Food Additives

Our experience with food additives includes:

• Assisting in preparing Food Contact Notifications for new indirect food additives and Generally Recognized As Safe (GRAS) Notices.
• Advising on the scope of FDA approvals of direct and indirect food additives, as well as prior sanctions.
• Successfully defending litigation challenging a municipal ordinance banning food contact materials made from an FDA-approved food additive.
• Counseling on the defense of an FDA-approved food additive under attack, including advocacy, marketing, scientific, and strategic considerations.
• Counseling on indirect food additive requirements for printing inks.
• Advising on good manufacturing practice requirements and guidance for direct and indirect food additives.
• Being involved in a multi-stakeholder project on FDA regulation of nanoscale indirect food additives.

Food

Our experience with food products includes:

• Advising on FDA inspections of food processing facilities.
• Negotiating with FDA over airline food safety requirements.
• Conducting advocacy to FDA on adoption of emerging international standards for dietary fiber.
• Providing guidance on the regulation of pesticide residues on raw and processed food under the Food Quality Protection Act.
• Advising and conducting advocacy on FDA review of bioengineered pharmaceutical proteins grown in food crops which may inadvertently appear in food.
• Counseling on food security issues under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.
• Advising on state requirements for animal feed components.

Dietary Supplements

Our experience with dietary supplements includes:

• Assisting in the development of new dietary supplements, including counseling on requirements, data development, and regulatory review.
• Reviewing dietary supplement marketing claims.
• Counseling on good manufacturing practice standards and reporting requirements for dietary supplements.