Our Services

Through our regulatory consultants and affiliated attorneys our clients can obtain confidential, proven, and effective counsel and advice regarding compliance with complex FDA, USDA, TTB, Customs, or International Transportation regulatory requirements.

Our affiliated attorneys routinely represent our clients before federal and state agencies defending their legal rights and obtaining outcomes that benefit our clients' abilities to compete in the U.S. market place. If an enforcement action has already been initiated against a company, it is important to quickly obtain effective counsel to defend against the action.

FDAImports.com is led by a gentlemen with over 20 years of combined, direct, and practical experience in the regulation of foods, drugs, medical devices, cosmetics, veterinary products, and electronic products and the application and enforcement of FDA, USDA, EPA, and Customs laws, regulations and policies.

FDAImports.com is supervised by Benjamin L. England, an attorney with 20 years of experience in various aspects of FDA regulation and enforcement, 17 of which he worked for the FDA. Benjamin England was a senior Special Agent for FDA's Office of Criminal Investigations during portions of his FDA career and has investigated and brought to successful prosecutions many criminal cases involving a wide array of FDA regulated industry and products. He operated as one of FDA's primary points of contact for other agencies involved in managing risks associated with highly regulated imported commodities including, USDA, Customs and EPA.

FDAImports.com has also associated itself with other attorneys with extensive experience in dealing with administrative and regulatory enforcement actions and with the knowledge to assist in civil or criminal inspections, investigations, defense, or litigation.

FDAImports.com can assist you in identifying regulatory and legal requirements for your products or advertising and help you comply with the requirements before a case is initiated against your company or your products.

Continue to browse FDAImports.com. Review our issues pages and our links pages for additional information on our services or on matters of concern to your company or industry.

• Regulatory label reviews for foods, cosmetics, dietary supplements
• Compliance with current good manufacturing practices
• Developing risk management programs for participating in voluntary government programs (C-TPAT, FDA's green lane, etc.)Assisting in designing label or labeling claims for foods, dietary supplements in accordance with FDA requirements
• Assisting with obtaining USDA permits
• Assisting with obtaining export certificates
• Assisting in complying with multi-state registration requirements for food, device, or drug distribution
• Assisting with implementing required steps to bring articles, manufacturing, warehousing, or distributing practices, or registrations and pre-market requirements into compliance
• Assisting in generally recognized as safe evaluations or petitions for new food or drug ingredients
• Analysis
• Assistance in obtaining and using private laboratory analysis for release of FDA or USDA detained or refused goods
• Evaluation, review or analysis of evidence relied upon by the government to
  • initiate an administrative action (FDA detention, refusal, debarment, warning letter),
  • support a civil seizure action (under FDA or Customs authority),
  • support an injunction action initiate and prosecute a criminal case involving an FDA or USDA regulated product
• Advice
  • Provide counsel through an affiliated attorney regarding legal and regulatory requirements of various federal or state agencies
  • Advise companies through an affiliated about regulatory compliance status of their products under federal and state law
  • Obtain opinions from affiliated counsel regarding required steps to bring articles, processes, companies, or records into compliance with regulatory and legal requirements
• 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

• Product Label Reviews/Revisions
• Marketing (Labeling) Reviews/Revisions
• Internet Site Compliance
• Resolving FDA Detentions
• Rescinding FDA Refusals
• Resolving Import Alerts
• Medical Device 510(k)s
• Device Classifications
• Expert Witness/Testimony
• U.S. Agency Services
• Registration & Listing
• Regulatory Consulting
• Talk to FDA Legal Counsel
• Talk to Customs Legal Counsel
• Talk to USDA Legal Counsel
• Talk to TTB Legal Counsel
• Recall Support
• Correspondence with Government
• Supply Chain & Logistics Support