viernes, 22 de enero de 2016

FDA Law Blog - Soy Protein and Coronary Heart Disease Health Claim Stands – For Now

Posted: 22 Jan 2016 01:15 AM PST
By Ricardo Carvajal -
On January 4, FDA denied the Weston A. Price Foundation’s citizen petition seeking revocation of the health claim for soy protein and coronary heart disease (CHD).  As reported in a prior blog posting, the Foundation filed the citizen petition in 2008, and sued the agency in 2014 to compel a response.
By way of background, FDA authorized the challenged health claim in October 1999, having concluded that it met the standard of significant scientific agreement.  In December 2007, FDA initiated a reevaluation of the challenged claim in response to the emergence of new scientific evidence.  In reevaluating a health claim, FDA engages in as exhaustive a review as it does in the claim’s approval, by poring over the “totality of publicly available scientific evidence.”  Thus, the claim was already under scrutiny when the Foundation filed its petition seeking revocation of the claim.
FDA denied the Foundation’s petition because it “fails to reflect the totality of scientific evidence that was publicly available at the time of the petition… and is insufficient to support the conclusion that the SSA standard has not been met.”  FDA reviewed the studies cited in the petition and winnowed out those of no relevance, which left only six studies “of moderate quality” that “did not show a benefit for intake of soy protein and risk reduction of CHD.”  However, the petition failed to address the significant number of intervention studies that do show a reduced risk of CHD – a critical deficiency given the obligation in FDA’s citizen petition regulation to include “all relevant information and views on which the petitioner relies, as well as representative information known to the petitioner which is unfavorable to the petitioner's position.”
Although FDA’s response should bring the related litigation to a close, it doesn’t mean that the health claim is entirely in the clear.  FDA intends to complete its review, after which FDA will decide “whether there may be grounds to initiate the rulemaking process for amending or revoking the health claim.”

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