Daniel R. Dwyer | Kleinfeld Kaplan & Becker LLP

Overview

Dan Dwyer has built a nationally recognized practice in FDA law, advertising law and related matters. He has expertise in food and drug safety issues, clinical trials, labeling and advertising claim substantiation, sales and marketing practices, good manufacturing practices, FDA inspections, recalls, corporate compliance programs, Food Safety Modernization Act (FSMA) requirements, and prescription drug exclusivity. He serves a diverse range of organizations in the food, cosmetic, pharmaceutical, medical device, and consumer product industries. He also frequently assists clients in developing strategies for FDA compliance, especially FSMA compliance for foods, good manufacturing practice (GMP) compliance for drugs and dietary supplements, hemp law compliance for hemp product manufacturers, and good advertising and marketing practices for FDA-regulated products.

Dan is particularly called on to help with difficult or unusual FDA regulatory matters. His experience includes representing clients in FDA and Lanham Act litigation as well as representing a number of businesses in advertising law cases at the National Advertising Division of the Council of Better Business Bureaus involving competitive challenges on behalf of food, dietary supplement, cosmetic and OTC drug manufacturers.

Previously in his career, Dan was an investigator and legal advisor to the Vice Chairman at the U.S. International Trade Commission (ITC). He is a frequent author and speaker on legal topics and has taught food-and-drug law as an adjunct professor at George Mason University Law School. Dan has been highly rated by Martindale-Hubbell AV Rating program, the Best Lawyers program for his work in FDA law, and other rating services.

Experience

Obtained FDA acceptance of one of the first “functional foods,” a cholesterol-reducing food, and related GRAS status, structure-function claims, and health claims
Litigated advertising claims by dietary supplement manufacturers under the Lanham Act
Prepared guidelines on the interaction of pharmaceutical companies with healthcare professionals
Interacted with FDA and USDA on issues relating to “mad cow” disease to ensure continued safe use of cattle-derived products.
Obtained USDA acceptance of a new egg product regulatory status
Negotiated with FDA on scientific and legal requirements for labeling of food allergens
Handled product recalls and interacted with FDA to resolve agency concerns over manufacturing processes.
Resolved the status of products imported into the US and potentially subject to FDA import alert.
Provided advice on implementing OTC drug marketing rules enacted in 2019.
Advised on responding to FDA inspectional issues for foods, drugs, medical devices and cosmetics.
Assisted manufacturers and retailers of FDA-regulated hemp products (such as foods, drugs and cosmetics) on developing specifications and labeling to support compliance with federal and state laws.
Advised a drug manufacturer in managing exclusivity issues relating to old antibiotics and products under FDA’s qualified infectious disease program.

Publications & Speaking Engagements

“FDA Labeling Update,” panel discussion at ACI 4^th Annual Advanced Summit on Food Law, July 15, 2020 (virtual conference).

“OTC Drug Reform in the CARES Act,” webinar for clients, April 7, 2020.

“The Somewhat Dis-United States: A Patchwork Quilt of Hemp Laws,” presentation at FDLI Food Enforcement and Compliance Conference, March 26, 2020 (virtual conference).

“To CBD or Not to CBD: How to Know If Your CBD Is 2018 Farm Bill Compliant and Key Considerations Before Diving Into the Market,” Retail Industry Leaders Association, Nashville, TN, October 17, 2019.

“Food Recalls,” panel discussion at Food Safety Consortium, Schaumburg, IL, October 1, 2019 “Case Study on Pharmaceutical Advertising and Promotion.”

“Drug and Biologics Advertising and Promotion 101,” speech at American Conference Institute, FDA Boot Camp, Boston, MA, September 19, 2019.

“What Lies Ahead for Hemp and Cannabis-Related Ingredients,” speech at American Conference Institute, Advanced Summit on Food Law, Chicago, IL, April 10, 2019.

“Drugs and Biologics Advertising and Promotion 101,” speech at American Conference Institute, FDA Boot Camp, New York, NY, March 27, 2019.

“Edibles and Infused Products,” panel moderator, at Food & Drug Law Journal Symposium on Federal Regulation of Cannabis, Washington DC, November 2, 2018.

