Bill McGrath has spent his career working with manufacturers of consumer products, prescription and OTC drugs, medical devices, foods and beverages, cosmetics, alcoholic beverages, and tobacco products. He counsels clients on getting their products into the market, maximizing sales while ensuring that the company’s activities are in compliance with the law, designing and implementing programs to ensure quality, safety, and regulatory compliance, and responding to crisis situations.
Mr. McGrath has particular experience counseling manufacturers in FDA-regulated industries (tobacco, foods and beverages, nutritional supplements, cosmetics, prescription and OTC drugs, and medical devices) and has represented manufactures in landmark constitutional cases. In addition to his litigation and advocacy expertise, Mr. McGrath regularly advises manufacturers on issues relating to product labeling, safety monitoring, advertising, and marketing, to ensure regulatory compliance and avoid litigation. He also works with clients to develop effective advertising and promotional campaigns, sweepstakes, promotions, and Internet/new media commerce, services, and gambling sites in compliance with all applicable laws. Mr. McGrath has represented clients before the Food and Drug Administration, the Consumer Product Safety Commission, the Federal Trade Commission, other state, federal, and foreign administrative agencies, and in state and federal courts nationwide.
- Counsel manufacturers in all FDA-regulated industries on the development, path to market, safety, advertising, and promotion of new and existing products.
- Advise manufacturers, distributors, and advertisers of the entire range of tobacco products (cigarettes, smokeless, pipe, little and premium cigars, dissolvables, and other innovative products) on implementation, compliance, advocacy, and litigation with respect to issues arising under the Tobacco Control Act.
- Work regularly with consumer product manufacturers (including electronics, children’s products, clothing, household products, and motorized vehicles) on CPSC reporting requirements, safety monitoring, risk management, government investigations, and product liability consequences.
- Represent numerous clients in negotiating, developing, implementing, and executing product recalls, including the recall of over 35 million fire sprinkler heads installed in public and private buildings nationwide.
- Advise manufacturers and providers of consumer products (including children’s products, apparel, appliances, electronics, food, cosmetics, OTC drugs and dietary supplements, alcohol and tobacco) regarding compliance with FTC guides regarding substantiation of advertising claims, endorsements and testimonials, environmental marketing (Green Guides), .com disclosures and other advertising and promotional requirements.
- Successfully represented numerous manufacturers and retailers in FTC and state Attorneys General consumer protection/unfair trade practice investigations.
- Advise manufacturers and providers of consumer products on compliance with federal, state and local laws on design and conduct of sweepstakes and promotions, and use of social media in advertising
- Represent clients in false advertising/UTP claims before the FTC, FDA, state AGs and consumer protection agencies, the Better Business Bureau and advise clients re Lanham Act claims
- Discount Tobacco City & Lottery, Inc. v. United States, 674 F.3d 509 (6th Cir. 2012). Advised tobacco product manufacturer on First and Fifth Amendment challenges to Tobacco Control Act.
- Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001). Represented tobacco product manufacturer in successful First Amendment challenge to Massachusetts regulations restricting commercial speech rights of tobacco manufacturers.
- Brown & Williamson Co. v. FDA, 529 U.S. 120 (2000). Represented manufacturer in case holding that FDA had no authority to regulate tobacco products under the Food, Drug, and Cosmetic Act absent Congressional amendment.
- 44 Liquormart, Inc. v. Rhode Island, 517 U.S. 484 (1996). Drafted amicus brief cited by multiple Justices for the proposition that commercial speech is entitled to the same full First Amendment protections as core speech.
- Wiley Rein LLP, Partner
- Professor of Procedure, Washington and Lee University School of Law
HONORS AND AWARDS
- District of Columbia Bar Pro Bono Lawyer of the Year for work on behalf of people living with HIV and AIDS (1998).
PRO BONO AND COMMUNITY INVOLVEMENT
- Legal Services Program Advisory Committee, Whitman-Walker Health
- Chaired Legal Community AIDS Walk Taskforce
- Developed Policy Manual on bullying protections for D.C. Government and advised working group re D.C. anti-bullying legislation for Metro TeenAIDS
- Developed self-help debt management manual and seminar for clients of multiple pro bono providers
- Presented medical privacy workshops to health care providers and patients
- Represented pro bono clients on public and private disability benefits denials, reasonable workplace accommodations, employment and public accommodations discrimination, and other issues
MEMBERSHIPS AND AFFILIATIONS
- Food & Drug Law Institute
- Member, FDLI Tobacco Committee
- Editorial Board, FDLI Update
REPRESENTATIVE PUBLICATIONS AND SPEECHES
- Co-Author, “The Changing Face of Marijuana Regulation: Current Federal Status,” FDLI Update Magazine (September/October 2017)
- “Americans for Safe Access v. DEA,” Top 20 Food & Drug Cases, 2013 & Cases to Watch, 2014 (FDLI 2014).
- “Discount Tobacco City & Lottery v. US,” Top 20 Food & Drug Cases, 2012 & Cases to Watch, 2013 (FDLI 2013).
- “R.J. Reynolds Tobacco Co. v. FDA,” Top 20 Food & Drug Cases, 2011 & Cases to Watch, 2012 (FDLI 2012).
- “Modified Risk Tobacco Products,” Tobacco Regulation and Compliance: An Essential Resource (FDLI 2011).
- “The Tobacco Act and the First Amendment,” Tobacco Regulation and Compliance: An Essential Resource (FDLI 2011).
- Co-Author, “A Look at FDA’s New Substantial Equivalence Requirements for Tobacco Products,” FDLI Update Magazine (May-June 2011).
- Co-Author “Commonwealth Brands, Inc. v. United States,” Top 20 Food & Drug Cases, 2010 & Cases to Watch, 2011, Chapter 19 (FDLI 2011).
- Co-Author, “What’s Black and White But Not to Be Read? FDA Restrictions on Tobacco Product Advertising.” FDLI Update Magazine (September/October 2009).
- FDA Bar Expert Panel, Tobacco Merchants Association Deeming Regulation Conference (June 16-17, 2014).
- “The Tobacco Control Act: Five Years Later,” FDLI Annual Conference (April 23, 2014).
- “Self-Regulation in FDA-Regulated Industries,” Tobacco Merchants Association Annual Conference (May 17, 2013).
- “Tobacco Product Deeming Regulations – A Conversation,” Tobacco Merchants Association Annual Conference (May 16, 2013).
- “Tobacco Product Litigation and Regulatory Update: 2012,” FDLI Annual Conference on FDA Regulation of Tobacco (October 18, 2012).
- “Litigation Update: Top Cases in Tobacco: 2011,” FDLI Tobacco Regulation and Litigation Conference (December 5, 2011).
- “Tobacco Product 905(j) Applications – What’s Next?” Tobacco Merchants Association Annual Conference (May 23, 2011).
- “Marketing and Packaging of Tobacco Products Under the Tobacco Control Act,” Tobacco Merchants Association Annual Conference (May 24, 2010).
- “Scientific Basis for the Regulation of Tobacco,” FDLI Tobacco Legislation and Regulation Conference (November 10, 2009).
- “Framing FDA’s New Harm Reduction Policy,” Tobacco Merchants Association Annual Conference (April 10, 2018).