Wendi Finch May is an attorney with Fuerst Ittleman. She focuses her practice on assisting clients with navigating the complex regulatory systems implemented and enforced by the U.S. Food and Drug Administration (“FDA”), United States Department of Agriculture (“USDA”), Federal Trade Commission (“FTC”), state and local authorities, and third-party accrediting bodies. She has experience representing clients and companies involved with the development, manufacture, importation/exportation, distribution and promotion of food, drugs, medical devices, cosmetics, dietary supplements, biologics, animal drugs and feed, and human cells, tissues, and cellular and tissue-based products (HCT/Ps).
Ms. May represents clients throughout the entire product lifecycle. She routinely advises clients on the manufacturing, product labeling, and distribution for food, dietary supplements, medical devices, drugs and over-the-counter drugs, and HCT/Ps. She has successfully drafted Standard Operating Procedures for a stem cell banking and processing facility covering current Good Tissues Practices (“cGTPs”) in accordance with federal, state, local, and AABB standards. Furthermore, Ms. May has drafted Standard Operating Procedures covering different aspects of current Good Manufacturing Practices (“cGMPs”) and adverse event reporting requirements for a dietary supplement manufacturer and a pharmaceutical drug wholesaler in compliance with federal and state law.
Furthermore, Ms. May has experience dealing directly with the FDA regarding the import and export of regulated products. She has successfully gained the release of FDA-regulated products that were detained upon importation into the United States. Additionally, she has petitioned the FDA to have a cosmetic client removed from import alert to prevent the detention of imported products. She has also counseled clients regarding obtaining Export Certificates, including a Certificate of a Pharmaceutical Product (“CPP”) and Certificate of Exportability, from the FDA.
In addition to her significant experience in Food and Drug Law, Ms. May has assisted clients with “organic” labeling claims requirements under the USDA’s National Organic Program (“NOP”). She provides guidance on the level of evidence needed to substantiate claims in compliance with the appropriate regulatory bodies. She also provides guidance to clients on the regulatory requirements under the FTC regarding product advertising and marketing. She is able to effectively counsel clients to find a balance between the regulatory requirements for labeling claims and a client’s marketing objectives. Ms. May has also represented clients in the areas of intellectual property, health care law, and litigation.
Ms. May graduated with honors from the University of Florida with a Bachelor’s degree in Food Science. While at the University of Florida, Ms. May completed an internship with the FDA. Ms. May graduated with honors from Wayne State University School of Law where she was the recipient of the Barrister’s scholarship and earned the Boaz Sigel award for excellence in health care law and worker’s compensation law.
Position:
Associate
Office:
Miami
1001 Brickell Bay Drive
32nd Floor
Miami, FL 33131
Phone:
305.350.5690
Email:
wmay@fuerstlaw.com
Practice Areas:
Food and Drug Law
Intellectual Property Law
Customs, Import, and Trade
Administrative Law
Agricultural Law
Federal Regulatory Law
Education:
Wayne State University Law School
Detroit, Michigan
J.D., cum laude, 2007
University of Florida
Gainesville, Florida
B.S., cum laude, 2004
Admitted:
Maryland 2007
Florida 2008
U.S. Patent and Trademark Office 2007
