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President Obama Signs Federal GMO Law, Preempts Vermont Law

On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label products that contain genetically modified organisms (“GMO”).[1] The law...more

The Future of Medical Device Manufacturing Is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing

A few years ago, a custom-fabricated bioresorbable tracheal splint saved the life of an infant suffering from a collapsed bronchus due to severe tracheobronchomalacia. The splint was implanted around the baby’s airway,...more

How Americans Eat: Unveiling of the New Nutrition Facts Label

Over a decade in the making, the U.S. Food and Drug Administration (“FDA” or the “Agency”) recently issued two final rules revising its nutrition labeling regulations, most notably, the Nutrition Facts label. The revisions...more

U.S. FDA Finalizes Medical Foods Guidance

On May 12, 2016, the U.S. Food and Drug Administration (“FDA” or “Agency”) finalized its 2013 draft guidance for industry, “Frequently Asked Questions About Medical Foods; Second Edition.” Despite significant industry...more

Vermont Act 120 and Beyond: Genetically Engineered Foods, Where Are We Now?

On July 1, 2016, Vermont’s genetically engineered food labeling law is set to become effective. Act 120 and its implementing rule (Vermont Consumer Protection Rule 121) require food manufacturers to label food products that...more

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter - 3rd Edition

Welcome - We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Global Food, Drug and Medical Device Newsletter

In this issue: Legislative Updates: - (i) USA - (ii) EU - (iii) China - (iv) Australia - (v) Japan. - Featured Articles: - (i) Caffeinated Energy Drinks - a Global Perspective - (ii)...more

Getting Over the Goal Line: Congress Shows Strong Support for Medical Device Tax Repeal, but Issues Remain

Introduction - The Patient Protection and Affordable Care Act (“ACA”) generates very few areas of agreement. However, in recent months, proposals to repeal one of the most visible and controversial provisions of the...more

FTC Rules that “Randomized Clinical Trial” Evidence is Necessary to Support Advertising Claims for Juice Beverage and Related...

I. Introduction - If you represent food and beverage manufacturers who advertise their products, you will want to be familiar with In the Matter of POM Wonderful LLC, a recent decision by the Federal Trade Commission...more

5/15/2013  /  Advertising , FTC , POM Wonderful

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

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