IAHF Webmaster: Breaking News, Codex Emergency, USA and All Countries, What to Do
IAHF List: I am quite happy to learn of the court's decision to unban low dose ephedra. (see news story below- also note upcoming IAHF radio shows below) It was absurd when ephedra (the herb ma huang) was banned, especially given that it is far safer than ephedrine which is found in a slew of OTC cold preparations and which really IS dangerous.
At the same time, however, this court ruling will help to push Durbin's bill when it gets reintroduced sometime this spring under a new bill number (was S.722) (Will let you know the moment its reintroduced under a new # so you can help kill it.)
While this is great news that the court overturned the ban on ephedra, I urge all Americans on the IAHF list to email the form letters from the following 2 websites in an effort to kill CAFTA and the FTAA. FTAA threatens to create a carbon copy of the EU Dictatorship in our hemisphere, and this would be the main vehicle for ushering in Codex harmonization.
We have little leverage over the UNELECTED BUREAUCRATS from the world's FDA's who will be delegates at the 28th General Session of Codex in Rome in July, but we DO have leverage over state and federal officials and we CAN kill CAFTA and the FTAA- we HAVE to or it won't just be our dietary supplement laws that will be harmonized to international standards, it will be ALL of our laws.
See http://www.stoptheftaa.org and also http://www.citizen.org/trade/cafta/
Between both of these organizations, they cover the whole political spectrum. Please send both of their form letters from their sites, and also write your own HAND WRITTEN letter to your Senators because they could hold a FAST TRACK vote on CAFTA in MAY. Please forward this alert widely.
John Hammell of IAHF is doing a radio show on Saturday night (ERSKINE OVERNIGHT 10-11 PM West Coast time will be archived, hear on the web at http://www.gcnlive.com , and another on Monday night with Jackie Patru (6-7 pm west coast time) http://www.sweetliberty.org
Next week we'll be participating in a conference with other activists concerned about Codex in DC.Your donations will help us get there and to continue doing public speaking, organizing and lobbying on this important issue. See below to donate.
STORY ON JUDGE LIFTING THE BAN ON EPHEDRA:
http://news.yahoo.com/news?tmpl=story&u=/nm/20050415/ts_nm/health_ephedra_dc_2
Court Says FDA Ephedra Ban Too Broad
26 minutes ago Top Stories - Reuters
By Susan Heavey
WASHINGTON (Reuters) - The Food and Drug Administration failed to prove certain "low dose" ephedra supplements are unsafe, a U.S. court said in a ruling announced on Thursday that could allow some types of the controversial weight loss pill back on the market.
The agency's decision to ban all ephedra dietary supplements -- regardless of dose -- until manufacturers could demonstrate a benefit "is contrary to the clear intent of Congress," the court said in its decision issued on Wednesday.
Nutraceutical International Corp., a leading supplier of dietary supplements, which filed the suit challenging the agency's ban, posted the ruling on its Web site on Thursday.
The ruling comes one year after FDA officials banned the controversial weight loss pill. It lifts the restriction on ephedra supplements with 10 milligrams or less of the active ingredient, but at least one doctor said that even low doses of the pills could be abused.
It was not clear if the FDA would challenge the ruling, but a spokeswoman for the agency said it was reviewing the judge's decision.
FDA officials have linked ephedra to death, heart attacks and strokes, but manufacturers have said it is safe when used as directed and have promoted it for shedding pounds, boosting energy and enhancing athletic performance.
The ruling "clarified that the FDA ... cannot treat dietary supplements like drugs or medical devices," Nutraceutical President Bruce Hough said.
Unlike prescription medicines, supplements do not have to be proven safe before they can be sold. The government must show a supplement is too risky to force it off the market.
Judge Tena Campbell of the U.S. District Court for the District of Utah ruled the FDA could not place the burden to prove safety on dietary supplement manufacturers as it does for drug and device makers.
Instead, the agency "must establish that (ephedra supplements) pose a significant or unreasonable risk by a preponderance of the evidence," Campbell wrote. In the case of low dose versions of ephedra, the FDA failed to meet that test, the judge said.
UNREASONABLE RISK
The ruling sparked renewed debate over the stimulant.
"A low dose is almost ridiculous in that the potential for using any amount by taking multiple pills still remains," said Dr. Julian Bailes, a former National Football League consultant and physician.
Ephedra "remains a very suspect and dangerous supplement," said Bailes, now a neurosurgeon at the West Virginia University School of Medicine.
Chuck Bell of Consumers Union, said Congress should give FDA more authority over supplements. "The FDA ... should fight hard to make sure that this hazardous supplement stays off the market," he added.
Industry groups said the ruling showed current law works but that the FDA must better evaluate unreasonable risks.
"What the court has said is that FDA needs to pay better attention to this detail," American Herbal Products Association President Michael McGuffin said.
Ephedra sales fell after risks were publicized several years ago and major retailers stopped selling it. The FDA banned it in April 2004.
Ephedra sales were about $500 million in 2003, a 60 percent drop from $1.25 billion in 2002, according to the Nutrition Business Journal, a trade publication.
Shares of Park City, Utah-based Nutraceutical closed up 8 cents at $15.81 on Nasdaq on Thursday.
