ephedra users who suffered complications in 1997 through 1999, finding about one-third of the problems definitely or probably were caused by the ephedra and another one-third possibly were caused by it.
12) In one-fifth of the cases, there was insufficient information to draw conclusions, and the rest were deemed unrelated to ephedra use.
13) John Hathcock of the Council for Responsible Nutrition, a trade group for supplement makers, criticized the criteria used to classify which complications were probably caused by ephedra. He also said a soon-to-be-published study by other researchers found no link between such complications and ephedra use.
14) Dr. Steven Karch, an expert working for the Ephedra Education Council, a group funded by supplement makers, said in some of the cases studied, he believes pre-existing health problems such as heart disease caused the complications.
15) Dr. Stephen Schneider, an endocrinologist and nutrition expert at University of Medicine and Dentistry of New Jersey, said the study provides strong evidence ephedra caused the side effects in many of the patients, but not enough evidence to ban it.
16) He said some of the patients had medical conditions, were taking other medicines or were drinking caffeine that could heighten ephedra's effects.
17) ``Many people have no idea that they're taking it,'' because the label is often incomplete or misleading, Schneider said. Also, past research has shown that the dosage in ephedra pills often varies widely from what is on the label.
18) Schneider and Benowitz stressed that ephedra should not be taken by anyone who is pregnant or has a history of heart disease, stroke, psychiatric disorders, asthma, thyroid or kidney disease, diabetes or seizures.
19) Benowitz and Haller said federal regulators should require health warnings on products containing ephedra and should resurrect a proposal to impose dose limits. That idea was scrapped in 1997 under pressure from the industry. At the time, the FDA had 800 reports of side effects, including 44 deaths; the number has since risen.
20) The FDA asked Benowitz and Haller, another team of outside experts, and two in-house panels of scientists to evaluate the latest batch of cases where ephedra users suffered heart palpitations, very high blood pressure, heart attacks, strokes, seizures or other complications. The study by Benowitz and Haller is the first to appear in a medical journal.
21) The FDA's Levitt said the four research groups had similar findings, though in some cases they did not agree on whether ephedra was to blame.
2000-12-20
Industry to FDA: Ephedra Is Safe
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1) Challenging a prestigious medical journal report that a popular herbal stimulant can kill, the dietary supplement industry disclosed its own review Wednesday that contends ephedra is safe for most people, in the proper dose.
2) Up to 90 milligrams of ephedra a day, taken in three 30-milligram doses, cause no serious side effects, said the industry report, sent Wednesday to the Food and Drug Administration.
3) The report acknowledged that certain people, such as those with heart disease, diabetes and a list of other ailments, shouldn't take ephedra.
4) The report is the latest round in a three-year controversy over the largely unregulated dietary supplement used by millions of Americans for weight loss and bodybuilding. Some people also use large doses for an ``herbal high.''
5) The FDA has received about 1,000 reports of complications among ephedra users, including 54 deaths, since the mid-1990s. And a study in last month's New England Journal of Medicine concluded ephedra can cause heart attacks, strokes, seizures and death in otherwise healthy young people.
6) The FDA proposed restrictions on ephedra including slashing the legal dosage but backed off those plans last year under industry pressure. The agency is debating whether to order ephedra warning labels, which it had planned to decide by year's end.
7) FDA officials didn't return calls seeking comment Wednesday.
8) The industry's Council for Responsible Nutrition hired a scientific consulting firm, Cantox Health Sciences, to review 19 medical studies of ephedra and FDA's death-and-injury reports.
9) Wednesday, the council sent FDA the report that concluded 90-milligram daily doses were safe for most people. Deep in the report, Cantox listed people who shouldn't take the herbal stimulant: people with heart disease, diabetes, glaucoma, high blood pressure, thyroid disease, kidney impairment or enlarged prostates; anyone under age 18; or pregnant or nursing women. The report recommends ephedra be labeled with such warnings.
2001-05-08
Metabolife Recalls Energy Bars
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1) Metabolife International is voluntarily recalling its nationally distributed energy bars that may contain toxic levels of vitamin A, the company announced Tuesday.
2) The recall involves 1.5 million Metabolife Diet & Energy Bars made Dec. 25 through May 4.
3) San Diego-based Metabolife said the excessive amounts of vitamin A were discovered during recent routine sampling. The company reported its tests to the contract manufacturer, which confirmed the results, and then contacted the Food and Drug Administration.
4) The bars contain about 32,500 International Units or IUs of vitamin A. According to Metabolife, vitamin A levels above 25,000 IU can cause severe liver damage, bone and cartilage abnormalities, increased pressure in the brain and birth defects.
5) No illnesses have been associated with the product so far, but it poses special risk to pregnant women and people with liver disease or viral hepatitis. Women who are breast-feeding children could also pass excessive vitamin A through their milk.
6) The bars were made by Fairfield-based MLO Products, which makes nutritional products and supplements. Company president Mel Williamson said a ``transposition error'' involving a misplaced decimal resulted in too much vitamin A being added to the energy bar mix.
7) The bars have a red label and come in the varieties: Outrageous Oatmeal Raisin, Perfectly Peanut, Downright Chocolate and Lemony Lemon.
8) Consumers can get more information by calling Metabolife at 1-800-540-7099.
2001-09-08
NFL bans ephedra as performance enhancer By BARRY WILNER
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1) The NFL has banned the stimulant ephedra as a performance enhancer, a source familiar with the decision told The Associated Press on Saturday.
2) The league and the NFL Players Association agreed on the decision. The ban is immediate, although a plan for testing ephedra still is being formed.
3) Use of the herbal stimulant in highly competitive situations has been linked to heart attacks, strokes and seizures in otherwise healthy young people.
4) A report in the New England Journal of Medicine last November said at least 54 deaths and about 1,000 reports of complications have been linked to the popular bodybuilding supplement since the mid-1990s. The Food and Drug Administration has since said about 80 deaths have been associated with ephedra.
5) ``We've been talking about this for a while with the league,'' NFLPA executive director Gene Upshaw told The New York Times, which originally reported the ban. ``It's time to be proactive in this area. It may not be popular with some of our players, but it is needed because we just don't know enough about these substance and we have to be careful.''
6) Upshaw has said that the death of Minnesota Vikings tackle Korey Stringer of heatstroke has made the union more diligent in its approach to stimulants.
7) Products containing ephedra often are sold in health food stores. There are hundreds of unregulated ephedra products on the market.
8) The NFL and its union are concerned that ephedra in strong doses for performance enhancement reasons has the potential for doing harm. Ephedra also can be found in such products as herbal tea, where it is present in such small amounts that it is not believed harmful.
9) John Hathcock of the Council for Responsible Nutrition, a trade group for supplement makers, said that while excessive use of any stimulant can be harmful, ``ephedra can be used safely and responsibly. Those with hypertension and heart disease should avoid it.''
2002-06-14
U.S. Government orders more safety study of controversial herb
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1) Two years after U.S. health officials wanted warning labels on ephedra, the Bush administration instead is ordering a start-from-scratch safety review of the herb that has been linked to dozens of deaths.
2) The move prompted outrage from consumer advocates and doctors who want ephedra banned, citing the dietary supplement's link to heart attacks and strokes.
3) ``This is a black day in medicine,'' said Dr. Raymond Woosley, vice president of health sciences at the University of Arizona, who called the risk clear enough that further study would be unethical.
4) But supplement makers, including leading ephedra marketer Metabolife International, praised the decision.
5) ``Clinical trials that have been done over the years ... show the products are safe,'' said Wes Seigner, attorney for the Ephedra Education Council.
6) Also Friday, the Food and Drug Administration ordered six companies illegally selling synthetic ephedrine in the guise of an herb to stop. The synthetic form of ephedra has long been outlawed, and the FDA for years has sought to stop such sales, which occur mostly via the Internet.
7) The FDA ordered a seventh company to stop selling ``energizing herbs,'' including high ephedra doses, as alternatives to LSD, cocaine and other street drugs. The Web site advertises ``legal speed'' and products that ``felt like an acid trip,'' claims that FDA rules prohibit.
