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The Ephedra Decision: The Real Story ... - On april 14th 2005, a federal court in UTAH Ruled against the FDA's ban on low dose ephedra products. The plaintiffs were Nutraceutical Corporation and its subsidiary Solaray. They sued not just to protect their ephedra product, but to protect your access to other supplements. Why did they sue and what does this mean for you?
Media and Political Rhetoric Vs. Real Science
Protecting DSHEA and your access to dietary supplements
Why did Nutraceutical challenge FDA's actions?
We wanted to make sure the FDA followed DSHEA (The Dietary Supplement Health And Education Act) and uses sound science to stop the sale of ingredients at dose levels that cause harm.
We were concerned about a new concept -- a "Risk-benefit" test -- that caused all supplements to be treated like drugs and gave FDA the power to ban any dietary supplement at its discretion.
Dietary supplements should not be treated like drugs. Supplements are typically natural food products. Treating them like drugs -- with pre-market approval and clinical studies required -- would mean an end to consumer access to supplements.
We believed our low-dose ephedra product was safe. It was not designed for weight loss, but for traditional uses, like respiratory support.
Why did FDA Ban Ephedra?
Over eighty years, FDA proposed, withdrew and re-proposed limits on dietary supplements with ephedrine alkaloids. Until the final rule, all the proposed rules exempted low-dose ephedra products.
During those eighty years, FDA took few actions against manufacturers who sold high-dose ehpedra. The Result? Negative and often inaccurate publicity surrounding ephedra supplements.
In the final Rule, FDA announced to ban all dietary supplements containing any ephedrine alkaloids, but did not ban them in foods like chinese herbal teas.
What did the court Decide?
Under DSHEA, dietary supplements are to be regulated as foods.
Like other foods, Dietary supplements are "presumed to be safe."
FDA's "risk-bene ...
Federal Court Overturns FDA Ban on Ephedra at Low Doses
by Rakesh M. Amin and Mark Blumenthal
A Utah Federal District Court recently limited the scope of a year old Food and Drug Administration’s (FDA) Final Rule1 banning the sale of all ephedrine-alkaloid dietary supplements.2 The Court’s ruling has a limited affect on the ability of companies to sell ephedrine nationally, but is important regarding FDA procedure for creating rules and enforcement powers. Ephedrine alkaloids are found primarily in the controversial herb ephedra (Ephedra sincica Stapf., Ephedraceae).
The District Court determined that the FDA’s use of a risk-benefit analysis was against the intent of Congress in passing the Food, Drug and Cosmetic Act,3 which presumes all foods are safe and requires the FDA to prove the existence of a significant or unreasonable risk. The court held that to require food producers to establish a benefit before selling their product places an improper burden on them and was inconsistent with Congress’s intent when it passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) to clearly place the burden of proof of safety of a dietary ingredient on the FDA.4
Secondly, the court determined the FDA had to show by a preponderance of the evidence “a significant or unreasonable risk of illness or injury.”5 Therefore, in order to ban all sales of a given product, the FDA must first prove that the dosage amount in the product presents an unreasonable risk.6 Prior to this ruling, the FDA was not required to consider dosage size before banning a substance.
This ruling has limited effects at the moment since the FDA may appeal this decision. Additionally, the ruling has no effect on the laws of several states (including California, Illinois and New York) which have banned all sales of ephedrine alkaloids in dietary supplements. The ruling also only applies to products containing 10 mg or less of ephedrine alkaloids per daily dosage. Any produ ...
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