Fred Degnan,

a partner in the firm’s FDA & Life Sciences Practice Group, came to King & Spalding in 1988 bringing with him over eleven years of broad experience in FDA’s Office of the Chief Counsel. From 1980 to 1988, Mr. Degnan served as FDA’s Associate Chief Counsel for Foods and as an Associate Chief Counsel for Enforcement. His career at FDA included extensive experience with food and drug issues including safety, nutrition and health, labeling, good manufacturing practice, packaging, biotechnology and the use of risk assessment and risk management in the regulation of the safety of food components. He was FDA’s attorney liaison with DEA and Chairman of the Interagency Council on Drug Control. He also had substantial litigation and enforcement responsibilities and appeared on behalf of FDA in over thirty states.

At King & Spalding, Mr. Degnan specializes primarily in food law. He handles a wide array of food safety, biotechnology, good manufacturing practice and labeling issues as well as occasional CPSC-related issues. He represents several large multinational food companies, a number of domestic food producers, and several international science-based nonprofit associations. Mr. Degnan served for eight years as General Counsel to the Food and Drug Law Institute and from 2009 to 2010 he served as Chair of the organization’s Board.

From 1989 through 2010, in addition to his responsibilities at King & Spalding, he taught food and drug law at the Catholic University of America’s Columbus School of Law where he served as a “Distinguished Lecturer.” He has published and lectured extensively on FDA-related issues and is the author of the book FDA’s Creative Application of the Law: Not Merely A Collection of Words (Second Edition, 2006), a consideration of FDA’s implementation of its statutory authority to adapt to the practical demands of modern regulation.

While at FDA, Mr. Degnan received the agency’s highest awards. In 2002, Mr. Degnan received the FDLI Distinguished Leadership Award for his contributions to the food and drug community. In independently conducted surveys, Mr. Degnan has consistently ranked among the top food and drug lawyers both “nationwide” (Chambers USA; LMG Life Sciences “Life Sciences Star”) and in Washington, D.C., (Washingtonian Magazine “Best” Lawyers; Law & Politics Washington, D.C., “Super Lawyers,” and Best Lawyers in America.

From 2008 through 2014 Chambers USA designated Mr. Degnan as one of three lawyers nationwide practicing food and beverage law who merit the organization’s highest ranking, “Band 1.” Chambers has observed that Mr. Degnan has been praised by sources for his ability “to bridge and explain the different disciplines of law and science.” Chambers has also reported that clients have described him as “the perfect balance between expertise and client service” and as seeing “issues from the point of view of FDA as well as the client” and as providing “just the right balance of legal innovation and conservative responsibility … to help maintain an excellent relationship with FDA.” Chambers also notes that Mr. Degnan “is a go-to guy for serious regulatory problems … superb, very experienced, very professional.’” LMG Life Sciences stated these views: “Fred is an extraordinary person and a dedicated and devoted lawyer – very thoughtful, resourceful and very involved in the FDA industry … a positive force in the broader FDA ecosystem.”

Mr. Degnan received his undergraduate degree, cum laude, from the College of the Holy Cross, Worcester, Massachusetts and his law degree from Georgetown University, Washington, D.C.

Publications

Book

Degnan, Fred H., FDA’s Creative Application of the Law: Not Merely A Collection Of Words (2000) FDLI; Second Edition (2006)

Book Chapters

Degnan, Fred H., “Introduction: FDA Food Safety Regulation from 1906 to the Enactment of the FDA Food Safety Modernization Act,” THE FDA FOOD SAFETY MODERNIZATION ACT, FDLI (2012)

Degnan, Fred H., “Food Safety,” FOOD AND DRUG LAW AND REGULATION, ch. 2, FDLI, Washington, D.C. (2008); Second Edition, ch. 2 (2012)

Degnan, Fred H., “The Food and Drug Administration — How it is Organized and Works,” A PRACTICAL GUIDE TO FOOD AND DRUG LAW AND REGULATION, ch. 4, FDLI, Washington, D.C. (1998); Second Edition, ch. 4 (2002); Third Edition, ch. 4 (2008); Fourth Edition, ch. 4 (2011); Fifth Edition, ch. 4 (2014)

