Jonathan Havens

Jonathan A. Havens
Experience

Cannabis Industry

Jonathan counsels state cannabis license applicants and awardees, ancillary service and product providers, investors, underwriters, 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. Since 2019, Jonathan has been listed in Chambers USA: America's Leading Lawyers for Business for his nationwide cannabis law practice. In 2021, he was named a Rising Star by Law360 for his cannabis law practice, in 2020, he was selected to serve on Law360's inaugural Cannabis Editorial Advisory Board, and in 2018, he was named to the National Law Journal's inaugural Cannabis Law Trailblazers list. 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, Hemp Industry Daily, Marijuana Business Daily 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. He was selected to serve a second term on that committee in 2021.
 

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 multi-national pharmaceutical company, global health care company, 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 and pharmaceutical  companies targeted for acquisition, and negotiated and drafted transactional documents related to the same.
  • Drafted numerous FDA pre-submission meeting requests, prepared background packages related to the same, and led negotiations with regulators on behalf of clients.
  • 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."
Experience quote