Prior results do not guarantee future outcomes.
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.
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.
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.