Product Regulatory & Compliance

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

CBD Advertising Proceed with Caution to Avoid Confusion, Stay Out of State AG Crosshairs

April 29, 2021

State AG Group members, Meghan Stoppel and Mira Baylson penned an article for Cannabis Business Executive on the real threat of regulatory scrutiny and the importance of a carefully crafted marketing campaign for companies manufacturing and selling CBD.

Making Sense of "Made in the USA"

July 30, 2020

Richard Fama and Brenden Coller contributed an article to Retail Leader discussing what “Made in the USA” really means and if the definition of that phrase will change given the Federal Trade Commission’s (FTC) recent announcement of a proposed rule governing “Made in the USA” claims.

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.

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.

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.

Events & Seminars

Past Events

Health Law 2020

December 04, 2019 - Philadelphia, PA

2017 Health Law Year In Review

December 06, 2017 - Philadelphia, PA

Emerging Legal Issues in Health and Pharmaceutical Law

October 10, 2017 - Indianapolis, IN

Contacts

Richard Fama

Member

rfama@cozen.com

(212) 908-1229

Jillian Thornton Flax

Member

jflax@cozen.com

(215) 665-2034

People

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