FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates

FDA didn't change its estimates for industry's annual regulatory burden – 929,140 hours – from compliance with recordkeeping requirements in supplement GMPs, its estimates of eight hours needed to prepare a request for exemption from identity-testing requirement also in unchanged.

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The US Food and Drug Administration combined its estimates on separate parts of dietary supplement firms' regulatory burden from good manufacturing practices requirements in 2020, though the Natural Products Association ays the agency continues underestimating the costs.

"They're kind of downplaying what the recordkeeping costs, and so much of it is recordkeeping," said NPA president and CEO...

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