8) More controversial is the legal use of ephedra _ the actual herb, not chemical cousins _ for weight loss and bodybuilding.
9) An analysis in the New England Journal of Medicine two years ago said at least 54 deaths and about 1,000 reports of complications have been linked to the popular supplement since the mid-1990s. One theory is that the herb, especially when combined with caffeine or exercise, overstimulates the heart.
10) There now are 100 reported deaths, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.
11) Federal law forbids most regulation of dietary supplements unless the FDA proves danger. Three years ago, citing death reports, the agency attempted to bar certain high ephedra doses. Industry protests killed the move, so officials instead began pushing for warning labels _ and then Public Citizen petitioned for a ban.
12) Health and Human Services Secretary Tommy Thompson announced Friday that instead of deciding that petition now, the government had hired Rand Corp. to review all scientific reports on ephedra's safety. Results are due this fall, when the National Institutes of Health will determine what additional research is needed.
13) Canada a year ago warned consumers not to use ephedra, and the National Football League banned it. The U.S. military, citing the deaths of several supplement-using soldiers, has issued cautions. Wolfe provided FDA a Fort Hood, Texas, directive last month asking officers ``to identify their soldiers using these supplements and strongly discourage their use under any circumstances.''
14) ``The world knows these things are toxic. What's wrong in Washington?'' said Woosley, who recalled treating a 30-year-old ephedra user left mute by a stroke. ``Her husband looked at me and said, 'Why didn't the FDA tell us?' and I didn't have an answer.''
15) Manufacturers counter that reports of sick patients don't count as proof an herb is risky _ the illnesses could be coincidence.
16) But Wolfe responds that prescription drugs are banned on the basis of such reports and herbs shouldn't be held to a different standard.
2002-06-22
Ephedra ban opens debate on role, need for stimulants in NFL AP Photos
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1) On Sunday mornings in locker rooms across the NFL, players prepare themselves for three hours of physical violence that most people can't fathom. A 250-pound (112.5-kilogram) linebacker must come to terms with painful, full-speed collisions with 300-pound (135-kilogram) linemen, or else he can't play the game.
2) Some spend the time in prayer. Some call home. Some listen to music.
3) And some take drugs.
4) Quite a few, it turns out, were taking ephedra, an herbal stimulant that eventually was banned by the league.
5) ``Guys were killing that stuff,'' Washington Redskins linebacker Eddie Mason said. ``Ephedra was like a major, major product for the last several years. You take this drug _ first of all, your hormones before a game, your endorphins, your testosterone levels are already up, so your heart's already racing. So you got all this stuff going on inside your body, and you put another stimulant inside, it's going to cause your heart to race. Guys can die from that stuff.
6) ``I just think it was the best move the league could have made by banning the substance.''
7) Not everyone agrees.
8) ``Ephedra's not a bad deal. We turned it into a bad deal because we take too much of it,'' San Diego Chargers strength coach Dave Redding said. ``A responsible amount of ephedra is OK, I really believe that.''
9) And so goes the latest debate on the role of stimulants and other supplements in the NFL. Conflicting messages and rule changes leave many players confused over what they should or shouldn't take, yet many feel that they need to be taking something _ just to keep up with everyone else.
10) ``The majority of the league uses supplements in one form or another,'' New York Jets center Kevin Mawae said.
11) And sometimes they come from the team. Redding, who followed coach Marty Schottenheimer to San Diego from Washington, made supplements readily available last year in his only season with the Redskins. Defensive tackle Dan Wilkinson grew so skeptical of Redding's products that he took some home to Ohio for his own doctor to examine.
12) ``A lot of that stuff had some mixes and stuff that guys shouldn't be taking, and No. 1 was ephedra,'' Wilkinson said. ``I was telling Doc, 'he's got guys taking pills with this mess and all these protein shakes and other mess. Your liver and kidneys can only take so much.'
13) ``It was unrealistic. We're not training to be ultimate fighters or some type of sumo wrestler. We're training just for football.''
14) Redding defended his methods. Although he said he stopped offering ephedra products to players when the NFL announced its ban, he's not convinced the league did the right thing.
15) ``They've haven't solved the problem,'' Redding said. ``They've just created another problem _ because these guys will find something else.''
16) ``These guys are under a lot of pressure,'' Redding said. ``It's a pressure cooker every day, and sometimes they feel like they need to do a little extra.''
17) The NFL has been pro-active when it comes to drugs. Steroids, the subject of controversy now in baseball, were banned 13 years ago. Random testing is routine.
18) So when word grew about the potential dangers of ephedra, the NFL became the first U.S. pro sports league to ban it. It cited the ``growing evidence linking these products to several life-threatening conditions such as strokes, seizures, thermo-regulatory disorders and heart arrhythmias.''
19) The Ephedra Education Council, a group funded by supplement makers, insists that ephedra dietary supplements are safe and effective for weight loss when used as directed. ``The industry fully supports fair competition and the NFL if it wishes to ban even mild stimulants, such as caffeine and ephedra, out of concern for competition,'' said Wes Siegner, the counsel for the industry group.
20) The NFL is ahead of the pack. Earlier this month, the Bush administration delayed a government ban of ephedra and instead ordered a new safety review, stunning doctors who claim the stimulant is responsible for as many as 100 deaths since the mid-1990s. Ephedra remains available in about 200 supplements used for weight loss, building muscle and boosting energy.
21) ``I'm sure at some point in time, everybody's used it,'' Miami Dolphins linebacker Derrick Rodgers said. ``It was just in cold medicines and stuff like that. There's still some items that you can buy at GNC that have some banned substances in it.''
22) Although the NFL's ban came into effect last September, random testing for ephedra doesn't begin until July 1. A positive test could result in a four-game suspension, and that has players' attention.
23) ``As far as walking about the locker room, I don't see any of those bottles that I used to see,'' Mason said. ``Guys are going to be smart. Once you see that sign saying 'this substance banned' _ you weigh the costs. You test positive, you won't be here.''
24) Some see another cost. They've heard that a bottle of Ripped Fuel, which contains ephedra, was found in the locker of Minnesota Vikings tackle Korey Stringer after he collapsed and died during a training camp practice last year. The Vikings and Stringer's agent have said there's no evidence ephedra caused his death, but many players are anxious.
25) ``A lot of guys are afraid to take anything nowadays after what happened in Minnesota,'' Redskins linebacker Kevin Mitchell said.
26) Estimates vary widely on how many players have used ephedra. Giants trainer Ronnie Barnes estimated that around 40 players on New York's 53-man roster used it before the ban and 20 kept using it after the ban went into effect.
27) Redding estimated that perhaps one-third of all players used ephedra at some point. Mitchell said ``no more than 10'' players used it with the Redskins.
28) Tennessee Titans defensive tackle John Thornton said he took an ephedra product only a couple of times before quitting.
29) ``I heard it was bad, and I didn't use it anymore,'' Thornton said. ``You think that's legal, and you think it's fine. You find out it has adverse effects and you can actually die. Once they told us that, nobody does it.''
30) Most players and coaches wouldn't hazard a guess. Even Minnesota coach Mike Tice, whose team is still dealing with the repercussions of Stringer's death, indicated the matter wasn't his concern.
31) ``I try not to get involved with what players put in their bodies,'' Tice said. ``I've never really brought it up with them.''
32) Still others wondered whether the NFL's efforts to keep a clean image are getting too intrusive.
33) ``It's not the same as steroids,'' Jets cornerback Ray Mickens said. ``In five years, all we're going to be able to eat is bread and water. They're going to ban everything.''
34) With the ban, players who would never dream of taking ephedra are now having to watch for it on ingredient lists at the pharmacy.
35) ``Guys always ask us, 'Can you take something? Can you not take something?''' Titans trainer Brad Brown said. ``We'll look at it and see. But we can't give you a guarantee what we're seeing on the box is what's inside.''
36) Meanwhile, others are already searching for the next ephedra. Brown thinks it could be already be finding its way into supplements.
