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John Fuson

Partner

jfuson@crowell.com
Phone: +1 202.624.2910
1001 Pennsylvania Avenue NW
Washington, DC 20004-2595

John Fuson is a partner in the firm's Health Care, Product Risk Management (PRM), and White Collar and Regulatory Enforcement groups, focusing on U.S. Food and Drug Administration (FDA) enforcement and counseling matters. 

John’s FDA counseling is informed by his role as associate chief counsel at the FDA, prior to joining Crowell & Moring. In this position, he had broad law enforcement responsibilities, handling major enforcement actions brought by the agency, including seizure actions, injunction actions, actions for civil money penalties, and contempt actions. His cases involved drugs, devices, food, and veterinary drugs.

Building on his FDA experience, John is able to offer clients invaluable perspective on FDA matters. He has an insider’s understanding of how the agency thinks, applying its public health focus to his client’s needs regarding product risks and benefits.  John also understands the importance of having a strong, trusted relationship with the FDA, and he works with clients to help them develop that. He regularly counsels clients on their critical interactions with the agency, including advising on product approval strategies, reporting obligations, manufacturing practice compliance, labeling concerns, and product recalls. Clients also turn to John for help with answering  agency inquiries, handling facility inspections, and responding to observations and warning letters. 

Building on his FDA experience, John works primarily with clients in the food, medical device and pharmaceutical industries. He also provides clients in the electronic nicotine delivery industry regulatory guidance related to the Family Smoking Prevention and Tobacco Control Act.

Food Industry: John helps food industry clients navigate new obligations under the Food Safety Modernization Act, handle the burdens of preventive control inspections, evaluate safety risks, and manage product recalls. He also counsels clients on food labeling questions. In these matters, he considers not only the regulatory requirements, but also helps clients balance competitive marketing claims and the threat of false advertising litigation.

Medical Device Manufacturers: John helps medical device manufacturers understand their pathways to market, particularly as FDA seeks to open access to new digital technologies. As they develop claims on labeling and other materials, John helps clients understand risk in competitive marketing environments, including safety concerns, reporting obligations, and Quality System Regulation compliance.

Drug Manufacturers: John provides drug manufacturers on compliance and enforcement matters, focusing on FDA inspections, current good manufacturing practice (GMP) requirements, and data integrity responsibilities. When clients receive inspectional observations, warning letters, and other communications, he helps clients efficiently and effectively respond to agency concerns.

Family Smoking Prevention and Tobacco Control Act: John counsels clients on emerging obligations under the Family Smoking Prevention and Tobacco Control Act, particularly as they relate to FDA’s attempts to balance concerns with electronic nicotine delivery systems and its desire to make tools available to help individuals quit smoking conventional cigarettes.

Animal Food and Veterinary Drugs: While at FDA, John oversaw injunction actions against dairy farms for improper use of new animal drugs and failure to control medicated livestock, oversaw a mass seizure of adulterated pet food from a dirty warehouse, and worked with agency experts to develop an enforcement strategy against distributors of unlawfully compounded new animal drugs. Today, he advises clients on a range of product labeling, content, and manufacturing issues.

John was born in Ohio and grew up in Southern California. He received his B.A. from Grinnell College in Iowa and received his J.D. from the University of Pennsylvania Law School. After law school, he clerked for Judge Marsha S. Berzon on the U.S. Court of Appeals for the Ninth Circuit and now lives with his family in Washington, D.C.

Education

  • Grinnell College, B.A. history (1993)
  • University of Pennsylvania Law School, J.D. (2000)

Affiliations

Admitted to practice: District of Columbia, California (inactive)

View More

"FDA Plans to Resume Domestic Facility Inspections," Mass Tort, Product, and Consumer Litigation Alert (July 17, 2020). Contacts: John Fuson, Chalana N. Damron, Emily Tucker
Client Alert / Newsletter
"COVID-19 Investigations Webinar – Current Congressional, Federal Agency, and State AG Oversight & Investigations Priorities," Crowell & Moring Webinar (July 15, 2020). Presenters: James G. Flood, John Fuson, Natalie O. Ludaway, and Rebecca Monck Ricigliano.
Speech/Presentation
"FinCEN Provides Additional Guidance for Financial Institutions on Hemp-Related Businesses," International Trade Bulletin (July 10, 2020). Contacts: Caroline E. Brown, Carlton Greene, John Fuson, Amanda Lineberry, Nicole Sayegh Succar, Erik Woodhouse
Client Alert / Newsletter
"Medical Supply Chains: Questions Companies are Asking and Evolving Government Actions in the Aftermath of COVID-19," Crowell & Moring International Webinar (June 24, 2020). Presenters: Ambassador Robert Holleyman, Patricia L. Wu, John Fuson, James G. Flood, Himamauli Das, and Joshua Boswell.
Speech/Presentation
"FDA Advises Consumers to Avoid Hand Sanitizers Found to Contain Methanol," Mass Tort, Product, and Consumer Litigation Alert (June 23, 2020). Contacts: John Fuson, Chalana N. Damron, Amanda Lineberry
Client Alert / Newsletter
When Manufacturing New Product Lines, Be Aware Of New Compliance Risks Compliance Week (June 5, 2020)
Media Mentions
"HHS Advisory Opinion Clarifies PREP Act Preemption Measures and Protection for Pharmacists," Mass Tort, Product, and Consumer Litigation Alert (May 27, 2020). Contacts: John Fuson, Chalana N. Damron, Mena Gaballah, PharmD, Mariam Sarwar
Client Alert / Newsletter
"A Guide To Evaluating And Advertising COVID-19 Products," Law360 (May 26, 2020). Authors: Christopher A. Cole, Warren Lehrenbaum, Chalana Netasha Damron, John Fuson, and Lauren Aronson.
Publication
"Post COVID-19: FDA Regulatory Considerations for Face Mask and PPE Companies ," Mass Tort, Product, and Consumer Litigation Alert (May 26, 2020). Contacts: John Fuson, Chalana N. Damron, John Arszulowicz
Client Alert / Newsletter
"The Regulatory Pathway To A Vaccine For COVID-19," Law360 (May 22, 2020). Authors: John Fuson, Anne Elise Herold Li, and Mena Gaballah, PharmD.
Publication

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Crowell & Moring LLP is an international law firm with more than 500 lawyers representing clients in litigation and arbitration, regulatory, and transactional matters. The firm is internationally recognized for its representation of Fortune 500 companies in high-stakes litigation, as well as its ongoing commitment to pro bono service and diversity. The firm has offices in Washington, DC, New York, Los Angeles, San Francisco, Orange County, London, and Brussels.

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