John Fuson

Speeches & Presentations

• "CBD and Pet Products: Regulatory Update," American Pet Products Association (November 21, 2019). Speakers: John Fuson and Amanda Lineberry.
• "Inspection and Enforcement Authority," FDLI 2019 Food Advertising, Labeling, and Litigation Conference (September 24, 2019). Speaker: John Fuson.
• "Cataclysmic Change or Business as Usual: Product Regulation in the Trump Administration," Product Liability Advisory Council Webinar (October 25, 2018). Speakers: Cheryl A. Falvey, John Fuson, and Peter B. Miller.
• "Management Oversight and Control: How to Ensure Compliance and Limit Liability," Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries, Washington, D.C. (December 7, 2017). Panelist: John Fuson.
• "FDA Inspection and Enforcement Trends," ABA Section of Litigation Food & Supplements Seventh Annual Workshop, Hershey, PA (June 13, 2017). Panelist: John Fuson.
• "GMO Labeling: Analysis of the New Law and Strategies for Practical Implementation," ACI Food Law and Regulation Forum, Chicago, IL (May 24, 2017). Presenter: John Fuson
• "Center for Food Safety and Applied Nutrition (CFSAN)," FDLI Annual Conference, Washington, D.C. (May 4, 2017). Panelist: John Fuson
• "The Safety Agencies in Transition – What to Expect at FDA, CPSC, and NHTSA in the First 100 Days," Crowell & Moring Webinar (March 30, 2017). Presenters: Cheryl A. Falvey, John Fuson, Matthew Cohen, Scott L. Winkelman, Lauren Bell, Daniel T. Campbell, and Rebecca Baden Chaney.
• "New & Evolving IP Changes Impacting the Landscape," Maximizing the Value of Intellectual Property and Strategic Collaborations, Rockville, MD (February 7, 2017). Presenters: John Fuson and Terry Rea.
• "Under the Watchful Eye of the FDA: What Do FDA Warning Letters Tell Us?" Third Annual ABA Life Sciences Legal Summit, San Francisco, CA (September 21, 2016). Presenter: John Fuson.
• "UDI Update," FDLI - Hot Topics in Medical Device Law, Washington, D.C. (March 31, 2016). Presenter: John Fuson.
• "Food & Beverage Industry: What Will 2016 Bring?" Webinar (February 10, 2016). Presenters: John Fuson, Michelle Gillette, Andrew Kaplan, and Chalana N. Williams.
• "Regulatory Considerations in the Medical Device Litigation Discovery Process," Exponent Webinar (November 12, 2013). Presenter: John Fuson.
• "How Internal Policies & Practices Can Prevent - or Fuel - a Crisis: Managing a Product Recall Crisis," Crowell & Moring Advertising Product Risk Management Seminar (March 19, 2013). Moderator: Laura Jastrem Walther; Panelists: Daniel T. Campbell, John Fuson, and Steve Edwards (Stericycle).
• "Navigating High-Profile Litigation and Administrative Enforcement," Crowell & Moring Advertising and Product Risk Management Seminar (March 19, 2013). Moderator: Andrew Kaplan; Panelists: Kevin C. Mayer, Keith J. Harrison, and John Fuson.
• "Consumer Protection and What Obama's 2nd Term Means to Your Business (Including Advertising; Data/Privacy Protection; Product Safety & More)," Association of Corporate Counsel San Francisco Bay Area Chapter, San Francisco and Palo Alto, CA (February 12-13, 2013). Presenters: Bridget E. Calhoun; Christopher A. Cole; Cheryl A. Falvey; John Fuson.
• "Failure Analysis, Product Recalls, and Liability Preventative Measures to Help Prevent the FDA from Knocking on Your Door," Exponent and Crowell & Moring, Menlo Park, CA (January 29, 2013). Presenters: Kevin C. Mayer and John Fuson.

