Ephedra Unbanned

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A federal judge in Utah has ruled that the Food and Drug Administration's 2004 ban on dietary supplements containing ephedra goes beyond the agency's statutory authority. In a case brought by supplement makers Nutraceutical Corp. and Solaray, U.S. District Judge Tena Campbell concluded that the FDA erred in determining that any amount of ephedrine renders a product "adulterated."

Under the Dietary Supplement Health and Education Act, supplements are considered adulterated if they pose "a significant or unreasonable risk of illness or injury." The FDA interpreted "unreasonable" to mean that the product's risks outweigh its benefits. "The FDA's imposition of a risk-benefit analysis places a burden on the producers of [ephedrine-containing products] to demonstrate a benefit as a precondition of sale, and that is contrary to Congress' intent," Campbell concluded.

She also found that the FDA should have presented more evidence to show that even relatively low doses of ephedrine (such as the 10 milligrams a day recommended by the plaintiffs) present a significant or unreasonable risk. "The plain language of the statute requires a dose-specific analysis," she wrote. Campbell enjoined the FDA from blocking the sale of supplements containing 10 milligrams or less of ephedrine in a daily dose and instructed it to rewrite its rule.

Over the short term, the ruling will increase consumer choice (in Utah, at least), but over the long term it will encourage the FDA and other critics of the dietary supplement law to seek more power for the agency to order the removal of products it doesn't like. Let's hope they fail. Although the legal treatment of so-called dietary supplements that are actually drugs in raw form is hard to justify in the context of the federal government's broader regulatory system, it gives people a little more leeway than they would otherwise have to ingest what they choose.

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  1. Expect obnoxious political grandstanding and calls to repeal the DSHEA in the very near future.

  2. Estimated time before WorldNet Daily runs a headline reading “Activist Judges Put Poison in Veins of America’s Youth” – 2 hours

  3. when ephedra is criminalized, only the criminals will…well, you know…

    The FDA’s case against ephedra was the weakest shite I’ve ever seen. Oh, wow, over 10 years, a handful of people died after taking aggregious doses and then exercising in the hot summer sun. Meanwhile, the weightloss and fat-loss benefits are plain for all to see. Good god, imagine how many people die from aspirin…every year. Weakest. Case. Ever.

  4. A little more freedom beats a little less freedom I suppose. Kudos to the judge. (Now there’s a phrase I haven’t uttered in a while.)

  5. Estimated time before WorldNet Daily runs a headline reading “Activist Judges Put Poison in Veins of America’s Youth” – 2 hours

    Except the judge was sticking to an “out of control Bureaucracy”.

    Kinda like an “irresistable force/immovable object” paradox goin’ on here.

    How can they pick sides in the Battle of the Unelected, Unaccountable Titans? 🙂

  6. beat’n back the ocean with a straw broom

  7. I think if pressed WND would choose for the holy, tax-and-spend drugwar.

  8. For a wonderful bio of Judge Campbell, written by a former law clerk of hers… go to: http://www.fedbar.org/utah-profile_campbell.pdf

    It begins: “Judge Campbell grew up in Wendell, Idaho. She studied French at the University of Idaho and the University of French Studies in Paris… (she) taught French at the high school and junior college level for four years.” As an Assistant US Attorney, Judge Campbell tried many complicated cases involving fraud and high finance and due to her proclivity to undermine defense witnesses with disturbing details reflecting on their credibility, she came to be known as “the duchess of dirt”. She was appointed to the bench by President Clinton.

    Wouldn’t it have been fun to hear a judge like that tell you her real thoughts about the FDA flouting the law so brazenly and thinking she’d let it slide.

  9. I’m gonna stay up all night and celebrate!

  10. The FDA’s case against ephedra was the weakest shite I’ve ever seen.

    I also nominate the banning of tryptophan after some people died from a few bad batches from a single company. Sort of like banning automobiles after the Pinto.

  11. Hail to the Judge and to the attorney for the plaintiff!!!

    Had the attorney for the plaintiff, Jonathan Emord, been living in 1776, his name would be listed on the Declaration of Independence. Visit the modern day hero at http://www.emord.com.

    He is my attorney and the attorney of Durk Pearson & Sandy Shaw. Want to help fight the FDA and the ongoing legal battles? Purchase Willpower Tea (ephedra herb tea) on my website (or anything else!) and help me fight the expensive legal battles that are helping everyone.

    Ban ignorance, not ephedra!!!

    Greg Pryor, President
    Life Priority, Inc
    http://WWW.lifepriority.com

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