A former US Food and Drug Administration (FDA) regulatory counsel, Jonathan Havens focuses on the food, drug, and healthcare arenas. Jonathan represents clients in regulatory, compliance, enforcement, and transactional matters. Clients turn to him for guidance on medical devices, prescription and nonprescription pharmaceuticals, foods, food additives, dietary supplements, tobacco products (including e-cigarettes), and cosmetics, as well as marketing, promotion, and advertising issues.
At the US federal level, Jonathan represents clients before the FDA, the US Department of Health and Human Services, the Federal Trade Commission (FTC), the US Consumer Product Safety Commission (CPSC), and the Committee on Foreign Investment in the United States (CFIUS). He advises clients on regulatory compliance under the US Drug Enforcement Administration (DEA), the US Department of Veterans Affairs, the US Small Business Administration (SBA), and US Customs and Border Protection (CBP). Additionally, he navigates state regulatory and licensing requirements on behalf of healthcare providers, pharmacies, and drug and device manufacturers and distributors.
As a regular presenter with the Food and Drug Law Institute’s FDA in-house training program, Jonathan instructs new FDA Center for Devices and Radiological Health (CDRH) staff on medical device law and regulation. He speaks on a variety of topics including tobacco regulation, food safety, and federal and state transparency requirements, and has written about food product label claims, tobacco products, mobile medical applications, food safety, and pharmacy billing practices.
Jonathan sits on the Morgan Lewis Office Relations Committee and Pro Bono Committee in the Washington, DC office. On a pro bono basis, he has represented clients before the Superior Court of the District of Columbia, the US Social Security Administration, and the Centers for Medicare and Medicaid Services and related state agencies.
As a regulatory counsel with the FDA, Jonathan won two awards in recognition of his work. Prior to his legal career, Jonathan was a legislative aide in the US Senate and House of Representatives. He also worked as a legislative specialist with a national law firm.
Mr. Havens's recent representative client matters include:
Represented a multinational food processor and marketer in defeating a federal government contract bid protest
Represented a multinational pharmaceutical company in its successful request for orphan drug designation
Represented a medical device company in a pair of successful applications for marketing clearance
Represented a mail order pharmacy in its sale of stock to a pair of private equity groups
Catholic University of America, Columbus School of Law, 2010, J.D.
University of Virginia, 2005, B.A.
District of Columbia
Awards and Affiliations
Recipient, FDA Group Recognition Award
Recipient, FDA Center for Tobacco Products Team Excellence Award
Member, Food & Drug Law Institute Tobacco Committee (2015–2018)
Member, Scholarship Selection Committee, Beta Iota Foundation
Member, Health Law Section, American Bar Association