To: IAHF List
Subject: HHS: Congress Should Rewrite Ephedra Law
Date: 24 Jul 2003 02:36:02 -0000
IAHF List: See the AP Article about this hearing below my comments
I watched day one of the US Congressional Witch Hunt against dietary supplements today on the webcast of a hearing that will resume tomorrow morning at 9 AM. Today's witch hunt "featured" congressmen who can't tell the difference between ephedra and ephedrine, who asked moronic questions, and who clearly are hell bent on attacking consumer access to supplements, supposedly "for our own good." We don't need these people protecting us from safe supplements, we need firearms to protect us from these members of Congress and from the terrorists at the FDA.
(Notice they're not doing anything to try to railroad far more dangerous substances such as aspirin and tylenol off the market, to say nothing of dangerous Rx weight loss drugs that never should have been "approved."
This is part of the global attack on dietary supplements which is being orchestrated at the top most level by ICDRA International Conference of Drug Regulating Authorities, a UN Umbrella Group Overseeing the World's FDA's which organizes attacks against the supplement industry world wide You can watch tomorrow's ongoing hearing at http://energycommerce.house.gov/108/Hearings/07232003hearing1021/hearing.htm
See the AP Article about this hearing below my comments: Health and Human Services Commissioner Tommy Thompson is calling for the Dietary Supplement Health and Education Act to be repealed by S.722 and HR 1075, plus HR 5564- all of which would gut the bill if passed into law by putting the burden of proof on supplement manufacturers to prove their products are safe before they can be marketed. Currently the burden of proof is where it BELONGS (on the FDA) to prove the products are UNSAFE before they can remove them from the market. (FDA can't prove ephedra is unsafe if taken as directed, but they're claiming the law "ties their hands" preventing them from taking action to protect the public, which is a lie.
Tomorrows testimony will include Thompson, FDA Commissioner McLellan, as well as spokesmen for the National Football League, Major League Baseball, NASCAR, Major League Soccer, the NCAA and other sports groups, most if not all of which will call for DSHEA to be repealed.
These idiots have another thing coming if they think the American people are going to stand for this. It will be interesting to see if any of these bills start moving in the aftermath of the hearing. Currently S.722 only has 3 cosponsors, HR 1075 has 4, and HR 5565 has 3. S.722 incorporates the information from both House bills. If either House bill starts to move, they'll both most likely be combined into one bill at some point.
While IAHF is monitoring this situation closely, it has not yet risen to the top of my priority list due to the timeliness of ANH being able to file a lawsuit to overturn the EU Food Supplement Directive and the international impact it threatens to have. [ See http://www.iahf.com/anh_lawsuit.html
HHS: Congress Should Rewrite Ephedra Law
By JONATHAN D. SALANT
Associated Press Writer
WASHINGTON (AP)--Congress should rewrite a law that rolled back dietary-supplement regulations and require manufacturers to acknowledge potential side effects, Health and Human Services Secretary Tommy Thompson said Wednesday.
Thompson's comments came as the House Energy and Commerce oversight subcommittee opened two days of hearings on the supplements, with a particular focus on ephedra, often promoted as a weight-loss product. Ephedra has been linked to as many as 100 deaths.
Ernie and Pat Bechler, the parents of Baltimore Orioles pitcher Steve Bechler, were among those who testified. Their son died during spring training last February. He had been trying to lose weight, and toxicology tests after his death showed ephedra in his system.
Kevin Riggins, whose 16-year-old son, Sean, died of a heart attack after taking ephedra, also testified.
``How many Steve Bechlers or Sean Rigginses have to die to prove that these are not safe?'' Mrs. Bechler said, sitting behind a framed picture of her son in his Orioles uniform, her voice cracking. ``We need to get this off the market. We need to help our children.''
The hearing resumes Thursday when lawmakers are scheduled to hear from officials of Major League Baseball, the National Football League, Major League Soccer and NASCAR, as well as the FDA and Federal Trade Commission.
Executives of several companies that make ephedra-based products say that studies have proven that they are safe when used properly.
``Anyone who has read our label knows that we go to great lengths to inform our customers about the proper use of our products,'' said Russell Schreck, chief executive officer of San Diego-based nutritional supplement-maker Metabolife International. ``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.' ``
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.
The General Accounting Office, Congress' investigative arm, looked into the issue and found many people who reported problems had followed the label's instructions.
Marcia Crosse, the GAO's acting director of health care-public health and science issues, said the health problems reported to Metabolife included heart attacks, strokes and seizures. Five deaths also were reported.
Crosse said the problems reported to Metabolife ``are consistent with the types of adverse events reported to FDA and with the documented physiological effects of ephedra.'' The records of calls to Metabolife, she said, ``contain reports of serious adverse effects in consumers who were young and among those who used the product within the recommended guidelines.''
