Daniel C. Rubenstein

Food and Food Contact:

• Prepared and submitted Food Contact Notifications (FCNs) to the US Food and Drug Administration (FDA) for polymers, additives, processing aids, and components of food-contact plastics and paperboard for adult and infant foods.
• Submitted petition to the European Food Safety Authority (EFSA) for addition and listing of new substance to the European Union (EU) Plastics Regulation No. 10/2011.
• Filed petitions with China National Center for Food Safety Risk Assessment (CFSA) for addition of new substances and expanded uses for existing additives under GB 9685 Standard.
• Submitted Application for Authorization of a Food Contact Substance to the United Kingdom (UK) Food Standards Agency (FSA) for additive used in food packaging.
• Authored opinion letters establishing the suitable regulatory status of food-contact materials in the US, EU, China, Japan, and South America (MERCOSUR), including "No Migration," self-determined Generally Recognized as Safe (GRAS) and equivalent positions.
• Conducted FDA regulatory due diligence evaluation for proposed Merger and Acquisition (M&A) of FDA-regulated medical device company.
• Evaluated GRAS status of substances added to Distillers Dry Grains with Solubles (DDGS) as a byproduct of ethanol production for use in animal feed applications.
• Organized coalition to support successful industry abandonment of food-contact material no longer used in food packaging applications.
• Authored chapter for Global Legislation for Food Contact Materials, Second Edition (2022).
• Provided Continuing Legal Education (CLE)-eligible training and educational programs for food and food packaging manufacturers.

Good Manufacturing Practice and Facility Audit

• Investigated, identified, and provided advice and guidance regarding potential packaging contamination and recall obligations due to faulty manufacturing equipment.
• Conducted external audit of FDA-regulated manufacturing facilities in accordance with Good Manufacturing Practice (GMP) requirements, under attorney-client privilege.
• Advised clients on US and EU regulatory requirements pertaining to use of recycled polyethylene terephthalate (PET), high-density polyethylene (HDPE), and other materials in food-contact applications.
• Provided advice and guidance regarding compliance with warning requirements under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65).
• Prepared and submitted Drug Master Files (DMF) and administrative updates for packaging materials used to hold pharmaceutical products in the US and China.

E-Vapor, Hemp and Hemp-Derived Cannabidiol (CBD)

• Served as lead counsel to the Hemp Leaders Coalition Trade Association.
• Advised E-liquid industry regarding FDA Temporary Policy on Alcohol-Based Hand Sanitizers and associated registration requirements with the Alcohol and Tobacco Tax and Trade Bureau (TTB).
• Advised clients regarding the sale, use and labeling of food and cosmetic products containing hemp-derived CBD under state and federal law.

Pro Bono Activities

• Successfully assisted pro bono client in preventing wrongful foreclosure through the use of the US Department of the Treasury Home Affordable Modification Program (HAMP).
• Supported Catholic Charities of the Archdiocese of Washington Legal Network (CCLN) volunteer pro bono legal intake program.
• Provided pro bono tax credit filing assistance to low-income residents of the District of Columbia.
• Prepared wills, durable power of attorney, healthcare power of attorney, and advance directive estate planning documents for District of Columbia residents.

• "FCM Regulation: the US and How it Relates to Other Regions," Chem-Academy Food Contact Materials Regulation, February 10, 2025

• "Exploring Alternatives to PFAS," Smithers Plastics & Paper in Contact with Foodstuffs, December 10, 2024
• "The 'State' of PFAS Regulation in the United States," SPE PFAS in the Plastics Industry 2024, October 30, 2024
• University of Maryland I.P. Alumni Networking Event, October 10, 2024
• "FDA Regulation of Silicones and Rubber in Food-Contact Applications," Rubber Division, American Chemical Society 2024 International Elastomer Conference, September 10, 2024
• "FDA Chemistry Guidance Revision – What Could the Future Hold?" Enhesa (Chemical Watch) Food Contact Regulations North America 2024, June 20, 2024
• "US State Packaging Legislation Trends and Updates," Smithers Global Food Contact 2024, May 23, 2024
• "FDA Regulation of Polyethylene Films used in Food-Contact Applications," AMI Polyethylene Films North America 2024, February 13, 2024
• "Discussing the Role of Regulations in Promoting Plastics Recycling," AMI Plastics Recycling World Expo 2023, November 16, 2023
• "Overview of Green Claims for Food Packaging in the U.S.," Bech-Bruun Food Law and Policy Forum 2023, November 7, 2023
• Panelist in "Round Table on Sustainability and Legislation," SACMI Green & Digital Conference, October 19, 2023
• "Update to FDA Consumption Factors: Technical and Legal Considerations," 9th Annual FSAP In-Person Meeting, October 10-11, 2023 – with Patricia Kinne
• "Spotlight Address: Nothing Lasts Forever: The Changing Landscape of PFAS Regulation," FoodBev Exchange, October 9, 2023
• "Sustainability in Food Packaging: Regulatory and Supply-Chain Developments and Considerations,” Smithers E-Pack USA 2023, October 3, 2023
• "FDA Regulation of Caps and Closures used in Food-Contact Applications," AMI Plastic Closure Innovations Conference, June 15, 2023
• "Introduction to Food Contact Regulations in China and Japan," Steptoe Food Contact Conference, April 25, 2023
• The Rubber Band Effect: Supply Chain Impacts on FDA-Regulated Food and Food Packaging Manufacturers, FoodBev Exchange, October 25, 2022
• "Demanding Supply: Perspectives on Supply Chain Impacts on FDA-Regulated Products," Institute of Industrial Engineers' Annual Conference, May 23, 2022
• "Update on Cannabinoid Product Regulation," Hemp Leaders Summit, June 25, 2021
• "Regulation of Food Contact Materials in China and Japan," Smithers Global Food Contact 2021 Online, June 15, 2021
• "Regulation, Trade, and Standards Relating to Consumer Products Containing Hemp - Derived CBD," co-sponsored webinar with Dorantes Advisors and LGCA Consulting Affairs, September 30, 2020
• "Looking at the Future of the Hemp-CBD Market," International Life Sciences Institute (ILSI North America), July 10, 2020
• "Plastics in Plain Language - A Roadmap to FDA Regulation," AMI Plastics Regulations Conference, December 10, 2019

• Alumni Feature, University of Maryland Francis King Carey School of Law, February 20, 2023
• Contributing author, Global Legislation for Food Contact Materials, Second Edition (ISBN: 9780128211816) (June 30, 2022)

• Recipient of the 2020 Institute of Industrial & Systems Engineers (IISE) Outstanding Middle Career Leadership Award for Business and Industry

• Recipient of the 2015 John Carroll Society Pro Bono Legal Service Award

• American Bar Association
• Maryland State Bar Association
• Member, Cannabis-Derived Products Committee, Food and Drug Law Institute (FDLI)