Dan Dwyer is a partner who has been with the firm since 1987. His practice focuses primarily on representing food, cosmetic, pharmaceutical, medical device, and consumer products/services companies on a variety of matters involving FDA law, USDA law and advertising law. Mr. Dwyer has substantial 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 and related matters. He regularly advises clients on developing strategies for FDA compliance; compliance with USDA meat, poultry and egg inspectional requirements; and compliance with federal and state advertising law.

Mr. Dwyer has more than 20 years of experience in FDA law and related matters. He has built a national reputation for successfully resolving difficult and complex FDA compliance and regulatory matters. He has participated in FDA and Lanham Act litigation, and has pursued a number of 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.

Prior to joining the firm, Mr. Dwyer was investigator and legal advisor to the Vice Chairman at the U.S. International Trade Commission. He frequently writes and speaks on legal topics and has taught food-and-drug law as an adjunct professor at George Mason University Law School.

Best Lawyers in America 2014-2019.

  • 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

Martindale-Hubbell AV Rated

Chair, Food and Drug Law Institute Academic Programs Committee; 2004-2009.

Chair, Food and Drug Law Institute Law Professors Committee; 2004-2009.

Best Lawyers in America, 2014-2019

Mr. Dwyer is scheduled to conduct a training class at FDA’s Center for Devices and Radiological Health on June 6, 2011.

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

“Drug and Medical Device Advertising and Promotion,” speech at American Conference Institute, New York, NY, March 24, 2010.

“Direct-to-Consumer Advertising of Medical Devices,” speech at American Conference Institute, Chicago, IL, June 10, 2009.

“Drug and Medical Device Advertising and Promotion,” speech at American Conference Institute, New York, NY, March 24, 2009.

“Introduction to Drug Law,” speech at Food and Drug Law Institute program, Washington, DC, February 3, 2009.

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 (2008).

Dwyer, D and T Henteleff: “Over-the-Counter Drugs,” in Food and Drug Law Institute, Fundamentals of Law and Regulation (2008).

“Special Concerns for DTC Advertising,” speech at American Conference Institute, Boston, MA, September 23, 2008; and New York, NY, April 1, 2008.

“Direct-to-Consumer Advertising,” speech at American Conference Institute, New York, NY, March 27, 2007.

“Risks and Benefits of Utilizing Health Claims: Implementing Best Practices,” speech at American Conference Institute, Chicago, IL, September 25, 2006.

Chair, Panel Discussion on “Food Security,” Food and Drug Law Institute Annual Meeting, April 7, 2006.

“Introduction to Food and Drug Law,” training class for Food and Drug Law Institute Program for FDA/CDRH employees, October 26, 2004, April 18, 2005, and February 7, 2006.

“Health Claims for Foods,” speech at American Conference Institute, Orlando, FL, January 19, 2006.

“New Drug Applications,” speech at Food and Drug Law Institute program, June 14, 2004.

“Medical Device Reclassification,” speech at Advanced Medical Technology Association (AdvaMed) meeting on postapproval requirements, May 20, 2004.

Young, A and D Dwyer: Carrots and Sticks: Now Dietary Supplements Get Leeway on Notices and More Enforcement, Legal Times (March 1, 2004).

Dwyer, D and M Foster: Regulation of Dietary Supplements, in Food and Drug Law Institute, A Practical Guide to Food and Drug Law and Regulation (2002).

Dwyer, D and R Winters: Postmarket Surveillance: Summary of FDA’s Proposed Ruling. Regulatory Affairs Journal (Devices), 2000:8(4), 324-325.

“Drug Regulation,” speech at Food and Drug Law Institute Summer Internship Program (for law students); June 20, 2000.

“Food Safety,” speech at Food and Drug Law Institute program, April 10, 2000.

Dwyer, D: Functional Foods in the US Marketplace. Regulatory Affairs Journal, 1999:10(12),954-955 (guest editorial).

“Origins and Organizational Structure of FDA” and “FDA’s Regulatory Processes,” speeches at Food and Drug Law Institute program, November 4, 1999.

“Current FDA Implementation for Drugs and Biologics,” speech at Food and Drug Law Institute Summer Internship Program (for law students), June 23, 1998.

“Corporate Compliance Programs for National and International Companies,” co-chairman and speaker, Food and Drug Law Institute program, February 11, 1998.

Kaplan, A, K Reagan, B Beavers and D Dwyer: Over-the-Counter Drugs, in Food and Drug Law Institute, Fundamentals of Law and Regulations (1997).

Dwyer, D: “The Three Pillars of Corporate Compliance,” FDLI Update, Issue 6, 1997.

“The Three Pillars of Corporate Compliance,” speech before the New Jersey Corporate Counsel Association’s Food and Drug Law Committee, November 4, 1997.

“The Full NDA”, “FDA’s Regulatory Processes”, and “Obtaining Information from the FDA and Preventing FDA Disclosure,” speeches at Food and Drug Law Institute program, October 27-28, 1997.

“Food Safety Update: the Clinton Food Safety Initiative and Ongoing Food Safety Issues,” (moderator), speech at Food and Drug Law Institute program, June 2, 1997.

“Advertising, Promotion and Education on the Internet,” speech at Food and Drug Law Institute Annual Educational Conference, December 9, 1996.

“Corporate Compliance Programs and Investigations,” co-chairman and speaker, Food and Drug Law Institute program, October 30, 1996.

“The Responsibilities of Clinical Investigators and IRBs: Avoiding Warning Letters Relating to Clinical Investigations,” speech at Food and Drug Law Institute, Biologics Update, July 25, 1995

“The Federal Food, Drug, and Cosmetic Act: Clinical Data Requirements and Responsibilities of the Sponsor,” speech at Society for Biomaterials course on Approaches to the Clinical Evaluation of Medical Devices, December 1, 1994.

“The FDA Application Integrity Policy and Debarment,” speech at Food and Drug Law Institute program, June 23, 1994.

“Cases and Policies on Promotional Labeling,” speech at Institute for International Research, April 25, 1994.

“FDA Enforcement Activities Related to Advertising and Promotion,” speech at Regulatory Affairs Professionals Society, September 15, 1993

“FDA Inspections,” speech at Regulatory Affairs Professionals Society, May 1993

“Trying the Contaminated Food Case,” seminar at Dickinson College of Law, August 1992

“New Requirements for Medical Device Reporting,” speech before North Carolina Pharmacists Association, December 1990.

Kaplan A, R Becker, D Dwyer: Everyone is Due Due Process – Even at FDA, Pharmaceutical Executive 10,11:74 (1990).

Kaplan A, R Becker, D Dwyer: Deadline 1992: A United Pharmaceutical Market in the European Community, Pharmaceutical Executive 9,10:66 (1989).

Kaplan A, R Becker, D Dwyer: Trading Places: New Import-Export Laws Will Help U.S. Drug Makers, Pharmaceutical Executive 8,11:76 (1988).

Kaplan A, R Becker, D Dwyer: Under Fire: Defending FDA’s Role in Product Liability Lawsuits, Pharmaceutical Executive 8,10:60 (1988).