News & Analysis as of

Labeling Public Comment

Bergeson & Campbell, P.C.

EPA Announces Public Comment Period for Application of Proposed New Herbicide Product Containing Dicamba from Bayer CropScience

On May 3, 2024, the U.S. Environmental Protection Agency (EPA) announced it received an application from Bayer CropScience LP for a new product containing the currently registered active ingredient dicamba. The proposed...more

Davis Wright Tremaine LLP

EPA Seeks Comments on "Clean" Label for Construction Industry

Inflation Reduction Act pledged millions to label program intended to cut climate pollution linked to manufacturing of construction products and materials - The Environmental Protection Agency ("EPA") is seeking public...more

Troutman Pepper

TTB Seeking Public Input on Potential Alcoholic Beverage Labeling Changes

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As we previously reported, the Treasury Department released a 2022 report on Competition in the Markets for Beer, Wine, and Spirits (the Competition Report) recommending, in part, that the Alcohol and Tobacco Tax and Trade...more

Foley & Lardner LLP

A Look at FDA’s Proposed Changes to Labeling for Biosimilars and Interchangeable Biosimilars

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The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more

Foley Hoag LLP

FDA and Prescription Drug Use Related Software – FDA’s Draft PDURS Guidance Answers Years-Old Questions and Introduces New Ones

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After remaining silent on the topic for decades, the Food and Drug Administration (FDA) provided an expansive definition of “promotional labeling” in its recently issued draft guidance document on Regulatory Considerations...more

Troutman Pepper

FDA Proposes New Rules for Prescription Drug Labeling

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On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more

ArentFox Schiff

FTC Launches Review of "Green Guides"

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The Federal Trade Commission (FTC) announced on December 14, 2022, that it is seeking public comment on potential updates and changes to its “Green Guides,” kicking off a process that may lead to the first significant changes...more

McDermott Will & Emery

NIST Publishes Draft Security Criteria for Consumer Software

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Consumer software providers will soon have the option to label their software as compliant with National Institute of Standards and Technology (NIST) standards for software security. On November 1, 2021, NIST published its...more

Beveridge & Diamond PC

USDA Opens Comment Period for Labeling Requirements for Cell-Cultured Meat and Poultry Products

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On September 3, 2021, the U.S. Department of Agriculture, Food Safety and Inspection Service (USDA-FSIS) opened a comment period in advance of a proposed rule on labeling requirements for meat and poultry products comprised...more

Foley Hoag LLP

USDA Seeks Comment on Cultured Meat and Poultry Labeling

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The Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) recently published an advanced notice of proposed rulemaking (ANPR) seeking public comment pertaining to the labeling of meat and...more

Vicente LLP

Cannabis Administration And Opportunity Act: What The Proposed Federal Cannabis Laws Would Mean For Hemp

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On July 14, 2021, Senators Chuck Schumer (D-NY), Ron Wyden (D-OR), and Cory Booker (D-NJ) released the discussion draft of historic federal cannabis legalization legislation, the Cannabis Administration and Opportunity Act...more

WilmerHale

FTC’s First Open Meeting Highlights Aggressive Enforcement Priorities and Partisan Divide

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On Thursday, July 1, the Federal Trade Commission held its first meeting under Chair Lina M. Khan and first open business meeting in over twenty years. The Commission considered four items during the nearly two hour long...more

Cozen O'Connor

The State AG Report - Volume 7, Issue 27 | July 2021

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Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: FTC’s New Rule Aims to Crack Down on False “Made...more

Smart & Biggar

Health Canada Consultation on Electronic Media in Prescription Drug Labelling

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On March 12, 2021, Health Canada released for consultation its new Draft Guidance Document on Electronic media in prescription drug labelling. The draft Guidance sets out Health Canada’s expectations for drug manufacturers...more

Faegre Drinker Biddle & Reath LLP

FDA Issues Guidance for Applicants Seeking Biosimilar/Interchangeable Approval

The Food and Drug Administration (FDA) released new draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act, intended for prospective applicants of biologics...more

King & Spalding

FDA Releases Draft Guidance on Promotion of Biological Reference and Biosimilar Products

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Part of a New Joint Initiative with FTC to Deter Anti-Competitive Practices, Including False or Misleading Comparisons - On February 3, 2020, the U.S. Food and Drug Administration (“FDA”) released draft guidance providing...more

Fisher Phillips

OSHA To Hold Informal Meeting In Preparation For United Nations Session on Chemicals

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OSHA announced yesterday that registration is open for an upcoming open informal public meeting to discuss proposals in preparation for the 38th session of the United Nations Sub-Committee of Experts on the Globally...more

McDermott Will & Emery

TTB Publishes NPRMs to Repeal Standards of Fill for Wine and Distilled Spirits

On Monday, July 1, 2019, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published two eagerly anticipated notices of proposed rulemaking (NPRMs) to largely repeal the standards of fill for wine and distilled spirits...more

Wilson Sonsini Goodrich & Rosati

FDA Signals a Deliberative Approach to Cannabis at Public Hearing

While it was ostensibly convened to gather scientific input from stakeholders on how to appropriately regulate cannabis-infused products, the Food and Drug Administration (FDA) also used the May 31, 2019 public hearing as a...more

McDermott Will & Emery

Learnings from the FDA Hearing on Cannabis and Cannabis-Derived Compounds

On Friday May 31, 2019, the Food and Drug Administration (FDA) held a public hearing on the topic of cannabis or cannabis-derived compounds. The FDA held the hearing to gather information regarding the safety risks and health...more

Perkins Coie

Food and Drug Administration Considers Pathway for Legalizing CBD at Public Hearing

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On May 31, 2019, the Food and Drug Administration (FDA) held its first public hearing concerning products containing cannabis or cannabis-derived compounds (in particular, cannabidiol (CBD), a popular additive to food,...more

Smart & Biggar

Rx IP Update - April 2019

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PMPRB amendments expected to come into force no earlier than Spring 2020 - On April 1, 2019, Health Canada released Forward Regulatory Plan 2019-2021: Regulations Amending the Patented Medicines Regulations. This brief...more

Smart & Biggar

Enjoy your cannabis hot chocolate, but not so fast on the cannabis beer

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The Canadian Federal government’s proposed amendments to the Cannabis Act and Regulations were published last month. Until February 20, 2019, Health Canada will be accepting comments on the proposed amendments, which set out...more

Sheppard Mullin Richter & Hampton LLP

FDA Issues New Draft Cybersecurity Guidance for Medical Devices

The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more

Mintz - Consumer Product Safety Viewpoints

FDA Resets Enforcement Priorities for OTC Homeopathic Drugs

Happy New Year! And now on to your regular Consumer Product Matters programming… Another Federal agency with a consumer-protection mandate has taken a significant step to reset compliance expectations and enforcement...more

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