News & Analysis as of

Labeling

FDA Pushes UDI System Compliance Date Back for Class I and Unclassified Devices

by Hogan Lovells on

On June 2, 2017, the U.S. Food and Drug Administration (FDA) announced in a letter to device labelers that it will issue a guidance document stating that FDA will exercise its enforcement discretion for the unique device...more

My problem with Target Date Funds

by Ary Rosenbaum on

When it comes to consumer products and food products, we have stringent labeling requirements. Products must have the contents to support that they are Made in the USA, organic, and juice in order to put that claim on their...more

Picking Up the Post-Preemption Pieces

by Reed Smith on

Parties often file motions in limine on fairly case-specific issues, building on the history of discovery and motions practice in the case. Applying a ruling on in limines from one case to another can be a dicey proposition...more

A Damages Class Is Certified, but No Standing for Declaratory and Injunctive Class

by Carlton Fields on

A representative plaintiff who purchased Aveeno sunscreen products and baby bath products brought putative class actions against the products’ manufacturer, Johnson & Johnson, in the United State District Court for the...more

FDA to Extend E-Cig Marketing Compliance Deadline

by Klein Moynihan Turco LLP on

Last week, the U.S. Food and Drug Administration (“FDA”) disclosed in an Alabama federal court filing its plan to defer enforcement of all future e-cig marketing compliance deadlines for a period of three months....more

Patent Marking

by Fenwick & West LLP on

Labeling your product with information about patent(s) that cover that product is called “patent marking” and is one way to inform the public about your IP rights. While under U.S. law you aren’t required to mark your...more

TTB Releases Results of Annual Sampling Program: Many Common Label Violations Can Easily Be Avoided

Each year the TTB conducts its Alcohol Beverage Sampling Program where it randomly purchases products to assess whether their labels comply with federal regulations and to test whether their contents comply with the...more

RCRA Update: New Hazardous Waste Generator Rule Goes Into Effect in May 2017

EPA’s final Hazardous Waste Generator Improvements Rule (“Rule”), which goes into effect on May 30, 2017, contains approximately 60 revisions to the hazardous waste generator regulatory program. The revisions focus on...more

Trump’s Nominee for FDA Commissioner Likely Dooms Generic Drug Labeling Rule

President Trump recently announced his intent to nominate a new commissioner of the U.S. Food and Drug Administration (FDA), likely sealing the fate of FDA’s proposed generic drug labeling rule. The proposed rule would give...more

Task Force Report: Branding and Packaging of Cannabis

by Bennett Jones LLP on

In this edition of our series on the Task Force’s final report "A Framework for the Legalization and Regulation of Cannabis in Canada" (the "Report") we explore the Task Force’s recommendations in relation to advertising,...more

Implications of EU Ingredient Labeling Proposal for US Suppliers

by McDermott Will & Emery on

On March 13, the European Commission approved a report that calls on members of the alcohol beverage industry to develop a comprehensive self-regulatory system of ingredient and nutritional labeling for beer, wine, and...more

Proposed Regulation in Texas on Name and Address Labeling for Malt Beverages

by McDermott Will & Emery on

Last week, the Texas Alcoholic Beverage Commission (“TABC”) circulated a draft amendment of Texas’ name and address labeling regulation for “malt beverages” (beer). ...more

Blog: Have an IoT Product? Follow Federal Labeling Requirements.

by Cooley LLP on

A device that connects wirelessly to the internet, such as a fitness tracker, smart coffee pot, or home security system, must comply with country-specific equipment authorization and labeling rules. In the US, IoT devices...more

Made-in-the-U.S.A. Complaint Does Not Make the Cut

In a case decided in December that flew beneath our radar, a judge in the Southern District of California dismissed without prejudice a proposed class action alleging that Citizens for Humanity falsely labeled its jeans as...more

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

FDA Devices Center Issues Multiple Guidances in the Obama Administration’s Final Months

by Morgan Lewis on

A flurry of regulatory activity preceded the transition in administration on January 20. Anticipating that the new administration would impose a regulatory slowdown, the Food and Drug Administration’s (FDA’s or the...more

FDA-Approved Labeling Does Not Equal Medical Standard Of Care

by Reed Smith on

We’ve been defending the ability of physicians to engage in off-label use ever since the Bone Screw litigation of the 1990s. Buckman Co. v. Plaintiffs Legal Committee, where the United States Supreme Court affirmed that...more

[Webinar] Biologics and Biosimilars: Development with an Eye Towards FDA Approval - February 17th, 10:00am PST/1:00pm EST

In January 2017, the U.S. Food and Drug Administration (FDA) released a highly anticipated draft guidance detailing the agency’s expectations for demonstrating biosimilar interchangeability with a reference product and final...more

Talk This Way: FDA Provides Guidelines on Medical Product Communications Consistent With the FDA-Required Labeling

Channeling Aerosmith’s 1975 single, “Walk This Way,” and the song lyric “Talk This Way,” the Food and Drug Administration issued a draft guidance to industry on how it can communicate certain types of product information...more

FDA Issues Three Key Documents Relating to Medical Product Manufacturer Communications

by Ropes & Gray LLP on

On January 18, 2017, the Food and Drug Administration (“FDA”) released three key documents outlining the agency’s current thinking regarding drug and device manufacturers’ communication of information not contained in...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

by Pepper Hamilton LLP on

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

FDA Offers Some Clarity (But Few Concessions) on Off-Label Communication of Medical Products

Among the flurry of policies the Food and Drug Administration (FDA) released in the waning days of the Obama administration are several documents that seek to clarify the agency’s positions on communications about medical...more

FDA Issues Draft Guidance on Communications That Are Consistent with FDA-Required Labeling

by McDermott Will & Emery on

This On the Subject reviews the US Food and Drug Administration’s recently released draft guidance on promotional materials and communications that are consistent with FDA-required labeling. The guidance provides a...more

FDA Response to Biosimilar Naming Petitionx Just Issued

by Goodwin on

On January 13, 2017, the FDA published a final version of its industry naming guidance Nonproprietary Naming of Biological Products. In it, the FDA specified a naming convention that gives biosimilar products and their...more

In The Midnight Hour: FDA Issues 2 Draft Guidances and a First Amendment Memorandum on the Cusp of a New Administration

by Hogan Lovells on

Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more

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