Joseph Levitt on Rulemaking Process

FDA to test voluntary “healthy” symbols through consumer research

The U.S. Food and Drug Administration (FDA) has recently signaled its continued interest in developing a voluntary “healthy” symbol for packaged foods as a representation of the nutrient content claim....more

5/10/2021 / Comment Period , Food and Drug Administration (FDA) , Food Manufacturers , Food Products . , Food Safety , Food Supply , Health Claims , Nutrition Facts Labels , Product Labels , Regulatory Oversight , Regulatory Reform , Regulatory Standards , Rulemaking Process

HHS proposes to sunset regulations Issued by FDA, CMS, and other regulatory agencies

Our team wanted to highlight a proposed rule issued by the U.S. Department of Health and Human Services (HHS) on 4 November 2020 - with only a 30-day comment period - that would establish sunset (expiration) dates for...more

11/19/2020 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda , Regulatory Requirements , Rulemaking Process , Sunset Provisions

FDA Releases Third and Final Installment of Draft Guidance for FSMA Intentional Adulteration Rule

The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more

2/20/2020 / Corrective Actions , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , Public Health , Recordkeeping Requirements , Regulatory Oversight , Regulatory Requirements , Rulemaking Process , Verification Requirements

OMB Releases Fall 2019 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Fall 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

12/19/2019 / Agribusiness , APHIS , Farms , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Safety and Inspection Service (FSIS) , Food Supply , FSMA , Imports , OMB , Regulatory Agenda , Regulatory Oversight , Rulemaking Process , USDA

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

The U.S. Food and Drug Administration (“FDA”) recently issued a proposed rule entitled “Laboratory Accreditation for Analyses of Foods” (“Proposed Rule”), which was mandated by the FDA Food Safety Modernization Act (FSMA)....more

11/14/2019 / Accreditation , Food and Drug Administration (FDA) , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , FSVP , Imports , Laboratory Developed Tests , Proposed Rules , Public Health , Regulatory Oversight , Regulatory Requirements , Rulemaking Process , Test Guidelines

FDA Issues Final Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The...more

10/29/2019 / Disclosure Requirements , Final Rules , Food and Drug Administration (FDA) , Food Labeling , Food Manufacturers , Nutrition Facts Labels , Public Health , Regulatory Oversight , Regulatory Requirements , Rulemaking Process , Vending Machines

FDA Issues Draft Guidance on Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting

FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting,...more

7/3/2019 / Agribusiness , Draft Guidance , Farms , Food and Drug Administration (FDA) , Food Borne Bacteria , Food Contamination , Food Manufacturers , Food Safety , Food Supply , FSMA , Public Health , Regulatory Oversight , Rulemaking Process , Seeds

OMB Releases Spring 2019 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Spring 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

6/20/2019 / Agribusiness , APHIS , Food Manufacturers , Food Safety and Inspection Service (FSIS) , OMB , Regulatory Agenda , Rulemaking Process , USDA

OMB Issues Memorandum Guidance on Executive Departments’ and Agencies’ Compliance with the Congressional Review Act

The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019...more

5/17/2019 / Congressional Review Act , Cooperative Compliance Regime , Food and Drug Administration (FDA) , Food Supply , OIRA , OMB , Regulatory Agencies , Regulatory Agenda , Regulatory Oversight , Rulemaking Process

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing,...more

4/4/2019 / Agricultural Land , Commodities , Enforcement Authority , Farms , Food and Drug Administration (FDA) , Food Safety , FSMA , New Guidance , Regulatory Agenda , Rulemaking Process

OMB Releases Fall 2018 Unified Agenda of Regulatory Actions

The Office of Management and Budget (OMB) recently released the Fall 2018 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum...more

11/14/2018 / APHIS , Bioengineering , Disclosure Requirements , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , FSMA , OMB , Plant Based Products , Regulatory Oversight , Regulatory Requirements , Rulemaking Process , USDA

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