FDAImports.com was founded and is supervised by Benjamin England, Esq., a 17- year veteran of the U.S. Food and Drug Administration, and privately practicing attorney operating out of offices in Washington, D.C., Miami, FL, and Baltimore, MD.

Domestic and International matters routinely handled by the FDAImports.com Consultants and affiliated attorneys.  

The following links will open a new window to valuable information about the selected topic and how FDAImports.com can assist in resolving problems related to it. Feel free to browse through the information.  It is provided here as a service to you.  If you have specific questions regarding any of the topics, return here and click on the Contact Us button in the left margin.

• FDA Import Process – Understanding What Happens
• FDA Bioterrorism Act compliance,
• FDA’s Import Alerts -- Getting on an Alert & Getting off of an Alert
• Resolving FDA import Delays, import Detentions, Reconditioning Plans, Import Refusals & Re-importation of Previously Refused Foods,
• Obtaining Rescissions of FDA Refusals of Admission,
• Petitions to Customs for cancellation, mitigation, or remission of:
  
  • Customs liquidated damages assessment,
    
  • Customs civil monetary penalties, and
    
  • Customs administrative and civil forfeiture (seizure) actions;
     
• Defending FDA enforcement actions such as
  
  • Administrative detentions,
    
  • In rem seizures,
    
  • Civil TROs and injunctions,
    
  • Criminal enforcement actions (search warrants, subpoenas, and Grand Jury investigations) and prosecutions, and
    
  • Food importer and drug application debarment actions;
     
• Counseling related to export & import requirements of products regulated by multiple federal agencies;
• Assistance with food, medical device, and drug facility registration & medical device listing;
• FDA product labeling requirements (food, drugs, devices, cosmetics, etc.);
• TTB product labeling requirements for wine and alcoholic beverages;
• Electronic product performance standard, reporting & certification requirements;
• Advise regarding current Good Manufacturing Practices (cGMP) requirements for Foods, Drugs, and Biological Products and Quality System Regulations (QSR) for Medical Devices;
• Assistance in developing cGMPs for Dietary Supplements;
• Assistance in establishing safety of New Dietary Ingredients or handling dietary supplements with Drug Residues or Analogs
  
• Designing and submitting Structure/Function or General Health and Well Being claims for dietary or nutritional supplement products
• Seafood and juice HACCP compliance matters (foreign and domestic);
• Domestic and Foreign FDA inspection preparation and responses to Warning Letters, Untitled Letters, and FD-483s,
• Preparation for and response to FDA Filer (Customs broker) Evaluations,
• Conducting food additive (GRAS) assessments,
• Evaluating food, drug, device, or cosmetic color certification requirements,
• Resolving Environmental Protection Agency (EPA) and FDA tolerances for pesticides in foods (raw agricultural commodities and processed foods),
• Managing FDA product recalls,
• Reporting requirements for light and radiation emitting products (electronic product reporting) to obtain FDA Accession Numbers;
• Review and application of FDA Guidance Documents relative to regulated products, processes, and facilities under Good Guidance Practices (GGPs) as mandated by the Food and Drug Administration Modernization Act (FDAMA);
• Evaluation and challenge of FDA procedures, policies, practices and regulations under the Administrative Procedures Act (APA); and
• Advise foreign exporters and U.S. importers on U.S. Department of Agriculture (USDA) permitting requirements and foreign Veterinary Health Certificate requirements.

CONTACT:

Benjamin L. England, Esq.       blengland@fdaimports.com, 410-740-3403 (office line) (dir)
                                                                                                          443-583-1464 (fax)

The FDAImports.com successfully integrates attorneys and consultants with over 45 years of combined practical experience in dealing with domestic and international FDA, USDA and Alcohol and Tobacco Tax and Trade Bureau (TTB) problems. FDAImports.com consultants and affiliated attorneys have a particular focus on assisting foreign companies and U.S. importers (and the products being imported) achieve and maintain regulatory compliance with FDA, USDA and TTB requirements and navigating safe passage through the difficult and complex intersections of FDA/USDA/TTB and Customs laws and regulations.  

" Failing to comply with FDA or USDA requirements can result in refusal or rejection of shipments intended for the US market.  In addition, these governmental agencies may issue import alerts that are specific to product/manufacturer or shipper combinations resulting in a virtual importation ban of the affected products.  In certain extreme cases, government agencies may seize and forfeit non-complying FDA or USDA regulated products if the agencies perceive a significant risk related to them. "

One of the most unique capabilities at FDAImports.com is its combination and integration of specific regulatory and legal strengths providing the client with solutions that take into consideration the intersection of multiple federal regulatory regimes.  For instance, our consultants and affiliated attorneys are as fluent in discussing FDA requirements as USDA requirements.  In addition, because of their background and experience they are capable of evaluating problems in the context of Customs, International Trade, and International Tax considerations while reviewing the FDA, USDA, or other governmental agency requirements associated with a given matter.  

As federal power has expanded over the last several years, in response to the terrorist attacks of September 11, 2001, so has the jurisdiction and “reach” of regulatory agencies.  For instance, FDA and USDA both have new jurisdictions to directly regulate the transportation of food across state lines.  Because we have affiliated ourselves with two premier attorneys who routinely handle maritime and transportation matters for freight forwarders, carriers, NVOCCs, etc., FDAImports.com is uniquely situated to provide integrated recommendations and access to legal advice and counsel regarding FDA, USDA, Customs, Department of Transportation, Federal Maritime Commission, and U.S. Coast Guard issues.

FDAImports.com consultants and affiliated attorneys regularly represent domestic and international clients before the FDA, the USDA and Bureau of Customs & Border Protection (Customs) in matters relating to the importation and exportation of FDA- and USDA-regulated products.  FDAImports.com emphasizes proactive compliance strategies covering the requirements of multiple U.S. regulatory agencies.  This ensures compliance is comprehensive and is achieved in a cost-effective manner.   This may put the foreign manufacturer or shipper or the US importer in the best position to seek expedited clearance from FDA, USDA and other regulatory agencies on imported shipments.  FDAImports.com provides access to compliance counseling through regulatory and legal based strategies that may reduce the risk of regulatory actions that often result from non-compliance.  

FDAImports.com affiliated attorneys can also be called on to provide a full array of litigation services in matters relating to FDA, USDA, Customs and trade, and maritime law.