Ephedra News

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Most Important and Late Breaking News on ephedra October 18, 2006: Press Release from Jonathan Emord, the ephedra attorney: Nutraceutical will file on or before January 8, 2007, a petition seeking U.S. Supreme Court review of the FDA's rule banning ephedra. 10th Circuit Refuses to Rehear Ephedra Case Nutraceutical Appeals to Supreme Court Denver, CO -- In a per curiam decision (without a written opinion) issued on October 18, the U.S. Court of Appeals for the Tenth Circuit denied Nutraceutical Corporation's petition asking the court to rehear its decision to overturn the decision of Judge Tena Campbell (U.S. District Court, Utah) striking FDA's Final Rule banning all ephedrine-alkaloid containing dietary supplements, regardless of dose. In a pertinent part the petition faults the panel for imposing "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved by statute for pre-market review of drugs," explaining that the "decision's impact extends far beyond a ban on EDS" by granting "FDA authority to declare any dietary ingredient adulterated on FDA's subjective assessment of the adequacy of the ingredient's health benefits if FDA finds even so much as an infinitesimal risk of illness or injury from ingestion of the ingredient (a ubiquitous condition because all ingredients pose some risk at some dose)." The petition faults the panel for interpreting the Food Adulteration provision of the Act to be internally inconsistent and irrational: "FDA's Rule produces the absurd result of causing raw crushed ephedra sinica herb to be unlawful when placed in a gelatin capsule but legal when placed in a tea bag." Nutraceutical will file on or before January 8, 2007, a petition seeking U.S. Supreme Court review of the case. If the Supreme Court denies review, the case will continue on remand before District Court Judge Campbell on two remaining causes of action under the Administrative Procedure Act that have not yet been tried. In those causes of action raised in the original complaint, Nutraceutical argues that FDA's Final Rule is invalid because FDA never gave notice in the Federal Register of its risk-benefit test for dietary supplement adulteration, thus denying the regulated class its statutory right to comment on the test before adoption of the rule. In another yet to be tried cause of action in the original complaint, Nutraceutical argues that FDA violated the APA prohibition on arbitrary and capricious decision making by banning ephedrine alkaloids from supplements but allowing their use in foods and traditional chinese medicines. October 16, 2006: Federal appeals court refuses to reconsider its ruling, upholding the prohibition on ephedra Nutraceutical Corp. will now ask the U.S. Supreme Court to overturn the federal ban on ephedra. September 28, 2006: Nutraceutical Corporation Appeals 10th Circuit Ephedra Decision Denver, CO -- Today Nutraceutical Corporation filed its Petition for Rehearing or Rehearing en Banc in the United States Court of Appeals for the 10th Circuit. The petition calls on the entire 10th Circuit to rehear the case, explaining that the three judge panel of the court violated the Supreme Court's canons of statutory construction and raised questions of exceptional importance by reversing the U.S. District Court decision (Judge Tena Campbell presiding). Counsel for Nutraceutical on appeal include law professor Richard A. Epstein (University of Chicago), Jonathan W. Emord (Emord & Associates) and Marcy G. Glenn (Holland & Hart). In a pertinent part the petition faults the panel for imposing "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved by statute for pre-market review of drugs," explaining that the "decision's impact extends far beyond a ban on EDS" by granting "FDA authority to declare any dietary ingredient adulterated on FDA's subjective assessment of the adequacy of the ingredient's health benefits if FDA finds even so much as an infinitesimal risk of illness or injury from ingestion of the ingredient (a ubiquitous condition because all ingredients pose some risk at some dose)." The petition faults the panel for interpreting the Food Adulteration provision of the Act to be internally inconsistent and irrational: "FDA's Rule produces the absurd result of causing raw crushed ephedra sinica herb to be unlawful when placed in a gelatin capsule but legal when placed in a tea bag." The petition explains that, in context, the statutory term "unreasonable risk" is defined as that dose level that causes illness or injury and above. The statutory term "significant," by contrast, "describes the degree of illness or injury incurred (e.g., a tumor as opposed to a headache)." August 28, 2006: The following is an important message we received from Jonathan Emord, the attorney representing the companies seeking to preserve your freedom to buy and use ephedra: The 10th Circuit decision [on August 17, 2006] makes it illegal across the United States for anyone to sell dietary supplements containing any quantity of ephedrine alkaloids. Doing so will place those involved in imminent peril of being prosecuted, having their inventory confiscated, and being incarcerated. We are undertaking every effort