37) ``Everybody's looking for that special pill that's going to make them lose weight,'' Brown said, ``or that special pill that's going to give them an advantage on the field.''
38) Ephedra was a favorite because it does both. Redding said he prefers that players diet sensibly rather than use supplements, but ephedra became on option when they didn't.
39) ``Sometimes in a January, February, March, they don't take care of business,'' Redding said. ``They come back and want a quick weight loss program. They come to you begging, 'What can you do to help me?' Being a helper and strength coach and nutritionist person, you try to guide them and lead them.''
40) Then there are those moments before the games on Sunday, when the mere excitement of playing a game before 60,000 people just isn't enough to get some players pumped.
41) Redskins defensive coordinator Marvin Lewis, formerly with the Baltimore Ravens, said defensive tackle Tony Siragusa once came to him in the locker room before a road game and asked if a newly signed player was going to play. When Lewis asked why, he said Siragusa told him: ``I've got to know how many 'Goose' pills to give him, because I don't want him bouncing off the plane on the way home.''
42) ``All it was was some kind of stimulant,'' Lewis said.
43) For many, the stimulant of choice is caffeine, which is legal and everywhere. There are caffeine pills and caffeine drinks. Redding said the same case made against ephedra could be made against caffeine: Too much is bad, but the right dose could do some good.
44) ``A little bit of caffeine, a responsible amount of caffeine, can enhance performance,'' Redding said. ``No one says anything about them drinking coffee all day long. It's OK for everybody to have a Coca-Cola machine their locker room and have as much as they want, but if I hand them a responsible caffeine drink with a lot of nutrients in it, I'm crazy.''
45) By most accounts, Redding's drinks and other supplements were not popular among the Redskins, who were a disappointing 8-8 last season.
46) ``People don't understand how much influence a strength coach can have on the team,'' cornerback Champ Bailey said. ``If you've got somebody in there that nobody gets along with, then it's going to affect everybody because the guys that like to lift won't go in there.''
47) That doesn't mean the Redskins are now supplement-free. Mason and his wife are independent distributors for a company that sells a fruit drink called Tahitian Noni Juice, and he said about 20 teammates drink it.
48) ``A lot of guys are taking the juice, and it's benefiting them,'' Mason said. ``It's not going to cause you to test positive, and it's natural.''
49) But in the current climate, everyone is cautious. Receiver Kevin Lockett said Mason's drink has helped his endurance, but he researched it for more than a month before trying it.
50) ``As far as we know, it's all natural,'' Lockett said. ``At the same time, if I find out there is something in it, I'll drop it.''
51) Bubba Tyer is unconvinced. The dean of NFL trainers before accepting a management position with the Redskins this year, Tyer sees no room in the NFL for ephedra, caffeine concoctions _ or even Mason's fruit drink.
52) ``There's no need for that. It's a joke,'' Tyer said. ``I've always been that way. That's why, as a club, I've never encouraged us to buy any supplements. These young men here don't need it.
53) ``I saw us win three Super Bowls eating McDonald's hamburgers for lunch. I had a coach tell me red meat's not good for you. Well, if you want to think that, football's not good for you. There's more damage playing football than there is to eating red meat when you're 26 years old.''
54) Tyer knows his arguments don't win over all the players. Stimulants and other supplements aren't going away anytime soon. He even said some will keep using ephedra, despite the risk of getting caught by a random test.
55) ``They won't have it here in their locker _ they'll have it at home,'' Tyer said. ``What are you going to do?''
2002-07-31
FDA pressed for action on herbal supplement ephedra
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1) A leading U.S. senator took the Food and Drug Administration to task Wednesday for failure to act on the potentially dangerous food supplement ephedra.
2) ``Either the law is bad, the resources are not being given to you or there is no will to deal with this threat,'' said Sen. Richard J. Durbin, chairman of the Senate Governmental Affairs Committee's oversight panel.
3) His comments came just over a month after the Bush administration outraged doctors by delaying action on ephedra by launching a new safety review of the herbal stimulant.
4) Joseph A. Levitt, director of the FDA's Center for Food Safety and Applied Nutrition, said the agency does have a plan to deal with ephedra but lacks enough data, which is currently being collected.
5) The use of food supplements is growing rapidly and represents a ``significant challenge'' for the agency, Levitt said.
6) Durbin retorted: ``Evidence keeps piling on about the danger of this product. Proposed rules are fine, but nothing has been done.''
7) Canada a year ago warned consumers not to use ephedra and it has been banned by the International Olympic Committee, National Football League and National Collegiate Athletic Association.
8) Because ephedra, made from herbs, is sold as a food supplement, U.S. law does not require its manufacturers to prove safety, meet standard drug manufacturing rules or provide any specific warning labels.
9) To remove a supplement from the market, the FDA has to prove it is dangerous. It has blocked sales of synthetic ephedra.
10) Three years ago, citing death reports, the agency attempted to bar certain high doses of ephedra. Industry protests killed the move, and a General Accounting Office report said that while ephedra clearly was risky to some people, the FDA's statistics were sloppy.
11) So FDA officials reanalyzed and began working toward warning labels. The consumer group Public Citizen petitioned for a ban.
12) But instead of deciding on either option, the Department of Health and Human Services in June surprised the medical community and hired Rand Corp. to review all scientific reports on ephedra's safety. Results are due this fall, when the National Institutes of Health will determine what additional research is needed.
13) Michael F. Mangano, principal deputy inspector general of the department, noted that the FDA's system for supplement makers to report customers who suffer bad reactions to their products is voluntary.
14) ``For the year 1999, we found that FDA received 460 reports compared to 13,000 reports that poison control centers reported receiving nationwide related to dietary supplements,'' Mangano said.
15) Karen Ruiz of San Clemente, Calif., told the subcommittee she had tried to report her experience with ephedra to the FDA but got ``lost in the shuffle.''
16) Ruiz said that she began taking the supplement in 1996 to lose weight and within a few days began experiencing manic episodes that required sedation and lengthy hospital treatment.
17) In written testimony submitted to the subcommittee, the Council for Responsible Nutrition, a trade association of the dietary supplement industry, contended that it had commissioned a study that showed ephedra is safe under the recommended uses with a daily dose of 90 milligrams.
18) Durbin noted that at least one product on sale in the United States is a pill containing 325 milligrams of ephedra.
19) Michael McGuffin, president of the American Herbal Products Association, said in testimony that members of his group engage in self-regulation, recommending business and safety practices.
20) And the Consumer Healthcare Products Association issued a statement urging improvements in the FDA's system for learning of bad reactions to products and calling on the agency to establish standards for good manufacturing practices.
2002-08-15
2002-10-08
FDA cracks down on illegally promoted ephedra product
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1) Health regulators are cracking down on Yellow Jackets, an herbal product promoted as an alternative to illegal street drugs.
2) The Food and Drug Administration said Monday it was stopping imports of Yellow Jackets, e-mailing the Dutch operator of an Internet site selling the pills that it is illegal to market dietary supplements as alternatives to cocaine and other street drugs.
3) Yellow Jackets contain the herb ephedra and other stimulants.
4) The FDA's warning came a day before the parents of a teenager who took Yellow Jackets and died were scheduled to testify before a Senate hearing on the broader issue of how safe any ephedra-containing supplements are.
5) Ephedra is an herb that is legal to sell as a dietary supplement _ popular for weight loss and body building _ as long as that street-drug claim isn't made. But even legal ephedra is highly controversial, linked to dozens of deaths. Some critics have asked FDA to ban all ephedra, and the government has begun a criminal investigation of whether one U.S. manufacturer lied about the herb's safety.
6) The Yellow Jackets issue is separate, focusing not on ephedra safety but on illegal marketing.
7) ``There does not appear to be any legitimate use for this product,'' the FDA said in a warning letter e-mailed to the Dutch operator of a Yellow Jackets Web site.
8) ``Consumers should not purchase or use these or similar products available through the Internet or elsewhere,'' FDA Acting Commissioner Lester Crawford said.
