FDA Plans For Soy Health Claims, Pyridoxamine's Use Questioned By CRN, NPA
This article was originally published in The Rose Sheet
FDA’s proposed rule to revoke soy protein heart health ignores research supporting the claims and cites evidence that isn't compelling, CRN an NPA say in comments to the agency. CRN also submits comments supporting an ingredient firm's petition asking FDA to remove any uncertainty about the of use of pyridoxamine as a dietary ingredient.
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"The reality is that the FDA remains unwilling to rely upon a meta-analysis of only the highest quality studies in order to guide its final decision," GOED VP Harry Rice. "I think FDA has really lost sight of how the dietary supplement industry has changed," says attorney Charles Jolly.
ViGuard Health says in a petition that with two IND programs for studies of pyridoxamine's potential therapeutic use formally withdrawn, FDA should rescind its 2009 decision that it did not qualify as a dietary ingredient.