John W.M. Claud
Partner
Suite 900
Washington, D.C., 20001
John is a member of the firm’s Washington, D.C., office and a former federal prosecutor and Assistant Director at the U.S. Department of Justice (DOJ). He represents clients across the healthcare and life sciences spectrum, from emerging and growth-stage technology, wellness, and medical product companies to large publicly traded corporations, in all matters that implicate...
John is a member of the firm’s Washington, D.C., office and a former federal prosecutor and Assistant Director at the U.S. Department of Justice (DOJ). He represents clients across the healthcare and life sciences spectrum, from emerging and growth-stage technology, wellness, and medical product companies to large publicly traded corporations, in all matters that implicate FDA litigation, enforcement, and compliance under the Food, Drug, and Cosmetic Act (FDCA).
His practice includes counseling pharmaceutical, medical device, food, dietary supplement, cosmetics, pharmacies, and wellness clients on current Good Manufacturing Practices (cGMP), FDA inspections, responding to and remediating Form 483 observations, responding to warning and untitled letters, negotiating consent decrees, and conducting internal investigations. Drawing on his 15 years at DOJ, John implements proactive strategies to avert agency entanglements and resolve issues arising from inspections, investigations, and regulatory reviews. He guides clients through high-stakes regulatory crises with an insider’s understanding of how federal and state agencies build cases and how companies can proactively identify and remediate issues, combining deep knowledge of cGMP and quality management systems with his experience litigating significant FDCA civil and criminal cases.
John also reviews labeling and marketing claims for products across all FDA-regulated industries to identify compliance issues and potential exposure to plaintiffs’ litigation. His brand integrity work includes helping clients combat counterfeits as well as unfair and deceptive practices, exploiting enforcement gaps. John’s cosmetics, OTC, and personal care products practice guides clients through the complex compliance challenges under the Modernization of Cosmetics Regulation Act and its evolving regulatory landscape.
In addition to the FDCA, John routinely handles False Claims Act (FCA) matters affecting life sciences companies. At DOJ, he reviewed FCA suits for potential criminal investigations and litigation and coordinated parallel criminal investigations alongside civil FCA cases. His understanding of the interplay between civil and criminal enforcement enables him to help clients navigate the complexities of parallel litigation proceedings.
Prior to joining Nelson Mullins, John was a counsel at an FDA-focused boutique firm. Before that, he served as the Assistant Director of the Consumer Protection Branch at the DOJ, where he led the Corporate Compliance and Policy Unit. He additionally prosecuted and supervised complex criminal and civil trial litigation involving multi-million-dollar penalties and multi-year investigations under the FDCA and Federal Trade Commission Act. He also held leading roles in the DOJ’s response to three recent significant national health crises, including the COVID-19 pandemic.
John is an accomplished trial lawyer, having started his career as an Assistant District Attorney in Manhattan. He frequently speaks and writes on government enforcement strategies under the FDCA and corporate compliance best practices. As a sought-after public presenter, John provides compliance training to legal and non-legal personnel on FDA-related topics.
FDA litigation, enforcement, and compliance under the Food, Drug, and Cosmetic Act (FDCA).
His practice includes counseling pharmaceutical, medical device, food, dietary supplement, cosmetics, pharmacies, and wellness clients on current Good Manufacturing Practices (cGMP), FDA inspections, responding to and remediating Form 483 observations, responding to warning and untitled letters, negotiating consent decrees, and conducting internal investigations. Drawing on his 15 years at DOJ, John implements proactive strategies to avert agency entanglements and resolve issues arising from inspections, investigations, and regulatory reviews. He guides clients through high-stakes regulatory crises with an insider’s understanding of how federal and state agencies build cases and how companies can proactively identify and remediate issues, combining deep knowledge of cGMP and quality management systems with his experience litigating significant FDCA civil and criminal cases.
John also reviews labeling and marketing claims for products across all FDA-regulated industries to identify compliance issues and potential exposure to plaintiffs’ litigation. His brand integrity work includes helping clients combat counterfeits as well as unfair and deceptive practices, exploiting enforcement gaps. John’s cosmetics, OTC, and personal care products practice guides clients through the complex compliance challenges under the Modernization of Cosmetics Regulation Act and its evolving regulatory landscape.
