FDA Food Safety Modernization Act Signed Into Law
On January 4, 2011, President Obama signed into law the FDA Food Safety Modernization Act (“Act”). The Act marks the first major change to the country’s food safety laws since 1938, and significantly expands the authority of the U.S. Department of Health and Human Services (“HHS”) and the Food & Drug Administration (“FDA”).
The Act covers a wide range of articles used for food and drink, but excludes meat, poultry, and some egg products (which are regulated by the U.S. Department of Agriculture). The Act places new obligations on food producers and importers of food products, including:
- Requiring certification or other assurance from an agent or representative of the government of a foreign country where the food product originated that the food product complies with U.S. food safety laws. Failure to provide such certification could lead to the food product being denied entry into the United States.
- Imposes obligation on U.S. importers of covered food products to perform risk-based foreign supplier activities for purposes of determining compliance with U.S. food safety laws through such measures as annual on-site inspections and periodic testing and sampling of shipments.
- Imposes record keeping obligations on U.S. importers of covered food products to maintain records related to foreign supplier verification program for at least 2 years and to make these records available to representative of HHS upon request.
The Act also gives the HHS the authority to issue cease and desist orders for potentially dangerous food products and to order mandatory recall of the product. Previously, HHS could only negotiate with businesses to cooperate with recalls and remove potentially harmful food from the shelves.
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