Fwd: Ephedra ban not truly lifted

[Guest guest]

==

>

> Ephedra ban not truly lifted

> Bryce Edmonds

>

> 4/20/2005 7:41:28 PM

>

> When it comes to ephedra, what happens in Utah stays

> in Utah. In fact,

> what happens for Nutraceutical is only for

> Nutraceutical.

>

> On April 13, a district court in Utah ruled for

> Nutraceutical Corp. and

> Solaray Inc. in a case challenging the validity of

> the U.S. Food and

> Drug Administration's ban on ephedra. Tena Campbell,

> the district judge

> in the case, sent the ban back to FDA for further

> rulemaking consistent

> with her order, and blocked all action by FDA

> against Nutraceutical and

> Solaray for the sale of " a dietary supplement

> containing 10 mg or less

> of ephedrine alkaloids per daily dose. "

>

> Justin Prochnow, an attorney with Greenberg Traurig

> LLP, said the

> specific effect of the ruling pertains only to

> Nutraceutical. " This was

> a U.S. District Court in Utah case. The reality is

> that district court

> cases really only have precedent on that particular

> case. They're not

> dispositive on even other judges in that same

> district. … If the 10th

> Circuit Court of Appeals affirmed the decision then

> it would have

> precedence over all the cases in the 10th Circuit,

> but when an

> individual district court judge makes a ruling you

> can look at it as

> influential in what the court might decide but it

> doesn't control the

> other cases. "

>

> However, the case may still have implications for

> the industry. " With

> respect to the ruling itself, we view it as a good

> ruling for the

> supplement community as a whole, " Prochnow said. " It

> says FDA basically

> tried to shift the burden and instead of FDA having

> to prove that a

> product was unreasonably dangerous or harmful, they

> made the

> manufacturers prove that it was safe, and that was

> an unfair shifting

> of the burden. Manufacturers don't have to prove the

> safety, the FDA

> has to prove the harmful nature of it. " The Dietary

> Supplement Health

> and Education Act makes that so by classifying

> supplements as foods.

>

> As for FDA's " further rulemaking, " Prochnow said the

> agency might still

> have the necessary evidence to reinstate the full

> ban. " All the judge

> said was that the way they went about it is wrong

> and she sent it back.

> All the FDA really has to do is go back and do it

> the right way and

> provide evidence that it is harmful and they can

> still ban it. And my

> guess is that's probably going to happen in the long

> run.

>

>

http://www.naturalfoodsmerchandiser.com/asp/articleDisplay.asp?

>

> strArticleId=1419 & strSite=NFMSite

> ====== End Forwarded Message ======

>

 

I am only one; but still I am one.

I cannot do everything, but still I can do something;

I will not refuse to do the something I can do.

- Helen Keller