FDA cracks down on illegally promoted ephedra product
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1) A day after the government banned imports of an herbal drug containing ephedra, the parents of a teenager who died after taking the product testified Tuesday before a Senate hearing on how safe any ephedra-containing supplements are.
2) Sean Riggins was a 16-year-old athlete in exceptionally good condition, but on Sept. 2 he was so sick that he couldn't play in a big game with his Lincoln, Illinois, high school football team, testified his father, Kevin Riggins.
3) Instead, Sean sat on the bench, suffering from a headache and stomach pain, and later went home to sleep. A doctor, the next day, said he had bronchitis and sent him home. But within a few hours, Sean went into convulsions and stopped breathing. He died at a hospital of what doctors said was a heart attack.
4) ``When my son passed away of a heart attack, I had no idea what to think,'' Kevin Riggins testified at a Senate subcommittee hearing. ``He didn't smoke or do marijuana or take drugs.''
5) But an autopsy showed that he did take Yellow Jackets, an herbal drug laced with the herb ephedra, along with a kola nut extract which contains caffeine. The combination can cause blood vessel constriction, a rapid heart beat, a sudden rise in blood pressure.
6) And that's what killed Sean Riggins, Logan County Illinois coroner Charles Fricke told the Senate Subcommittee.
7) ``The heart was racing so fast it could pump the blood,'' said Fricke. ``It's our opinion that the (heart attack) is consistent with the effects of ephedrine. No other problems were found.''
8) Sean's death was not the first caused by ephedra, a dietary supplement that is sold at service stations and convenience stores as an energy booster and weight control product, said Sen. Dick Durbin, an Illinois Democrat. He said Food and Drug Administration reports link ephedra to 81 deaths and 1,400 incidents of heart attack, high blood pressure and stroke.
9) And, yet, said Durbin, the FDA still allows the herbal supplement to be sold.
10) ``We have seen a reluctance on the part of this administration to act to protect American consumers from this product and I just can't understand it,'' he said.
11) The FDA on Monday did stop imports of Yellow Jackets, e-mailing the Dutch operator of an Internet site selling the pills that it is illegal to market dietary supplements as alternatives to cocaine and other street drugs.
12) Ephedra is an herb that is legal to sell as a dietary supplement _ popular for weight loss and body building. But Durbin and some critics have asked the FDA to ban all ephedra products. One manufacturer, Metabolife International Inc. of San Diego, is now under investigation by the Justice Department about claims by a company official that it had received no reports of adverse health linked to its product.
13) Lanny Davis, a Washington attorney representing Metabolite, however, testified that many reports of dangerous side effects from ephedra are based on ``unverified telephone calls.''
14) He said there have been 30 scientific studies showing that Metabolite's ephedra product ``is safe and effective'' when used by adults as directed.
15) The Yellow Jackets issue is separate, focusing not on ephedra safety but on illegal marketing.
16) ``There does not appear to be any legitimate use for this product,'' the FDA said in a warning letter e-mailed to the Dutch operator of a Yellow Jackets Web site.
17) ``Consumers should not purchase or use these or similar products available through the Internet or elsewhere,'' FDA Acting Commissioner Lester Crawford said.
18) Riggins, in his testimony, said that students in Lincoln and in other small towns now can easily buy ephedra-laced supplements, using them to stay awake, to get a ``buzz'' and to lose weight.
19) Sean's mother, Debbie, said that ``kids are the target'' of manufacturers of Yellow Jackets and other ephedra supplements.
20) ``They do it to get hyper so they can stay awake,'' said Debbie Riggins. ``They will take several at a time to keep them wired all day.''
21) Ephedra products have been banned in Canada. The U.S. armed services have ordered ephedra products removed from military base stores where they were once sold. The National Collegiate Athletic Association banned use of the supplement by student athletes and now conducts test each year to enforce that ban.
22) Dr. Ronald M. Davis of the American Medical Association said that based on reports of adverse medical effects, his organization believes ``the weight of available clinical evidence supports the remove of dietary supplement products contain ephedrine alkaloids from the market.''
2003-02-03
HOLD FOR RELEASE AT 2200 GMT Study recommends limits for ephedra, an herb linked to deaths
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1) Ephedra, an herb found in weight-loss and bodybuilding supplements, is unsafe even when taken in recommended doses and should be restricted, according to doctors who studied reports of bad reactions to the herb.
2) U.S. poison control centers reported 1,178 adverse reactions to ephedra dietary supplements in 2001, said the study, which was to be posted on the Annals of Internal Medicine's Web site Tuesday and published in the journal next month.
3) Ephedra accounted for 64 percent of all adverse reactions involving herbs, even though it is found in fewer than 1 percent of all herbal products sold.
4) ``It comes down to a risk-benefit ratio,'' said one of the report's authors, Dr. Stephen Bent of the San Francisco Veterans Affairs Medical Center. ``The benefits for ephedra are not at all well established. It is a minimal benefit that goes away when you stop using the product. And the risks are really substantial.''
5) The study, based on data collected by the American Association of Poison Control Centers, is just the latest to question ephedra's safety.
6) The Food and Drug Administration has reports of nearly 100 deaths of people who had taken the herb, a stimulant that can quicken a person's heart rate and cause their blood vessels to constrict.
7) The American Medical Association has also advised people not to use ephedra, which has been banned by the International Olympic Committee, the National Football League and the National Collegiate Athletic Association.
8) The Bush administration ordered a review of ephedra's safety in June.
9) Wes Seigner, a lawyer for the Ephedra Education Council, a group funded by the supplement industry, insisted the herb can be used safely.
10) He noted that the study compared ephedra only to other herbs, including such mild agents as ginseng and St. John's wort, and not to medications used by people trying to lose weight.
11) The study also didn't explore the seriousness of the reactions reported to poison centers, Seigner said. Some of the reported side effects could be as benign as a headache, he said.
12) Seigner said that while the industry generally agrees that ephedra supplements should come with a mandatory warning label and shouldn't be marketed to children, banning them would be to ignore a potential treatment for obesity.
13) Ephedra, also known by its Chinese name, Ma huang, was once widely used in the United States as a decongestant and asthma treatment. Doctors stopped prescribing it in the 1930s in favor of safer medications.
14) Now it shows up most in ``performance enhancing'' dietary supplements marketed to athletes.
15) An Alabama jury last year ordered supplement maker Metabolife International to pay $4.1 million to four people who suffered strokes or heart attacks after taking an ephedra-based appetite suppressant. And the families of a dead 28-year-old bodybuilder in Las Vegas and a dead 27-year-old Marine Corps officer in Florida sued supplement-maker Twin Laboratories Inc. blaming the deaths on an ephedra supplement called ``Ripped Fuel.'' _ _ _ =
16) On the Net:
17) Annals of Internal Medicine: http://www.annals.org
18) Federal ephedra information: http://www.cfsan.fda.gov/dms/ds-ephed.html
19) Industry-sponsored ephedra information: http://www.ephedrafacts.com
2003-02-19
2003-02-28
2003-03-07
Baseball union to players: Stay clear of ephedra
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1) Surrounded by memories of Steve Bechler, the Baltimore Orioles closed their clubhouse on Friday and silently gathered around players' union head Donald Fehr to hear his stark message: Stay away from ephedra.
2) Fehr personally backed up a one-page memo sent by his office to all major leaguers this week, warning them to ``be extremely reluctant to use any products containing ephedra.''
3) The union cited action taken last week by the federal Department of Health and Human Services, which cautioned that users of ephedra-based products face ``potentially serious risks.''
4) Making his annual tour of spring training camps, Fehr's visit to Fort Lauderdale Stadium took on special significance. Bechler, a 23-year-old Orioles pitching prospect, died of heatstroke on Feb. 17, and a Florida medical examiner linked the death to ephedra, an herbal supplement used by some athletes to lose weight.
5) ``If that's the cause of the guy's death, then I think we need to stop using that, period,'' Minnesota Twins star Torii Hunter said in Fort Myers.
