The Food Safety Modernization Act (FSMA), enacted on January 4,
2011, is the US Food and Drug Administration's most sweeping
reform in over 70 years. FSMA gives the FDA a new public health
mandate in response to the changes that have occurred in the global
food system over the last 25 years. It incorporates a greater
scientific understanding of foodborne illness and its consequences,
recognizing preventable foodborne illness as a significant public
health problem and a threat to the economic health of the food
FSMA is based on the need to protect food safety in the global
It requires the FDA to implement new rules and mandates in the
inspection and compliance
The FDA/ drafting new rules
The FDA is in the process of drafting appropriate rules and
guidance, which will underpin the standards required by FSMA. The
industry will need to put systems in place to comply with these
The FDA/inspection mandate
FSMA provides the FDA with a fresh mandate covering the
frequency with which food and feed facilities are inspected and its
public health prevention framework calls for a complete change in
the FDA's use of its inspection authority. As a result, the FDA
is set to adopt a wider range of inspection, sampling, testing, and
other data collection mechanisms.
The FDA/enforcement tools
New enforcement tools are now available under FSMA –
including mechanisms for administrative compliance and judicial
enforcement – and the FDA will make use of these tools.
FSMA gives the FDA the authority to suspend food facility
registrations. It exercised this power for the first time in 2012
with the suspension of Sunland Inc (a New Mexico producer of nuts
and nut-and-seed spreads whose plant was connected to a salmonella
outbreak that affected some 35 people across 19 states) and is
expected to enforce compliance still more often in the future.
The FDA has not yet taken a great deal of action under FSMA, but
that could all change soon.
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