On January 25, 2018, the Food and Drug Administration (FDA) released new guidance related to the regulation of food under the Food Safety Modernization Act (FSMA) (Pub. L. No. 111-353, 124 Stat. 3885(2011)), which was enacted in 2011 (and became effective in 2015) to amend the Food, Drug, and Cosmetic Act (FD&C Act). The new guidance released by FDA is intended to assist companies in complying with several requirements put in place by the FSMA, including:

The guidance issued by FDA represents the current thinking of FDA on these topics. However, the guidance is nonbinding on FDA and the public. Alternative approaches to the recommendations made in the guidance may be used by industry stakeholders if they comply with the requirements of the applicable statues and regulations. For more information on the regulation of food under the FD&C Act, see Practice Note, FDA Food and Dietary Supplement Regulations. For more information on the Food Safety Modernization Act, see Practice Note, FSMA Regulation on Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.