Publications

• "FDA Issues New Guidance for the Management of Cybersecurity in Medical Devices," Crowell & Moring's Health Law Blog (October 19, 2018). Authors: Jodi G. Daniel, John Fuson, Brandon C. Ge, and Amber Mulcare.
• "A Science-Driven Agency Makes a Science-Based Decision: FDA Acknowledges Qualified Health Claim Aimed at Preventing Peanut Allergies," Crowell & Moring's Retail & Consumer Products Law Observer (September 25, 2017). Author: John Fuson
• "The Devil is in the Details: Recordkeeping a Central Focus in FSMA Inspections," Crowell & Moring's Retail & Consumer Products Law Observer (May 9, 2017). Authors: John Fuson and Chalana N. Williams.
• "Safety Agencies after Trump’s “2 for 1” Executive Order: What it May Mean for Regulating the Safety of IoT and other Emerging Technologies," Crowell & Moring's Retail & Consumer Products Law Observer (March 22, 2017). Authors: Cheryl A. Falvey and John Fuson.
• "The FDA Unveils an Updated Nutrition Facts Label," Crowell & Moring's Retail & Consumer Products Law Observer (May 24, 2016). Authors: John Fuson and Chalana N. Willams.
• "Regulatory Forecast 2016: What Corporate Counsel Need to Know for the Coming Year," a Crowell & Moring LLP publication (January 2016). Contributor.
• "Food & Beverage — The Belt Gets Tighter," Crowell & Moring's Regulatory Forecast 2016 (January 2016). Contributors: John Fuson and Andrew Kaplan.
• "The Long and Winding Road for BIOSIMILARS: Charting a Pathway through Patent, FDA, Antitrust, Prescription Filling, Reimbursement and Liability Law," Bloomberg BNA Pharmaceutical Law & Industry Report (September 18, 2015). Authors: Chiemi Suzuki, Deborah H. Yellin, Barbara H. Ryland, Lauren B. Patterson, and John Fuson.
• "New Food Recall Guidance May Signal Tougher FDA," Law360 (May 22, 2015). Authors: John Fuson and Chalana N. Williams.
• "Sunscreen Innovation Act Paves Way for New OTC Sunscreen Ingredients U.S. Market Approval," Crowell & Moring's Health Law Blog (February 24, 2015). Authors: John Fuson and Monica M. Welt.
• "Regulatory Forecast 2015: What Corporate Counsel Need to Know for the Coming Year," a Crowell & Moring LLP publication (January 2015). Contributor.
• "Don't Mistake FDA's Peanut Prosecution As Setting The Bar," Law360 (April 2, 2013). Co-Authors: Ann Mason Rigby and John Fuson.
• "More FDA Detention Slips For Food Cos." Law360 (March 6, 2013). Co-Authors: John Fuson and Michael L. Kuppersmith.
• "Frankenfood Fight: Why Mandatory Labeling of GMO Foods is Unnecessary and Unwise," Pesticide & Chemical Policy Week in Review (October 26, 2012). Co-Authors: John Fuson and Warren Lehrenbaum.
• "FDA Publishes Cyber Guidance for Medical Devices," Crowell & Moring's Health Law Blog Co-Authors: Evan D. Wolff, John Fuson, Elliot Golding, Kathryn A. Linsky and David Z. Bodenheimer

