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2021 Health Care Predictions

One year ago – in early 2020 – most of us did not know what COVID-19 meant (co-Corona; vi-Virus; d-disease; 19 – 2019); had no idea how to “zoom”; did not know what social distance meant; and, were largely unfamiliar with...more

Analyzing the Growing Complexity of Food Law, Industry Advances and the Road Ahead Under a New Administration [Audio]

In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with Tony Pavel, Senior Food Lawyer and Global Food Law Team Leader at Cargill, a global...more

On Heels of Senate’s Adoption of Cannabis Research Bill, DEA Issues Rule to License More Research Cannabis Growers

On December 18, 2020, just three days after the U.S. Senate adopted the Cannabidiol and Marihuana Research Expansion Act (CMREA or the Act) (more on this below), the U.S. Drug Enforcement Administration (DEA or the...more

From FDA to USDA – the Alphabet Soup of Regulatory Agencies and How the Government Has Permitted Some Flexibility During the... [Audio]

In this episode, host Kermit Nash, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with fellow FBA Practice co-chair, Jonathan Havens, on the portfolios of the U.S. Food and...more

From More Delivery, Takeout and Outdoor Dining Options to Financial Relief – How Restaurants Have Managed Throughout the Pandemic [Audio]

In this episode, host Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, speaks with the Firm’s Labor and Employment Practice vice-chair Dena Calo and Carrie Leishman,...more

From Farm to Shelf – COVID’s Impact on Global Supply Chains [Audio]

In this episode, host Jonathan Havens speaks with Kermit Nash, both of whom are co-chairs of Saul Ewing Arnstein & Lehr’s Food, Beverage and Agribusiness (FBA) Practice, about how the COVID-19 pandemic has disrupted the...more

Wheels Are in Motion for Recreational Marijuana in New Jersey and Several Other States

The clear winner after the November 3 election was marijuana. In four states – New Jersey, Arizona, South Dakota and Montana – voters approved initiatives to legalize recreational marijuana. South Dakota and Mississippi also...more

CMS Proposes Medicare Coverage of Certain New Medical Devices, Clarification of “Reasonable and Necessary” Definition

On September 1, 2020, the Centers for Medicare & Medicaid Services (CMS) published in the Federal Register a proposed rule that, if finalized, would establish a Medicare coverage pathway to provide Medicare beneficiaries with...more

DEA Issues Hemp and CBD Rules to Implement Farm Bill

On August 21, 2020, nearly two years after the passage of the Agriculture Improvement Act of 2018 (2018 Farm Bill), the Drug Enforcement Administration (DEA or the Agency) published an interim final rule that, according to...more

FDA Sends CBD Enforcement Policy to OMB, Issues Cannabis Clinical Research Draft Guidance, and Submits CBD Testing Report to...

This summer has been a busy one in the cannabis and cannabis-derived products spaces. On Wednesday, July 22, 2020, the U.S. Food and Drug Administration (FDA or the Agency) sent to the White House Office of Management and...more

Restaurants Given a Green Light in Pennsylvania’s Green Phase, Other Colorful Limitations Follow

After weeks of confusion and business closure, the Governor of Pennsylvania announced on May 27, 2020 extensive guidelines for businesses in the food service industry, which will allow restaurants and bars within...more

Key Health Care Legal and Business Issues in the Transitional/Post-COVID-19 World

INTRODUCTION - The health care world – in fact, THE WORLD – has changed significantly since March with the onset of COVID-19. As we collectively work to return to a “new normal,” the health care delivery system will be one of...more

Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Deemed Tobacco Products in Light of COVID-19;...

On April 23, 2020, the U.S. District Court for the District of Maryland granted the U.S. Food and Drug Administration’s (FDA or the Agency) request for an extension of the submission deadline for certain deemed tobacco...more

USDA to Implement COVID-19 Food Assistance Program

On Friday, April 17, 2020, the U.S. Department of Agriculture (USDA or the Department) announced the creation of the Coronavirus Food Assistance Program (CFAP). In implementing CFAP, USDA will undertake a number of actions to...more

Manufacturing and Distributing Personal Protective Equipment in Response to COVID-19: What Higher Education Institutions Need to...

In response to widespread shortages of protective masks, face shields and other medical devices and device components (e.g., ventilators and ventilator parts) in light of COVID-19, some colleges and universities with the...more

COVID-19, Shelter In Place Orders, and the Food, Agribusiness, and Beverage Industries: What You Need to Know

As the Coronavirus (COVID-19) pandemic continues, states are issuing executive orders that restrict most businesses from operating and require individuals to “shelter in place” (SIP) by staying home to avert the virus’s...more

2020 Health Care Predictions

The Saul Ewing Arnstein & Lehr, LLP Health Care Practice includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery system, including: ...more

Post-Holiday Roundup: 2019 Concludes With Big Changes for Tobacco, Cannabis, and Food and Beverage Industries

A new decade is upon us, as are substantial federal and state policy, regulatory, and enforcement developments for the tobacco, cannabis, and food and beverage industries. ...more

FDA Issues Round of CBD Warning Letters and Revised Consumer Update, Restates Potential Risks and Unknowns

On November 25, 2019, the U.S. Food and Drug Administration (FDA or the Agency) announced that it had issued Warning Letters to 15 companies for illegally selling products containing cannabidiol (CBD). ...more

USDA Issues Long-Awaited Hemp Production Rule, Some Questions Answered, Many Remain

On October 29, 2019, the U.S. Department of Agriculture (USDA) issued a pre-publication version of its long awaited hemp production interim final rule. Public comments are due 60 days after USDA publishes the rule in the...more

Pennsylvania Senators Introduce Recreational Marijuana Legalization Bill

Overview - This week, Pennsylvania Senators Daylin Leach (D-Montgomery/Delaware) and Sharif Street (D-Philadelphia) introduced a bill, the “Adult-Use Cannabis Act” (Senate Bill 350), that would legalize adult-use (i.e.,...more

House Passes First-Ever Standalone Cannabis Reform Bill, SAFE Act Would Provide Cannabis Businesses With Much Needed Banking...

On September 25, 2019, the U.S. House of Representatives overwhelmingly passed the Secure And Fair Enforcement (SAFE) Banking Act (SAFE Act) by vote of 321 to 103. ...more

In Response to Vaping-Related Deaths and Injuries, Trump Administration To Ban Flavored E-Cigarettes; Impact on CBD an Open...

On Wednesday, September 11, 2019, in response to a number of highly-publicized vaping-related deaths and illnesses, the Trump Administration (the Administration) announced its intention to ban most flavored e-cigarette...more

FDA Publishes Court-Ordered Cigarette Graphic Warning Proposed Rule, Industry Challenge Expected

On August 15, 2019, the U.S. Food and Drug Administration (FDA or the Agency) published a court-ordered proposed rule that, if finalized, would mandate graphic health warnings for cigarette packaging and advertisements to...more

NJ Establishes Permanent Hemp Program, Friendlier Environment for CBD Than NY and PA

On August 9, 2019, New Jersey Governor Phil Murphy signed A5322 into law, making the Garden State the latest to establish a permanent program for the cultivation, handling, processing, transport, and sale of hemp and...more

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