Daniel Dwyer's Email & Phone

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