[iDriveX]

Judge Strikes Down FDA Ban on Ephedra
18 minutes ago Health - AP
By MARK THIESSEN, Associated Press Writer


SALT LAKE CITY - A federal judge Thursday struck down the FDA ban on
supplements containing ephedra, the once-popular weight-loss aid that was
yanked from the market after it was linked to dozens of deaths.

The judge ruled in favor of a Utah supplement company that challenged the
Food and Drug Administration's ban. Nutraceutical claimed that ephedra "has
been safely consumed" for hundreds of years, and that ephedra was wrongly
being regulated by the FDA as a drug and not a food.

Judge Tena Campbell agreed, saying federal law places more restrictive rules
on the FDA in determining whether to ban foods as opposed to drugs. The
judge said the law requires the FDA to prove that a dietary supplement is
harmful, rather than having the manufacturer prove it is safe, as is
required with drugs.

Nutraceutical President Bruce Hough said the lawsuit had little to do with
ephedra and more to do with forcing the FDA to follow the rules Congress set
down for it.

He said Nutraceutical interprets the ruling to mean that the company is
allowed to start selling ephedra supplements again, but added that it is too
soon to say whether it will put the products back on the market.

"This is a great affirmation for the system, that the court goes back and
says, 'This is Congress' intent,' and follow it," he said.

FDA spokeswoman Kimberly Rawlings said the agency is "evaluating the
decision."

Supplements that included ephedra were 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 been linked to 155 deaths, including that of Baltimore Orioles
pitching prospect Steve Bechler. The federal government banned it one year
ago.

Campbell's sends the matter back to the FDA "for further rulemaking
consistent with the court's opinion" and keeps the agency from enforcement
action against the companies.


While I personally won't be taking any Ephedra it just goes to show you waht kind of a fear based society we live in. Out of the 12 million users of Ephedra only 155 have died according to this article. But because one quasi-famous person died and it made headlines, it means everyone is dying from this. Moms are crying about their children taking Ephedra but not when they jump in the car to go to their friend's house even though the odds of dying in a car wreck are higher.

[Zimphire]

The real reason they took it off was because it's one of the main ingredients in meth.

That is why there was laws saying you could only buy a certain amount at once.

They thought if they got rid of the Ephedra, the meth problem would go away.

But they just found something else to use.

[Steve]

Hopefully the manufacturer is able to start selling the supplement again. I wanted to purchase some recently then realized that it had been banned.

[ghporter]

While "only" 155 people have died, a huge number have suffered irreparable harm from the consumption of ephedra-containing concoctions. The real problem is that ephedra IS a drug, but it's not "classified" as one so not only can the FDA not ban it, but it can't regulate it sufficiently to ensure that the consumer gets a known quantity per serving-and to ensure that manufacturers ensure that quantity is consistent.

Steve, if you can't count on a "food additive" or "supplement" being consistent, how can you count on its effect? This is specifically the issue the FDA was addressing by attempting to ban ephedra. You'll notice that you can't just wander into a GNC and buy foxglove, the primary source of natural digitalis. That's because there is no way to control how much digitalis is in each leaf of foxglove. This, in fact, is the whole problem with "herbal medicine." There's no way to actually control the active ingredients' concentration or quality from dose to dose, so something that works fine today may not work at all tomorrow-or it may kill the user.

Zimphire, the meth issue was only one of many, and pseudophedrine HCL is a suitable substitute in meth production-you'll notice that in many jurisdictions it's impossible to simply walk in and pick up a bunch of over-the-counter Sudafed; you're restricted to "a reasonable quantity needed for a single adult" and in some places you have to provide valid ID and sign a log. Ammonium nitrate is a bigger issue in locking down meth production, and "explosives monitoring" has taken its toll on a lot of meth labs. Add that to a lot of farmers getting pissed as hell at people who steal their fertilizer and securing it very well, and you see why in some areas meth has been radically curtailed.