profile

Will Woodlee is an associate who joined the firm in February 2010. His practice focuses primarily on counseling and advocating on behalf of food, cosmetic, pharmaceutical, medical device, dietary supplement, and tobacco companies on matters involving FDA law, USDA law, and related federal and state laws.

Prior to joining the firm, Mr. Woodlee clerked for two administrative law judges at the United Stated Department of Labor, where he also served as counsel to a committee tasked with revising 29 C.F.R. Part 18. Mr. Woodlee earned his J.D. from Wake Forest University School of Law, where he served as an Executive Editor for the Wake Forest Law Review. He earned his B.A. from Wake Forest University, graduating magna cum laude, with Honors in English, and as a member of Phi Beta Kappa.

matters

· Assisted client in preparing brief for DEA scheduling proceeding

· Represented clinical investigator in FDA disqualification proceeding

· Assisted client in successfully pursuing revocation of USANC’s proposed nonproprietary name for competitor’s product

· Assisted clients in preparing responses to NAD challenges

· Assisted client in revising company guidelines regarding "natural" claims

· Assisted client in preparing response to demand letter from consumer watchdog organization

· Negotiated close of state veterinary board's investigation regarding complaint involving client

· Counseled client on informed consent issues involving samples obtained during clinical trials

· Assisted trade association in preparing comments and correspondence to FDA regarding regulation of tobacco products

· Assisted trade association in preparing comments to FDA regarding agency's transparency initiative

· Prepared, submitted, and successfully pursued trade complaint to ATF on client's behalf

· Negotiated successfully on client's behalf with state tobacco tax administrator regarding federal PACT Act's registration and tax provisions

· Conducted comprehensive surveys of licensing requirements for spas and internet pharmacies

· Counseled client on TTB labelling requirements for products containing specially denatured alcohol

publications

Chapter 19: Sottera, Inc. v. FDA, in Top 20 Food and Drug Cases, 2010 & Cases to Watch, 2011 (John Reiss ed. 2011) (with Stacy L. Ehrlich).

Combating Teen Tobacco Use One Convenience Store at a Time: FDA Issues First Warning Letters to Tobacco Retailers, FDLI Update (May/June 2011) (with Stacy L. Ehrlich).

Marlboro Onserts: Another Colorful Addition to the Tobacco Regulatory Landscape, FDLI Update (July/Aug. 2010) (with Stacy L. Ehrlich).