“I have had the unique privilege of working for nearly 40 years at the intersection of FDA- and Customs-enforced laws and regulations, policies, and procedures both inside the FDA and in private practice. I have taken these experiences and devoted my practice to empowering people to improve lives with the many fabulous products my clients make, market, and move in the U.S. marketplace.”
Overview
Mr. England routinely represents domestic and foreign companies of all sizes, informing guiding their understanding, counseling them related to their compliance and defending their interests related to the requirements of Food and Drug Administration, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), Customs and Border Protection (CBP), and state requirements. His clients operate all nodes of the international supply chain and are members of all FDA-regulated industry verticals, including food and agriculture, dietary supplements, cosmetics, OTC and Rx pharmaceuticals, homeopathic and natural medicines, medical devices, electronic products, and vaping (tobacco) products.Â
A 17-year veteran of the FDA, Mr. England last served as Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and before that as an FDA Investigator, Compliance Officer, Senior Special Agent with the Office of Criminal Investigations (OCI). He began his career in the Baltimore Lab as an analytical regulatory microbiologist.
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Marshaling his decades of experience from his many years inside and outside the FDA, Mr. England successfully represents clients before federal agencies, as defense counsel in consumer-based litigation matters (including CA Proposition 65 Notices and claims) and serves as an Expert Witness for clients (plaintiff and defendant) in cases involving foods, food additives, dietary supplements, cosmetics, pharmaceuticals, medical devices, and FDA and CBP enforcement cases.Â
Focus Areas:
Regulatory Counsel and Representation; FDA-Regulated Industries
Benjamin represents many domestic and international food clients in matters related to product design, development, manufacturing, labeling, pre-market clearances, importation, exportation, and distribution of all products regulated by FDA such as foods, dietary supplements, drugs (Rx, OTC, homeopathic), and medical devices.
Food and Dietary Supplement Safety, Compliance, and Enforcement. Â
Benjamin provides advice and counsel to foreign and domestic clients related to food and dietary supplement safety and manufacturing/processing, labeling and marketing/claims compliance and GRAS notifications. He also represents clients before the FDA related to agency inspections, product recalls, and other regulatory and compliance actions, as well as civil and criminal investigations and enforcement actions.
Medical Devices.
Benjamin assists domestic and international clients with regulatory compliance and guidance for pre-market submissions to the FDA including pre-market notification (510(k)s) submissions, de novo medical device submissions, Pre-Market Approval (PMA) counsel, and 513(g) requests for classification. He regularly represents clients before the FDA related to regulatory and civil actions, including support in litigation against the Agency.
Drugs
Benjamin regularly provides counsel to clients in the pharmaceutical industry related to FDA regulations, procedures and policies governing OTC and Rx, allopathic and homeopathic drug products. He provides guidance and represents clients before the FDA in matters involving investigational new and new drug application submissions and counsels and represents clients in enforcement actions including recalls and defending against FDA consent decree actions.
Customs and Border Protection, Federal Trade Commission and Litigation matters
Because of his extensive background with the FDA and CBP, Benjamin has regularly provides counsel to clients regarding compliance and enforcement risks associated with marketing and advertising claims regulated by the FDA and FTC in all FDA regulated commodities. He counsels clients in constructing financial transactions related to goods in international and interstate commerce to minimize federal agency interference and enforcement risks. He has successfully represented clients before CBP in matters involving Withhold Release Orders (WROs) based upon alleged Forced Labor violations and as co-counsel in litigation matters involving claims related to false or misleading advertising and marketing, slack fill cases, and private enforcement of California Proposition 65.
Corporate Counsel and Expert Witness Experience
Benjamin supports clients with Due Diligence associated with corporate merger and acquisition transactions and Initial Public Offerings involving FDA-regulated domestic and foreign companies. Benjamin also serves as an expert witness in civil and criminal matters involving FDA policy, procedures, approval, compliance and enforcement associated with FDA regulated goods.
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