News & Analysis as of

Comment Period Food and Drug Administration (FDA) Rulemaking Process

Bergeson & Campbell, P.C.

FDA Extends Comment Period on Method for Ranking Chemicals in Food for Post-Market Assessments

The U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As...more

Venable LLP

Operation Stork Speed Update: FDA Issues RFI for Infant Formula Nutrition Review

Venable LLP on

On May 14, as part of Operation Stork Speed (the Operation), the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) to begin its review of infant formula nutrition requirements. FDA’s last...more

Dickinson Wright

Breaking: FDA, HHS Seek Public Input on Cutting Rules

Dickinson Wright on

On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) announced a public Request for Information to “identify and eliminate outdated or unnecessary...more

Venable LLP

Regulatory Freeze: FDA Pushes Back Effective Date of "Healthy" Nutrient Content Claim Rule

Venable LLP on

On February 25, the Food and Drug Administration (FDA) announced a delay in the effective date for its final rule updating the criteria to use the "healthy" nutrient content claim on food labeling....more

Troutman Pepper Locke

FDA Withdraws Proposed Bans on Menthol Cigarettes and Flavored Cigars

Troutman Pepper Locke on

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more

Health Care Compliance Association (HCCA)

Bucking History, ORI Deputy Denies Requests For Misconduct NPRM Comment Extension

Report on Research Compliance 20, no. 12  (December 2023) In a move that is unprecedented in recent memory, a federal agency has denied a request to extend the comment period on a substantive proposed rule, turning down a...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Ervin Cohen & Jessup LLP

FDA Foods Program Releases Guidance Topics

On June 29, 2021, the U.S. Food and Drug Administration’s (“FDA”) Center for Food Safety and Applied Nutrition and Office of Food Policy and Response released a list of draft and final guidance topics that are a priority for...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

Hogan Lovells

Comment period ending for proposal to automatically sunset HHS/FDA/CMS regulations

Hogan Lovells on

The Department of Health and Human Services (HHS) recently published a proposed rule that would establish automatic sunset (expiration) dates for a potentially large number of regulations issued by HHS or its constituent...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

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

Hogan Lovells on

Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...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

Holland & Knight LLP

CMS Releases FY 2020 Inpatient Prospective Payment System Proposed Rule

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) on April 23, 2019, released the Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. • The proposed payment rate increase...more

Mintz - Health Care Viewpoints

FDA Extends Comment Period on Third-Party Medical Device Servicing

As an update to my post on Friday, April 22, FDA has extended the deadline for comments on third-party servicing of medical devices. According to FDA’s notice of extension, comments are now due by June 3, 2016....more

Faegre Drinker Biddle & Reath LLP

Long-Awaited FSMA Final Rules Published

On September 10, 2015, the U.S. Food and Drug Administration (FDA) made public two final Food Safety Modernization Act (FSMA) rules: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls...more

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