Sharon Lindan Mayl

Partner

Emailsharon.mayl@us.dlapiper.com

Call+1 202 799 4675

Washington, DC

About

With more than 25 years of experience as Senior Advisor in the Office of the Commissioner at the Food and Drug Administration (FDA), Sharon Mayl advises clients in the areas of food and ingredient safety, imports and exports, third-party audits, nutrition labeling, dietary supplements, infant formula, cosmetics, and cannabis products. She applies her insider experience to help clients navigate the black box of FDA, finding strategic and practical solutions to regulatory and compliance problems.

Sharon provides strategic advice and regulatory counsel to clients in a variety of areas, including the FDA Food Safety Modernization Act (FSMA), Make America Health Again (MAHA) initiative, ingredient and product development, supplier verification, traceability, nutrition labelling and claims, infant formula, and dietary supplements. She also advises cosmetics clients on compliance with the Modernization of Cosmetics Regulation Act (MoCRA), labelling and safety issues. Sharon uses her decades of experience at the agency to assist clients with FDA interactions and meetings, including with respect to policy development and compliance actions such as warning letters and inspection reports.

Sharon is a frequent conference speaker at industry conferences on a variety of topics including FSMA compliance, contaminants, MAHA and ultra-processed foods, dietary supplements, and navigating FDA's new Humans Foods Program. She also provides tailored training to clients and trade associations to facilitate regulatory compliance.

During her time as Senior Advisor at FDA, Sharon counseled several deputy commissioners on a wide range of regulatory, legislative and policy issues. Sharon played a leading role in implementing FSMA and the Nutrition Labelling and Education Act, as well as developing FDA’s policies on imports and cannabis. Her role included significant rulemakings and she regularly represented the agency in meetings with senior administration officials, Congress, federal and state regulatory agencies, foreign governments, industry representatives and consumer and public health groups. Sharon established herself as a top government official in her space and forged close and cooperative relationships with a wide range of stakeholders to achieve solutions to novel, controversial and complex issues.

Sharon has received numerous awards and distinctions for her public service, including the FDA Distinguished Career Service Award and the Commissioner's Award of Excellence for her outstanding contributions to the agency.

Areas of FocusRegulatory and Government Affairs

Bar admissionsDistrict of Columbia

EXPERIENCE

FDA Food Safety Modernization Act (FSMA)

Served on FDA FSMA Implementation Steering Committee
Served as the overall lead for implementation of the import provisions, including the Foreign Supplier Verification Program (FSVP), Voluntary Qualified Importer Program, Accredited Third-Party Certification Program
Played a coordinating role to ensure consistency among the various FSMA rules, particularly for the supply chain provisions in each of the rules
Represented the agency at national and international conferences and meetings on FSMA implementation

Foreign Supplier Verification Program (FSVP)

Led the FDA team that developed regulations, guidance documents, and operational policy documents implementing this provision of FSMA
Served as the agency subject matter expert for development of training for FDA investigators and for industry training through the Food Safety Preventive Controls Alliance
Represented the agency at national and international conferences and meetings on FSVP and all the import provisions of FSMA

Third-Party Audits

Oversaw the development of the FSMA regulations, guidance documents, and operational policy documents implementing FDA's third-party regulation and program mandated by FSMA
Served as the lead for developing the agency's policies on private third-party audits, beyond the FSMA rule
Served as a key leader in developing FDA's private third-party standards alignment pilot
Represented the agency at national and international conferences and meetings on third-party audits

Imports

Led the development of several agency strategic plans to oversee the importation of FDA products, turning the agency’s focus from reaction to prevention
Led teams that developed the FSMA regulations, guidance documents, and operational policy documents implementing the import provisions of the FDA Food Safety Modernization Act, including the Foreign Supplier Verification Program (FSVP), Voluntary Qualified Importer Program, Accredited Third-Party Certification Program
Frequent speaker at conferences, including teaching the imports section of FDLI's Introduction to Food Law and Regulation course on several occasions

Cannabis

Served as food lead on FDA's Cannabis Products Committee (and its predecessor the Marijuana Working Group)
Oversaw FDA policy for the development of potential non-drug regulatory pathways for cannabis products, as well as enforcement policy against violative cannabis products
Represented the agency at numerous conferences and meetings on cannabis, including speaking at FDLI cannabis programs

Dietary Supplements

Acted as Director of the Office of Dietary Supplements, overseeing the divisions responsible for NDINs, compliance/enforcement, and regulatory policy
Engaged with potential legislative updates to DSHEA, including product listing and modernizing enforcement authorities
Led the development of agency policy around cannabis in dietary supplements

New Era of Smarter Food Safety

Led the FDA multidisciplinary team implementing the New Era of Smarter Food Safety blueprint, which included four key elements:
- Tech-Enabled Traceability
- Smarter Tools and Approaches for Prevention and Outbreak Response
- New Business Models and Retail Modernization (including overseeing FDA's recent Summit on E-Commerce)
- Food Safety Culture
Oversaw FDA's 2021 Summit on E-Commerce to explore ways to help ensure the safety of foods ordered online and delivered directly to consumers