In addition to the FDCA, John routinely handles False Claims Act (FCA) matters affecting life sciences companies. At DOJ, he reviewed FCA suits for potential criminal investigations and litigation and coordinated parallel criminal investigations alongside civil FCA cases. His understanding of the interplay between civil and criminal enforcement enables him to help clients navigate the complexities of parallel litigation proceedings.
Prior to joining Nelson Mullins, John was a counsel at an FDA-focused boutique firm. Before that, he served as the Assistant Director of the Consumer Protection Branch at the DOJ, where he led the Corporate Compliance and Policy Unit. He additionally prosecuted and supervised complex criminal and civil trial litigation involving multi-million-dollar penalties and multi-year investigations under the FDCA and Federal Trade Commission Act. He also held leading roles in the DOJ’s response to three recent significant national health crises, including the COVID-19 pandemic.
John is an accomplished trial lawyer, having started his career as an Assistant District Attorney in Manhattan. He frequently speaks and writes on government enforcement strategies under the FDCA and corporate compliance best practices. As a sought-after public presenter, John provides compliance training to legal and non-legal personnel on FDA-related topics.
Experience
Previous Professional Experience
- Counsel, FDA-focused law firm (2022-2026)
- U.S. Department of Justice, Assistant Director, Corporate Compliance and Policy Unit, Consumer Protection Branch (2019-2022); Trial Attorney (2008-2019)
Representative Matters
Governmental Policy and Leadership
- Supervised the Consumer Protection Branch’s Corporate Compliance and Policy Unit.
- Directed DOJ’s national oversight of FDCA criminal cases, including the national enforcement response to FDCA violations related to the COVID pandemic.
- Directed DOJ’s criminal investigative response to the 2019 EVALI vaping crisis.
Selected Counseling, Enforcement, Litigation, and Trial Work
- Conducted internal investigation for publicly traded drug manufacturer following employee allegations of wrongdoing.
- Counsel for generic drug manufacturer during its FDA inspection response.
- Counsel for excipient manufacturer during its FDA inspection response.
- Counsel for generic drug manufacturer during recall of drug purchased in bankruptcy.
- Counsel for manufacturer of recently approved drug on brand integrity matters.
- Counsel for generic drug manufacturer in response to multi-site FDA inspections.
- Counsel for start-up wellness company on FDA compliance matters.
- Counsel for food manufacturer in response to FDA inspection and worker health and safety matters.
- Co-lead counsel and then supervisor of investigation and subsequent indictment in ground-breaking, $900 million telemedicine prescription drug fraud scheme. Oversaw investigation, indictments, plea agreements, and trials of pharmacy owners, telemarketers and other co-conspirators, and associated corporate defendants, which resulted in numerous individual and organizational convictions.
- Supervised negotiated resolution of permanent injunction and consent decree of pharmaceutical manufacturer accused of introducing misbranded and adulterated drugs into interstate commerce.
- Member of investigative and trial team in the prosecution stemming from 2012 national meningitis outbreak caused by adulterated drugs produced at a Massachusetts compounding pharmacy that resulted in 100-plus deaths and hundreds of infections nationwide. Co-counsel during 10-week jury trial of the lead defendant, which resulted in convictions on 57 felony counts, including Racketeering and Mail Fraud.
- Lead counsel in investigation, indictment, and prosecution of counterfeit prescription drug smuggling ring, resulting in numerous convictions.
- Co-lead counsel in criminal jury trial conviction of defendants operating foreclosure rescue fraud scheme.
- Co-lead counsel in criminal jury trial conviction of defendant operating nationwide business opportunity fraud scheme and subsequent appeal.
Education
- Catholic University of America Columbus School of Law, JD, cum laude
-
University of Colorado,
Graduate School of Public Affairs, Master of Criminal Justice
- Honored as Outstanding Student of Criminal Justice Program
- Trinity College, BA
Admissions
- District of Columbia
Practice Areas
Previous Professional Experience
- Counsel, FDA-focused law firm (2022-2026)
- U.S. Department of Justice, Assistant Director, Corporate Compliance and Policy Unit, Consumer Protection Branch (2019-2022); Trial Attorney (2008-2019)
Representative Matters
Governmental Policy and Leadership
- Supervised the Consumer Protection Branch’s Corporate Compliance and Policy Unit.