Client Alerts & Newsletters

• "FDA Enforcement Trends: Reflecting on 2019 and Looking Onward to 2020," Mass Tort, Product, and Consumer Litigation Alert (January 16, 2020). Contacts: John Fuson, Chalana Netasha Damron, Emily Tucker, Mena Gaballah, PharmD
• "FDA Cracks Down on Health Claims in CBD Advertisements," Mass Tort, Product, and Consumer Litigation Alert (December 10, 2019). Contacts: Kevin C. Mayer, John Fuson, Lauren Aronson
• "Supreme Court Decision Raises New Questions on Impossibility Preemption in Cases Challenging Sufficiency of Drug Label Warnings," Mass Tort, Product, and Consumer Litigation Alert (June 7, 2019). Contacts: Andrew D. Kaplan, John Fuson, Robbie Rogart, Skyler R. Peacock
• "There May Be Hope for That Label Claim, After All: FDA Proposes to Add Additional Non-Digestible Carbs to the Definition of Dietary Fiber," Mass Tort, Product, and Consumer Litigation Alert (April 2, 2019). Contacts: John Fuson, Chalana Netasha Damron
• "Recent Happenings in Advertising & Product Risk Management – February 2018," Advertising & Product Risk Management Alert (February 26, 2018). Contacts: Helen Osun, Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen
• "Recent Happenings in Advertising & Product Risk Management – December 2017," Advertising & Product Risk Management Alert (December 20, 2017). Contacts: Rebecca Baden Chaney, Chalana Netasha Damron, Robbie Rogart, Kate M. Watkins, Rukiya Mohamed, Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen
• "Recent Happenings in Advertising & Product Risk Management – October 2017," Advertising & Product Risk Management Alert (October 3, 2017). Contacts: Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen, Peter B. Miller, CIPP/G/US/E, CIPM, CIPT
• "Recent Happenings in Advertising & Product Risk Management – July 2017," Advertising & Product Risk Management Alert (July 25, 2017). Contacts: Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen
• "Recent Happenings in Advertising & Product Risk Management – May 2017," Advertising & Product Risk Management Alert (May 17, 2017). Contacts: Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen
• "Recent Happenings in Advertising & Product Risk Management – March 2017," Advertising & Product Risk Management Alert (March 27, 2017). Contacts: Christopher A. Cole, Cheryl A. Falvey, John Fuson, David Ervin, Lauren Aronson, Carolyn W. Wagner, Matthew Cohen
• "FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices," Regulatory Alert (February 1, 2016). Contacts: Jodi G. Daniel, John Fuson
• "Revised EU Novel Foods Regulation Simplifies Approval Process, Increases Food Innovation, and Maintains High Food Safety Standards," Advertising & Product Risk Management Alert (December 2015). Contact: John Fuson
• "'Natural' Claims: FDA Requests Comments on Use of the Term 'Natural' on Food Labeling," Advertising & Product Risk Management Alert (November 13, 2015). Contacts: Cheryl A. Falvey, John Fuson, Andrew D. Kaplan, Chalana Netasha Damron
• "A Hashtag Away from a Warning Letter? Kim Kardashian’s Instagram Post Triggers FDA Warning Letter that Sends a Strong Message to Drug Makers," Advertising & Product Risk Management Alert (August 2015). Contacts: John Fuson, Chalana Netasha Damron
• "U.S.D.A. Announces Plans to Implement a Non-GE Verification Program," Advertising & Product Risk Management Alert (May 2015). Contacts: John Fuson, Chalana Netasha Damron
• "Draft Guidance for Industry on Mandatory Food Recalls Available for Public Comment," Advertising & Product Risk Management Alert (May 12, 2015). Contacts: John Fuson, Chalana Netasha Damron
• "U.S. District Court Declines to Enjoin Vermont's Genetically Engineered Ingredient Labeling Law," Advertising & Product Risk Management Alert (May 1, 2015). Contacts: John Fuson, Chalana Netasha Damron
• "Bipartisan Bill Would Expand FDA’s Reach Over "Personal Care Products" and Cosmetics," Advertising & Product Risk Management Alert (April 2015). Contact: John Fuson
• "Sunscreen Ingredients' New Path to U.S. Market Approval," Advertising & Product Risk Management Alert (February 19, 2015). Contacts: Danielle Rowan, John Fuson
• "FDA's Latest Round of Warning Letters Signal that the Agency is Closely Watching and Policing Improper "Healthy" Claims," Advertising & Product Risk Management Alert (January 28, 2015). Contacts: John Fuson, Chalana Netasha Damron
• ""Natural" Food Labeling Decision Delivers Defense-friendly Clarity," Advertising & Product Risk Management Alert (December 19, 2014). Contacts: John Fuson, Robbie Rogart
• "New Danger in Delay: FDA Guidance Merits Review of Internal Procedures for Facility Inspections ," Advertising & Product Risk Management Alert (November 21, 2014). Contacts: John Fuson, Carolyn W. Wagner
• "FDA Publishes Cyber Guidance for Medical Devices," Advertising & Product Risk Management Alert (October 7, 2014). Contacts: Evan D. Wolff, John Fuson, David Z. Bodenheimer
• "FDA Issues New Guidance on the Unique Device Identification System," Advertising & Product Risk Management Alert (August 22, 2014). Contact: John Fuson
• "FDA Prohibits Claims of High Levels of Omega-3s on Food Labels," Advertising & Product Risk Management Alert (May 22, 2014). Contact: John Fuson
