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.
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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
Provides guidance on the design and implementation of sweepstakes, contests, and related promotional programs, especially those conducted using social media
Serves as general counsel to the American Herbal Products Association, the national trade association of the herbal products industry
Education
JD, Wake Forest University School of Law (Executive Editor, Wake Forest Law Review)
BA, Wake Forest University (magna cum laude, Honors in English, Phi Beta Kappa)
Admissions
District of Columbia
Commonwealth of Virginia
U.S. Court of Appeals for the Second Circuit
U.S. District Court for the District of Columbia
U.S. District Court for the Eastern District of Virginia
Best Lawyers in America – “FDA Law” (2021-2027), “Administrative / Regulatory Law” (2025-2026), & “Cannabis Law” (2026-2027)
Super Lawyers – Rising Star – “Food & Drugs” (2015-2021)
Will 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.
KKB Partner Will Woodlee to Discuss DSHEA 2.0 (and Its Potential Pitfalls) at CRN and Natural Products Insider Panel - April 16, 2021
KKB Partner Will Woodlee to Discuss National Bioengineered Food Disclosure Standard at Food & Beverage Industry Conference - December 1, 2020
Kleinfeld, Kaplan & Becker Attorneys Selected to the 2021 Washington, D.C., Super Lawyers List - November 19, 2020
KKB Partner Will Woodlee Presents on CBD and Hemp Regulations at the ChiroCongress Convention - November 12, 2020
KKB Attorneys Author Chapter in FDLI’s “A Practical Guide to FDA’s Food and Drug Law and Regulation” (7th Edition) - October 27, 2020
PLI Publishes 2021 Edition of Medical Devices Law and Regulation Answer Book, Co-Edited by KKB Partner Suzan Onel and Chapters Authored by KKB Partners - October 20, 2020
Kleinfeld, Kaplan and Becker, LLP, Attorneys Recognized in “Best Lawyers” Rankings - August 20, 2020
Kleinfeld, Kaplan & Becker Well Represented on the Washington, DC, 2020 Super Lawyers List for “Food and Drugs” - April 23, 2020
PLI Publishes 6th Edition of Medical Devices Law and Regulation Answer Book for 2019 - December 20, 2018
KKB Attorneys Author Chapters in FDLI “Top Cases” Publication - May 11, 2018
KKB Partners Present VTA Webinar on E-Liquid Ingredient Listings - February 11, 2017