- Directed DOJ’s national oversight of FDCA criminal cases, including the national enforcement response to FDCA violations related to the COVID pandemic.
- Directed DOJ’s criminal investigative response to the 2019 EVALI vaping crisis.
Selected Counseling, Enforcement, Litigation, and Trial Work
- Conducted internal investigation for publicly traded drug manufacturer following employee allegations of wrongdoing.
- Counsel for generic drug manufacturer during its FDA inspection response.
- Counsel for excipient manufacturer during its FDA inspection response.
- Counsel for generic drug manufacturer during recall of drug purchased in bankruptcy.
- Counsel for manufacturer of recently approved drug on brand integrity matters.
- Counsel for generic drug manufacturer in response to multi-site FDA inspections.
- Counsel for start-up wellness company on FDA compliance matters.
- Counsel for food manufacturer in response to FDA inspection and worker health and safety matters.
- Co-lead counsel and then supervisor of investigation and subsequent indictment in ground-breaking, $900 million telemedicine prescription drug fraud scheme. Oversaw investigation, indictments, plea agreements, and trials of pharmacy owners, telemarketers and other co-conspirators, and associated corporate defendants, which resulted in numerous individual and organizational convictions.
- Supervised negotiated resolution of permanent injunction and consent decree of pharmaceutical manufacturer accused of introducing misbranded and adulterated drugs into interstate commerce.
- Member of investigative and trial team in the prosecution stemming from 2012 national meningitis outbreak caused by adulterated drugs produced at a Massachusetts compounding pharmacy that resulted in 100-plus deaths and hundreds of infections nationwide. Co-counsel during 10-week jury trial of the lead defendant, which resulted in convictions on 57 felony counts, including Racketeering and Mail Fraud.
- Lead counsel in investigation, indictment, and prosecution of counterfeit prescription drug smuggling ring, resulting in numerous convictions.
- Co-lead counsel in criminal jury trial conviction of defendants operating foreclosure rescue fraud scheme.
- Co-lead counsel in criminal jury trial conviction of defendant operating nationwide business opportunity fraud scheme and subsequent appeal.
Media
Recognitions
- National Health Care Anti-Fraud Association Investigation of the Year (2022; 2019)
- Executive Office of United States Attorneys Director’s Award (2020)
- Department of Justice Civil Division Special Commendation (2020)
- FDA Special Citation (2020)
Professional Activities
- Member, Food and Drug Law Institute
John is a member of the firm’s Washington, D.C., office and a former federal prosecutor and Assistant Director at the U.S. Department of Justice (DOJ). He represents clients across the healthcare and life sciences spectrum, from emerging and growth-stage technology, wellness, and medical product companies to large publicly traded corporations, in all matters that implicate... FDA litigation, enforcement, and compliance under the Food, Drug, and Cosmetic Act (FDCA).
His practice includes counseling pharmaceutical, medical device, food, dietary supplement, cosmetics, pharmacies, and wellness clients on current Good Manufacturing Practices (cGMP), FDA inspections, responding to and remediating Form 483 observations, responding to warning and untitled letters, negotiating consent decrees, and conducting internal investigations. Drawing on his 15 years at DOJ, John implements proactive strategies to avert agency entanglements and resolve issues arising from inspections, investigations, and regulatory reviews. He guides clients through high-stakes regulatory crises with an insider’s understanding of how federal and state agencies build cases and how companies can proactively identify and remediate issues, combining deep knowledge of cGMP and quality management systems with his experience litigating significant FDCA civil and criminal cases.
John also reviews labeling and marketing claims for products across all FDA-regulated industries to identify compliance issues and potential exposure to plaintiffs’ litigation. His brand integrity work includes helping clients combat counterfeits as well as unfair and deceptive practices, exploiting enforcement gaps. John’s cosmetics, OTC, and personal care products practice guides clients through the complex compliance challenges under the Modernization of Cosmetics Regulation Act and its evolving regulatory landscape.
In addition to the FDCA, John routinely handles False Claims Act (FCA) matters affecting life sciences companies. At DOJ, he reviewed FCA suits for potential criminal investigations and litigation and coordinated parallel criminal investigations alongside civil FCA cases. His understanding of the interplay between civil and criminal enforcement enables him to help clients navigate the complexities of parallel litigation proceedings.
