Guest guest Posted April 15, 2005 Report Share Posted April 15, 2005 > William Egloff <bill > April 15, 2005 5:40:41 AM PDT > < > Crane : more on Ma Huang ruling > > AHPA Update • April 14, 2005 > > > Court Overturns FDA Ban on Low-dose Ephedra Products > > > A United States District Court ruled yesterday that the Food and Drug > Administration failed to prove that a dosage of 10 milligrams or less > of > ephedrine alkaloids presents an unreasonable risk of illness of injury > when > the agency banned all ephedrine-containing dietary supplements last > year. > The ruling has no effect on FDA’s ban on higher dose products, such as > products that were formerly sold to promote weight loss. > “This court has provided a rational opinion that the amount of an > ingredient > must be considered when evaluating the safety of that ingredient,” > commented > Michael McGuffin, AHPA president. “This is not a new idea. This has > been the > way we evaluate the ingredients we add to foods, the way we evaluate > drug > safety, and now it will be the way we evaluate the safety of dietary > supplements. And what the court has said is that FDA needs to pay > better > attention to this detail.” > Judge Tena Campbell ruled on a case brought by Nutraceutical > Corporation and > Solaray, Inc., who had filed suit against FDA last May to allege that > FDA’s > final rule on ephedrine alkaloids in dietary supplements was unlawful > as > applied to the company’s whole herb low ephedrine level product. In its > lawsuit Nutraceutical Corporation stated that in order for FDA to > completely > ban an ingredient it bears the burden of proving that an ingredient > presents > an unreasonable or significant risk at every dose level and as > labeled. The > complaint also argued that when Congress passed the Dietary Supplement > Health and Education Act it did not intend for FDA’s new authority to > remove > unsafe ingredients to be used to ban ingredients at every dosage level > with > no consideration of the use of warning labels. > Yesterday’s District Court decision also concluded that FDA’s use of a > risk-benefit analysis in determining an unreasonable risk of > ephedrine-containing dietary supplements was “improper.” The Court > explained > that it is “contrary to the clear intent of Congress” to require > marketers > to demonstrate a benefit for their ephedra dietary supplements, as is > implied by FDA’s use of a risk-benefit analysis. In addition, FDA was > instructed by the court to consider further rulemaking “consistent > with this > Order” and to refrain from taking any enforcement action against > Nutraceutical Corporation for their sale of products containing less > than 10 > mg of ephedrine alkaloids. FDA was not, however, specifically > instructed to > refrain from acting against other brands that contain less than 10 mg > of > ephedrine while it reviews its current regulation. > This case is Nutraceutical Corporation and Solaray, Inc., Plaintiffs, > vs. > Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug > Administration, et al., Defendants, and can be downloaded at > http://www.ahpa.org/05_0413_USDistrictCourt_Nutraceuticals.pdf. > > > > > Chinese Herbs Quote Link to comment Share on other sites More sharing options...
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