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Either way, if the FDA is not provided with the regulatory tools to take appropriate enforcement action against these new and emerging products marketed as PMTA Exempt, the FDAs authority and its capability to protect public health are further undermined

Archived from the original on April 6, 2025

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In the CY 2024 PFS rule (88 FR 79239 through 79240), we codified these policies in regulations at 410.10(l) and 410.57(c)