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In Pearson, the plaintiffs challenged FDA's common well being claims laws for dietary supplements and FDA's resolution not to authorize well being claims for 4 particular substance/illness relationships. To accomplish this, FDA will pursue a range of options for scientific evaluate of data submitted in petitions in help of a substance/disease relationship. Based on Pearson, the December 2002 steerage, just like the October 2000 Federal Register notice included as a criterion whether the scientific proof in assist of the claim outweighs the scientific proof in opposition to the claim. 659 and n.10. This language was the genesis of the "weight of the evidence" criterion that FDA mentioned in the October 2000 Federal Register notice and the December 2002 steering. In Whitaker, the District Court, interpreting Pearson, discovered that "credible proof," reasonably than "weight of the evidence," is the appropriate standard for FDA to use in evaluating certified health claims.(11) In gentle of Whitaker, FDA believes that the weight of the proof standard within the October 2000 Federal Register notice and the December 2002 steering have to be tempered by the check of credible proof. 1 National Center for Health Statistics (NCHS).
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