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Tag Archives: FDA

Massachusetts Court Finds Plaintiffs’ Claims Against Generic Drug Manufacturers Are Barred By Preemption

Posted in Massachusetts Courts, Pharmaceutical and Medical Devices

Written by Jonathan F. Tabasky and Kate B. Puccio Massachusetts Superior Court Judge Bruce R. Henry recently dismissed a series of claims against several manufacturers of the generic drug Metoclopramide (“MCP”), against whom failure to warn claims was alleged.  See White v. Elsevier, Inc., Middlesex Superior Court Civil Action No. 11-04441.  In so doing, Judge… Continue Reading

FDA Prepares to Release a Regulation on the Labeling of “Gluten-Free” Food by the End of 2012

Posted in False-Labeling Claims, Litigation Trends, Products Liability

The Food & Drug Administration (FDA) is preparing to release a regulation on the labeling of “gluten-free” food by the end of 2012. Although the regulation will provide much needed guidance to consumers and food manufacturers, it will also establish a standard that food manufactures will need to follow in order to use a “gluten-free”… Continue Reading

Are California Food Manufacturers Prepared for Proposition 37: Imposed Labeling Mandates For Genetically Modified Organisms?

Posted in California Courts, False-Labeling Claims, Foodborne Illness, Litigation Trends

California’s Secretary of State recently announced that the California Right to Know Labeling Initiative will be Proposition 37 on this November’s state ballot. If passed, this initiative would require labeling by food manufacturers of any genetically modified organisms (GMOs), also known as genetically engineered organisms (GEOs). GMOs made their first public appearance in 1994, when… Continue Reading

Ben & Jerry’s Recall: Container Label Missing Nut Allergen Advisory in Chocolate Nougat Crunch

Posted in Foodborne Illness, Products Liability

With the Summer Solstice only days away, and peak ice cream eating season upon us, Unilever,PLC, the company which owns Ben & Jerry’s, is voluntarily recalling pints of Ben & Jerry’s Chocolate Nougat Crunch Ice Cream because the container label does not include a statement which warns that the product was manufactured on equipment also… Continue Reading

FDA Pumps The Brakes On Nanotechnology In The Food Industry

Posted in Foodborne Illness, Litigation Trends

Nanotechnology is a cutting edge technology which involves the use of engineered, non-soluble material so tiny, it cannot be seen through a light microscope. Through manipulation of the chemical, physical and biological properties of nanomaterials, manufacturers can significantly alter the product into which they are added.   The potential capabilities of this technology in the food industry are… Continue Reading

Food Safety: Assessing The Future Of Third-Party Auditors

Posted in Foodborne Illness

Co-authored by Brian Gross  A company’s interest in protecting its brand by providing a safe product to consumers, in conjunction with the increased regulatory requirements set forth under the Food Safety Modernization Act (FSMA) require that entities active in the food supply chain take appropriate measures to verify that their suppliers comply with Current Good Manufacturing… Continue Reading

Congress Boosts FDA’s Ability to Effectuate Food Safety Modernization Act

Posted in Foodborne Illness, Products Liability

Co-authored by Brian Gross In our October 25, 2011 post, Food Safety Modernization Act: Did Congress Bite Off More Than It Can Chew? we expressed concern regarding the FDA’s ability to fully implement the Food Safety Modernization Act (“FSMA”) given its budgetary restrictions.   As outlined in our prior post, FSMA provides for increased regulation and oversight… Continue Reading

Food Safety Modernization Act: Did Congress Bite Off More Than It Can Chew?

Posted in Foodborne Illness, Products Liability

Co-authored by Brian Gross The recently enacted Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, provides the U.S. Food and Drug Administration (FDA) with increased power.  The FSMA, which represents the culmination of more than a decade long effort to reform this country’s food safety oversight system,… Continue Reading