FDA Ephedra Ban REVERSED by US Court…

Opinion by Consumer Advocate Tim Bolen

 

There is no question that the the US Food & Drug Administration (FDA) is owned and operated as an adjunct to Big Pharma.  It is.

FDA executives are at the beck and call of Planet Earth’s pharmaceutical industry.  They don’t even bother to hide that fact.  FDA leaders see their role as four things:  (1)  get as many mega-dangerous drugs as possible approved as fast as possible, with the least amount of testing, (2)  turn a blind eye towards, and cover up as much negative drug information (adverse reaction) as possible (3) act as a marketing partner for Big Pharma, (4)  use their authority to attack, and harass, Big Pharma’s competitors for health dollars.

The US FDA is one of “Medicine’s” top war tools in the battle raging, worldwide, between the forces for “Health” versus “Medicine.”   All over the US, flak-jacketed FDA thugs, accompanied by other government agencies, smash their way into “health” related establishments, screaming, battering, scattering, seizing, grabbing – establishing emotional and financial chaos to anyone who dares to compete with Big Pharma’s interests – with some effect.

Despite this “health” is winning, everywhere.

One of Big Pharma’s major competitors is the vitamin/supplement industry.  Big Pharma wants to stop it, or slow it as much as possible, and they have two major tools working for them:  (1) the US FDA, and (2) “Codex.”

We’ll talk more about “Codex” later.

The FDA, not long ago, attacked the supplement industry, using the ruse that “Ephedra,” an ingredient commonly used in supplements worldwide for hundreds of years, was somehow so suddenly dangerous that it needed to be taken off the market, immediately.  And, a ruse it was…

But yesterday, a Federal Judge in Utah smacked the FDA right in the face, hard.  Read the press release below…

Court Rules in Favor of Nutraceutical

Park City, Utah (April 14, 2005) — Nutraceutical International Corporation (NASDAQ: NUTR) today announced an important court decision that it believes will benefit its retail customers and the public. On April 13, 2005, the United States District Court for the District of Utah, Central Division, granted Nutraceutical’s motion for summary judgment against FDA in Nutraceutical’s lawsuit involving FDA’s Final Rule on Ephedra.

Mr. Bruce Hough, President of Nutraceutical, commented that yesterday’s decision “is, in our view, about protecting the public’s access to safe and effective dietary supplements and in clarifying the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA). The Court’s ruling clarifies the steps FDA must take to comply with the law in its regulation of dietary supplements.”

Mr. Hough continued, “The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are “presumed to be safe.”

Nutraceutical and its subsidiary Solaray, Inc. marketed whole-herb ephedra as a dietary supplement from 1988 until April of 2004. At the time the Final Rule on Ephedra was issued, Nutraceutical and Solaray’s product contained directions limiting dosage to 10 mg. or less of naturally occurring ephedrine alkaloids per daily serving. Under the Court’s Order, FDA’s Final Rule on Ephedra has been remanded to FDA for further rulemaking consistent with the Order, and FDA has been enjoined from taking enforcement action against Nutraceutical or Solaray for the sale of dietary supplements containing 10 mg. or less of ephedrine alkaloids per daily dose. FDA has the right to appeal the Court’s decision.

A complete copy of the Court’s decision may be found at http://www.nutraceutical.com/courtruling/

Health Radio personality Robert Scott Bell will be interviewing Nutraceutical President Bruce Hough this Sunday, April 17th, 2005, about the case, from 1:00PM to 2:00PM.  Hough will be backed up by author Mike Fillon of “Ephedra: Fact and Fiction” fame.  Robert’s show plays nationwide, and can be found by going to his list of national affiliates.

For those of you that are unfamiliar with Robert Scott Bell and his show, the following commentary by Robert, on this issue says it all:

Of course, this vindicates author Mike Fillon and his book Ephedra: Fact and Fiction, confirming the faulty conclusion and sloppy science that led to the “banning” of a dietary supplement, while allowing its synthetic cousin, pharmaceutical pseudo-ephedrine to remain on the market, providing a cheap source of raw materials for the manufacture of “street” methamphetamines. You’ve got to hand it to the FDA for its sheer audacity and consistency in protecting pharmaceutical interests from having to genuinely compete with substances from nature.

The FDA’s black eye keeps getting blacker. I hear the violins now. 

It is getting really hard to find friends, these days, if you’re Big Pharma.  Merck recently announced that it can’t find anybody to take over as its CEO.

Big Pharma isn’t doing well, worldwide. Just a few days ago, in my newsletter article The Coming “US Health Movement v. Big Pharma” Codex War…, I announced the demise, in EU Court, of Big Pharma’s attempt to shut down the supplement industry.  But little did I know at the time that that day, Tuesday, April 5th, 2005, would go down in the annals as a double-whammy of Big Pharma’s murderous intent.

Then I did “UK Parliament SMASHES Big Pharma”.   And, this story you are almost NOT going to believe. I’m going to have to convince you with data.  To do that I’m going to tell you that you are going to have to do what I just did – you’re going to have to read a 126 page report just issued by the British government titled“House of Commons Health Committee – THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY”

The British government is setting up the “guillotine” for Big Pharma.  There’s going to be a “Bastille Day” in London.  Sell your pharmaceutical stock – quick.

We are heading for a health care “Nuremberg…”  And, it’s about time…

Stay tuned…

Tim Bolen – Consumer Advocate