John works with companies to develop and implement practical and cost-effective solutions for complying with the laws administered by Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Customs and Border Protection (CBP) and other federal and state agencies. He works with manufacturers, distributors, brand owners, importers and retailers of food, drugs, medical devices, cosmetics and animal products to satisfy their regulatory obligations.
John also represents companies before FDA and other government agencies subject to inspections or compliance activities, including a judicial action, Warning Letter, Untitled Letter, regulatory meeting, administrative detention, import detention and import alert, and FDA Form 483. Additionally, he helps companies evaluate complaints to determine if a recall is necessary, and if so, he works with clients to manage the product recall to remove the product from market while minimizing any disturbance to the business. In his representation, he advocates for clients while also seeking to improve their relationships with regulators.
John counsels clients throughout the product life cycle, including product development and specifications; marketing and labeling; registrations, permits, licenses and pre-market submissions; and manufacturing, importation, distribution and sales. He works with clients about the federal rulemaking process involving potential regulatory changes, the impact on their business, and ways to be involved in the regulation process. In his counseling, he provides regulatory advice that is tailored to the client’s business and marketing objectives for the product. Also, he works with clients to create, implement and maintain internal programs to help foster smooth compliance.
Negotiated a consent decree with the Department of Justice concerning threatened litigation to enforce FDA requirements and assisted the client’s company in complying with the decree.
Resolved FDA Warning Letters for seafood manufacturers through guiding them on how to improve their food safety program and effectively demonstrating the improvements to FDA.
Developed compliance program for a manufacturer to successfully import materials to manufacture an unapproved drug product and export it to the market where it was approved.
Developed importers’ compliance program to satisfy the Foreign Supplier Verification Program (FSVP) requirement for imported foods, which were successfully inspected by FDA.
Managed the recall of seasonal product during the holidays, while minimizing disruption to business.
Handled the import hold of approximately 100 separate shipments, coordinating with the manufacturer, multiple importers, third parties and FDA to obtain an import release for the individual shipments. Concurrently petitioned FDA to lift the import alert that caused the import detentions.
Persuaded FDA that clients’ products comply with the law, despite FDA’s initial allegation of non-compliance, through identifying FDA error in the science, product characteristics or law, and then concisely explaining this to the agency.
Challenged government “guidance” that failed to comply with the notice-and-comment rulemaking requirement in the Administrative Procedure Act.
Conducted U.S. Customs classification for FDA-regulated products, including identifying possible duty-savings measures.
Moderator, OTC Drug Reform: Moving From Regulations and Orders and What’s Next?, Food and Drug Law Institute Annual Conference, May 20, 2021.
FDA’s Foreign Supplier Verification Program Enforcement: Learned Lessons from FDA’s First Actions, Webinar, National Customs Brokers & Forwarders Association of America, Inc. (NCBFAA) Educational Institute, December 10, 2020 (with Elizabeth Fessler).
What are FDA’s Tools for Responding to Public Health Emergencies Such as the Coronavirus (COVID-19)?, Webinar, Food and Drug Law Institute (FDLI), March 19, 2020.
Telling the Compliance Story, Florida Customs Brokers & Forwarders Association, FDA Seminar, June 2018.
FDA’s Preventive Controls Rule: Common Misconceptions Revealed, Webinar, Alchemy Academy, July 2017.
FDA and Dietary Supplements, NPA Webinar, December 2015 (with Richard Chiang).
A Taste of FDA’s 2021 Food Priorities: Undeclared Major Food Allergens, Food & Beverage Litigation Update, Special Supplement, Shook, Hardy & Bacon, March 12, 2021 (with Anna El-Zein).
Why Honey Is a Sweet Target for Consumer Litigation, Law360, January 28, 2021 (with Jim Muehlberger).
It’s More than a New Graphic: How the New Nutrition Facts Panel Can Impact a Food’s Labeling, Marketing and Formulation, Guide to U.S. Food Labeling Law, August 11, 2020 (with Zac Parker).
Imports and International Issues, Introduction to Medical Device Law and Regulations, November 2019.
History and Law of Food Standards, FDLI Food Advertising, Labeling and Litigation, September 2019.
Consumer Fraud Cases in Food and Drugs, FDLI Enforcement, December 2018.
Helping to Stop Death, Destruction, and Diarrhea: FDA’s Tools to Respond to Public Health Emergencies, FDLI Update, April 2018.
How FDA’s Program Alignment Affects Your Industry: Food and Dietary Supplements, FDLI Enforcement, December 2017.
Health and Wellness Products: How the FDA Decides What to Regulate, Response Magazine, May 2017 (with Schevon Salmon and Thomas Knott).
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.
Fighting With KINDness: FDA’s Unhealthy Enforcement of the “Healthy” Nutrient Content Claim Regulation, FDLI Update, November/December 2016 (with Nicole Ault).
Issues to Watch: FDA’s Deeming Regulations, FDLI Update, September/October 2016 (with Sung Won Park).
FDA Enforcements Against Imports, FDLI Enforcement, December 2015.
Legal Grey Areas in the Produce Safety Rule, FDLI Update, November 2015.
All I Want From CFSAN Is: An Effective Voluntary Qualified Importer Program, FDLI Annual Conference, April 2015.
FDA Enforcement Against Imports, FDLI Enforcement, December 2014.
FSMA: Third-Party Auditors and the Sanitary Transportation of Food, FDLI Food Week, September 2014.
Imported Orange Juice Gets the Squeeze: FDA’s Illegal Treatment of Brazilian Orange Juice During the Carbendazim Incident, FDLI Update, May/June 2012 (with Rick Quinn).
Macaroni, 60 Seconds of Legal Insights, Shook, Hardy & Bacon, March 8, 2021.
Toothpaste, 60 Seconds of Legal Science, Shook, Hardy & Bacon, January 26, 2021.
U.S. FDA’s ‘Narrow Path’ Squeezes Some Firms New to Sanitizer Space Under Enforcement Discretion, HBW Insight, July 20, 2020.
FDA Takes Steps to Speed Diagnostics, Provide Regulatory Relief Amid Pandemic, Smart Brief, March 27, 2020.
Coronavirus Products Would Get Safe Harbor Under Senate Bill, Pink Sheet, March 23, 2020.