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Recent Federal Developments - FDA - March 2020
Tuesday, March 17, 2020

Pre-Submission Consultation Process For Animal Food Additive Petitions Or Generally Recognized As Safe (GRAS) Notices: The U.S. Food and Drug Administration (FDA) announced on February 13, 2020, the availability of draft guidance for industry (GFI) #262. 85 Fed. Reg. 8297. The draft guidance is intended to assist industry with the collection of data for “effective and efficient consultations with FDA regarding investigational animal food substances.” The draft GFI includes details on the types of information FDA is seeking when preparing a pre-submission consultation for a food additive petition for food additives intended for use in animal food; a GRAS notification for animal food; or for a permit to use, in human or animals foods, animal products derived from animals that have been administered an investigational substance. FDA is accepting comments on the draft GFI until April 13, 2020.

Supplemental Guidance For The Intentional Adulteration FSMA Rule: FDA announced on February 14, 2020, the availability of supplemental draft guidance for industry titled “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.” 85 Fed. Reg. 8599. The Food Safety Modernization Act (FSMA) enables FDA to protect public health better by helping to ensure the safety and security of the food supply. The draft guidance includes the following additions:

  • Chapter 5 -- Mitigation Strategies Management Components: Food Defense Corrective Actions;

  • Chapter 6 -- Mitigation Strategies Management Components: Food Defense Verification;

  • Chapter 7 -- Reanalysis;

  • Chapter 9 -- Records;

  • Appendix 2 -- Mitigation Strategies in the Food Defense Mitigation Strategies Database; and

  • Appendix 3 -- Determination of Status as a Very Small Business or Small Business Under Part 121: Mitigation Strategies to Protect Food Against Intentional Adulteration.

FDA is accepting comments on the draft guidance, which must be submitted by June 15, 2020.

Food Additive Petition For Potassium Iodate: On February 25, 2020, FDA announced the submission of a food additive petition (FAP) submitted by Unilever for potassium iodate. 85 Fed. Reg. 10632. The FAP proposes to amend 21 C.F.R. Part 172, Food Additives Permitted for Direct Addition to Food for Human Consumption, to allow use of the substance in various foods at the maximum level of 40 milligrams of potassium iodate per kilogram of salt (sodium chloride).

Extended Comment Period For FSMA Rule: On February 28, 2020, FDA extended the comment period for the proposed FSMA rule, titled “Laboratory Accreditation for Analyses of Foods,” to April 6, 2020. 85 Fed. Reg. 11893. The proposed rule would establish a program for the testing of food by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act.

International Cooperation On Cosmetics Regulation Preparation Meeting Set: FDA, on March 3, 2020, announced that a public meeting titled “International Cooperation on Cosmetics Regulation (ICCR -- Preparation for ICCR-14 Meeting” will be held on April 14, 2020. The purpose of the preparation meeting is to solicit public input to help FDA prepare for the ICCR-14 meeting that will be held June 8 to 10, 2020, in Brussels, Belgium. Interested parties should register with FDA by March 31, 2020.

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