This program will provide an overview of federal regulation of the cannabis industry, in light of the Department of Justice’s recent rescission of the Cole Memorandum, a 2013 memo that symbolized a major shift in drug enforcement. Presented by Jonathan Havens, Co-Chair of Saul Ewing Arnstein & Lehr’s Cannabis Law Practice, the program will also briefly explore the role of the Federal Drug Administration (FDA) and Drug Enforcement Administration (DEA) in cannabis regulation, and finally, will conclude with insights as to what’s in store for the future of cannabis regulation.
Discern the Trump Administration’s current position on marijuana regulation
Evaluate the Department of Justice's role in enforcing federal drug laws, particularly in the wake of its rescission of the Cole Memorandum
Consider how the FDA’s approval of cannabis products could steer the scheduling debate
Discuss current federal legislative efforts and proposals, and which, if any, could succeed
Comprehend the scope of the current state regulatory regimes and what is on the horizon
Navigate the legal challenges that local marijuana businesses face in light of the federally illegal status of the product (e.g., tax, IP, real estate, banking, etc.)
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.