Gaps In Adverse Event Reporting Guidance For Dietary Supplements Speak Volumes
This article was originally published in The Pink Sheet Daily
Supplement makers must start submitting reports on serious adverse events starting Dec. 22.
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“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.”
Judge ordering permanent injunction against Confidence USA on a complaint filed in 2019 questioned FDA's calculations for requiring the firm to recall and destroy all products it had distributed since February 2018.
White House, Democrat majority in Congress and likely next FTC chair support the agency wielding the authority, says advertising law attorney Holly Melton. Supreme Court, though, likely will rule in pending cases that a strict reading of an FTC regulation doesn’t grant monetary penalty authority.