Prior to joining Nelson Mullins, John was a counsel at an FDA-focused boutique firm. Before that, he served as the Assistant Director of the Consumer Protection Branch at the DOJ, where he led the Corporate Compliance and Policy Unit. He additionally prosecuted and supervised complex criminal and civil trial litigation involving multi-million-dollar penalties and multi-year investigations under the FDCA and Federal Trade Commission Act. He also held leading roles in the DOJ’s response to three recent significant national health crises, including the COVID-19 pandemic.
John is an accomplished trial lawyer, having started his career as an Assistant District Attorney in Manhattan. He frequently speaks and writes on government enforcement strategies under the FDCA and corporate compliance best practices. As a sought-after public presenter, John provides compliance training to legal and non-legal personnel on FDA-related topics.
Experience
The following is a selected sampling of matters and is provided for informational purposes only. Past success does not indicate the likelihood of success in any future matter.Previous Professional Experience
- Counsel, FDA-focused law firm (2022-2026)
- U.S. Department of Justice, Assistant Director, Corporate Compliance and Policy Unit, Consumer Protection Branch (2019-2022); Trial Attorney (2008-2019)
Representative Matters
Governmental Policy and Leadership
- Supervised the Consumer Protection Branch’s Corporate Compliance and Policy Unit.
- Directed DOJ’s national oversight of FDCA criminal cases, including the national enforcement response to FDCA violations related to the COVID pandemic.
- Directed DOJ’s criminal investigative response to the 2019 EVALI vaping crisis.
Selected Counseling, Enforcement, Litigation, and Trial Work
- Conducted internal investigation for publicly traded drug manufacturer following employee allegations of wrongdoing.
- Counsel for generic drug manufacturer during its FDA inspection response.
- Counsel for excipient manufacturer during its FDA inspection response.
- Counsel for generic drug manufacturer during recall of drug purchased in bankruptcy.
- Counsel for manufacturer of recently approved drug on brand integrity matters.
- Counsel for generic drug manufacturer in response to multi-site FDA inspections.
- Counsel for start-up wellness company on FDA compliance matters.
- Counsel for food manufacturer in response to FDA inspection and worker health and safety matters.
- Co-lead counsel and then supervisor of investigation and subsequent indictment in ground-breaking, $900 million telemedicine prescription drug fraud scheme. Oversaw investigation, indictments, plea agreements, and trials of pharmacy owners, telemarketers and other co-conspirators, and associated corporate defendants, which resulted in numerous individual and organizational convictions.
- Supervised negotiated resolution of permanent injunction and consent decree of pharmaceutical manufacturer accused of introducing misbranded and adulterated drugs into interstate commerce.
- Member of investigative and trial team in the prosecution stemming from 2012 national meningitis outbreak caused by adulterated drugs produced at a Massachusetts compounding pharmacy that resulted in 100-plus deaths and hundreds of infections nationwide. Co-counsel during 10-week jury trial of the lead defendant, which resulted in convictions on 57 felony counts, including Racketeering and Mail Fraud.
- Lead counsel in investigation, indictment, and prosecution of counterfeit prescription drug smuggling ring, resulting in numerous convictions.
- Co-lead counsel in criminal jury trial conviction of defendants operating foreclosure rescue fraud scheme.
- Co-lead counsel in criminal jury trial conviction of defendant operating nationwide business opportunity fraud scheme and subsequent appeal.
Education
- Catholic University of America Columbus School of Law, JD, cum laude
-
University of Colorado,
Graduate School of Public Affairs, Master of Criminal Justice
- Honored as Outstanding Student of Criminal Justice Program
- Trinity College, BA
Admissions
- District of Columbia
Practice Areas
- FDA Regulatory Compliance & Litigation
- Healthcare Government Investigations & Litigation
- Qui Tam Litigation
- Consumer Product Safety, Risk Prevention & Regulatory Compliance
- White Collar Defense & Government Investigations
Industries
- National Health Care Anti-Fraud Association Investigation of the Year (2022; 2019)
- Executive Office of United States Attorneys Director’s Award (2020)
- Department of Justice Civil Division Special Commendation (2020)
- FDA Special Citation (2020)
- Member, Food and Drug Law Institute
Highlights from the Firm’s Insights
