Jonathan A. Havens

Jonathan A. Havens

Partner

Contact Info

Phone: (410) 332-8757
Fax: (410) 332-8862

Primary Office

Baltimore
500 E. Pratt Street
Suite 900
Baltimore, MD 21202-3133

Secondary Office

Washington
1919 Pennsylvania Avenue, N.W.
Suite 550
Washington, DC 20006-3434

Jonathan A. Havens

Partner

Jonathan Havens counsels clients on regulatory, compliance, enforcement and transactional matters related to products regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA) and the U.S. Drug Enforcement Administration (DEA). Companies in the cannabis (both hemp and marijuana), consumer health care products, life sciences, food and beverage, cosmetics and tobacco industries, among others, turn to Jonathan for advice on how to get and keep their products on the market. He advises companies throughout the product life cycle, including product development, formulation, manufacture, distribution and promotion. More specifically, Jonathan handles matters involving labeling, good manufacturing practice (GMP), quality system regulation (QSR), product design, and registration and listing, to name a few. When disputes, including litigation, arise relating to these and other issues, Jonathan helps clients navigate them. This includes preparing for FDA inspections, responding to inspectional observations (FDA Form 483) and warning letters, managing product recalls and resolving import and export issues. He also counsels clients through business transactions that involve oversight by myriad federal and state agencies.

Beyond his FDA, FTC, USDA, and DEA work, Jonathan's experience extends to matters involving the U.S. Consumer Product Safety Commission (CPSC), U.S. Customs and Border Protection (CBP), a wide array of state and municipal agencies, state attorneys general and district attorneys. His deep understanding of the complex regulatory and statutory requirements that govern a wide range of products and services is enhanced by his experience working in government and on Capitol Hill. Before entering private practice, Jonathan served as regulatory counsel with the FDA, where he focused on compliance and enforcement related to promotion, advertising and labeling. Prior to law school, Jonathan served as a legislative aide in both the U.S. Senate and U.S. House of Representatives.

Experience

Cannabis industry

Jonathan counsels state cannabis license applicants and awardees, ancillary service and product providers, investors, management companies and various other entities that are affected by federal and state cannabis laws, such as such long-term care facilities and higher education institutions. In addition to his cannabis law practice, Jonathan maintains an active food, beverage and topicals practice, particularly with regard to cannabidiol (CBD) products. His work in these areas includes counseling manufacturers, importers, distributors, and retailers of conventional foods, dietary supplements, beverages and cosmetics on product development, claim substantiation, labeling, promotion, registration, reporting and recall issues to ensure compliance with FDA, USDA, and state and local requirements.

Jonathan, who co-founded and serves as co-chair of the Firm's Cannabis Law Practice, regularly speaks about, writes on and is interviewed regarding industry developments, challenges and best practices. In 2020, Jonathan was selected to serve on Law360’s inaugural Cannabis Editorial Advisory Board. Jonathan was listed in Chambers USA 2019: America's Leading Lawyers for Business for his nationwide cannabis law practice and named to the National Law Journal's Cannabis Law Trailblazers list in 2018. He is regularly interviewed by mainstream and trade press outlets, alike, and has been quoted by or authored pieces for CNBC, The New York Times, The Los Angeles Times, WIRED, MarketWatch, Engadget, Law360, High Times Magazine, Cannabis Business Times and HEMP Magazine. When the Food and Drug Law Institute formed its Cannabis-Derived Products Committee in 2019, Jonathan was selected as a founding member to help shape the organization’s agenda related to this developing area of the law.

Life sciences industry

When a drug, medical device, or human cell, tissue, and cellular and tissue-based product (HCT/P) company wants to bring a product to market, Jonathan advises them on relevant regulatory considerations. Once a product is on the market, he provides counsel on, among other things, matters such as quality control and quality assurance (QC/QA), product safety, adverse event reporting, and responding to enforcement actions. When regulated companies are exploring partnerships, licensing deals, and purchase agreements, he conducts due diligence reviews and drafts and negotiates transactional documents on their behalf.

Select representative matters include:

Served on promotional review committees for a medical technology company and a global health care company.
Provided medical device post-market compliance advice, including with regard to medical device reporting (MDR), device recalls, QSR, and responses to FDA Form 483s and Warning Letters.
Counseled clients on issues related to clinical trial agreements, informed consent, and interactions with Institutional Review Boards (IRBs).
Conducted regulatory due diligence reviews and risk assessments of medical device companies targeted for acquisition, and negotiated and drafted transactional documents related to the same.
Drafted numerous FDA pre-submission meeting requests and prepared background packages related to the same.
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.
Food and beverage industry

Manufacturers, importers, distributors, and retailers of conventional foods, dietary supplements, and beverages seek Jonathan's counsel on product development, claim substantiation, labeling, promotion, registration, reporting, and recall issues to ensure compliance with FDA and USDA requirements. He also provides advice to chain restaurants and retail food establishments, such as grocery stores and convenience stores, on federal and state menu labeling requirements, truth-in-advertising laws, and to minimize the risk of litigation.

