Georgia counsels manufacturers, distributors, and retailers who manufacture and market prescription drugs, biologics, cosmetics and over-the-counter drugs, consumer products, food products, dietary supplements, and vitamin products. She has extensive experience in reviewing labeling, advertising, and packaging to ascertain compliance with applicable Food and Drug Administration (FDA) and Federal Trade Commission (FTC) regulations. Georgia also counsels clients on regulatory compliance and FDA inspections, participates in agency rulemaking and adjudicatory proceedings, responds to federal and state administrative enforcement efforts, import detention matters involving FDA and the Department of Homeland Security, and advises on civil and criminal litigation relating to FDA and related regulatory matters. Additionally, an integral component of her practice is advising companies on the level and type of product claims substantiation that will be necessary to satisfy the National Advertising Division (NAD) and the FTC. Georgia advises FDA-regulated establishments on the need to implement stock recovery and product recalls.
Georgia also works closely with manufacturers, distributors, importers, specialty retailers, and product vendors in the development of new, innovative products subject to the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, the Federal Hazardous Substances Act, the Consumer Product Safety Act, the CPSIA, and the various regulations enforced by the FDA and the CPSC. Over the years, Georgia has worked on many product recalls from cosmetics to electrical products to children’s products, and a wide range of other FDA regulated, personal and household products in between. She advises clients on the CPSIA and its corresponding rules, providing guidance on compliance certificates, third party testing of children’s products, tracking labels, new limits on lead and phthalates, and labeling requirements for toy and game advertisements, among other matters. Georgia actively participates in CPSC rulemakings and public meetings on the CPSIA.