With a focus on FDA Law, Justine Lenehan represents a broad client base in connection with regulatory matters before the FDA and other regulatory agencies (including the FTC, USDA, EPA, and CPSC). Her practice encompasses advising pharmaceutical, tobacco, dietary supplement, food, medical device, and cosmetic clients on a range of issues as they relate to regulatory strategies for product development and post-marketing compliance, as well as advertising and labeling issues.*
Previously, Justine worked as a corporate associate at a global law firm in New York. There, Justine focused her time on representing pharmaceutical companies in an extensive range of corporate and compliance matters, including transactional work, corporate governance, corporate restructuring, strategic alliances, and supply and distribution matters. Justine also served as a law clerk for the Hon. Harry D. Leinenweber of the United States District Court for the Northern District of Illinois and interned with a pharmaceutical company.
Representative matters include:
- Advised on product labeling and marketing materials for numerous dietary supplements, over-the-counter pharmaceutical products, and electronic cigarettes to identify and mitigate potential risks and to ensure compliance with federal law
- Conducted FDA regulatory due diligence on multi-national premium cigar company in connection with stock acquisition in order to identify regulatory and compliance related risks and reviewed and revised related transaction documents to address such risks
- Prepared and submitted over 250 tobacco product-related filings with FDA, including grandfathered submissions, Substantial Equivalence reports, and follow-up responses to information requests regarding such submissions
- Assisted a client in navigating interactions with multiple federal agencies in connection with a proposed agency action and prepared comments and correspondence advocating on behalf of the client
- Conducted audit of various companies’ websites and social media channels regarding compliance with federal law
- Advised on state and city statutes, regulations, and ordinances related to the regulation of certain tobacco products and drafted opinion letters for use by clients
- Summarized laws in 50 states on various legal questions, including the legality of online sales of various types of tobacco- and nicotine-containing products and the legality of hemp and CBD (derived from hemp or otherwise) in food and personal care products
- Drafted privacy statement for U.S. pharmaceutical company to address developments in state data privacy laws
- Advised on approval pathway for biologic product, including on application/user fees, informed consent requirements, tax benefits associated with designation as an orphan drug, implications of public disclosure, and CMC requirements
- Assisted client in navigating FDA medical device regulations regarding exemption from certain laser product requirements
- Counseled client on best practices regarding FDA inspections and assisted in the preparation of client’s SOP regarding such inspections
- Advised on state excise tax implications for various regulated tobacco products
Publications & Speaking Engagements
Publications & Speaking Engagements
- “2019 Significant Settlements,” Chapter Author, Food and Drug Law Institute Top Food and Drug Cases, 2019 & Cases to Watch, 2020, October 2020.
- “Regulation of Dietary Supplements,” Co-Author, A Practical Guide to FDA’s Food and Drug Law and Regulation, Seventh Edition, August 2020.
- “Informed Consent, Institutional Review Boards (IRBs), Protection of Human Subjects,” Speaker. FDLI/CDRH In-House Training Course: Introduction to Medical Device Law and Regulation, Virtual Webinar, June 2020.
- “Informed Consent, Institutional Review Boards (IRBs), Protection of Human Subjects,” Speaker. FDLI/CDRH In-House Training Course: Introduction to Medical Device Law and Regulation, Virtual Webinar, April 2020.
B.A., Northwestern University
Law Clerk for the Honorable Harry D. Leinenweber, United States District Court for the Northern District of Illinois
District of Columbia