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Through our regulatory consultants and affiliated attorneys our clients 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 and supervised by Mr. Benjamin L. England, a 17-year FDA veteran and an attorney with over 20 years of combined, direct, and practical experience in the regulation of foods, dietary supplements, 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 retained 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.
Below you will find a few examples of the types of services FDAImports.com consultants and affiliated attorneys are able to provide:
FDAImports.com successfully integrates the skills and talents of attorneys and consultants with decades of combined practical experience in dealing with domestic and international FDA, USDA, Customs 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
Domestic and International matters routinely handled by FDAImports.com
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 Happen
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
- Customs administrative and civil forfeiture (seizure) actions
- Administrative detentions
- In rem seizures
- Civil TROs and injunctions
- Criminal enforcement actions (search warrants, subpoenas, and Grand Jury investigations) and prosecutions
- 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.)
FDA product labeling requirements
- foods
- drugs
- devices
- cosmetics
TTB product labeling and formulation 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
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
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)
Advise foreign exporters and U.S. importers on U.S. Department of Agriculture (USDA) permitting requirements and foreign Veterinary Health Certificate requirements
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 of regulatory agencies. For instance, FDA and USDA both have new jurisdictions to directly regulate the transportation of food across state lines.
Because FDAImports.com is affiliated 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 upon to provide a full array of litigation services in matters relating to FDA, USDA, Customs and trade, and maritime law.
FDA Enforcement Actions (Administrative, Civil, and Criminal)
