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Isula Rain

This article was originally published in The Tan Sheet

Executive Summary

FDA has "significant concerns" regarding the safety of two new dietary ingredients contained in the company's "Temporal Tension Extract"; the agency's comments respond to a 75-day premarket notification filed April 11. FDA's June 29 response notes scientific information for Kalanchoe pinnata and Ruta chalepensis do not meet the requirements of the FD&C Act "because it does not contain a description of the dietary supplement that contains the new dietary ingredients including the level of the new dietary ingredients in the dietary supplement...nor does it describe, in any quantitative manner, the amount to be consumed daily." The letter to the Larkspur, Calif.-based company goes on to say that history of use information provided fails to adequately establish safety

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