DIEARY SUPPLEMENT CLAIMS SUBJECT TO FDA "COURTESY LETTERS"
This article was originally published in The Tan Sheet
["Courtesy letters" are sent by FDA to notify dietary supplement companies of claim provision violations under the Dietary Supplement Health & Education Act; F-D-C Reports, Inc. compiled the redacted list from information recently made available by the agency.
You may also be interested in...
Roche/Genentech oncology partnering maintained a robust dealmaking pace through the pandemic, keeping the percentage of partnered R&D programs at about 50% of the cancer drug pipeline.
To mitigate pandemic disruption of component supply chains, the US FDA said it will downgrade some post-approval change categories for sterile drug container closure systems. The downgrade will cover drugs in shortage and those used to treat COVID-19.
“This is truly uncharted territory because we’ve never had this situation,” says CHPA regulatory VP David Spangle. Asking Congress instead to instruct FDA to first determine a safe daily limit would be a threatening precedent for the supplement market, says CRN CEO Steve Mister. “That really turns DSHEA on its head.”