Mr. England routinely represents domestic and foreign companies of all sizes, assisting them in understanding and complying with USDA, FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), and state requirements. His representation enables his clients to 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 Regulatory Counsel to the Associate Commissioner for Regulatory Affairs, and before that as an FDA Consumer Safety Officer, Compliance Officer, Senior Special Agent with the Office of Criminal Investigations, and analytical regulatory microbiologist.
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 Benjamin L. England & Associates and FDAImports.com, Mr. England focuses his practice on FDA matters, such as challenging FDA administrative actions and import alerts; resolving FDA and Customs problems when importing or exporting products; preparing for, managing, and responding to FDA inspections; interpreting and applying FDA and USDA regulations, guidance, and procedure; labeling and advertising compliance for foods, drugs, medical devices, dietary supplements, and cosmetics; interpreting medical device requirements, including assisting companies in completing and filing pre-market notifications [510(k)s]; compliance with Electronic Product radiation emission and control requirements (e.g., FDA Accession Numbers, Product Reports, and record-keeping requirements); and export certification for medical devices, drugs, and foods.
- University of Miami School of Law, J.D. summa cum laude
- University of Maryland, B.A. in biology
- Spearheaded FDA’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
- Served as FDA’s lead in its strategic planning efforts to reinvent import programs
- Wrote the initial statement of work and acted as program manager over FDA’s new PREDICT (risk-based electronic entry screening system)
- Directed the development of 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.
- Benjamin L. England, Sung Won Park, FDA Flash Publication, A Victory Finally? FDA’s Perseverance in Facteau Pays Off – Some (October 18, 2016).
- Benjamin L. England, John F. Johnson, Sung Won Park, Solving or Compounding the Problem? – Issues in the Compounding & “Transaction Trinity” Under the Drug Quality and Security Act, FDLI Update (July/August 2015).
- More of the Same: Dramatic Changes in U.S. Regulation of Catfish Unlikely – Catfish Magazine, CAPPMA, Fish First Magazine, January 2015
- Understanding the Chinese Value Add – Maryland-China Business Council, June 2014
- Seafood and FSMA: We Don’t See No Stinking Exemptions – Seafood Expo North America, March 2014
- FDA Import Enforcement Changes for Chinese Seafood Exporters – China Fisheries and Seafood Expo, November 2013
- Exporting Food & Beverages to the USA/Getting in and Staying in the USA – IFEX, June 2013
- Exporting Alternative Medicine, Dietary Supplements and Cosmetics – IFEX, June 2013
- US Regulation of Imported Food & Beverages, Drugs, Cosmetics, & Dietary Supplements – IFEX, June 2013
- Importing Food and Drugs into the United States: A Technical and Strategic Approach – Hubei, May 2013
- Quantifying Added Costs of Operating Under New Regulation Standards – Food Safety Summit, April 2013
- State Bar of Maryland
- State Bar of Florida
- District of Columbia Bar