Product Recall Insurance and the New FDA Food Safety Modernization Act

Anderson Kill White Paper

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PUBLISHED ON: May 29, 2012

The increased recall authority of the FDA created by the FDA Food Safety Modernization Act (“FSMA”) has important implications for policyholders. The FSMA was enacted on January 4, 2011. 21 U.S.C. § 2201 et seq., Pub. L. No. 111-353, 124 Stat. 2885 (2011), amending the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (1938). While some provisions of the FSMA were not designed to take effect immediately, the "FDA's new authority to order [mandatory] recalls" was effective as of January 4, 2011. Deborah M. Strauss, An Analysis of the FDA Food Safety Modernization Act: Protection for Consumers and Boon for Business, 66 FOOD & DRUG L.J. 353, 359 (2011).