Product Regulatory & Compliance

Featured Publication:

New Federal Hemp Regulations: What Businesses Should Know to Comply

Less than one year after hemp production was legalized by the 2018 Farm Bill, the U.S. Department of Agriculture (USDA) released its proposed industrial hemp regulations. These eagerly anticipated regulations establish a proposed federal domestic hemp production program, as authorized by the 2018 Farm Bill.

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Cozen O’Connor helps global product manufacturers, distributors and retailers achieve regulatory compliance, reduce exposure to civil litigation and government enforcement actions, and manage product withdrawals and recalls. We serve many highly regulated companies, including those in the consumer products, food & beverage, dietary supplement, drug & medical device, cosmetics, cannabis, pet, and home safety industries.

Successful companies manufacture innovative products and create bold marketing campaigns. We get that. And that is why Cozen O’Connor regulatory attorneys do not put up roadblocks to growth or product development; we put up guardrails to keep clients moving ahead at full speed.

Our attorneys have deep knowledge of all applicable federal regulations, including those enforced by the Food and Drug Administration (FDA), Consumer Product Safety Commission (CPSC), and Federal Trade Commission (FTC); model regulations of voluntary membership organizations, such as the Association of American Feed Control Officials (AAFCO); state regulations that apply to specific industries (such as cannabis) or specific geographies (such as California’s Prop 65); commonly adopted industry standards, such as ASTM and ASME; and best practices issued by major trade associations. 

Equally important, we know our way around the gray areas. Regulatory language is often ambiguous or incomplete, so decisions must be guided by broader knowledge of litigation trends, case law, and industry norms. Our regulatory team closely tracks all legal developments to stay abreast of shifting expectations and identify emerging “hot spots” may become the next big target for litigation. 

Even with robust compliance programs, companies may face product withdrawals/recalls and legal challenges by individuals, classes, and government agencies. Cozen O’Connor partners with product manufacturers and sellers in times of crisis. We advise on the unique legal, reputational, and logistical issues stemming from product recalls and aggressively defend product liability claims when necessary.

Cozen O’Connor has decades of experience advising companies on products regulations pertaining to:

  • Advertising & Claims Made
  • Labeling & Packaging
  • Trademark & Copyright
  • Product Safety
  • Design & Manufacturing
  • Product Withdrawals & Recalls
  • Rebates, Gift Cards & Promotions
  • Consumer Privacy
  • Consumer Class Actions & Mass Torts

Experience

Publications

New Federal Hemp Regulations: What Businesses Should Know to Comply

December 02, 2019

Less than one year after hemp production was legalized by the 2018 Farm Bill, the U.S. Department of Agriculture (USDA) released its proposed industrial hemp regulations. These eagerly anticipated regulations establish a proposed federal domestic hemp production program, as authorized by the 2018 Farm Bill.

Recent Decisions Impacting Cannabis Contracting and How to Protect Your Business

November 26, 2019

Abby Sacunas discusses how cannabis companies can help ensure their contractual agreements are enforced.

DEA Issuing New Regulations to Address Growing Cannabis Research Needs [Alert]

September 05, 2019

Abby L. Sacunas discusses a DEA Federal Notice advising of its intent to issue new regulations for its marijuana growers program for scientific and medical research.

What Marketers Should Know About the Regulation of CBD-Based Products

August 05, 2019

Richard Fama & Kristin Keehan discuss the different regulatory bodies as well as various state laws that create these challenges for companies marketing CBD-containing products.

Avoiding a Legal Hangover [Bar Business Magazine]

August 01, 2019

Richard Fama and Dean Porter contributed an article to the Bar Business Magazine discussing different types of bar and restaurant advertisements along with the federal regulations behind it.

Pennsylvania Department of Health Revokes Argimed Grow Process Permit for Regulatory Violations [Alert]

July 31, 2019

Abby L. Sacunas discusses the importance of remaining compliant with reporting obligations under the MMA.

How Smart is it for Medical Devices to Learn New Tricks? The FDA Seeks Feedback On Its Proposed Regulatory Framework for Artificial Intelligence/Machine Learning-Based Medical Devices [Products Liability Prevention & Defense Blog]

May 29, 2019

In the shadow of the FDA’s new Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device, manufacturers are left to contemplate enhanced product liability exposure. AI-powered devices ingest new data and adjust accordingly – a feature that could result in entirely...

