FDA Practice

Many chemicals and products have applications or potential applications regulated by the U.S. Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA) and related statutes.  Beveridge & Diamond, P.C. counsels clients on these complex requirements.  Our attorneys have assisted companies in bringing new FDA-regulated products to market; provided key guidance on pitfalls and strategies for ensuring both FDA approval and ongoing compliance; helped resolve compliance issues and FDA enforcement actions; handled FDA inspections; counseled on product recalls; advocated for changes in FDA regulatory requirements and adoption of new rules; and advised on foreign counterparts to FDA requirements. 

Our practice combines detailed understanding of how FDA works with the practical perspective of a company faced with the real-world challenge of bringing highly regulated products to market and successfully keeping them there.

Representative Matters
Representative Matters

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

Food Additives

  • Assistance in preparing Food Contact Notifications for new indirect food additives
  • Assistance in preparing Generally Recognized As Safe (GRAS) Notices
  • Advice on the scope of FDA approvals of direct and indirect food additives, as well as prior sanctions  
  • 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
  • Counseling on indirect food additive requirements for printing inks
  • 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
  • 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
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