6) Commissioner Bud Selig last week banned players with minor league contracts from using ephedra, but that did not cover players on 40-man major league rosters, who all have major league contracts.
7) Baseball's labor contract prohibits only illegal drugs and certain steroids. Fehr had said the union would await the yet-to-be-released toxicology report from Bechler's autopsy before deciding whether to re-evaluate its position, which is that players should be allowed to use any legal product.
8) Ephedra is available without prescriptions in diet supplements.
9) ``It's a legal drug available over the counter, so I don't know what we can do. It's up to Don and those guys,'' said Jason Johnson, the Orioles' player representative.
10) Fehr talked to the Orioles for 90 minutes and, with no lingering labor issues for the players to discuss, the No. 1 topic clearly was ephedra.
11) Bechler's No. 51 is posted on an outfield billboard and seven members of the Baltimore organization will attend a memorial service for him Saturday in his hometown of Medford, Oregon. And all season long, the Orioles will wear his number on their sleeves.
12) ``When you have a tragic event, it focuses people's attention in a different way,'' Fehr said. ``Baseball's a pretty small family, and I think players everywhere pretty much reacted the same way.
13) ``It may be that Congress is going to take another look at it. If they decide that it's unreasonably dangerous and should be banned, then that would eliminate any need to have discussion on the issue.''
14) The memo listed the potential side effects of ephedra and stressed that the HHS warning was directed to ``athletes and those who engage in strenuous physical activities.''
15) ``Just for overall health, people should take a long look at ephedra,'' Oakland outfielder Chris Singleton said. ``I'm a strong believer that players need to be educated instead of telling them what they can do, or else you make it like a forbidden fruit and people will want it more.''
16) Cleveland pitcher Dave Burba echoed that thought.
17) ``As a father of three, I am not about to risk anything, that's for sure. But I think if you try to ban it, there will be guys somehow, someway that will find a way around it and get the stuff,'' he said. ``The best thing to do is educate people and let them make the decision.''
18) The topic even caused teammates to disagree.
19) ``If it isn't good for a baseball player or any athlete to put it into his body, then it should be banned,'' Pittsburgh shortstop Jack Wilson said.
20) But Pirates outfielder Craig Wilson said, ``My personal feeling is if it's a legal supplement then I don't see why it should be banned. If you can go into a health food store or a vitamin center or whatever, then how can you say it's illegal? You're taking it at your own risk.''
21) Twins outfielder Dustan Mohr was fine with that.
22) ``I use it. Every once in a while before a day game and you're not feeling so good, you get a little energy,'' he said. ``I think unless they ban it no one's really going to stop using it.''
2003-03-11
Eight counties sue maker of supplement containing ephedra
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1) Eight California counties and one city have filed suit against the maker of a dietary supplement linked to the death of Baltimore Orioles pitcher Steve Bechler, alleging deceptive advertising.
2) The counties accuse Cytodyne Technologies of false and misleading advertising that does not mention possible health risks associated with Xenadrine.
3) Cytodyne says the pill can help people lose weight 17 times faster than diet and exercise alone. The company also contends the supplement increases strength, energy and endurance and that no other similar product has produced such results.
4) The suit says dietary supplements containing ephedra, an herbal stimulant, have been associated with increased blood pressure and increased irritability of the heart, which can lead to heart conditions and death.
5) Ephedra is banned by the NFL, the NCAA and IOC but not by Major League Baseball. The U.S. Food and Drug Administration has reports of at least 100 deaths linked to the supplement.
6) Baseball commissioner Bud Selig has already banned players on minor league contracts from using ephedra and the players union urged its members last Friday to ``be extremely reluctant to use any products containing ephedra.''
7) The counties are seeking a court order forcing the company, which is based in Manasquan, New Jersey, to stop using claims about Xenadrine that haven't been substantiated and to have the company include information about known health risks in its ads for the supplement. It also seeks restitution for California customers and civil penalties.
8) ``There is a known association between ephedra products and very serious health problems,'' San Francisco Deputy District Attorney Michael Hudson said. ``People don't realize that just because it's natural, that doesn't make it safe. Tobacco is natural.''
9) The company defended its product and said prosecutors are trying to take advantage of publicity surrounding ephedra.
10) A Florida medical examiner linked ephedra to Bechler, who died Feb. 17 after collapsing at spring training. The toxicology report from Bechler's autopsy is scheduled to be released on Thursday.
11) ``Cytodyne Technologies confidently stands behind the efficacy of its products and the truthfulness of our advertising claims,'' company chief executive Bob Chinery said in statement. ``It's not a coincidence that at this time the prosecutors have decided to file these allegations, given the current sensationalized climate surrounding ephedra.''
12) The suit was filed Monday in Napa County Superior Court by Napa, San Francisco, Alameda, Marin, Sonoma, Monterey, San Benito and Kern counties, as well as the city of San Diego.
13) On Feb. 28, the Food and Drug Administration proposed warning labels that pills containing ephedra can cause heart attacks and strokes or even kill. Health and Human Services Secretary Tommy Thompson said a full ban was still possible.
2003-03-13
2003-03-16
NBA union warns players on ephedra
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1) The NBA players' union sent a letter to members last month warning them about ephedra, the supplement linked to the death of Orioles pitcher Steve Bechler during spring training.
2) Ephedra is not banned by the NBA.
3) Union director Billy Hunter sent a letter alerting players to the Bechler case and warning them to consult a doctor before taking anything containing ephedra, union spokesman Dan Wasserman said Sunday.
4) Bechler was taking the supplement to lose weight at the start of spring training when he collapsed Feb. 16. The 23-year-old pitcher died the next day after his temperature rose to 42 degrees C (108 degrees F).
5) Ephedra, which has been linked to heatstroke and heart trouble before, is banned by college sports, the NFL and the International Olympic Committee.
6) After Bechler died, baseball commissioner Bud Selig banned players with minor league contracts from taking ephedra, and the players' association urged major leaguers not to use the substance.
7) The Food and Drug Administration says at least 100 deaths have been linked to ephedra, but it remains available without a prescription in diet supplements.
2003-04-02
2003-04-09
Six sports asked for ephedra data by Congress
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1) Six more sports organizations were asked Wednesday for documents on ephedra use by the House Energy and Commerce Committee.
2) Congress is investigating dietary supplements containing ephedra, and baseball has come under scrutiny since the death of Baltimore Orioles pitcher Steve Bechler in February. A coroner said ephedra contributed to Bechler's death from heatstroke.
3) Last week, the committee asked for information from baseball commissioner Bud Selig and union chief Donald Fehr on the use of the supplement in baseball.
4) Wednesday's letters went to the the NFL, NBA, NHL, Major League Soccer, NASCAR and the NCAA college tournament, as well as the unions in the team sports. The letters asked for the information by April 23.
5) Following Bechler's death, the Department of Health and Human Services cautioned that users of ephedra-based products face ``potentially serious risks.''
6) The letter was sent by committee chairman Billy Tauzin, and Reps. Michael Bilirakis, Cliff Stearns, and James Greenwood.
2003-05-01
Auditors: company's records not enough to link ephedra to heart attacks
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1) Some 16,000 customer complaints about the popular Metabolife brand of ephedra are not enough to prove whether the herb caused dozens of heart attacks and strokes, some fatal, congressional investigators say.
2) The report released Wednesday doesn't mean ephedra is safe, the Food and Drug Administration stressed: There is evidence from other sources that the pills can cause serious health problems.
3) Armed with reports of more than 100 deaths and thousands of side effects linked to ephedra use, the FDA two months ago pledged to put warning labels on every bottle that say the amphetamine-like stimulant can cause heart attacks, strokes or even kill.
4) The General Accounting Office, Congress' investigative arm, examined 16,000 records of phone calls from ephedra customers with health complaints turned over to the Justice Department last year by Metabolife International.
5) The GAO counted 92 reports of serious side effects _ including 18 heart attacks, 26 strokes, 43 seizures and five deaths _ made by Metabolife customers to a company hot line.
