Sharon Lindan Mayl
SociaAs 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.
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
- J.D., Harvard University
- B.A., Cornell University
Awards
- The Legal 500 United States
- Recommended, Cannabis (2023)
- 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
Bylines
- "Two hemp-derived CBD bills are re-introduced despite FDA's call for a different legislative fix," DLA Piper Cultivate, March 29, 2023
- "Food and Drug Administration’s Final Food Traceability Rule: What It Says and What It Means for the Future," The Journal of Federal Agency Action, Vol. 1, No. 2, pp. 91–103, March-April 2023
- "FDA’s Traceability Rule: What are the next steps for the agency and industry," Food Safety News, January 19, 2023
- "FDA seems willing to make room for a drug ingredient in a supplement, but what does that mean for CBD? NAC and the Drug Exclusion Clause of 201(ff)," DLA Piper Cultivate, December 12, 2022
Seminars
- 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
Memberships And Affiliations
- Food and Drug Law Institute
- American Bar Association
