Smitha G. Stansbury specializes in conventional food and beverages, dietary supplements and personal care products regulated by the U.S. Food and Drug Administration. A partner in our FDA and Life Sciences practice, Smitha represents clients in regulatory matters at the federal and state levels, and conducts risks assessments and due diligence reviews of FDA-regulated companies involved in mergers, acquisitions and other corporate transactions.
With particular expertise in food law, Smitha provides strategic regulatory counseling to clients on important issues relating to the development, promotion and sale of foods and dietary supplements, as well as cosmetics, drugs, medical devices and tobacco products.
She also assists clients in responding to regulatory enforcement actions such as FDA warning letters, product seizures, recall requests and import detentions. In addition, she guides clients in conducting regulatory due diligence on corporate transactions and private equity investments.
Smitha has worked extensively with food and beverage manufacturers and distributors, food industry trade associations, equipment suppliers, retailers and restaurants on issues related to food safety, ingredients and product formulation, and food labeling and advertising.
She regularly prepares and submits public comments, citizen petitions and other regulatory submissions to the FDA and other federal agencies on behalf of food industry clients, and also helps develop strategies for responding to legislative initiatives, agency rule-makings and guidance documents, and other actions that could materially affect the industry.
Smitha is a frequent author and speaker on food safety and labeling, FDA regulations and related topics.