Jonathan, who serves as co-chair of the Firm's Food, Beverage and Agribusiness Practice, offers clients industry-specific knowledge, business understanding, multi-disciplinary capability, strategy, and pragmatism.

Select representative matters include:

Advised leading restaurant chains, supermarkets, and convenience stores regarding federal, state, and municipal menu labeling requirements.
Counseled global FDA and USDA regulated clients regarding myriad compliance and enforcement matters, including, but not limited to, GMO and organic labeling, FDA Food Safety Modernization Act (FSMA) compliance, USDA Food Safety and Inspection Service (FSIS) investigations, and hazard analysis and critical control point (HACCP) programs.
Represented a multinational food processor and marketer in defeating a federal government contract bid protest.
Tobacco industry

Jonathan began his legal career as regulatory counsel with FDA's then newly-established Center for Tobacco Products (CTP). In this role, he evaluated tobacco industry compliance with and carried out enforcement of tobacco product promotion, advertising, and labeling requirements under the Federal Food, Drug and Cosmetic Act (FD&C Act). He also drafted regulations in this role. Since entering private practice, Jonathan has written and spoken extensively on FDA's authority to regulate tobacco products, with a particular focus on FDA's "deeming rule," which extended such authority to, among other things, electronic nicotine delivery systems (ENDS) (e.g., e-cigarettes and vapor products) and cigars.

Select representative matters include:

Advised investors and investment research firms regarding FDA's tobacco products regulatory, compliance, and enforcement landscape.
Counseled a leading trade association regarding compliance with FDA's "deeming rule."

Thought Leadership

Credentials and Accolades

Honors and Awards

Named to Law360’s Cannabis Editorial Advisory Board 2020

Named to The Best Lawyers in America: Ones to Watch list, Administrative / Regulatory Law, 2020 

Named to The Daily Record's "VIP List," 2019

Named one of "America's Leading Lawyers in Cannabis Law" by Chambers USA, 2019 to  present

Named to the National Law Journal's Cannabis Law Trailblazers list, 2018

Recipient of The Daily Record's Generation J.D. Leadership in Law Award, 2018

Named to the Maryland Super Lawyers "Rising Stars" List for Food and Drugs, 2018 to present

Named to the Washington, D.C. Super Lawyers "Rising Stars" List for Food and Drugs, 2016 to present

FDA Group Recognition Award, 2011

FDA Center for Tobacco Products Team Excellence Award, 2011

Memberships and Affiliations

Beta Iota Foundation, Scholarship Selection Committee, 2011 to present

Leadership Council on Legal Diversity, Success in Law School Mentoring Program, 2015 to present

American Diabetes Association - Maryland Chapter, Community Leadership Board, 2018 to present

Sinai Hospital, Board of Directors, 2020 to present

LifeBridge Health, Leadership Society Council, 2018 to 2020 

Food and Drug Law Institute

  • Audit Committee, 2020
  • Cannabis-Derived Products Committee, 2019
  • Tobacco Committee, 2015 - 2017

Towson University Hillel, Governing Board, 2019 to present

The Associated: Jewish Community Federation of Baltimore, Young Leadership Council, 2017 to 2019

Education

J.D., Columbus School of Law at The Catholic University of America, 2010

B.A., University of Virginia, 2005

Bar Admissions

District of Columbia
Florida
Maryland
Virginia

Firm Involvement

Co-Chair, Cannabis Law

Co-Chair, Food, Beverage and Agribusiness

Jonathan Havens counsels clients on regulatory, compliance, enforcement and transactional matters related to products regulated by the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the U.S. Department of Agriculture (USDA) and the U.S. Drug Enforcement Administration (DEA). Companies in the cannabis (both hemp and marijuana), consumer health care products, life sciences, food and beverage, cosmetics and tobacco industries, among others, turn to Jonathan for advice on how to get and keep their products on the market. He advises companies throughout the product life cycle, including product development, formulation, manufacture, distribution and promotion. More specifically, Jonathan handles matters involving labeling, good manufacturing practice (GMP), quality system regulation (QSR), product design, and registration and listing, to name a few. When disputes, including litigation, arise relating to these and other issues, Jonathan helps clients navigate them. This includes preparing for FDA inspections, responding to inspectional observations (FDA Form 483) and warning letters, managing product recalls and resolving import and export issues. He also counsels clients through business transactions that involve oversight by myriad federal and state agencies.

Beyond his FDA, FTC, USDA, and DEA work, Jonathan's experience extends to matters involving the U.S. Consumer Product Safety Commission (CPSC), U.S. Customs and Border Protection (CBP), a wide array of state and municipal agencies, state attorneys general and district attorneys. His deep understanding of the complex regulatory and statutory requirements that govern a wide range of products and services is enhanced by his experience working in government and on Capitol Hill. Before entering private practice, Jonathan served as regulatory counsel with the FDA, where he focused on compliance and enforcement related to promotion, advertising and labeling. Prior to law school, Jonathan served as a legislative aide in both the U.S. Senate and U.S. House of Representatives.