Benjamin L. England, Esq.

Position: Founder & CEO

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.

A 17-year veteran of the U.S. Food and Drug Administration (FDA), Mr. England served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and previously, 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 as 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 FDA’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; wrote the initial statement of work and acted as program manager over the FDA’s new PREDICT, risk-based electronic entry screening system; and directed the development of the FDA’s agency-wide Risk-based Import Strategic Plan 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. Currently, as Founder and CEO of FDAImports.com, Mr. England focuses his practice on FDA matters, including:

• Preparing for, managing, and responding to FDA inspections;
• 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;
• Labeling for Food, dietary supplement, drug, medical device, and cosmetics;
• 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) when importing or exporting 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.