To: IAHF List
Subject: FDA's McLellan Testifies That FDA Is Attempting to Work Within DSHEA Via The Courts to Ban Ephedra
From: IAHF.COM
Date: 24 Jul 2003 21:26:04 -0000
IAHF List: See the latest AP article on todays second and final day of the ephedra hearing in the House. I watched today's conclusion of the Congressional Witch Hunt against Ephedra and against the dietary supplement industry, and am markedly less concerned now than I was before about any threat posed by this hearing to consumer access.
Ironically, FDA Commissioner Mark McLellan, MD, PhD did not agree with any congressman who attempted to prod him into saying that he wanted legislative changes made to the Dietary Supplement Health and Education Act.
He would not say what they wanted to hear which was that DSHEA "ties the FDA's hands blocking them from acting" by banning ephedra, or from regulating the industry over label claims.
What McLellan told them repeatedly was that no one has ever tested the unreasonable risk standard found within DSHEA in court- and that the last time the FDA attempted to ban ephedra, they were blocked in court from doing so because all they had was Adverse Event Reports, which are anecdotal and there often are other mitigating circumstances that can cause an apparent reaction to a substance besides the suspected cause. He said the Judge admonished the FDA that to get ephedra banned they'd need more than just AERs, they'd need hard clinical evidence that proves the risks outweigh the benefits.
In the face of enormous congressional pressure to ban ephedra coming from intense questioning from Congressmen Greenwood, Degette, Waxman, Tauzin, Stupak and others- McLellan's testimony surprised me because I thought for sure he'd welcome their desire to attempt to repeal DSHEA, but he made it clear FDA intends to work within the current law, stating many times that it had NOT in fact overly limited their ability to act to protect the public by enforcing labeling laws- its just that the safety standard was untested in court- but they intend to "test it soon."
The implication was that if the FDA failed in court, then McLellan would welcome and support a congressional effort to repeal DSHEA, but not before.
McLellan's comments surprised me in light of previous statements made by Health and Human Services Director Tommy Thompson who on Wednesday told the media that DSHEA should be overturned- that it ties FDA's hands- that FDA should be able to compel supplement manufacturers to turn Adverse Event Reports over to the FDA just like drug manufacturers do.
Aside from McLellan's surprisingly balanced, reasoned testimony, the only other ray of sanity in the hearing today came from New Jersey Congressman Frank Pallone, a long time ally of the supplement industry.
Pallone commented that many times the industry had requested the FDA stop dragging their feet on implementing the new Good Manufacturing Practice Regulations which DSHEA required them to enact, saying that their slowness hurt the industry's reputation unfairly since many in the industry WANT GMPs for proper quality control.
Pallone commented that when FDA dragged its feet on issuing GMP regs that some in the industry clamored for the FDA to move faster on finalizing a rule on ephedra, because otherwise the whole industry could be unfairly criticized by the media and by congress.
Pallone asked McLellan to comment on this. McLellan's response was that since arriving at FDA he was making finalization of GMP regs for supplements a priority, and the same was true for FDA's efforts to generate an advance notice of proposed rulemaking regarding allowable ephedra potency levels- but that they were still sifting through thousands of comments received on the issue.
He insisted that the Agency would be coming back to court "soon" on the ephedra issue, and that at that time they hope to prevail against ephedra, and in so doing "successfully test the safety standard within DSHEA" which is that benefits must outweigh risks or FDA can ban a product.
I hope the FDA loses in court because I feel that it should be strictly a matter of personal choice whether or not someone wants to take any dietary supplement, or any substance for that matter.
Contary to Congresswoman Degette's vehement assertions to the contrary, we don't need a nanny state. We don't need Big Brother (in her case "Big Sister" making these decisions for us. So I hope FDA loses in court and that the vitamin consuming public succeeds in killing S.722 and the related House bill HR 1075.
Its not going to be easy for the sponsors of this legislation to get support for this legislation in the aftermath of McLellan's testimony, because he did not tell them what they wanted to hear.
Congress is out of session til September, so if any new cosponsors did come out of today's hearing, we wouldn't know that til September- but McLellan's testimony will make it harder for the sponsors of the bills to get cosponsors- which is good for vitamin consumers.