Crosse also noted the Food and Drug Administration has received more reports of problems from ephedra than from any other supplement.
A 1994 law left dietary supplements largely unregulated. The FDA has said the statute prevents it from banning such products.
Thompson said makers of dietary supplements should have to tell the FDA about potential side effects, just as drug makers do. He urged Congress to revise the 1994 law.
''FDA is somewhat hampered,'' Thompson said. ''We are unable to really do as effective a job as possible.''
A subcommittee member, Rep. Greg Walden, R-Ore., has co-sponsored legislation to amend the law.
''I don't think that the FDA is properly equipped to quickly deal with an issue of this magnitude,'' Walden said. ``While somebody does a study to figure out if something is safe or not, we let people get injured before we decide to act. The burden of proof should be on the manufacturer, not the consumers who suffer stroke, heart attacks and death, all of which is associated with these ephedra-based products.''
Rep. Henry Waxman, D-Calif., a member of the subcommittee, said he favors changing the law.
''They claim they don't have sufficient legal authority,'' Waxman said of the FDA. ``That may be an excuse, and I don't want them to have the excuse.''
On the Net:
House Energy and Commerce Committee: http://energycommerce.house.gov
Ephedra Education Council: http://www.ephedrafacts.com
07/23/2003 7:14 PM ET
Hearing held on ephedra
WASHINGTON -- Many people who followed guidelines for using the herbal stimulant ephedra still reported health problems, congressional investigators found.
In addition, many complaints came from users under 30, the General Accounting Office said in testimony prepared for Wednesday's hearing on dietary supplements before the House Energy and Commerce oversight subcommittee.
Marcia Crosse, the GAO's acting director of health care-public health and science issues, said the reports of health problems made to drug-maker Metabolife International included heart attacks, strokes and seizures. Five deaths also were reported.
Crosse also noted the Food and Drug Administration has received more reports of problems from taking supplements with ephedra than any other ingredient.
Crosse said the problems reported to Metabolite "are consistent with the types of adverse events reported to FDA and with the documented physiological effects of ephedra." In addition, she said, the records of calls to Metabolite "contain reports of serious adverse effects in consumers who were young and among those who used the product within the recommended guidelines."
She said the average age of those who included an age when they called was 38, and ranged from 17 to 65. More than one-third were under 30.
In a statement submitted to the subcommittee, Metabolite said the company "strongly believes in the science supporting the safety and efficacy of dietary supplements that contain ephedra when used as directed."
The House subcommittee is holding two days of hearings on ephedra, which was thrust into the spotlight in February following the death of Baltimore Orioles minor league pitcher Steve Bechler, who had taken a dietary supplement containing ephedra.
Testifying before the subcommittee was Kevin Riggins, whose 16-year-old son, Sean, died of a heart attack blamed on ephedra.
"The little packages, which promote weight loss, performance and energy enhancement, were being sold right next to the Twinkies and candy bars," Riggins said in his prepared testimony. "The use of these products was so casual, none of the kids believed they were taking a drug."
Congress in 1994 severely limited federal oversight of dietary supplements, but some lawmakers said they should reconsider the law. "Some say that the law has allowed 'buyer beware' to replace 'safe and effective when used as directed,'" said Rep. Diana DeGette, D-Colo.
House Energy and Commerce Committee chairman Billy Tauzin, R-La., raised the possibility that Congress could ban or restrict ephedra sales.
"These supplements ... can be bought at any 7-Eleven convenience store or gas station by anyone, including those under 18," Tauzin said, questioning "whether continuation of such a policy for ephedra makes sense, given what we have learned about the dangers of ephedra."
The FDA is sifting through 16,000 comments responding to its March proposal to order warning labels on bottles of ephedra. The FDA has not tried to ban the product, despite reports of more than 100 deaths being linked to the herb, citing the 1994 law.
In May, Illinois Gov. Rod Blagojevich signed the nation's first statewide ban on ephedra.
Kiley Bechler, the pitcher's widow, filed suit in federal court last week against the manufacturer and distributor of the supplement containing ephedra that was found in her husband's locker.
Medical Examiner Joshua Perper in Fort Lauderdale, Fla., where Bechler died, said ephedra in the weight-loss supplement Xenadrine RFA-1 contributed to the heatstroke that killed the pitcher.
Officials of Cytodyne, which makes Xenadrine, released a letter to the House committee from forensic pathologist Dr. Michael Baden, former New York City chief medical examiner, who said ephedra didn't cause Bechler's death.
This story was not subject to the approval of Major League Baseball or its clubs.
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