Kathleen Sanzo

Kathleen Sanzo

Morgan Lewis

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Practical Implications from Amarin

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more

8/11/2015 - Amarin Caronia FDA FDA Approval FDCA First Amendment Medical Devices Misbranding Off-Label Promotion Pharmaceutical Industry Physicians Preliminary Injunctions Prescription Drugs

Liquid Nicotine—New Warnings and Packaging?

FDA publishes an advance notice of proposed rulemaking for products containing liquid nicotine. On July 1, the Food and Drug Administration (FDA) published an advance notice of proposed rulemaking (ANPRM) to obtain...more

7/13/2015 - Advanced Notice of Proposed Rulemaking (ANPRM) Comment Period Consumer Product Safety Commission (CPSC) E-Cigarettes FD&C Act FDA Product Packaging Tobacco Tobacco Regulations Warning Labels

FDA Issues Updated Draft Guidance on Reporting Drug Samples

The guidance calls for 2014 reporting by April 1, 2015. When signed into law in March 2010, the Affordable Care Act (ACA) put a renewed focus on transparency. While section 6002, the Physician Payment Sunshine Act,...more

8/5/2014 - Affordable Care Act FDA Healthcare Hospitals Prescription Drugs Sunshine Act Teaching Hospitals

FSIS Proposes New Recordkeeping Requirements for Ground Beef Processors/Retailers

The proposal, if adopted, will require new recordkeeping by both processing establishments and retail facilities that grind raw beef products....more

7/18/2014 - Food Contamination Food Manufacturers Food Safety Recordkeeping Requirements Retailers

Food Companies Should Expect More False Advertising Claims

The Supreme Court holds that competitors may bring Lanham Act claims challenging food and beverage labels that are regulated by the FDA....more

6/13/2014 - Advertising Coca Cola FDA FDCA Food Labeling Lanham Act NLEA POM Wonderful POM Wonderful v Coca Cola SCOTUS

FDA Rule Prohibits Certain Nutrient Content Claims for Omega-3 Fatty Acids

The final rule prohibits label claims of food products, including dietary supplements, that are “high in,” “rich in,” or an “excellent source of” DHA or EPA and allows some nutrient content claims for ALA. On April 28,...more

4/29/2014 - Compliance Dietary Supplements FDA Final Rules Food Labeling

FDA Proposes Tobacco Products Rule; E-Cigarettes, Cigars To Be Regulated

The rule would ban the sale of e-cigarettes, cigars, pipe tobacco, and other products to those under 18; would require warning statements on product packages and in advertisements; and would require manufacturers to register...more

4/28/2014 - E-Cigarettes FDA

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

3/25/2014 - Exclusive Dealing Agreements FDA Pharmaceutical Industry Prescription Drugs

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

3/7/2014 - FDA Medical Devices Off-Label Promotion Pharmaceutical Industry Prescription Drugs Safe Harbors

FTC Cracks Down on False Advertising in Dietary Supplements

Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising. Recent Federal Trade Commission (FTC) enforcement activities—including a...more

2/27/2014 - Dietary Supplements False Advertising FDA FTC Weight-Loss Products

What Is That in Your Beverage? And Wait—Is It Really a Beverage?

FDA “reminds” manufacturers of the requirements for food and dietary supplement ingredients and finalizes long-awaited liquid dietary supplement guidance. On January 14, the U.S. Food and Drug Administration (FDA or...more

1/28/2014 - Dietary Supplements FDA Food Labeling

FDA Releases Good Manufacturing Practices for Animal Food

Proposed requirements dictate a substantial upgrade of the current regulatory standard of care. On October 29, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule—Current Good Manufacturing...more

11/1/2013 - FDA Food Safety FSMA Manufacturers

FDA Flexes Its FSMA Muscles, Initiates Mandatory Recall

Recall notification suggests the agency is ready and willing to use its new, enhanced enforcement authority. On February 13, the U.S. Food and Drug Administration (FDA) began its first enforcement action under the...more

3/13/2013 - FDA FSMA Notice Requirements Product Recalls

FDA Releases Major New Food Safety Proposals

Affected parties should familiarize themselves with proposed rules for safe food processing and handling and on-farm produce safety; comments to FDA are due by May 16....more

1/10/2013 - FDA Food Manufacturers Food Safety FSMA

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