Benjamin L. England, Esq.

Founder FDAImports.com, practicing private attorney

Contact Mr. England Directly:
Telephone: (410) 740-3403
Facsimile: (443) 583-1464
Email: blengland@fdaimports.com

6420 Dobbin Road, Suite E
Columbia, MD 21045

Mr. Benjamin L. England is an attorney and the founder of Benjamin L. England & Associates, LLC., and FDAImports.com, LLC

A 17-year veteran of the U.S. Food and Drug Administration (FDA), Mr. England focuses his practice on FDA matters, including:

• Preparing for, managing, and responding to FDA inspections;
• Food, dietary supplement, and cosmetic labeling;
• Dietary Supplement labeling and advertising compliance under FDA and FTC regulations, including preparation and filing of new dietary ingredient notices and structure and function and general health and well being claim notifications;
• Medical device requirements, including assisting companies in completing and filing pre-market notifications [510(k)s];
• Electronic Product radiation emission and control requirements under the Radiological Control Health and Safety Act of 1968 (e.g., FDA Accession Numbers, Product Reports, and Record Keeping requirements);
• Resolving problems associated with FDA and U.S. Bureau of Customs and Border Protection (Customs) during importation or exportation products;
• FDA criminal, regulatory and administrative enforcement actions;
• Interpretation and application of FDA and USDA regulations, guidance, and procedure;
• Challenging FDA administrative actions and import alerts;
• Customs civil actions such as petitioning for relief from Customs liquidated damages claims related to FDA imported products or Customs civil monetary penalty or forfeiture actions involving the incorrect interpretation of FDA law and requirements;
• Export certification for medical devices, drugs, and foods;
• US Department of State authentication and foreign embassy consularization of documents required for international transactions;
• Criminal enforcement of the Food Drug and Cosmetic Act; and
• All issues related to the development, interpretation, and involving implementation of FDA’s bioterrorism rules and initiatives.

Mr. England’s FDA experience ranges from guiding responses to FDA and U.S. Department of Agriculture (USDA) inspection and enforcement actions; to defending against FDA and Customs criminal investigations, inquiries, and prosecutions; to assisting clients in leveraging their risk management programs for food, medical device or drug distribution against FDA and Customs import clearance processes to obtain more rapid cargo clearance.   

Mr. England routinely represents domestic and foreign companies of all sizes, assisting them in identifying USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements.  His representation enables his clients to better understand and fully comply with these federal and state requirements and thereby reduce the risk of regulatory interference with products being imported, exported or distributed in interstate commerce.
 
Mr. England has overseen crossover applications of FDA’s bioterrorism and food security guidance into the drug and medical device industries and oversaw for FDA the development of the bioterrorism regulations affecting domestic and foreign food establishments, and the agency’s implementing guidances.  He also has handled complex matters involving imported products subject to FDA administrative or Customs’ civil enforcement (seizure, monetary penalties, or claims for liquidated damages) and criminal investigations and defense related to drug diversion, drug counterfeiting, smuggling, food importation, unapproved drugs, and dietary supplements.

While at FDA Mr. England served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Before this, he served in scientific, inspectional, compliance and criminal and civil enforcement capacities as an FDA Consumer Safety Officer (CSO), Compliance Officer (CO), a Senior Special Agent (SA) with the Office of Criminal Investigations (OCI) and an analytical regulatory microbiologist.

Most notably, during his last three years at FDA Mr. England spearheaded the agency’s integration efforts with Customs and USDA on crosscutting interagency enforcement and operational issues; served as the DA’s point-person in managing the intersection of imports and FDA’s new bioterrorism regulations; established joint agency and industry working groups to evaluate counterfeiting and tampering risks to food and drug distribution supply chains; was the agency lead in its strategic planning efforts to reinvent the FDA’s import programs; and directed the development of the FDA’s agency-wide Risk-based Strategy for Imports designed to improve compliance of foods, dietary supplements, drugs, medical devices, cosmetics, and biological products imported into the U.S.  

Mr. England received many distinguished service awards from the Department of Health and Human Services and FDA during his 17-years of public service.

Education
Mr. England received his Juris Doctor degree, summa cum laude, from the University of Miami School of Law where he was a member of the Order of the Coif and the University of Miami Law Review. He received his Bachelor of Arts degree in biological sciences from the University of Maryland.

Bar Admissions
State Bar of Florida
State Bar of Maryland
District of Columbia Bar.