John Johnson III practices FDA and Customs law with a focus on integration of the two agencies’ regulatory compliance requirements. He has extensive experience with representation of FDA-regulated clients before FDA, USDA, Customs and other regulatory agencies to include developing import and export operating procedures that smooth and expedite movement of highly-regulated goods.
Mr. Johnson aptly works with FDA Compliance Officers, Headquarters Officials, Customs officials, laboratories, warehouses, foreign suppliers, importers and brokers to remove unnecessary impediments in the supply-chain. He works with numerous clients to overturn FDA, USDA and Customs administrative, regulatory and civil enforcement actions restricting distribution of FDA-regulated goods.
To minimize the risk of FDA scrutiny and enforcement actions, Mr. Johnson advises firms on current Good Manufacturing Practices applicable to foods, dietary supplements, drugs and medical devices and developing and implementing Standard Operating Procedures to ensure compliance. He regularly advises the food industry with compliance in relation to the Food Safety Modernization Act (FSMA).
- Food & Drug Law Institute (FDLI)
- World Trade Center Institute (WTCI)
- 2018 Rising Star Lawyer by Super Lawyers®, part of Thomson Reuters
- Washington College of Law, American University, J.D., cum laude
- St. Mary’s College of Maryland, B.A. in history, cum laude
- Advised clients on compliance with FSMA requirements including FSVP and Preventive Control rules.
- Reviewed, evaluated and prepared responses to FDA for 483s, Untitled Letters, Warning Letters related to the labeling, marketing and manufacturing conditions of FDA-regulated products
- Routinely represents clients before FDA to obtain efficient releases of imported products subject to automatic detention while also obtaining removal of the foreign manufacturer from FDA import alerts.
- Advised private laboratories on FDA policies, methodologies and procedures for reviewing and accepting private laboratory reports.
- Managed recalls of FDA-regulated products while reducing client impact.
- Managed client meetings with FDA and other agencies advocating legal, regulatory and business interests of clients.
- Coordinated legal and regulatory reviews of foods, drugs, cosmetics, medical devices, tobacco products and alcoholic beverages with respect to labeling, registration, listing, pre-approvals, submissions of data prior to marketing, Good Manufacturing Practices, and permits and licenses, as required to ensure compliance with applicable requirements.
- Coordinated the efficient import releases of products subject to automatic detention while also removing the foreign manufacturer from FDA import alert
- Persuaded FDA that an import alert did not apply and thereby avoided automatic detention for dozens of shipments
- Advised private laboratories on FDA policies and procedures for reviewing and accepting private laboratory reports
- Managed the recall of holiday product during the holiday season, while minimizing the impact on the firm
- Corrected FDA in multiple instances on the proper labeling for infant and toddler foods
- Managed the successful importation of over 110 entries subject to an import alert, while minimizing the commercial impact of the FDA detentions
- John F. Johnson III, How FDA’s program Alignment Affects Your Industry: Food and Dietary Supplements – FDLI Enforcement, (December 2017)
- John F. Johnson III, FDA’s Preventive Controls Rule: Common Misconceptions Revealed – Alchemy Academy Webinar (July 26, 2017)
- John F. Johnson III, Schevon G. Salmon Jr., Thomas C. Knott, Health and Wellness Products: How the FDA Decides What to Regulate, DRMA- Response Magazine (May 16, 2017)
- John F. Johnson III, When Looks are All that Matter: A Primer about FDA’s Enforcement Authority over Imported Products, American Bar Association: Food, Cosmetics and Nutraceuticals Committee Newsletter (Winter 2017)
- John F. Johnson III and Nicole Ault, Fighting with KINDness: FDA’s Unhealthy Enforcement of the “Healthy” Nutrient Content Claim Regulation, FDLI- Update Magazine (Nov/Dec 2016)
- John F. Johnson III, Sung Won Park, Issues to Watch: FDA’s Deeming Regulations, FDLI Update (September/October 2016)
- John F. Johnson III, FDA Enforcements against Imports – FDLI Enforcement (December 2015)
- John F. Johnson III and Richard Chiang, FDA and Dietary Supplements – NPA Webinar (December 2015)
- John F. Johnson III, Legal Grey Areas in the Produce Safety Rule – FDLI (November 2015)
- Benjamin L. England, John F. Johnson III, 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).
- John F. Johnson III, All I Want from CFSAN is: An Effective Voluntary Qualified Importer Program – FDLI Annual Conference (April 2015)
- John F. Johnson III, More of the Same: Dramatic Changes in U.S. Regulation of Catfish Unlikely – Catfish Magazine, CAPPMA, Fish First Magazine (January 2015)
- John F. Johnson III, FDA Enforcement Against Imports – FDLI (December 2014)
- John F. Johnson III, FSMA: Third-Party Auditors and the Sanitary Transportation of Food – FDLI Food Week (September 2014)
- Rick Quinn and John Johnson III, Imported Orange Juice Gets the Squeeze: FDA’s Illegal Treatment of Brazilian Orange Juice During the Carbendazim Incident, FDLI Update 14 (May/June 2012)
- Rick Quinn and John Johnson III, S. Law & Regulation for OTC Drugs: Basics of Compliance and Importation, New York Health Forum Magazine (June 2012)
- Trained Individual for Seafood HACCP (Part 123), holding a NOAA Certificate of Completion