Degnan, Fred H.; Saavedra, Jose, “Regulatory Issues - United States,” HANDBOOK OF PROBIOTICS AND PREBIOTICS, Second Edition, ch. 1.8, John Wiley & Sons, New Jersey (2009)

Degnan, Fred H., “Regulatory Issues Concerning Food and Nutrient Products Containing Nanomaterials,” NANOTECHNOLOGY IN FOOD PRODUCTS, Institute of Medicine (2009)

Degnan, Fred H., “Biotechnology and the Food Label,” LABELING GENETICALLY MODIFIED FOOD, Chapter 3, pp. 17-31, Oxford University Press, New York (2007)

Degnan, Frederick H., “The Regulation of Food Safety,” FUNDAMENTALS OF LAW AND REGULATION, ch. 6, p. 161, FDLI, Washington, D.C. (1997)

Articles

“Clinical Studies Involving Probiotics: When FDA’s Investigational New Drug Rubric Applies … And When It May Not,” GUT MICROBES, Vol. 3, Issue 6 (Nov/Dec 2012)

Degnan, Fred H., “GRAS: What Is It Really? What Did Congress Intend” ANNALS OF THE TOXICOLOGY FORUM (2010)

Degnan, Fred H.; Grossman, Liana R., “‘Otherwise Unfit for Food’” A Modern Food Safety Tool?” UPDATE Food and Drug Law, Regulation and Education (May/June 2009), 14-18.

Degnan, Frederick H., “The US Food and Drug Administration and Probiotics: Regulatory Categorization,” CLINICAL INFECTIOUS DISEASES (1 February 2008, Vol. 46, Supplement 2)

Fahey, Jed W; Ourisson, Philippe J.; and Degnan, Frederick H., “Pathogen Detection, Testing, and Control in Fresh Broccoli Sprouts,” NUTRITION JOURNAL (April 2006)

Degnan, Fred, “DSHEA, The IOM, and Empowering Data-Based Decisionmaking,” JANA, VOL. 8, NO. 2 (2005)

Turner, R. Elaine, Ph.D.; Degnan, Fred H., Esq.; and Archer, Douglas L., Ph.D., “Label Claims for Foods and Supplements: A Review of the Regulations,” NUTRITION IN CLINICAL PRACTICE 20:21-32 (February 2005)

Degnan, Frederick H., “Background: U.S. Regulatory Framework for Health-Related Claims on Food,” Scientific Sessions and Poster Session Abstracts, International Life Sciences Institute 2004 Scientific Meeting, ILSI Press (2004)

Degnan, Fred, “FDA Proposes Comprehensive Current Good Manufacturing Practices Regulations for Dietary Supplements,” JANA, VOL. 6, NO. 3 (Summer 2003)

Degnan, Fred H., “Infant Formula Regulation Today,” UPDATE Food and Drug Law, Regulation and Education (May/June 2003), 31-33

Degnan, Fred H., “Federal Regulation of Dietary Supplements: Eight Years After the Enactment of DSHEA, Where are We?,” JANA, VOL. 6, NO. 1 (Winter 2003)

Archer, Douglas L. & Degnan, Fred H., “Impact of the Bioterrorism Threat,” FOOD TECHNOLOGY, VOL. 55, NO. 12 (December 2001)

Degnan, Fred H., “Food Additives and the Need to Show a Technical Effect in Food,” FOOD TECHNOLOGY, VOL. 55, NO. 7 (July 2001)

Degnan, Fred, “GMPs for Dietary Supplements: A Case in Point - BSE,” JANA, VOL. 4, NO. 1 (Spring 2001)

Degnan, Fred H., “FDA’s Recent Steps to Implement Pearson v. Shalala,” JANA, VOL. 3, NO. 3 (Fall 2000)

Degnan, Fred H., “Biotechnology and the Food Label: A Legal Perspective,” 55 FOOD AND DRUG LAW JOURNAL 301 (2000)

