The FDA Food Safety Modernization Act: What You Need to Know Now

Kelley Drye Client Advisory

The FDA Food Safety Modernization Act (FSMA), which became law on January 4, 2011, makes significant amendments to the Federal Food, Drug & Cosmetic Act (FDCA) which are designed to strengthen food safety protections in ways that help minimize the risk that unsafe food will enter the U.S. market, and expedite the removal of food that is discovered to be unsafe after it has entered the market. The new FSMA requirements will have far-reaching implications for virtually all domestic and foreign companies that produce, manufacture, transport, import, or market food that is destined for the U.S. market.

Affected companies are advised to promptly evaluate the implications of the new FSMA requirements for existing regulatory compliance programs, and the legal and business risks associated with potential noncompliance under the new law in order to identify and characterize issues that should be considered by FDA and the Congress as guidelines, regulations, and enforcement policies implementing the FSMA are developed.

This advisory discusses the changes to existing law and provides guidance on the specific actions companies can take now.