FDA Interaction

Served as Senior Advisor in the Commissioner's Office
Led strategic initiatives across agency components and oversaw the development of regulations and guidance documents
Worked closely with senior leaders across the agency to develop and implement strategic solutions to complex regulatory problems

Awards

The Legal 500 United States

Recommended, Cannabis, (2023, 2025)

Additional Recognitions

FDA Distinguished Career Service Award for outstanding contributions and leadership at FDA
Commissioner's Award of Excellence for outstanding contributions to food safety, imports and combination products initiatives
Secretary's Award for Distinguished Service for the FDA ephedra rulemaking and litigation team, the FDA counter/bioterrorism preparedness team and regulations to protect the nation's children from cigarette smoking
Commissioner's Special Citation for policy development and coordination in advancing significant cross-cutting initiatives to protect public health
Commissioner's Special Citation for the Office of Seafood Regulatory Initiative and reinventing government working group
Commissioner's Special Recognition Award for FDA's strategic action plan
FDA Award of Merit for the presidential initiative on the safety of imported food group
FDA Group Recognition Awards for the import safety working group, the ephedra final rule working group, the dietary supplement strategic plan group and the seafood HACCP final regulations task force
Center for Food Safety and Applied Nutrition Special Recognition Award for the bioterrorism guidance team, the budget and planning team and the bioterrorism legislative development team

Education

J.D., Harvard University

B.A., Cornell University

Publications

Seminars

Speaker, International Dairy Food Association Regulatory Roundup, IDFA Legal Roundtable Discussion: Tools and Strategies for Making Food Policy, July, 2025
Speaker, ACI Food Law Boot Camp, Ultra-Processed Food: Definitions, Regulations and Global Perspectives, July, 2025
Speaker, ACI’s Annual Legal, Regulatory and compliance Forum on Dietary Supplements , FDA Activity Round-Up and Industry Projections: Updates on the Healthy Rule, FOP Nutrition Labeling, Implications of Loper Bright and More, June, 2025
Speaker, DLA Client Webinar, Unpacking the Make America Healthy Again Report, May, 2025
Speaker, FDLI Annual (Steering Committee), Human Foods Program Update, May, 2025
Speaker, ACI's Advanced Summit on Food Law - Regulation, Compliance and Litigation (Co-Chair), Human Foods Program Update, April, 2025
Speaker, FDLI, Food and Dietary Supplement Safety Regulation Conference, Are You Ready for the New Administration? Engaging with FDA and Advising Clients in 2025, March, 2025
Speaker, Partnership for Food Safety Education, Food Safety in the Transition, February, 2025
Speaker, "Implications of a Zero Risk Food Safety Policy," International Dairy Foods Association (IDFA), July 25, 2023
Speaker and Co-chair, "Understanding the Requirements for Importing Food into the U.S.," ACI's Food Law and Regulation Boot Camp, July 19-20, 2023
Speaker, "Traceability," FMI, July 17, 2023
Speaker, "Contemplating the Future for CBD: Navigating the Sale of CBD and Other Hemp-Derived Cannabinoids in the Wake of FDA's Recent CBD Announcement," Counsel for Responsible Nutrition, June 28, 2023
Panelist and Planning Committee Member, "FDLI Annual Conference: 2023 FDLI Annual Conference," Food and Drug Law Institute (FDLI), May 17, 2023
Panelist, "FSS 2023: Legal Insights to Sharpen Your Food Safety Focus—and Stay Out of the Courtroom!" Food Safety Summit, May 11, 2023
Panelist, "Tracing Your Steps: What Every Food Lawyer Needs to Know About the FDA Final Rule on Traceability," Food Law – Regulation, Compliance and Litigation – Chicago, Illinois, April 18, 2023
Moderator "The Future of New Business Models in Retail," Food and Dietary Supplement Safety and Regulation Conference – Washington, DC & Virtual, March 24, 2023
Panelist, "Introduction to Food Law and Regulation," Food and Drug Law Institute (FDLI), March 24, 2023
Panelist, "Regulatory and Legislation: Toxicants, Chemicals and Law, Oh My," Consumer Products Goods Legal Forum – Rancho Palos Verdes, California, February 23, 2023
Speaker, "The Future of Food Regulation: Assessing the Reagan-Udall Foundation's Report on FDA's Human Foods Program," January 24, 2023

Media Mentions

Mentioned, "FDA FOOD TRACING RULES: THE OPPORTUNITY," p-Chip, 2023

Prior Experience

Sharon served in a variety of positions at the FDA, including Senior Advisor for Policy for the Office of Food Policy and Response in the Office of the Commissioner; acting Director for the Office of Dietary Supplement Programs (ODSP) in the Center for Food Safety and Applied Nutrition; acting Director for the Division of Policy for the Office of Strategic Planning and Operational Policy in the Office of Regulatory Affairs; Senior Policy Advisor for the Office of Policy in the Office of the Commissioner; and acting Deputy Director for the Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research.

Memberships And Affiliations