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