What does the legalization of CBD mean for marketers? [Marijuana Venture]

April 09, 2019

Richard Fama and Kristin Keehan published an article to the Marijuana Venture Magazine discussing the different markets obtained by this product and how Congress is reacting.

Power Lunch: Are Your Products Really 'Made in the USA'? [Food Processing]

June 25, 2018

Richard Fama and Brenden Coller, members in the firm's Commercial Litigation Department, published, "Power Lunch: Are Your Products Really 'Made in the USA'?" for Food Processing.

What Manufacturers Need To Know About “GDPR” – The New EU Privacy Law

June 19, 2018

Abby Sacunas, a member in the firm's Commercial Litigation Department, and Ude Lu, an associate in the firm's Intellectual Property Department, published "What Manufacturers Need To Know About “GDPR” – The New EU Privacy Law," for the DVIRC Newsletter.

'Made In USA' Ruling Reflects New, Looser Calif. Standard

May 08, 2018

Rich Fama and Brenden Coller, members of the firm's Commercial Litigation Department, co-authored, "'Made In USA' Ruling Reflects New, Looser Calif. Standard," for Law360.

Defending Made-In-The-USA Claims

October 09, 2017

Brenden Coller and Richard Fama, of Cozen O'Connor's Commercial Litigation Department, co-authored, "Defending Made-In-The-USA Claims," for Assembly Magazine.

New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance, and Enforcement [Products Liability Alert]

August 08, 2016

Abby Sacunas and Jillian Flax discuss the U.S. Food and Drug Administration recently released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices.

FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels [Products Liability Prevention & Defense Blog]

August 04, 2016

The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”.  The draft guidance is intended to assist both labelers and FDA-accredited...

2016 DTSA: Providing Manufacturers with New Avenues to Protect Trade Secrets

July 14, 2016

Abby L. Sacunas and Jeffrey D. Feldman discuss the Defend Trade Secrets Act of 2016 and its impact on manufacturing companies with trade secrets related to a products or services used in, or intended for use in, interstate or foreign commerce.

Product Liability Law Will Adapt To Driverless Car Regs [Law360]

June 30, 2016

Abby Sacunas, a member of Cozen O'Connor's Products Liability practice, discusses driverless car regulations in Law360.

New Weapon For Manufacturers: Defend Trade Secrets Act of 2016 [Products Liability Prevention & Defense Blog]

June 23, 2016

On May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic Espionage Act.  While the DTSA substantially mirrors the protections afforded...

Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure [Products Liability Prevention & Defense Blog]

June 02, 2016

Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad.  This situation presents an important cautionary tale and one that is not strictly limited to medical...

The FDA’s New Guidance on Cybersecurity Risks for Medical Devices [Corporate Counsel]

March 03, 2016

Jillian Thornton Flax and Abby Sacunas, both members of Cozen O'Connor's Products Liability practice, discuss the FDA's new guidance on cybersecurity risks for medical devices in Corporate Counsel.

In Pa., No Duty to Advise of Optional Safety Devices [Law360]

November 04, 2015

Abby Sacunas discusses the Eastern District Court of Pennsylvania’s decision to dismiss plaintiff’s negligence and §402(B) strict liability claims on summary judgment in Morello v. Kenco Toyota Lift.

Events & Seminars

Past Events

Health Law 2020

December 04, 2019 - Philadelphia, PA

2017 Health Law Year In Review

December 06, 2017 - Philadelphia, PA

2017 Drug & Device Defense Forum

October 24, 2017 - Philadelphia, Pa

Emerging Legal Issues in Health and Pharmaceutical Law

October 10, 2017 - Indianapolis, IN

DRI: Product Liability Conference

February 08, 2017 - Las Vegas, NV

Drug & Device Defense Forum

December 13, 2016 - Philadelphia, PA

2016 Greater Philadelphia Manufacturing Summit

October 19, 2016 - Drexel Hill, PA

Legal Series: Product Liability for 2015

March 20, 2015 - Webinar

Contacts

Richard Fama

Member

rfama@cozen.com

(212) 908-1229

Abby L. Sacunas

Member

asacunas@cozen.com

(215) 665-4785

People

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