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Diane C. McEnroe

Diane McEnroe

Adjunct Professor of Law

dmcenroe@sidley.com
Phone: 212-839-5621
Fax: 212-839-5599

Diance McEnroe has established long-standing relationships with domestic and international companies in the food, drug, medical device and personal care industries. As a member of the Food, Drug and Medical Device Regulatory practice, she provides clients strategic counsel on Food and Drug Administration regulatory questions on a broad range of issues, including product formulation and positioning, ingredient safety, claims substantiation, over-the-counter drug monograph issues, and post-marketing obligations, including adverse event reporting and food registry postings.

Diane also has extensive experience advising on drug sampling programs, track and trace systems, and state licensure issues. She supports clients in responding to Warning Letters, during facility inspections and recalls, and in addressing product integrity issues. In addition to her FDA advisory role, Diane has also assisted clients with Federal Trade Commission investigations relating to consumer products.

With her deep knowledge of foods, including functional and medical foods, and dietary supplements, Diane has guided clients through the implementation of significant legislative amendments, including the Nutrition Labeling and Education Act, the Dietary Supplement Health and Education Act, the Organic Foods Production Act, the Food Allergen Labeling and Consumer Protection Act, the Bioterrorism and Drug Preparedness Act and, most recently the Food Safety Modernization Act.

She regularly trains in-house counsel and regulatory teams on FDA compliance issues and assists companies in strengthening internal procedures to minimize compliance risks. In addition, Diane often leads FDA and FTC due diligence reviews for food and drug companies on behalf of major industry leaders and investment firms. She also closely coordinates with Sidley litigators nationwide to defend consumer fraud and product liability litigation targeting consumer products.

Diane is recommended in the top-tier rankings for Healthcare: Life Sciences in The Legal 500 US since 2013 and in Who’s Who Legal: Life Sciences 2015 and 2016. She is also recognized in the 2016 edition of The Best Lawyers in America.

Practices

Food, Drug and Medical Device Compliance and Enforcement
Food, Drug and Medical Device Regulatory

Areas of Focus

Good Manufacturing Practice
FDA Enforcement
Compliance Counseling - FDA

Industries

Life Sciences

Admissions and Certifications

U.S. Court of Appeals, Federal Circuit
U.S. District Court, E.D. of New York
U.S. District Court, S.D. of New York New York

Education

University of Connecticut School of Law (J.D., 1988)
Wellesley College (B.A., 1984)

Events

Diane’s most recent speaking engagements include:

Presenter, “Minimizing Risk by Maximizing Cross-Departmental Collaboration in Marketing and Advertising: How to Get Ahead of an Issue before it Starts,” 4th Annual Momentum Food & Beverage Litigation, Compliance & Regulatory Exchange (September 29–30, 2016).

Presenter, “Claim Substantiation for Food and Dietary Supplements,” FDLI, Food Advertising, Labeling and Litigation Conference (Washington, D.C., September 14–15, 2016).

Presenter, “Cosmetic Labeling 101,” National Product’s Association’s Webinar Series (August 24, 2016).

Presenter, “Backing the Proofs of Your Promotional Activities: Structuring Claim Substantiation in the Face of New FTC and NAD Activities” and “Claims Substantiation Master Class,” American Conference Institute, 4th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements (June 27–28, 2016).

Presenter, “OTC Post-Market Considerations: Adverse Events, Safety Communications and Label Warnings,” American Conference Institute, Advanced Legal, Regulatory and Compliance Forum on OTC Drugs (October 30, 2015).

Presenter, “Thinking Outside the Box: How to Utilize Market Actions to Moot Class Action Claims in Real Time” and “Focus on Social & Digital Media: Food & Beverage Industry Concepts for Innovative Marketing & Advertising Campaigns,” 3rd Annual Momentum Food & Beverage Litigation, Compliance & Regulatory Exchange (October 28, 2015).

Presenter, “Cosmetic Compliance: Don’t Get Sacked in a Warning Letter Blitz,” Natural Product’s Association’s Webinar Series (May 20, 2015.)

Presenter, “Life Sciences College: U.S. Pharmaceutical, Biotechnology and Medical Device Regulatory, Compliance and Corporate Update,” Sidley Austin LLP (New York, NY, April 2014).

Product Positioning for Food and Supplements: Strategies for Minimizing Regulatory and Litigation Attacks” webinar (December 4, 2012).

Co-Chair of The Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs, American Conference Institute (2012, 2013 and 2014), and presented “OTCs and Consumer Health Products 101: Defining, Establishing and Perfecting OTC-Ness” and “Define, Distinguish and Differentiate: Best Practices for Adverse Event Reporting on Non-Prescription Drug Products” (October 17–19, 2012).

Panelist, “U.S. & Brazil: Navigating New Frontiers in Pharmaceutical, Medical Device and Food Law & Regulation,” Food and Drug Law Institute (FDLI) Conference (São Paulo, Brazil, September 10–11, 2012).

The Federal Trade Commission and the Regulation of Medical Devices,” Advanced Medical Technology Association (AdvaMed) meeting on “Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing” (Washington, D.C., 2011).

Presenter, Basics of Food and Dietary Supplement Labeling, Introduction to Food Law and Regulation, The Food and Drug Law Institute (Washington, D.C., January 22, 2008).

Presenter, N.Y. State Food, Drug, and Cosmetic Law Section, Annual Meetings (January 2005 and January 2007).

Pro Bono

Diane works with The Alliance of African Shea Associations, which represents shea producers in Ghana, Nigeria, Burkina Faso, Mali, Benin and Côte d’Ivoire, assisting the Alliance in accessing the U.S. chocolate market and with efforts to permit the use of shea butter as an equivalent ingredient to cocoa butter. The goal of this pro bono initiative is to enhance the incomes of approximately four million women farmers who collect shea nuts in West Africa.

Diane also supports the Sidley Emerging Enterprises Pro Bono Program. Here, the firm provides international trade advice to the Bangladesh Shrimp and Fish Foundation, which represents some 600,000 shrimp farmers in Bangladesh who primarily export to the EU and the U.S.

Publications

Co-author with Scott Bass, Sarah Goldstein and Emily Marden “FDA’s Final Medical Foods Guidance Maintains Restrictions on Category,” International Law Office (2016).

Chapters on “Regulatory Status and Formulation” (with Scott Bass), “Product Claims and Intended Use” (with Nick Wimbush), “Dietary Supplement Labeling” (with Scott Bass and Nick Wimbush), and “Dietary Supplement Safety” (with multiple co-authors), Dietary Supplement Regulation: A Comprehensive Guide,Food and Drug Law Institute (2011).

Co-author with Paul E. Kalb, Karen O. Dunlop and Scott Stein “Analyzing the Laws, Regulations, and Policies, Affecting FDA-Regulated Products, Direct-to-Consumer Marketing: The Food and Drug Administration Is Not Alone,” Food and Drug Law Journal (2003).