to return the law to its statutory moorings. The 10th Circuit decision violates the plain and intended meaning of the dietary supplement adulteration provision. Congress never intended FDA to use a drug adulteration standard to evaluate the marketability of dietary supplements. Congress also clearly intended that the law of adulteration not be changed and that dietary supplements be treated like foods. Under the food standard a dietary supplement is deemed lawful unless the government meets the burden of establishing the supplement unsafe and then only at dose levels proven unsafe may it be banned from the market. FDA takes the view that if it shows some evidence of a lack of safety at some dose level, it may ban dietary supplements at every dose level. That is a power grab. It violates the rule of law, and it places all dietary supplements in jeopardy, marketable only at the whim of the FDA. We will do all we can to reverse this decision on behalf of our clients. Jonathan W. Emord Emord & Associates P: 202-466-6937 email: jemord@emord.com August 18, 2006: The following is an exclusive press release we received from Jonathan Emord, the attorney representing the companies seeking to preserve your freedom to buy and use ephedra: PRESS RELEASE FOR IMMEDIATE RELEASE: 8/18/06 RE: 10th Circuit Upholds Ephedra Ban Contact: Jonathan Emord (202-466-6937)  THE U.S. COURT OF APPEALS FOR THE 10TH CIRCUIT REVERSES LOWER COURT DECISION HOLDING FDA EPHEDRA BAN UNLAWFUL; NUTRACEUTICAL CORPORATION APPEALS   Denver, Colorado. On August 17, 2006, a three judge panel of the United States Court of Appeals for the Tenth Circuit overruled a lower United States District Court decision by Judge Tena Campbell for the District of Utah. On April 13, 2005, the lower court held FDA’s February 2004 ban on ephedrine alkaloid containing dietary supplements a violation of the adulteration provision of the Dietary Supplement Health and Education Act. Judge Campbell ruled that FDA overstepped its statutory limits when it banned low dose ephedrine alkaloid containing dietary supplements without any scientific proof of a significant or unreasonable risk of illness or injury at low dose levels. The Court of Appeals reversed, deferring to FDA. On or before September 29, 2006, Plaintiff Nutraceutical Corporation will file a petition for rehearing en banc by the entire 10th Circuit. The firm Emord & Associates of Washington, D.C. will represent Nutraceutical Corporation in the appeal. The petition calls upon all 19 judges of the circuit to review the decision of the three judge panel. Grant of the petition invites new pleading over the validity of the three judge panel’s decision. If the petition is denied, Nutraceutical Corporation will appeal the matter to the United States Supreme Court. A copy of the 10th Circuit and U.S. District Court decisions are available from Emord & Associates by calling 202-466-6937. # # # # August 18, 2006: Ruling upholds ban on ephedra, Appeals court ratifies FDA report that the supplement is unsafe August 17, 2006 Federal appeals court upholds ban on ephedra; ruling reverses Utah The Federal Appeals Court Decision May 9, 2006 Judges seem behind ephedra ban see also -   FDA Wants Ephedra Ban Restored May 17, 2006 FDA releases seized ephedra After agreeing to a keep-quiet clause signed on May 5th, the FDA finally released a shipment of 300,000 ephedra tablets confiscated from EMAX Enterprises. April 29, 2006 Ephedra ban again challenged in Utah On May 8th, Emax Enterprises is suing to get back its confiscated ephedra supplements and asking Utah's federal court to suspend the ban on ephedra. January 14 2006 Health Law and Politics Radio Program Beginning January 14, 2006, Jonathan Emord, the only attorney in history who has defeated the Food and Drug Administration in federal court on six separate occasions, will host “Health Law and Politics.”The inaugural January 14 program will discuss the FDA’s ban on ephedra, the agency’s unlawful maintenance of that ban in the face of a federal court order holding the ban unlawful, the scientific evidence on the safety and efficacy of low dose ephedra, and the effect on obesity in consumers denied access to the product for weight loss. Featured guests include Arne Astrup, M.D.; scientists Durk Pearson and Sandy Shaw; and the President of Nutraceutical Corporation (the party that won the ephedra case) Bruce Hough. Emord is the lead counsel for Nutraceutical Corporation in the case. April 15, 2005 Utah Judge Strikes Down Ephedra Ban (additional links from Google) A federal judge ruled in favor of a Utah supplement company and struck down the FDA ban on supplements containing ephedra. The judge sent the case back to the FDA for a determination of what are safe and dangerous levels of ephedrine. The judge determined that ephedra was wrongly being regulated by the FDA as a drug and not a food as required by a 1994 federal dietary supplement law. 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. The ruling's final page prohibits the FDA from enforcing the ban on the company's supplements containing 10 milligrams or less of ephedra. March 9, 2004 The Ephedra Battle Moves To The Courts - company sues government for banning ephedra Forbes.com Inc

