Bill A. McGrath

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.

Representative Experience

• 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

Representative Litigation

• 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.