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Food Safety User Fees On Hold Until FDA Creates Waiver Process

This article was originally published in The Tan Sheet

Executive Summary

Dietary supplement and food product firms will not incur user fees for facility or import re-inspections or mandatory recalls until FDA establishes a waiver process for small businesses.

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Dietary supplement manufacturers’ responses to FDA reports of good manufacturing practices problems not only are inadequate, but in some instances prompt the agency to warn of checking for corrective actions in later inspections, according to recently posted warning letters.

Dietary Supplement GMP Warning Letters

Dietary supplement manufacturers’ responses to FDA reports of good manufacturing practices problems not only are inadequate, but in some instances prompt the agency to warn of checking for corrective actions in later inspections, according to recently posted warning letters.

Pay Now For Better Supplement Industry Enforcement, Or Foot Higher Bill Later

By considering and addressing potential regulatory changes, the industry more likely can help shape changes and avoid greater regulatory burden such as pre-market review, suggests CRN President Steve Mister. User fees are an “issue that the industry is going to have to start looking at.”

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