People

Smitha 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.

Full Bio

Credentials

District of Columbia

Maryland

"She is very enjoyable to work with and provides pin-point accurate advice."


Chambers USA

"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs."


Chambers USA

Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues.


Chambers USA

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Recognition

"She is very enjoyable to work with and provides pin-point accurate advice."


Chambers USA

"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs."


Chambers USA

Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues.


Chambers USA

Matters

Routinely assist 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.

Routinely assist foreign and domestic food manufacturers and ingredient suppliers with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation.

Drafted influential comments to the FDA and USDA on behalf of major food industry trade associations in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances.

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Matters

Routinely assist 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.

Routinely assist foreign and domestic food manufacturers and ingredient suppliers with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation.

Drafted influential comments to the FDA and USDA on behalf of major food industry trade associations in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances.

Counseled global food manufacturers on the FDA’s requirements for health claims, nutrient content claims, and structure-function claims, as well as FTC’s substantiation standards and expectations for claims made in food advertising.

Counseled global food producers on labeling and advertising considerations related to “natural,” “organic,” "pure," "clean" and “GMO” claims.

In response to a major product recall, helped global food producer implement significant corrective actions and coordinated recall response and dealings with FDA.

Worked with a large dietary supplement manufacturer’s management team to develop and implement cGMP procedures and policies to assist with FDA compliance and avoid potential enforcement action.

Published, presented and advised clients on an array of issues involving FDA’s application of the new dietary ingredient, food additive and GRAS substance safety rubric.

Matters

Routinely assist 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.

Routinely assist foreign and domestic food manufacturers and ingredient suppliers with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation.

Drafted influential comments to the FDA and USDA on behalf of major food industry trade associations in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances.

See more
Icon close

Close

Matters

Routinely assist 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.

Routinely assist foreign and domestic food manufacturers and ingredient suppliers with new food safety compliance requirements under the FDA Food Safety Modernization Act; also authored a leading book chapter and numerous articles on this groundbreaking legislation.

Drafted influential comments to the FDA and USDA on behalf of major food industry trade associations in response to various FDA or USDA proposed rules, including those related to preventive controls for human and animal food, foreign supplier verification programs, sanitary transportation, updates to the Nutrition Facts Panel and serving size regulations, menu and vending labeling, competitive foods sold in school, and the National List of Allowed and Prohibited Substances.

Counseled global food manufacturers on the FDA’s requirements for health claims, nutrient content claims, and structure-function claims, as well as FTC’s substantiation standards and expectations for claims made in food advertising.

Counseled global food producers on labeling and advertising considerations related to “natural,” “organic,” "pure," "clean" and “GMO” claims.

In response to a major product recall, helped global food producer implement significant corrective actions and coordinated recall response and dealings with FDA.

Worked with a large dietary supplement manufacturer’s management team to develop and implement cGMP procedures and policies to assist with FDA compliance and avoid potential enforcement action.

Published, presented and advised clients on an array of issues involving FDA’s application of the new dietary ingredient, food additive and GRAS substance safety rubric.

Credentials

District of Columbia

Maryland

"She is very enjoyable to work with and provides pin-point accurate advice."


Chambers USA

"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs."


Chambers USA

Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues.


Chambers USA

Icon close

Close

Recognition

"She is very enjoyable to work with and provides pin-point accurate advice."


Chambers USA

"She is very responsive, very efficient and very creative in her approach to helping balance our regulatory needs."


Chambers USA

Smitha is praised by clients for her ability to deal with food recalls and all manner of FDA regulatory issues.


Chambers USA