Daniel R. Dwyer
Partner
ddwyer@kkblaw.com

Mr. Dwyer's practice is concentrated on the regulation of food,
pharmaceuticals, dietary supplements, cosmetics, medical devices, and
related medical and consumer products. Areas of practice include:

		Legal status of products
		Advertising and promotional rules
		Recalls and safety issues
		Regulatory submissions and negotiations
		Product life-cycle management; exclusivity and patent term restoration
		Clinical trial compliance
		Good manufacturing practices and good clinical practices
		Corporate compliance programs and investigations
		Government enforcement actions
		USDA regulation of meat and poultry products
		Advertising and unfair trade practice law
		Consumer Product Safety Commission regulation

Recent Projects:

		Obtaining FDA acceptance of one of the first "functional foods," a cholesterol-reducing food, and related GRAS status, structure-function claims, and health claims
		Litigating advertising claims by dietary supplement manufacturers under the Lanham Act
		Preparing guidelines on the interaction of pharmaceutical companies with healthcare professionals
		Interacting with FDA and USDA on issues relating to "mad cow" disease
		Negotiating with FDA on scientific and legal requirements for labeling of food allergens.

Mr. Dwyer has been adjunct professor of food and drug law at George Mason University Law School since 1996, and is a frequent writer and speaker on FDA topics. Most recently he co-authored a chapter on " Regulation of Dietary Supplements" in the Food and Drug Law Institute's" Practical Guide to Food and Drug Law and Regulation."

Education:
B.A., State University of New York at Buffalo, 1977
J.D., Georgetown University, Washington, D.C., 1984

Professional Affiliations:
Member of the District of Columbia Bar Association, Maryland State Bar Association, and American Bar Association

Practice Credentials:
District of Columbia, Maryland, and various Federal courts