6) The GAO concluded that there was far too little information to definitively link any of the reports to the pills because patients, not doctors, reported the problems, and Metabolife employees sometimes recorded just a single word from each phone call.
7) The FDA noted that the Rand Corp. also reviewed Metabolife's records, and called some of the cases ``sentinel events'' that warrant further investigation. Also, most of the agency's evidence is from other sources compiled before Metabolife revealed its records.
8) ``Today's report does nothing to change FDA's heightened concern that dietary supplements containing ephedra may present a significant and unreasonable risk of illness and injury,'' the agency said.
9) Metabolife insisted the GAO report supports its position ``that ephedrine-containing products such as Metabolife 356 are safe and effective when used as directed.''
10) Rep. Dan Burton, who requested the report, said the GAO's findings show the government needs to establish a federal tracking system for consumer complaints about any dietary supplement.
11) The FDA decision came just weeks after Baltimore Orioles pitcher Steve Bechler died after using ephedra. Health and Human Services Secretary Tommy Thompson has advised Americans, especially those who exercise, not to take the herb.
12) The American Heart Association and other health groups have urged a full ban on ephedra sales, calls the FDA currently is evaluating.
NFL supports supplement regulation laws
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1) The NFL has joined athletic and medical groups in supporting legislation that would regulate ephedra and other dietary supplements.
2) The U.S. Olympic Committee, the U.S. Anti-Doping Agency and other medical groups also support the legislation introduced in Congress by Rep. Tom Osborne of Nebraska, the longtime University of Nebraska football coach, as well as several others.
3) ``We have been outspoken about the health risk and dangers due to the presence of anabolic steroid precursors and ephedra in dietary supplements,'' said Harold Henderson, president of the NFL Management Council.
4) The NFL banned ephedra after the death of Minnesota Vikings offensive tackle Korey Stringer during training camp in 2001. Players are tested and can be suspended after the first violation, as rookie star Julius Peppers of Carolina was for the final four games of last season after he tested positive for the supplement.
5) The league is looking into using one authorized supplier for dietary supplements. Peppers and other players have said they unknowingly took ephedra because they were unaware it was in a supplement they were using.
6) The move for legislation intensified earlier this spring when ephedra was linked to the death of Baltimore Orioles pitcher Steve Bechler, who collapsed and died after a workout in February.
7) Among the other sports organizations in the new group are USA Track and Field, USA Swimming, USA Boxing, USA Luge, the U.S. Biathlon Association and the U.S. Soccer Federation.
2003-12-30
Sources: Bush administration has decided to ban dietary supplement ephedra
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1) The Bush administration has decided to ban the herbal weight-loss supplement ephedra from the marketplace because of concerns about its effects on health, government officials said Tuesday.
2) Health and Human Services Secretary Tommy Thompson and Food and Drug Administration chief Mark McClellan were to announce the ban at a midday news conference, the officials said, speaking only on condition of anonymity.
3) Critics called the federal crackdown too late. Sales nationwide already have plummeted because of publicity about roughly 155 deaths blamed on the amphetamine-like stimulant, including Baltimore Orioles baseball player Steve Bechler earlier this year. Ephedra is linked to heart attacks and strokes, even when used by outwardly healthy people at recommended doses, because it speeds heart rate and constricts blood vessels.
4) Three states _ New York, Illinois and California _ have passed their own ephedra bans; use has been banned in professional football, college athletics and minor-league baseball, and several retail chains, including supplement giant General Nutrition Centers, recently quit selling it, too.
5) ``It's a dead product and unfortunately it has become a dead product over the backs of a lot of dead people when the FDA could have acted before,'' said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen, which petitioned the government for a ban in 2001.
6) Wolfe urged remaining manufacturers to recall all ephedra-containing products still on store shelves. For any future ephedra-linked injuries, ``there's going to be hell to pay in terms of increased liability on the part of the companies that are allowing it to be sold,'' he said.
7) The supplement industry's Council for Responsible Nutrition said it didn't oppose a ban, noting that very few companies still make the stimulant _ its members who once did no longer do so.
8) ``We think the reputable players have found so much controversy and difficulty in this marketplace that they've decided to get out of it,'' said CRN's John Hathcock. ``We recognize the controversy is a cloud over our whole industry.''
9) Remaining ephedra manufacturers didn't immediately comment Tuesday, but have insisted that studies prove their products safe when used properly.
10) ``Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products,'' Metabolife International chief executive Russell Schreck said over the summer. ``We make it quite clear on our label that the ephedra products are not to be sold or used by minors and that customers with certain pre-existing medical conditions should 'consult a physician before product use'.''
11) But several scientists said that it was impossible to prove whether ephedra was safe because studies screen out participants who have health problems _ the people most likely to be hurt by the product.
12) The General Accounting Office, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.
13) The government ban, one of the first involving a dietary supplement, comes after Thompson this summer urged Congress to rewrite a law that rolled back dietary-supplement regulations and to require manufacturers to acknowledge potential side effects.
14) Because ephedra is an herb, U.S. law allows it to be sold over-the-counter with little oversight unless the FDA could prove a clear danger to public health. Manufacturers blocked a 1997 FDA attempt to restrict sales of certain dosages and to put warning labels on the herb by arguing the agency lacked enough proof of danger.
15) In March, the FDA again proposed those warnings and said it would re-examine a ban.
Government announces ban on herbal supplement ephedra
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1) The federal government announced on Tuesday a ban on the sale of ephedra, an herbal supplement used for weight control that has been linked to a number of deaths and harmful side effects.
2) Health and Human Services Secretary Tommy Thompson said that ``based on the best possible scientific evidence'' his agency would issue a consumer alert about the dangers of ephedra and will send notices to manufacturers to stop selling the herbs.
3) ``The time to stop taking this product is now,'' he said. ``They are just too risky to use.''
4) Thompson said the decision was ``well grounded'' and based on extensive scientific study. The ban would take effect in 60 days.
5) ``I don't want people turning to ephedra thinking they could lose weight,'' Thompson told a news conference.
Government bans herbal supplement ephedra
(APW_ENG_20031230.0296)
1) The U.S. government banned the sale of ephedra, a herbal supplement used for weight control that has been linked to a number of deaths and harmful side effects.
2) Health and Human Services Secretary Tommy Thompson said Tuesday that, ``based on the best possible scientific evidence,'' his agency would issue a consumer alert about the dangers of ephedra and will send notices to manufacturers to stop selling the herbs.
3) The ban will take effect in 60 days.
4) ``The time to stop taking this product is now,'' he said.
5) Critics called the federal crackdown too late. Sales nationwide already have plummeted because of publicity about roughly 155 deaths blamed on the amphetamine-like stimulant, including Baltimore Orioles pitcher Steve Bechler in February.
6) The NFL, NCAA and minor league baseball banned the use of ephedra. Three states _ New York, Illinois and California _ passed their own ephedra bans, while several retail chains recently quit selling it, too.
7) Bechler's father, Ernie, said in a telephone interview from Medford, Oregon, that he was awakened by a phone call around 6 a.m. with word of the decision.
8) ``It's the only thing that could make my wife and I be happy,'' he said. ``Nothing else could have done what this is doing. I mean to get this off the market and to save other peoples' lives is just amazing to us.''
9) Ernie Bechler testified in Congress, urging a ban. ``That's the last thing I said: 'Please don't let my son die in vain.'''
10) Ephedra is linked to heart attacks and strokes, even when used by outwardly healthy people at recommended doses, because it speeds heart rate and constricts blood vessels.
11) ``I don't want people turning to ephedra thinking they could lose weight,'' Thompson said at Tuesday's news conference.
12) Mark McClellan, head of the Food and Drug Administration, said his agency is notifying consumers and manufacturers that it will publish a rule making it illegal to sell and use ephedra.
13) He said the agency was concerned about young people and athletes looking to ephedra to boost their performance. Use of the supplement has led to serious health effects, he said.
14) ``We're sending a strong and clear signal'' that such products should come off the market, McClellan said.
15) McClellan said the FDA reviewed major studies of ephedra and publicly issued findings about the herb. He said the publication received thousands of comment and expressions of support for taking the product off the market.
