Representation

• Representation of clients, by consultants and/or affiliated attorneys before:
  • Federal or state agencies in administrative actions, such as:
    • Responding to FD-483s
    • Responding to FDA Warning or Untitled Letters or USDA notices of non-compliance
    • Responding to Notices of detention or other administrative actions
    • State embargoes
    • Appealing FDA refusals seeking release of the refused cargo
    • Regulatory meetings with FDA Center Compliance or FDA Office of
    • Enforcement or FDA District officials
  • Federal or state agencies seeking agency action or changes in agency policy or actions, such as:
    • Notifications regarding dietary supplement claims
    • Notifications regarding new dietary ingredients
    • Ingredient or additive GRAS petitions
    • Development of industry wide or company specific risk
    • management profiles to reduce screening of imported foods, drugs, devices, or cosmetics by regulatory agencies
  • Federal or state courts in civil or criminal enforcement actions