Degnan, Fred H., “Biotechnology and the Food Label: An Overview,” UPDATE Food and Drug Law, Regulation and Education (Oct. 2000), 4-6

Robinson, Cheryl & Degnan, Fred, “Not Merely a Collection of Words,” UPDATE Food and Drug Law, Regulation and Education (Aug. 2000), 35-41

Degnan, Fred H., “FDA Soldiers on in Implementing DSHEA,” JANA, VOL. 3, NO. 1 (Spring 2000)

Degnan, Fred, “Current Developments: FDA and the Regulation of Dietary Supplements,” JANA, VOL. 2, NO. 2 (Summer 1999)

Degnan, Fred, “Food Biotechnology Regulation: FDA Needs Only Current Authorities,” THE ENVIRONMENTAL FORUM, VOL. 16, NO. 2 (Mar./Apr. 1999)

Degnan, Fred, “DSHEA and the Role of Sound Science,” JANA, VOL. 2, NO. 1 (Winter 1999)

Degnan, Frederick H., “Emerging Technologies and Their Implications: Where Policy, Science, and Law Intersect,” 53 FOOD AND DRUG LAW JOURNAL 593 (1998)

Degnan, Fred, “Dietary Supplements and the Dietary Supplement Health and Education Act of 1994: A Primer,” JANA, VOL. 1, NO. 1 (Spring 1998)

Degnan, Fred H. & Steinborn, Steven B., “Toys and Confectionery — A Legally Compatible Combination,” 53 FOOD AND DRUG LAW JOURNAL 9 (1998)

Degnan, Frederick, “Future Processes: Examples,” ANNALS OF THE TOXICOLOGY FORUM, July 1998, p. 91

Degnan, Frederick H., “The Food Label and the Right-to-Know,” 52 FOOD AND DRUG LAW JOURNAL 49 (1997)

Degnan, Fred H., “Reforming the Delaney Clause,” ANNALS OF THE TOXICOLOGY FORUM, December 1996, p. 95

Harris, Kenton L. & Degnan, Frederick H., “Sanitation Law Enforcement for Foods Without Action Levels,” 592 Perspective, VOL. 40, NO. 9 (Sept. 1995)

Degnan, Frederick H. & Flamm, W. Gary, “Living with and Reforming the Delaney Clause,” 50 FOOD AND DRUG LAW JOURNAL 235 (1995)

Degnan, Frederick, “Looking Ahead: New Directions in Federal Food Safety Regulation,” GUIDE TO U.S. FOOD SAFETY LAW (Jan. 1995)

Degnan, Frederick H., “FDA’s Food Records Access Authority Under Section 704 of the Food, Drug, and Cosmetic Act,” FOOD, DRUG, COSMETIC AND MEDICAL DEVICE LAW DIGEST, VOL. 10, NO. 3 (Oct. 1993)

Degnan, Frederick H. et al., “The FDA’s Authority Under the Delaney Clause to Consider Mechanisms of Action in Determining Whether Additives ‘Induce Cancer’,” 47 FOOD AND DRUG LAW JOURNAL 77 (1992)

Degnan, Frederick H., “Rethinking the Applicability and Usefulness of the GRAS Concept,” 46 FOOD DRUG COSMETIC LAW JOURNAL 553 (Sept. 1991)

Degnan, Frederick H., “An Introduction to FDA Advisory Committees,” 45 FOOD DRUG COSMETIC LAW JOURNAL 709 (Nov. 1990)

Degnan, Frederick H., “What is in a Name? The Legal Effect of Food Standards,” 45 FOOD DRUG COSMETIC LAW JOURNAL 263 (May 1990)

Degnan, Frederick H., “The Role of the Lawyer in Agency Decision-Making,” 36 FOOD DRUG COSMETIC LAW JOURNAL 510 (Oct. 1981)

Degnan, Frederick H., “The Best Proof of Safety for Food Additives and New Animal Drugs,” 36 FOOD DRUG COSMETIC LAW JOURNAL 185 (Apr. 1981)