• "Stakeholders Urge Increased Flexibility, Transparency, and Accountability in FDA OTC Drug Review Process," Advertising & Product Risk Management Alert (May 22, 2014). Contact: John Fuson
• "District Court Allows Class Action Lawsuit over '100% Natural' Claims to Proceed," Advertising & Product Risk Management Alert (April 17, 2014). Contact: John Fuson
• "FDA to Consider Overhaul of Over-the-Counter Drug Approval Process," Advertising & Product Risk Management Alert (March 10, 2014). Contact: John Fuson
• "Top 5 Changes FDA Proposes for Nutrition Labels," Advertising & Product Risk Management Alert (March 3, 2014). Contact: John Fuson
• "This Month in International Trade - December 2013," International Trade Bulletin (January 8, 2014). Contacts: John B. Brew, Daniel Cannistra, Thomas De Meese, John Fuson, Alan W. H. Gourley, Jeffrey L. Snyder, David (Dj) Wolff, Edward Goetz, Pierce Lee
• "FDA Proposes Rule Imposing New Requirements for Manufacturing Practices, Hazard Analysis, and Preventive Controls for Animal Foods," Advertising & Product Risk Management Alert (November 21, 2013). Contact: John Fuson
• "In The Wake of Recent Supreme Court's Decisions, FDA Proposes Change to Generic Drug Labeling Rule," Advertising & Product Risk Management Alert (November 21, 2013). Contact: John Fuson
• "FDA Issues Final Guidance on Mobile Medical Apps," Advertising & Product Risk Management Alert (October 24, 2013). Contact: John Fuson
• "This Month in International Trade - July 2013," International Trade Bulletin (August 9, 2013). Contacts: John B. Brew, John Fuson, Alan W. H. Gourley, Maria Alejandra (Jana) del-Cerro, David (Dj) Wolff
• "FDA Proposes New Food Safety Rules Requiring Importers to Verify Compliance of Foreign Suppliers and Establishing Third-Party Accreditation Standards," Advertising & Product Risk Management Alert (August 8, 2013). Contacts: John Fuson, John B. Brew
• "FDA Issues Definition for 'Gluten-Free' on Food Labels," Advertising & Product Risk Management Alert (August 6, 2013). Contact: John Fuson
• "Supreme Court Again Finds Federal Preemption of Liability for Generic Drug Manufacturers: Will the FDA Finally Step In?," Advertising & Product Risk Management Alert (July 23, 2013). Contact: John Fuson
• "Food Safety Regulation Deadline: Court Orders FDA To Propose Regulations By November 30," Advertising & Product Risk Management Alert (June 27, 2013). Contact: John Fuson
• "The Supreme Court Rejects "Specious, but Scary-Sounding, 'Jurisdictional' - 'Nonjurisdictional'" Distinctions in City of Arlington v. FCC," Advertising & Product Risk Management Alert (June 20, 2013). Contacts: Thomas (Tim) C. Means, John Fuson
• "New FDA Guidance Offers Medical Device Makers New Options for Seeking Priority Review of Premarket Submissions and Appealing Adverse Decisions," Advertising & Product Risk Management Alert (June 20, 2013). Contact: John Fuson
• "Recent Happenings in Advertising & Product Risk Management - April 2013," Advertising & Product Risk Management Alert (April 19, 2013). Contacts: Christopher A. Cole, Cheryl A. Falvey, John Fuson, Jeffrey L. Poston
• "Study Finds Lead Contamination in Rice Imports—Could Litigation Be Close Behind?," Advertising & Product Risk Management Alert (April 15, 2013). Contacts: Cheryl A. Falvey, John Fuson, Kathleen Taylor Sooy, Kevin C. Mayer
• "This Month in International Trade - March 2013," International Trade Bulletin (March 29, 2013). Contacts: John B. Brew, John Fuson, David (Dj) Wolff
• "FDA Adopts Final Rule Authorizing Broad Authority to Detain Food," Advertising & Product Risk Management Alert (February 7, 2013). Contacts: John Fuson, Cheryl A. Falvey, John B. Brew
• "FDA Releases New Rule Directing the Application of Current Good Manufacturing Practices for Combination Products," Advertising & Product Risk Management Alert (January 30, 2013). Contacts: John Fuson, Kevin C. Mayer
• "FDA Issues Sweeping New Regulations Targeting Food Manufacturers, Processors, Packers, Holders, and Farms," Advertising & Product Risk Management Alert (January 8, 2013). Contacts: John Fuson, John B. Brew
• "New Study Raises More Questions About Triclosan Health Effects," Advertising & Product Risk Management Alert (August 20, 2012). Contacts: Kevin C. Mayer, John Fuson
• "Congressional Report Critical of FDA Enforcement Protocol," Life Sciences Alert (June 20, 2012). Contacts: John Fuson, Keith J. Harrison

In the News

• DOJ Memo Could Offer Additional Defenses In Enforcement Actions
  May 9, 2018 — MedTech Insight
• DOJ Enforcement Stance Won't Give Companies Free Rein
  May 4, 2018 — Bloomberg BNA
• Protecting Against Individual Prosecutions: Execs Remain A Focus, But There Are Ways To Reduce Risks
  December 13, 2017 — Medtech Insight
• Cyberattacks Have Yet to Hurt Health Care's Bottom Line
  September 12, 2016 — Politico
• Attorneys Want FDA to Improve Postmarket Compliance Guidance
  June 24, 2016 — Bloomberg BNA
• Food & Beverage Cases to Watch In 2015
  January 2, 2015 — Law360
• Life Sciences Legislation and Regulation to Watch In 2015
  January 2, 2015 — Law360
• Conferences: Planning, Coordination, Consistency Urged In Talks Geared to Business and Its Counsel
  March 25, 2013 — Bloomberg BNA Product Safety & Liability Reporter

Firm News & Announcements