FDA Practice

Our attorneys have helped clients with a wide range of FDA-related issues:

Food Additives

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

Food

• Advice on FDA inspections of food processing facilities
• Negotiation with FDA over airline food safety requirements
• Advocacy to FDA on adoption of emerging international standards for dietary fiber
• Guidance on regulation of pesticide residues on raw and processed food under the Food Quality Protection Act
• Advice and 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
• Advice on state requirements for animal feed components

Dietary Supplements

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

Cosmetics

• Guidance on use of antimicrobials in personal care products
• Advice on FDA requirements and voluntary programs to ensure quality of cosmetics
• Counseling on good manufacturing practice guidance for cosmetic components
• Counseling on marketing claims for cosmetics

Drugs

• Advice on testing requirements for potential new over-the-counter drugs
• Advocacy with Customs and Border Protection over imports of active pharmaceutical ingredients with alleged drug labeling deficiencies
• Counseling on good manufacturing practice standards for finished drugs and good manufacturing practice guidance for active pharmaceutical ingredients and excipients
• Advice on clinical testing requirements and guidance and good laboratory practice standards for pre-clinical testing

Medical Devices

• Advice on development of prospective medical devices
• Analysis of the Biomaterials Access Assurance Act of 1998
• Guidance on company policies involving use of products as components of medical devices, including tort liability and regulatory considerations
• Counseling on good manufacturing practice standards for medical devices and guidance for medical device components

General

• Assistance in product recalls and market withdrawals, including advice on regulatory, contract, tort, and customer relations issues
• Advice on FDA inspections and responses to Form 483 findings and warning letters
• Advocacy to FDA on limiting the burdens associated with its electronic recordkeeping requirements and compliance advice
• Analysis of the regulation of nanoscale components of medical devices, drugs, food, food additives, dietary supplements, color additives, and cosmetics under the FFDCA
• Guidance on FDA and other requirements for Institutional Review Board review of human testing
• Advocacy on the use of cattle-derived materials in FDA-regulated products due to concerns with bovine spongiform encephalopathy (BSE)
• Counseling on state counterparts to the FFDCA, and advice on inspections by state agencies
• Advice on European Union counterparts to FDA regulation, including directives on cosmetics, food additives, good laboratory practices, food supplements, and medicinal products