Anthony "Tony" Pavel

Anthony "Tony" Pavel

Morgan Lewis

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Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

7/23/2014 - Draft Guidance FDA Final Guidance Healthcare Manufacturers Marketing Medical Devices Unique Device Identifiers

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 FSIS Recordkeeping Requirements Retailers

FDA to Cease Active Regulation of MDDS and Other Health IT Devices

The draft guidance also enables some health IT manufacturers to avoid the device tax. The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more

6/24/2014 - FDA Health Information Technologies Healthcare Medical Devices Mobile Devices

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 Proposes Overhaul of Nutrition Facts Labeling

The first major overhaul of the Nutrition Facts panel in more than 20 years focuses on serving sizes, calories, and a refreshed design. The Food and Drug Administration (FDA or the Agency) on February 27 announced the...more

3/10/2014 - FDA Food Labeling NLEA Nutrition Facts Labels

FDA Warning Letters Signal Narrowing of “Medical Food” Category

Manufacturers seeking to enter the medical food market face increased challenges. The Food and Drug Administration (FDA or the Agency) has issued several Warning Letters to manufacturers of medical foods...more

2/17/2014 - FDA Food Manufacturers Food Safety Healthcare

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 Proposes Food Defense Rule to Protect Against Intentional Adulteration

New mandate would apply to major U.S. and international food processors and handlers. On December 24, the U.S. Food and Drug Administration (FDA or the Agency) issued a proposed rule, Focused Mitigation Strategies to...more

1/6/2014 - FDA Food Contamination Food Safety

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 Issues Long-Awaited Final Guidance on Mobile Medical Applications

Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients. On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more

9/26/2013 - FDA Final Guidance Mobile Apps Mobile Devices Telemedicine

FSMA Whistleblower Lawsuit Filed in Federal Court

Food industry should be aware of new risks associated with whistleblower protections for food and beverage company employees. On June 6, one of the first whistleblower lawsuits under the Food Safety Modernization Act...more

8/6/2013 - Employer Liability Issues Food Manufacturers FSMA Whistleblowers

Is EPA Setting Its Sights on Hydraulic Fracturing Compounds?

Agency implements rule requiring companies to disclose information regarding the use of certain industrial chemical substances commonly used in natural gas and oil well drilling....more

5/15/2013 - Disclosure Requirements EPA Fracking

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 Preventive Control Rule

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