Cannabis Regulation in a Post-Cole Memo World: Expecting the Unexpected

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), and the U.S. Consumer Product Safety Commission (CPSC). Companies in the consumer health care products, life sciences, cosmetics, tobacco, and medical cannabis 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 preparation for FDA inspections, response 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, and CPSC work, Jonathan’s experience extends to matters involving the U.S. Department of Agriculture (USDA), the U.S. Drug Enforcement Administration (DEA), 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 FDA, where he focused on compliance and enforcement related to promotion, advertising, and labeling. Jonathan has also held legislative and government affairs positions in which he facilitated the development and execution of strategic communications to members of Congress and their staff aides, and managed several areas of policy and drafted legislative proposals.