16) The rule will go into effect in 60 days ``and have the practical effect'' of banning ephedra, he said.
17) ``Ephedra raises your blood pressure and stresses your system,'' McClellan said. ``There are far better, safer ways, to get in shape.''
2004-01-12
New supplements pushed to replace ephedra
(APW_ENG_20040112.0598)
1) People who think ephedra helped them lose weight are looking to new ingredients with names like guarana, bitter orange and green tea extract to replace the soon-to-be-banned dietary supplement.
2) There's little proof yet that ephedra alternatives actually burn pounds, and scientists warn that some come with health considerations of their own _ including an ephedra mimic that might interact dangerously with medicines the dieter also swallows.
3) ``There are a number of, quote-unquote, `ephedra substitutes' on the market now where even less is known about potential side effects,'' the U.S. government's Food and Drug Administration Commissioner Mark McClellan cautioned in an interview last week.
4) The FDA will pull ephedra off the market soon and wants consumers to stop immediately using the herbal stimulant, which is linked to 155 deaths and dozens more heart attacks and strokes.
5) Many consumers are ignoring that advice. There has been a run on remaining ephedra supplements since FDA's warning two weeks ago, even though studies show ephedra helps people lose only a few pounds more than dieting alone.
6) Still, as January ushers in postholiday diets, Americans are turning to the burgeoning ephedra-free market, too. Topping the lists of new ingredients are caffeine-containing supplements, some that deliver the buzz of at least three cups of coffee in one dose. Not all mention caffeine on the label; consumers may have to learn herbal aliases such as guarana and green tea to ensure they don't get caffeine jitters by taking multiple supplements.
7) The ingredient drawing the most attention is bitter orange, which McClellan says the FDA is monitoring closely because it contains synephrine, a stimulant chemically similar to ephedra.
8) Also called citrus aurantium, the peel of this very sour ``Seville orange'' is found in some foods like orange marmalade.
9) ``It's not as potent as ephedra unless you take it in much higher doses,'' says Mark Blumenthal of the American Botanical Council.
10) But some scientists note that synephrine can increase blood pressure and constrict blood vessels, as ephedra does, and question whether using it with caffeine could worsen those effects the way taking ephedra with caffeine does.
11) ``There's not really a reason to think citrus aurantium will be safer,'' says Dr. Adriane Fugh-Berman of Georgetown University, an expert on herbal supplements.
12) More worrisome, she says, is that bitter orange could interact dangerously with prescription or over-the-counter drugs.
13) Why? It's related to a longtime warning against taking medications with grapefruit juice. Grapefruit contains a natural chemical that inhibits one of the body's drug-metabolism routes so that some medicines build up to dangerous levels, and bitter orange contains even more of that drug-boosting substance, says Fugh-Berman.
14) Studies to date show bitter orange inhibits metabolism of at least two drugs, the popular over-the-counter cough medicine dextromethorphan and the prescription blood-pressure drug Plendil.
15) As for shedding pounds, there's no evidence in people yet that it works.
16) Other ephedra alternatives: _ Green tea extract. Green tea typically contains less caffeine per cup than coffee, plus many antioxidant vitamins.
17) Caffeine itself can be a mild appetite suppressant, and proponents say there may be other substances in green tea that could slightly speed calorie burning. There's no evidence yet that green tea causes weight loss, but Fugh-Berman calls the possibility interesting and says the substance probably is harmless. _ Guarana, used in a popular Brazilian soft drink, contains two to three times as much caffeine as coffee, Blumenthal says. Other caffeine-containing supplements are kola and mate. _ Garcinia, also called hydroxycitric acid. A Journal of the American Medical Association research review found no good evidence of weight loss. _ ``Starch-blocking'' pills promise to help starchy foods pass through the body with less calorie absorption. Most are made with kidney-bean extracts not thought to be harmful. Supplement giant Metabolife International cites a small study that found users dropped slightly more weight than regular dieters, but the research has not been published.
18) Old-fashioned fiber works on the same principle and can fill people up so they eat less, notes Fugh-Berman. But she says it's impossible to get as much fiber in a pill as from a glass of Metamucil, made with the soluble fiber psyllium. _ Bladderwrack, an herb that contains a lot of iodine, which could cause or worsen thyroid disease, notes a recent supplement review by University of Montana pharmacists. Germany, which strictly regulates herbal medicines, lists bladderwrack as unapproved, citing the health risk and lack of evidence that it burns pounds.
2004-04-01
Report: Agency doesn't need proof of harm to curb risky supplements
(APW_ENG_20040401.0601)
1) The U.S. Food and Drug Administration doesn't need direct evidence of human harm before taking steps to curb sales of a dietary supplement, an advisory panel reported Thursday.
2) Data from animals, test-tube studies, even similar products can suffice, the panel said.
3) Still, Congress should require manufacturers to report customers' side effects, thus easing constraints lawmakers have placed on the FDA's ability to protect the public from dangerous supplements, the Institute of Medicine concluded Thursday.
4) The report promises to bolster new FDA efforts to crack down on risky supplements _ and challenges long-held assumptions that the agency must prove an ingredient unsafe before pulling it off the market.
5) Not true, concluded a panel of well-known scientists from the institute and its sister agency, the National Research Council.
6) ``You don't have to have proof of harm,'' stressed Barbara Schneeman, vice provost and a nutritionist at the University of California, Davis, who headed the panel.
7) The law requires the FDA to demonstrate significant or unreasonable risk from a supplement, something the panel insisted can be done with less strict evidence. The report provides FDA with step-by-step instructions on how to evaluate supplement safety when there isn't clear-cut human data.
8) By setting a scientific framework for the FDA's work, ``it's certainly our hope this is going to allow them to be more effective in identifying substances that could pose a risk for harm to human health,'' Schneeman explained.
9) Contrary to frequent claims by supplement proponents, neither an absence of reports of side effects nor a product's long history of use automatically mean it's safe, the report cautioned.
10) Indeed, legal ``constraints imposed on the FDA make it difficult for the health of the American public to be adequately protected,'' the report concluded, calling on Congress to better fund the FDA's oversight of supplement safety _ and to mandate manufacturers' reporting of customers' side effects, just like medication makers must.
11) Sen. Richard Durbin has introduced legislation for side-effect reporting; support is uncertain.
12) The $19 billion dietary supplement industry _ with products ranging from mainstream vitamins to controversial hormones and stimulants _ is loosely regulated. A 1994 law sought by the industry means that, unlike most medications, most supplements sold today never had to be proven safe, much less proven to bring any health benefit.
13) The burden is on the FDA's $10 million dietary supplements office, with a staff of 25, to uncover enough evidence to push risky ones off the market. Later this month, the heart attack- and stroke-causing herb ephedra is slated to become the first supplement formally banned under the law's provisions.
14) That ban comes after 155 deaths that were linked to the herbal stimulant and a pitched eight-year battle with ephedra supporters. The FDA at first said it lacked enough proof of harm for a major crackdown but later reversed that position. In December the agency set a legal precedent by making ephedra's actions inside the body key to its risk analysis, rather than simply trying to prove it caused individual deaths.
2004-04-11
Ephedra banned from Monday, unless judge orders reprieve
(APW_ENG_20040411.0232)
1) A U.S. government ban on sales of ephedra kicks in Monday unless a federal judge issues the dwindling industry a late reprieve.
2) The herbal stimulant, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths and dozens more heart attacks and strokes.
3) After years of fighting manufacturers over ephedra's risks, the Food and Drug Administration announced in December it would ban sales of the amphetamine-like herb _ the first such ban of a dietary supplement _ and urged consumers to quit using it immediately.
4) Research shows the herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it's particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise.
5) Ephedra sales already had plummeted because of publicity about the risks, which peaked after the ephedra-related death of Baltimore Orioles pitcher Steve Bechler a year ago. Three states _ New York, Illinois and California _ have prohibited the stimulant on their own.
6) The nationwide ban was set to go into effect Monday.