“Policies and Politics – Opportunities and Challenges Facing the FDA,” panel discussion at FDLI Annual Conference, Washington DC, May 3, 2018.

“Best Practices for Managing FDA and USDA Inspections,” panel discussion at American Conference Institute, Food Law Regulation, Litigation, and Compliance, Chicago, IL, April 23, 2018.

“Investigations of Foodborne Illness Outbreaks: The Growing Role of Environmental Monitoring and Whole Genome Sequencing,” panel moderator at FDLI Food Enforcement and Compliance Conference, Washington DC, April 12, 2018.

“What’s the Score with SCORE? FDA’s Guidelines for Food Safety and Enforcement,” panel moderator at FDLI Annual Conference, Washington DC, May 4, 2017.

“Overview of U.S. Food Law and Regulation,” speech at Intro to Food Law and Regulation, Food and Drug Law Institute, Washington, DC, March 2, 2017.

“FDA Update – Inside the Latest FDA Initiatives and How to Re-Adjust Compliance Protocols,” speech at American Conference Institute FDA & USDA Compliance Boot Camp, Chicago, September 28, 2015.

“Adulteration and Your Role in Delivering Value to Consumers: Quality, Safety & Efficacy,” presentation and panel discussion at Dietary Supplement Ingredient Marketplace, Orlando, FL, April 8, 2015.

“Overview of U.S. Food Law and Regulation” and “Food Safety: Unintended Components/Contaminants of Food,” presentations at Introduction to Food Law and Regulation Conference, Food and Drug Law Institute, February 23, 2015.

“Class Action Lawsuits Against OTC Drugs,” panel member and presentation at American Conference Institute program Regulatory and Compliance Forum on Over-the-Counter Drugs, New York, October 28, 2014.Panelist. FDLI Advertising and Promotion for Medical Products Conference. 17 October 2019.

“FSMA Update – A Comprehensive Review of FSMA Rules and How to Prepare Your Company for the Long Haul,” panel member and presentation at American Conference Institute program FDA & USDA Compliance Boot Camp, Chicago, September 29, 2014.

“Current and Emerging Regulatory Issues in the Tea and Infusion Products Industry,” presentation at World Tea Expo, Long Beach, CA, May 30, 2014.

“FDA-Related Compliance Issues,” speech at 25th Annual All Hands Meeting, Silicon Valley Association of General Counsel, Santa Clara, CA, December 5, 2013.

“Legal Issues Relating to NSURE and Use of New Technology to Assure Conditions of Safe OTC Use,” speech at American Conference Institute program on OTC Drugs, New York, October 29, 2013.

“Marketing and Advertising – How to Craft the Right Health, Nutrition, Structure-Function, Benefit, and Mental Performance Claims,” speech at American Conference Institute program FDA & USDA Compliance Boot Camp, Chicago, October 1, 2013.

“Inpections: Frequency, Manner and Targeting,” chapter in The Food Safety Modernization Act: A Comprehensive, Practical Guide to the Landmark Legislation, Food and Drug Law Institute, January 2012.

Planning committee member and panel speaker at “Food Safety at the Crossroads: How the Food Safety Modernization Act is Changing the Landscape,” Food and Drug Law Institute, Washington, DC, January 25, 2012.

“Issues in Advertising Law for OTC Drugs and Cosmetics – Ensuring that Claims are Legally Substantiated,” speech at Unilever United States, Inc., Englewood Cliffs, NJ, October 27, 2011.

“Introduction to Medical Device Law,” speech at FDA/CDRH (Food and Drug Law Institute), White Oak, MD, September 7, 2011.

Dwyer, D and A Young, “Regulation of Dietary Supplements,” in Food and Drug Law Institute, A Practical Guide to Food and Drug Law and Regulation (2011).

Dwyer, D and S Ehrlich: “Over-the-Counter Drugs,” in Food and Drug Law Institute, Fundamentals of Law and Regulation (2011)

“FDA Regulatory Briefing – Gelatin,” speech at Rousselot conference, El Paso, TX, April 14, 2010.