Food Safety Modernization Act
The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it. Below is additional information on FSMA.
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.
Foodborne illness is largely preventable if everyone in today’s global food chain could be held responsible and accountable at each step for controlling hazards that can cause illness. Under the new law, FDA will now have new prevention-
The elements can be divided into five key areas:
Inspection and Compliance-
Imported Food Safety-
U.S. consumers enjoy the benefit of imported foods from more than 150 countries. The Food Safety Modernization Act (FSMA) gives FDA new tools to ensure that those imported foods meet US standards and are safe for US consumers. New authorities under the Act include:
Importer accountability -
Third party certification -
High risk foods -
Additional resources are directed toward foreign inspections
FDA now has the authority to refuse entry into the US of a food that has refused U.S. inspection.
This new law puts prevention up front for FDA. For the first time, FDA will have a legislative mandate to require comprehensive, science-
The FDA attorneys and consultants of C. Humphrey & Associates, P.A. represents domestic and international companies who manufacture, hold and distribute foods. Our FDA law firm provides regulatory representation regarding a range of regulatory food law issues before federal and state agencies and courts involving the U.S. Food & Drug Administration (FDA), Federal Trade Commission (FTC) and U.S. Customs Border & Protection (CBP). Our FDA law firm provides regulatory counsel to clients in all phases of food product development and marketing.
Our FDA law firm counsels clients regarding compliance with a variety of statutory and regulatory requirements and guidance documents covering foods including:
Establishing Preventive Control Plans
Foreign Supplier Verification Program
Voluntary Qualified Importer Program (VQIP)
Labeling and advertising in compliance with FDA and FTC requirements
Establishment registrations under The Bioterrorism Act, including acting as U.S. agent for foreign facilities
Recordkeeping and records access under FSMA
FDA Import Alerts for Foods
Compliance issues relating to current Good Manufacturing Practices (cGMP), record keeping and product recalls
Defending against FDA and FTC administrative and enforcement actions (e.g. FDA Warning Letters, FDA seizure, FDA injunction, FDA criminal and civil penalties)
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