FDA Issues Three Draft Guidance Documents

FDA has released an updated draft guidance, “Control of Listeria monocytogenesin Ready-To-Eat Foods” and two draft guidance documents related to the final rules on Nutrition Facts labeling and Serving Sizes.

Lm Draft Guidance. The Listeria monocytogenes (Lm) draft guidance supports ongoing efforts by industry and government agencies to reduce the risk of Lm in ready-to-eat (RTE) foods. With an emphasis on prevention, it is consistent with the FSMA, reflecting FDA’s requirements for CGMP and hazard analysis and risk-based preventive controls, including verification of preventive controls.

Whether subject to CGMPs, preventive controls, or both CGMPs and preventive controls, all food facilities that manufacture, process, pack, or hold RTE foods will benefit from the clear guidance on measures to control Lm in the food processing environment, FDA said.

Additionally, the draft guidance incorporates industry best practices and the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service (FSIS) to enable more effective efforts to control Lm in RTE products. RTE facilities that produce foods that are regulated by both USDA/FSIS and FDA will also benefit from a uniform federal approach to reducing the risk of environmental contamination with Lm.

The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill L. mono and formulations to prevent it from growing during storage of the food between production and consumption. The updated draft guidance does not change or alter what constitutes an RTE food.

The FDA is accepting public comments beginning on January 17, 2017. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2008-D-0096 in the search box.

Nutrition Facts Label and the Serving Size. The first draft guidance answers questions related to compliance, labeling of added sugars, rounding as it relates to the declaration of quantitative amounts of vitamins and minerals, and label format (thickness of lines and space between lines).

The second provides examples of food products that belong to product categories included in the tables of Reference Amounts Customarily Consumed (RACCs) per Eating Occasion that are established in FDA’s serving size regulations. These examples are intended to help industry identify the appropriate food categories for their products and, in turn, determine the serving size on a product’s Nutrition Facts label.

The final rules on the Nutrition Facts label and serving sizes were published May 27, 2016, with a compliance date of July 26, 2018; smaller businesses with annual food sales of less than $10 million have until July 26, 2019.

Comments. FDA is accepting comments on all three draft guidance documents. For more information, see

• Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods

• Draft Guidance for Industry: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals