Representative Matters

Food Additives

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

Food

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

Dietary Supplements

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