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Experience
- Provided strategic regulatory counsel to facilitate commercialization of various food tech innovations, such as cultivated meat, precision fermentation, molecular farming, and sugar reduction technologies.
- Advised Fortune 100 and startup companies on U.S. human food regulations governing the transport, holding, processing, and sale of food from farm to fork.
- Advised corporations and industry trade associations on strategies to shape FDA and USDA food regulatory frameworks for labeling and premarket review oversight.
- Provided regulatory strategy and counsel to support premarket submissions to FDA, namely GRAS Notices and Food Contact Notifications, and to USDA for New Technology Notifications.
- Advised on FDA’s Food Safety Modernization Act (FSMA) compliance with a focus on hazard analysis and preventive controls drawing on his experience and certification as a Preventive Controls Qualified Individual (PCQI).
- Assisted clients with navigating and responding to FDA warning letters, FSIS Notices of Intended Enforcement, and unanticipated regulatory scrutiny, generally.
- Provided strategic regulatory support on a range of consumer class action food litigation matters.
- Counseled clients through recalls and market withdrawals to minimize business disruption, cost, and damage to brands.
- Advised on USDA-APHIS permits and export certifications needed for importation or exportation of products containing USDA-regulated ingredients.
- Advised on the legal landscape surrounding the development and marketing of CBD products, including synthetic analogs.
- Advised USDA-regulated companies on FSIS reinspection requirements for imported foods.
- Advised clients on bioengineering labeling and claims, including with respect to regulatory compliance and consumer fraud litigation risks.
- Provided regulatory advice and due diligence on a range of mergers and acquisitions in the food and dietary supplement sectors.
- Represented USDA-regulated stakeholders on compliance with the Packers and Stockyards Act and Perishable Agricultural Commodities Act.
- Assisted clients in complying with FDA’s Food Safety Modernization Act (FSMA), Nutrition Facts Label (NFL) requirements, and menu labeling requirements.
- Advised multiple food manufacturers and retailers on compliance with USDA's Supplemental Nutrition Assistance Program (SNAP) administered by the Food and Nutrition Service (FNS).
- Led FDA regulatory diligence for private equity firm L Catterton in largest ever investment in a cultivated seafood company to date ($100 million Series B Round for Wildtype).*
- On behalf of AFCO (a Zep Company), successfully obtained multiple Food Contact Notification (FCN) clearances from FDA for specialty chemical antimicrobial solutions intended for use in food processing.*
- Advised multiple clients in navigating administrative enforcement actions brought by USDA's Animal and Plant Health Inspection Service (APHIS), Agricultural Marketing Service (AMS), Food Safety and Inspection Service (FSIS), and the National Organic Program.*
- Obtained favorable rulings from the USDA FSIS prior label approval program.*
- Obtained USDA FSIS Directive 7120.1 listings for substances intended for use in meat, poultry, and egg products production.*
- Obtained USDA FSIS clearances for On-Line Reprocessing (OLR) and Off-Line Reprocessing (OFLR) Antimicrobial Intervention Systems.*
- Counseled clients on issues pertaining to the import and export of FDA-regulated products, including products under import alert and products requiring export certification by foreign governments.*
- Counseled clients regarding California Proposition 65 warnings and supply chain considerations.*
- Conducted training for new FDA CFSAN personnel and companies on FDA law and regulation.*
*Prior firm experience
