Kevin A. Sforza

KEVIN SFORZA advises clients in the food, drug, medical device, agricultural, and life sciences industries on FDA and USDA regulatory compliance, product development, and risk management. He works with companies ranging from early-stage innovators to leading multinational companies, providing guidance across the full product lifecycle, including marketing authorizations and approvals, ingredient safety, novel ingredient development, product classification, labeling and marketing compliance, and regulatory interactions with federal agencies.

Food, Dietary Supplement, and Agricultural Product Counseling

Kevin has substantial experience with regulation of human and animal food, dietary supplements, and agricultural biotechnology products. His work includes:

• Advising on GRAS (Generally Recognized as Safe) evaluations.
• Assessing the regulatory status of novel ingredients, including genetically engineered or biotechnology-derived ingredients.
• Counseling on labeling, claims, substantiation, and advertising.
• Monitoring and interpreting emerging FDA food policy, ingredient innovation frameworks, and agricultural product oversight.

Drug, Medical Device, and Life Sciences Regulatory Counseling

Kevin also advises drug, biologic, medical device, and life sciences companies on:

• Product classification and regulatory pathways.
• Premarket and postmarket FDA requirements.
• Clinical trial compliance and study data practices in connection with product development.
• Regulatory strategies for products that integrate biotechnology, protein engineering, or other advanced science.

Regulatory Due Diligence in Transactions

Kevin conducts FDA regulatory due diligence for:

• Mergers and acquisitions.
• Private equity and venture capital investments.
• Strategic partnerships involving regulated companies or regulated technologies.

His due diligence work includes analyzing regulatory histories, identifying compliance risks, evaluating product portfolios, and providing actionable guidance to support investment and transactional decision-making.

Scientific and Technical Background

Kevin’s regulatory practice is supported by deep scientific experience. He completed a Ph.D. dissertation in protein-folding thermodynamics and previously worked in the biotechnology sector, focusing on protein engineering, genomics analysis, and related research applications in antibody development. This technical background enhances his ability to advise clients that are developing products at the intersection of science, technology, and regulation.