Executive Summary

One lot of crospovidone from Chinese firm Tianjin Boai NKY International contains peroxide levels more than four times higher than the maximum set by global standards, FDA says Oct. 21. Although not a significant health risk, the peroxide could cause a loss of potency in dietary supplements and pharmaceuticals that use crospovidone and other providone analogues, the agency says. Daniel Fabricant, VP of scientific and regulatory affairs for the Natural Products Association, said the excipient aids dissolution in tablets and softgels, and the high peroxide levels likely signal ingredients past their shelf life expiry. FDA's advisory reminds supplement makers "it's another spec they need to be looking for" in their excipients, Fabricant said