Tracey helps food, beverage, cosmetic, and drug manufacturers, distributors, and importers ensure that their products reach the market. She practices from Sarasota, Florida.
Tracey divides her practice between assisting domestic clients with Food & Drug Administration (FDA) registrations, regulations, and approvals and working with organizations overseas to ensure that their imports meet both FDA and Customs & Border Protection (CBP) requirements. She regularly reviews labels, packaging, and marketing materials; handles FDA registrations and import alerts; conducts FDA-related due diligence for corporate transactions; and advises on facility inspections, enforcement actions, and product market withdrawals and recalls. After more than 15 years in the practice area, Tracey knows the FDA’s requirements backwards and forwards, and she is equally knowledgeable about Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) standards and regulations as well.
Early in her career, Tracey handled a seafood import matter and soon became the go-to attorney at her boutique firm for FDA and CBP questions. She quickly found herself assisting with products from makeup to medical devices, and she realized she was especially passionate about working with foods, beverages, and other everyday items that consumers use on a regular basis. Today, Tracey supports a wide variety of clients, from food and beverage startups to a medical spa to luxury goods providers.
A people person who values getting to know clients personally, Tracey regards her chief responsibility as simply providing the answers clients need. She’s always on hand to advise on a new regulation, answer a classification question, review a label, or weigh a potential drug claim. As a business-minded attorney, Tracey intuitively understands the essential nature of FDA and CBP compliance: getting these regulatory matters right ensures market access for the products that drive clients’ businesses.