Sharon Lindan Mayl

Partner

Emailsharon.mayl@us.dlapiper.com

About

As a prominent and highly experienced former senior FDA official with more than 25 years of experience at the agency, Sharon Lindan Mayl has a deep wealth of knowledge in the areas of food safety, imports, third-party audits, nutrition, dietary supplements and cannabis products. She applies her high-level experience working within the FDA to further strengthen the firm's rapidly growing Food, Beverage and Consumer Goods sector.

During her time as a senior advisor in the Commissioner's Office, Sharon advised several deputy commissioners on a wide range of regulatory, legislative and policy issues. Reaching the highest levels of the FDA, she spearheaded efforts across the agency's various components – such as the Center for Foods and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA) – to develop regulations and strategic initiatives for the FDA's food programs and beyond.

Sharon played a leading role in implementing the FDA Food Safety Modernization Act (FSMA) and developing strategic approaches to imports and cannabis policy. She also led implementation of the New Era of Smarter Food Safety initiative, which seeks to leverage technology and other tools and approaches to create a safer and more digital, traceable food system. Sharon has received numerous awards and distinctions for her public service, including the Commissioner's Award of Excellence for her outstanding contributions to food safety and imports.

Sharon regularly represented the agency in meetings with senior officials from the Department of Health and Human Services, Congress, federal and state regulatory agencies, foreign governments, industry representatives and consumer and public health groups, among other external stakeholders. In these cross-organizational efforts, she established herself as a top government official in her space and forged close and cooperative relationships to achieve solutions to novel, controversial and complex issues.

Areas of FocusRegulatory and Government Affairs FDA Regulatory

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 authoritiesLed 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

Education

J.D., Harvard University

B.A., Cornell University

Awards

Bylines

Seminars

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