Comments on ephedra news

1. This first comment was written just before the FDA's 2004 ban on ephedra. But it is still very applicable, considering the FDA is once again trying to ban ephedra!

   While ephedra.com does not promote the use of ephedra, it does seek to preserve our freedom of choice.  With our sympathy going out to the unfortunate few that did not abuse ephedra but may have suffered an adverse reaction, the following is the opinion of ephedra.com.

   It's all about the money! Where is the responsible reporting by the news industry when you need it?

   It started out as a few bad apples (abusers). Then the greedy litigating ambulance chasers saw a way to make money and created a parade of greedy copycat opportunists. And to help sway the opinions of juries, they encouraged everyone they could, especially the news industry, to jump on the ephedra bashing bandwagon.

   And the pharmaceutical industry took notice. They knew that ephedra (as is true with many natural remedies) was competing with their drug sales. And they figured that by spending a little money on hyping the problems of ephedra (no natural or manufactured remedy is perfect) and some more money in buying off politicians to manipulate the FDA (class action lawsuits had emptied the pockets of the ephedra product manufacturers - the only competing force that would have prevented this), they could get ephedra banned. And they would stand to make a killing from increased sales of their unnatural concoctions. And while we only see the tip of the iceberg - the FDA trying to "protect us" - what we really have is the FDA being manipulated by the industry they supposedly oversee.

   With the proposed FDA ban, there are more ephedra bashing news articles than ever. So it looks like the news industry wants a piece of ephedra too! Why sell any old news when what really sells is sensationalized bad news! Leave it to the news industry to take the easy road and help throw stones at ephedra rather than investigate, expose the truth and help defend our freedom of choice from the selfish interests that stand to profit from this ban! Say hello to being manipulated and good-by to our freedom of choice!

   To provide a contrary perspective, ephedra.com provides this page as a resource for published news (and opinion) articles that don't bash ephedra. (If you want to see the bashing articles, just do a search on any search engine for 'ephedra news'.)

   [ Please click here to send this page to the editors of your local newspapers. ]

2. Consumer advocate, Tim Bolen, has an interesting theory regarding the news media's motivations for bashing ephedra:
   The anti-EPHEDRA campaign, I believe, was a scam orchestrated by the real quackbusters operating out of that New York ad agency. The whole thing is a well-designed hoax to overturn gains we've made in dietary supplement legislation. All those newspaper articles, and the article in some magazines, etc., weren't the result of investigative journalism - they were PLACED in those publications, by the New York ad agency, as a condition of continued drug advertising in those publications.

   Why do I think so? Look at the publications in which those articles ran, and you'll see that a significant portion of those pub's income comes from drug ads. Writers and Editors like to get paid. Cancellation of drug ads for the next issue means lay-offs on the editorial staff, right this minute.