NVE Pharmaceuticals Challenges Ephedra Ban

Natural Products Insider ^ | March 10, 2004

[hchutch]

ANDOVER, N.J.--When announcing a ban on ephedra dietary supplements earlier this year, the Food and Drug Administration (FDA) left the door open for companies to challenge its decision in court--and the first company to do so is NVE Pharmaceuticals. The makers of ephedra-based Stacker 2® filed a lawsuit in U.S. District Court for the District of New Jersey to postpone FDA's ban to hear new evidence.

NVE’s suit is asking the court set aside the ban because it violates the Dietary Supplement Health and Education Act (DSHEA), while setting a precedent for further damage claims to be filed against the government. In the suit, NVE claims that between 2000 and 2003, revenues grew from $29 million to $80 million, mainly due to ephedra sales.

“This lawsuit is about our day in court on the science,” said Terry Gaffney, scientific counsel for NVE and director of product defense at The Weinberg Group in Washington. “The RAND report, the government's own study, concluded that when ephedra is used as directed, it’s safe.”

He added that from a legal standpoint, DSHEA does not support FDA’s actions. “They have not have not met their burden to meet the unreasonable risk--the agency based its decision on misuse of ephedra rather than recommended use.”

Ephedra-based products once counted for around 75 percent of sales at NVE; now, it is down to 5 percent. The company currently employs more than 200 people, and Gaffney said NVE owes it to them to fight this ban. “If it's going to happen to us, let it be because of the science and not because of the career politicians and career bureaucrats.”

[hchutch]

Good news for ephedra users!

[hchutch]

FYI ping.

Hope this suit succeeds.

[lelio]

"The RAND report, the government's own study, concluded that when ephedra is used as directed, it?s safe."

But, but a person might of died out there! We have to do something!

[11th Earl of Mar]

a person might of died out there! We have to do something!

And 250 people died last year due to peanut allergies. Are peanuts next?

[hchutch]

I wonder if the suit can also overturn the bans in California, Illinois, and New York...

[Wolfie]

In my opinion, anything safer than tobacco should be legal.
But keep in mind, this whole ephedra scam is about protecting the pharmaceutical industry's financial interests in prescripition weight loss products.

[wingnutx]

I hope so, too. I took some ephedra this morning, and my head hasn't exploded yet.

[doberville]

How about the young girls dying from RU-486, the abortion drug. Is nobody interested that women are dying from this drug
they are pushing?

[ServesURight]

The ephedra ban was a typical knee-jerk gov't ban. The FDA should ban Lamasil, the anti-fungus toe medication, which has been proven to devastate your liver.

There are dozens of prescription meds more dangerous than ephedra.

[hchutch]

That one has a powerful lobby behind it.

[hchutch]

Agreed. Problem is, some folks have more pull on K Street than others.