FSMA User Fees Make No Sense

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The Food Safety Modernization Act (FSMA) reinspection fees make no sense!

Under the FSMA, the FDA is allowed to collect user fees for reinspections (see FDA Fee Guidance).  Although the FDA has not yet collected fees, you should pay attention to them.

The FDA started publishing its domestic and foreign reinspection fees in 2013.

If you chart these fees (see inset image), their logic makes absolutely no sense.  The foreign costs are going down and the domestic costs are going up.

 if the trend continues, in ~13 1/2  years, the costs to have an inspection in San Paulo  will will less expensive than New York.

Further, the changes from one year to another do not make sense. The Consumer Price Index (see Bureau Labor Statistics) since 2013 has annually  varied from -0.1 and +2.0%.  Whereas reinspection fees have varied from -10% and +12%.

All we can say is make sure you have contingency budget set aside should the FDA actually start collecting what it has the authority to collect.



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