James William (“Will”) Woodlee is a partner who joined the firm in 2010. His practice focuses primarily on counseling and advocating on behalf of food, dietary supplement, cosmetic, pharmaceutical, medical device, tobacco, cannabis/hemp, and consumer product companies on regulatory and advertising law matters. In particular, he:
- Provides practical, creative, and strategic advice to help clients achieve their business goals in compliance with laws implemented and enforced by the U.S. Food and Drug Administration, Alcohol Tobacco Tax and Trade Bureau, U.S. Department of Agriculture, Federal Trade Commission, Consumer Product Safety Commission, Drug Enforcement Administration, and related federal, state, and local agencies;
- Represents clients before and against these agencies, including in the context of rulemaking and guidance development proceedings, facility and import inspections, premarket submission reviews, enforcement actions, and legal challenges to agency action;
- Assists clients with developing, reviewing, defending, and challenging advertising copy and claim substantiation;
- Provides due diligence and related services to clients in transactional matters involving regulated entities;
- Assists clients with internal and other (e.g., CRO) investigations involving regulatory issues; and
- Provides guidance on the design and implementation of sweepstakes, contests, and related promotional programs, especially those conducted using social media.
Will also currently serves as general counsel to the American Herbal Products Association, the national trade association of the herbal products industry.
Will has extensive experience with matters involving the federal, state, and local regulation of, among other goods:
- Prescription and OTC drugs;
- Conventional food and dietary supplement products;
- Tobacco products, electronic cigarettes, and other nicotine-containing products; and
- Products derived from cannabis, including hemp and cannabidiol (CBD) products.
Will has previously served on the Editorial Advisory Board of the Food and Drug Law Journal, the Food and Drug Law Institute’s (FDLI’s) Food, Dietary Supplements, and Cosmetics Committee, and the Editorial Advisory Board of FDLI’s Update magazine. He frequently writes and speaks about the FDA Food Safety Modernization Act, and he served as editor for FDLI’s The Food Safety Modernization Act: A Comprehensive, Practical Guide to the Landmark Legislation.
Will was included in the 2021, 2022, and 2023 editions of Best Lawyers in America under the “FDA Law” category. For 2015-2021, Super Lawyers named Will a “Rising Star” of the Washington, DC, metro area’s “Food & Drugs” bar.
BA, Wake Forest University (magna cum laude, Honors in English, Phi Beta Kappa)
Commonwealth of Virginia
U.S. District Court for the District of Columbia
U.S. District Court for the Eastern District of Virginia