Speeches & Presentations

• "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

• "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

• "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, Michelle Gillette, David Ervin, Lauren Aronson, Josh Thomas Foust, 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, Michelle Gillette, David Ervin, Lauren Aronson, Josh Thomas Foust, 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, Michelle Gillette, David Ervin, Lauren Aronson, Josh Thomas Foust, Carolyn W. Wagner, Matthew Cohen, Preetha Chakrabarti, Peter B. Miller, Niran S. Somasundaram
• "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, Michelle Gillette, David Ervin, Lauren Aronson, Josh Thomas Foust, 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, Michelle Gillette, David Ervin, Lauren Aronson, Josh Thomas Foust, 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, Michelle Gillette, David Ervin, Lauren Aronson, Josh Thomas Foust, Carolyn W. Wagner, Matthew Cohen, Brendan Sepulveda
• "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, Cari N. Stinebower, Christopher Monahan, David (Dj) Wolff, Edward Goetz
• "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, Christopher Monahan, 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, Melissa Morris
• "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