News & Analysis as of

Regulatory Oversight Food and Drug Administration (FDA) Rulemaking Process

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

Holland & Knight LLP

Food and Chemical Update: FDA Unveils Data-Driven Assessment Tool to Rank Food Chemicals

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) is overhauling its approach to post-market oversight of food chemicals, marked by the proposed rollout of a new Post-Market Assessment Prioritization Tool. The FDA first announced...more

King & Spalding

FDA Issues Two Guidances For the Device Q-Sub Process

King & Spalding on

CDRH and CBER Release Final Guidance for the Q-Submission Program and Draft Guidance for PreSTAR - On May 29, 2025, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Center...more

Morgan Lewis - Well Done

Food for Thought Implications of FDAs New Chemical Review Program

The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more

Hogan Lovells

FDA Announces Plans for Post-Market Chemical Review Program

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced plans to update its post-market food chemical review program. In its announcement, FDA explained that its forthcoming plans will take a proactive approach to...more

Latham & Watkins LLP

HHS Directs FDA to Explore Rulemaking to Increase Oversight of Food Ingredients

Latham & Watkins LLP on

On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a press release that he has directed the Food and Drug Administration (FDA) to explore rulemaking to implement a...more

Hogan Lovells

OMB releases Spring 2021 Unified Agenda of Regulatory Actions

Hogan Lovells on

The Office of Management and Budget (OMB) recently released the Spring 2021 Unified Agenda of Regulatory actions, which outlines the rulemaking actions currently under development in each federal agency. This article...more

Hogan Lovells

FDA to test voluntary “healthy” symbols through consumer research

Hogan Lovells on

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

Verrill

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including...

Verrill on

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket...more

Hogan Lovells

Council for Responsible Nutrition Submits Citizen Petition Requesting FDA Rulemaking to Allow CBD and other Hemp-Derived...

Hogan Lovells on

The Council for Responsible Nutrition (CRN) submitted a citizen petition to the Food and Drug Administration (FDA) requesting that FDA: FDA exercise its statutory authority to establish a regulation under which...more

Seyfarth Shaw LLP

Seyfarth on CBD – February 2020 Update

Seyfarth Shaw LLP on

CBD continues to flourish in the markets despite lack of federal regulations, and we’ve identified some significant events that indicate there’s no sign it’s stopping. ...more

Perkins Coie

FDA Releases Report to Congress Regarding CBD

Perkins Coie on

The federal Food and Drug Administration (FDA) just released a report to Congress regarding the agency’s progress toward comprehensive regulation of hemp-derived cannabidiol (CBD). The report echoes the hard-line approach to...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l February 2020 #3

LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

OMB Releases Fall 2019 Unified Agenda of Regulatory Actions

Hogan Lovells on

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

Hogan Lovells

FDA Issues Laboratory Accreditation Proposed Rule Required Under FSMA

Hogan Lovells on

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

Hogan Lovells

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

Hogan Lovells on

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

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l October 2019 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more

Hogan Lovells

New draft guidance on MR compatibility for medical devices

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." ...more

Hogan Lovells

Will FDA be forced to implement a drug importation program?

Hogan Lovells on

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.” The FDA working group was not assigned the task of...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

The Use of an Alternate Name for Potassium Chloride in Food Labeling: Guidance for Industry

Hogan Lovells on

Last week the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

Hogan Lovells on

On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more

Bilzin Sumberg

FDA to Consider Regulation of CBD in Food

Bilzin Sumberg on

Historically, all forms of cannabis—both hemp and marijuana—have been federally designated as illegal substances. That all changed this past December when the President signed the Agricultural Improvement Act (2018 Farm Bill)...more

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