By September, many other issues will be competing for Congress's attention when they go back into session and the distraction will also hinder Durbin's, and Sweeney's efforts to move this legislation.
All of this reinforces my view that this issue should not be a priority for us right now- a much more timely matter is the need for donations to the ANH lawsuit because the optimal time to file it would be no later than mid September according to the lawfirm handling the case- if we wait any longer than that we weaken our case. In theory we could file it at the end of October, 3 months after the FSD has gone into effect in the EU, but we shouldn't push it that long.
A bigger threat than how FDA deals with ephedra, and S.722 are what sort of final rule FDA comes out with later this summer on GMPs because they intend to violate the law and force us to try to get a federal injunction to stop them from enforcing GMP regs even more stringent than pharmaceutical GMPs (DSHEA only mandates them to come out with food based GMPs)
As discussed previously, the global implications of the EU Food Supplement Directive are long reaching- so the ANH lawsuit should remain our number one focus and priority. See my article at http://www.iahf.com/anh_lawsuit.html and please make a donation to ANH today and forward this to more people.
http://www.kron4.com/Global/story.asp?S=1374154&nav=5D7lH5M8
Posted: July 24, 2003 at 11:28 a.m.
WASHINGTON (AP) -- The government is considering banning ephedra, an herbal stimulant used in dietary supplements that has been linked to scores of deaths and myriad health problems, the head of the Food and Drug Administration said Thursday.
Commissioner Mark McClellan's testimony before House subcommittees marked a departure for his agency, which had said it had been prevented from banning such products by a 1994 law that left dietary supplements largely unregulated.
"A ban on ephedra use is in the range of options we are considering," he told the lawmakers.
McClellan said the agency needs to make sure the evidence it is reviewing, such as studies on the herb and health complaints submitted to companies that use it in their products, could support a ban under the law. The 1994 statute requires the FDA to prove that a dietary supplement is harmful rather than having the manufacturer prove that it is safe, as with drugs.
Ephedra, which can be used to lose weight and boost athletic performance, has been linked to as many as 100 deaths. Health problems can include strokes, heart attacks and seizures.
On Wednesday, Health and Human Services Secretary Tommy 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.
During two days of hearings, the House panel heard from scientists, health officials, the parents of two people who died after taking ephedra and representatives of pro sports leagues and players, as well as officials from companies that make products with ephedra.
The head of the major league baseball players' union told lawmakers Thursday that the sport should not ban dietary supplements containing ephedra unless the government does.
"The position of the players' association has long been that players should not be prohibited from using any substances that the United States government has effectively determined are not unsafe for consumption by other American consumers," said Eugene Orza, associate general counsel of the Major League Baseball Players Association.
The issue is particularly relevant to baseball because of the death in February of Baltimore Orioles pitcher Steve Bechler, who was taking a supplement with ephedra. Following the death, Baseball Commissioner Bud Selig banned players with minor league contracts from taking ephedra but did not prohibit major leaguers from using the stimulant.
Robert Manfred Jr., an executive vice president of major league baseball, explained Selig's decision, saying the players' union would not agree to ban any substance that could be purchased over the counter.
Other sports leagues do ban ephedra and test players to make sure they are not using the product. They include the National Football League and Major League Soccer, both of which sent representatives to Thursday's hearing before the House panel.
Orza said that a ban on ephedra would violate players' privacy rights, since they would be subject to random drug testing.
But several lawmakers criticized the union's stance.
"It's going to take a long time to legislate this. It always does," said Rep. Cliff Stearns, R-Fla., chairman of the commerce subcommittee. "You in the private sector have the opportunity to act much, much more quickly than that. I don't know why you're not rushing to get rid of it."
Manufacturers of ephedra insisted their products were safe.
"Ephedra supplements have been used by tens of millions of people in recent years," said Robert Chinery Jr., president of Nutraquest Inc., formerly Cytodyne Technologies Inc.
At Wednesday's hearing, three past or present Metabolife International officials took the Fifth Amendment and declined to testify. The San Diego-based company makes supplements that include ephedra.
The Justice Department is investigating whether the company lied about ephedra's safety. The president of the company in 1998 told the FDA that the firm had never received any consumer complaints of serious side effects, but later turned over more than 14,000 records of calls from ephedra consumers with concerns about health-related issues.
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