spections and botched recalls will
incur fees for FDA’s work, but for
those who fail an inspection or
conduct an incomplete recall, the
fees will be the least of their worries. The fees imposed by FDA will
only cover the costs to the agency;
it’s not a penalty.
• If an import entry is sampled or
detained, it’s best to work with the
agency. FDA employees are not
promoted or rewarded on the
basis of numbers of products detained. Antagonizing an investigator or compliance officer only
makes everyone’s job harder.
crease in funding and manpower. Foodborne illness costs the U.S.
economy an estimated $152 billion annually. FDA’s food budget is
about $280 million (which is not much to pay for 19,200 inspections
per year). The goal may be attainable in the first year, but it will be impossible for FDA to complete the prescribed number of foreign food
inspections in year six without a substantial increase in resources.
Ensuring food safety is not only the right thing to do, it is also a
good business investment. If adequately resourced and implemented,
the changes to the law will increase consumer confidence in domestic
and imported foods. They will reduce the number and seriousness of
outbreaks and the number of recalls—significant benefits to the food
industry and consumers alike. o
The number of changes in FDA’s
regulatory toolbox brought about by
FSMA is so large that this article addresses only a handful of them. If
FDA is to fulfill the objectives of the
new law, it will need a significant in-
Joseph R. Baca is a senior consultant for EAS Consulting Group, LLC
( www.easconsultinggroup.com), a firm that specializes in providing
consulting, training and auditing services for industries regulated by
the Food and Drug Administration. As the former director of the
FDA Office of Compliance, Center for Food Safety and Applied Nutrition, Joe has more than 37 years of agency experience. He previously served as
the district director of the FDA Dallas District Office, the compliance branch director at FDA’s Seattle District Office and as a compliance officer in the FDA Minneapolis District Office. At EAS, he specializes in providing regulatory advice on
domestic and import compliance matters related to foods and dietary supplements. Joe can be reached at email@example.com.
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