Smitha G. Stansbury

SMITHA STANSBURY focuses her practice on conventional food and beverages, dietary supplements, and personal care products regulated by the U.S. Food and Drug Administration (FDA). She advises clients on regulatory matters at the federal and state levels, including product development, promotion, and labeling, and she responds to FDA enforcement actions such as warning letters, recalls, and import detentions. Smitha also conducts regulatory due diligence for mergers, acquisitions, and private equity transactions involving FDA-regulated companies.

Smitha’s clients include food and beverage manufacturers, distributors, trade associations, retailers, and restaurants. She regularly submits public comments, citizen petitions, and other filings to the FDA and other federal agencies, helping clients navigate rulemakings, guidance documents, and legislative developments.

“[Smitha] is an expert at interpreting and applying technical FDA regulations to food and beverage supplement products.”
Chambers USA

Smitha has published, presented, and advised clients on a wide range of issues involving the FDA’s application of safety standards for new dietary ingredients, food additives, and Generally Recognized as Safe (GRAS) substances. She has also drafted influential comments on behalf of major food industry trade associations in response to FDA- and USDA-proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, nutrition facts and serving-size regulations, menu and vending labeling, competitive foods sold in schools, and the National List of Allowed and Prohibited Substances.

Smitha is ranked by Chambers USA for Nationwide Food & Beverages: Regulatory & Litigation (Band 1, 2019–2026) where clients note that she is “highly responsive, knowledgeable, and our first call when we have complex problems in the food manufacturing industry,” “is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues,” and that “she is very responsive, very efficient, and very creative in her approach to helping balance our regulatory needs.” Additionally, she has been ranked by The Best Lawyers in America® for FDA Regulatory Law (2023).

• Private equity firms and others in conducting FDA regulatory due diligence of target food, beverage, dietary supplement, personal care product, pharmaceutical, and medical device companies.
• Foreign and domestic food manufacturers and ingredient suppliers with new food safety compliance requirements under the FDA Food Safety Modernization Act
• Global food manufacturers on the FDA’s requirements for health claims, nutrient content claims, and structure-function claims, as well as the Federal Trade Commission’s substantiation standards and expectations for claims made in food advertising.
• Global food producers on labeling and advertising considerations related to “natural,” “organic,” “pure,” “clean,” and “GMO” claims.
• Global food producer to implement significant corrective actions and coordinate recall response and dealings with the FDA.
• Large dietary supplement manufacturer’s management team to develop and implement Current Good Manufacturing Practice (cGMP) procedures and policies to assist with FDA compliance and avoid potential enforcement action.

The above matters were handled prior to joining Sidley.