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FDA 'Program Alignment' Means Inspections Consistency To Supplement Industry

 
• By Malcolm Spicer

Reports are common about ORA officials not being knowledgeable about the agency's supplement manufacturing and marketing regulations or familiar with the commodity of dietary supplements, but relying on drug or food product manufacturing regulations when they inspect supplement facilities.

Inspector removing a white card with Inspector sign from the inner pocket of his jacket. Conceptual of health, business or other inspection coming over unannounced.

The dietary supplement industry could benefit most among FDA-regulated sectors with the agency's shift from a general approach to facility inspections to assigning inspectors to certain facilities based on their expertise.

FDA on May 15 announced that in its "program alignment" initiative, it restructured each of its five regional offices – Pacific, Central, Northeast, Southwest, Southeast – into seven commodity-specific programs:...

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