7) Last month, however, the maker of the Stacker 2 ephedra brand filed a lawsuit seeking to block the ban. NVE Pharmaceuticals of New Jersey contends the FDA lacks proof that ephedra is dangerous if used as directed. The suit argues that the agency simply reacted to the emotion of high-profile deaths like Bechler's.
8) Medications must be proven safe and effective before they're allowed to be sold, but federal law allows dietary supplements to be sold without any such proof. To curb a dangerous supplement, the law requires the FDA to show it poses a significant health threat, which is a high standard to meet.
9) The FDA argued that it amassed sufficient proof of ephedra's dangers from thousands of side-effect reports and scientific studies that proved the herb's stimulant-like effects inside the body.
10) A federal judge was scheduled to rule Monday on the ephedra maker's request for a temporary restraining order.
2004-04-12
Ephedra ban takes effect nationwide after judge rejects supplement makers' request
(APW_ENG_20040412.0449)
1) A federal judge allowed a nationwide ban on dietary supplements containing ephedra to take effect Monday, turning aside a plea from two manufacturers.
2) Ephedra, once hugely popular for weight loss and bodybuilding, has been linked to 155 deaths, including that of Baltimore Orioles pitcher Steve Bechler a year ago.
3) U.S. District Judge Joel Pisano refused to grant a temporary restraining order that would have prevented the Food and Drug Administration from banning the products.
4) After years of fighting manufacturers over the risks, the FDA announced in December that it was banning the sale of the amphetamine-like herb _ the first such ban of a dietary supplement.
5) ``These products pose unacceptable health risks, and any consumers who are still using them should stop immediately,'' Health and Human Services Secretary Tommy G. Thompson said.
6) NVE Pharmaceuticals of Newton, manufacturer of the diet supplement Stacker 2, had hoped to head off the ban, arguing its product is safe if used as directed. It was joined by a second company, the National Institute for Clinical Weight Loss, manufacturer of a product called Thermalean.
7) The judge said the manufacturers did not meet several legal requirements, including proving that they are likely to win the case and that they would suffer irreparable harm if the ban took effect.
8) Pisano's ruling means the ban will be in effect at least until NVE's lawsuit can be heard. No trial date has been set.
9) Ephedra sales already had plummeted because of publicity about the risks, especially after Bechler's death a year ago. Three states _ New York, Illinois and California _ prohibited the stimulant on their own.
10) ``Ephedra has killed more than 100 individuals and injured thousands of others,'' said Bruce Silverglade, legal director of the Washington-based Center for Science in the Public Interest. ``The only problem is, it took the FDA almost 10 years to ban the substance.''
11) Unlike medications, which must be proven safe and effective before they ae allowed to be sold, federal law allows dietary supplements to be marketed without any such proof. To curb a supplement, the FDA must show it poses a significant health threat.
12) NVE maintains that the FDA failed to prove such a threat if the supplement is taken correctly, and was swayed by the outcry over ephedra deaths.
13) ``The FDA chose to ignore valid science that showed that there wasn't a problem,'' said Walter Timpone, a lawyer for NVE. ``In 1999, (there were) 104 deaths as a result of aspirin ingestion. Are we going to ban aspirin now?''
14) Andrew Clark, a Justice Department lawyer arguing the case for the FDA, said the ban is based on sound science.
15) Research shows ephedra can speed heart rate and constrict blood vessels even in seemingly healthy people, and is particularly risky for those who have heart disease or high blood pressure or engage in strenuous exercise.
16) ``We think it's a rule that can save lives,'' Clark said.
17) The ban does not affect decongestants and other medicines containing ephedrine, a synthetic version of ephedra. Drugs containing ephedrine and a chemical cousin called pseudoephedrine are regulated and approved by the FDA and are safe, said agency spokesman Lawrence Bachorik.
2004-05-04
Utah company files suit challenging federal ephedra ban, saying product has been used safely
(APW_ENG_20040504.0428)
1) A dietary supplements company has filed a federal lawsuit challenging the Food and Drug Administration's ban on supplements containing ephedra.
2) The supplements were widely used for weight loss and bodybuilding, but have been linked to 155 deaths. The FDA's ban on all dietary supplements containing ephedra went into effect April 12.
3) Nutraceutical Corp. and its subsidiary Solaray claim in their lawsuit, filed Monday, that ephedra ``has been safely consumed for millennia.''
4) The company contends its product is safe because it contains only low doses of the ephedrine alkaloid. Ephedra contains two alkaloids, ephedrine and pseudoephedrine.
5) The lawsuit claims that the FDA did not meet its burden of proving that all ephedrine dietary supplements present ``a significant or unreasonable risk of illness or injury at every dose level and as labeled.''
6) The suit seeks to have the FDA's rule declared illegal. It asks that if the court does not find the rule to be illegal, then it rule that Nutraceutical's loss be considered a ``taking,'' which would require the government to pay compensation.
7) Research shows the herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it's particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise.
8) Ephedra is a plant with varieties growing in Asia, Australia, Europe and North America. In China, it has been used for 4,000 years to treat respiratory infections. Typically, the whole plant is powdered and used in pills or other preparations.
9) The FDA has argued that it amassed sufficient proof of ephedra's dangers from thousands of side-effect reports and scientific studies that proved the herb's stimulant-like effects inside the body.
10) A federal judge in New Jersey refused to block the ban in a similar case brought by other dietary supplement companies. That ruling, which rejected a request for a temporary restraining order, was issued the day the federal ban took effect.
2004-06-24
Jury awards $7.4 million to woman who took diet supplement containing ephedra
(APW_ENG_20040624.0346)
1) A jury awarded $7.4 million to a woman who suffered brain damage in a stroke two years ago after taking a diet supplement that contained the now-banned herbal stimulant ephedra.
2) The jury found Wednesday that San Diego-based marketer Metabolife International acted maliciously when it falsely told state and federal regulators that its Metabolife supplement had no adverse effects and that the company had comprehensive safety monitoring procedures.
3) Rhea McAllister was awarded $2.4 million in actual damages and $5 million in punitive damages.
4) "We were elated," her attorney Tommy Fibich said.
5) Ephedra was once widely used for weight loss and bodybuilding, with industry groups claiming at least 12 million users. The amphetamine-like stimulant, which speeds the heart rate and constricts blood vessels, has now been linked to 155 deaths and the federal government banned it in April.
6) McAllister, 35, is numb on one side following her stroke in April 2002, making use of her hand difficult and causing her to drag her foot, her attorneys say. She also has short-term memory loss and unpredictable dizziness, they say.
7) Metabolife attorney Michael G. Terry had argued that McAllister's problems might have been caused by oral contraceptives and that a doctor had pronounced her recovered from her injuries.
8) The jury found McAllister 30 percent liable for failing to tell her doctor that she was using Metabolife when she first complained of dizziness and other symptoms.
9) The suit was one of the first to be tried among the mounting number of cases since the ban.
2004-07-23
2004-07-28
2005-12-17
Herbal supplement company fined $600,000 in U.S. for tax evasion
(APW_ENG_20051217.0152)
1) Metabolife International, which made millions selling a diet supplement containing ephedra, must pay a $600,000 (euro500,700) fine for filing false income tax statements in 1997 and 1998, a federal judge ruled.
2) "Metabolife tried to cheat on its taxes, pure and simple," U.S. Attorney Carol Lam said Friday.
3) Calls to Metabolife offices in San Diego and Hauppauge, New York, Friday evening were not immediately returned.
4) The now-bankrupt company pleaded guilty on Oct. 5 to two counts of filing false returns. The company and one of its owners, William Bradley, admitted depositing funds in unrecorded domestic accounts. Bradley, who admitted using a charity, shell companies and at least one foreign business to avoid paying taxes, is scheduled to be sentenced in April.
5) Metabolife and co-founder Michael Ellis are still fighting federal charges of lying to the U.S. Food and Drug Administration about the dangers of Metabolife 356, a popular diet supplement containing ephedra, the now-banned herbal stimulant linked to dozens of deaths.