Ropes & Gray routinely advises domestic and international food companies, including medical food and dietary supplement companies, in a wide array of regulatory issues arising pursuant to the Dietary Supplement Health and Education Act of 1994 and a wide range of other laws enforced by the FDA, U.S. Department of Agriculture, and the Federal Trade Commission.
Our attorneys have extensive experience counseling companies in all areas of FDA regulation, including, but not limited to, assessment of ingredients for Generally Recognized as Safe (GRAS) and “new dietary ingredient” status, good manufacturing practices, reportable food registry requirements, submission of dietary supplement adverse event reports, the Bioterrorism Preparedness and Response Act of 2002, the Food Safety Modernization Act, the Food Allergen Labeling and Consumer Protection Act of 2004, color additives, food contact substances for use in food packaging materials, development of structure/function claims, nutrient content claims, health claims, qualified health claims, and dietary guidance claims. We also counsel clients on FTC compliance related to the advertising and promotion of foods and dietary supplements.
Our attorneys also routinely represent food and dietary supplement companies in responding to Warning Letters, import alerts, import detentions, post-inspection FDA Form 483s, recalls, FTC investigations and challenges brought before the National Advertising Division of the Better Business Bureau.
In addition to our regulatory experience, we have significant experience in representing food and dietary supplement companies and other consumer brand companies on a variety of transactional matters, including mergers & acquisitions, licensing and collaboration agreements, and joint ventures. We also routinely conduct regulatory and intellectual property due diligence on food, medical food, and dietary supplement companies.
Our work with food, medical food and supplement companies has included:
- Representation of a dietary supplement company in a precedent-setting FDA enforcement action based upon alleged inclusion of a drug ingredient in a dietary supplement, pursuant to the Dietary Supplement Health and Education Act “exclusionary clause.”
- Representation of the then-largest dietary supplement company in the United States in response to federal and state challenges brought against products containing ephedra.
- Representation of dietary supplement companies under investigation by the FTC (both in response to FTC access letters and Civil Investigative Demands).
- Representation of a leading dietary supplement company in challenges brought by the FTC and state attorneys general.
- Conducting due diligence on one of the largest dietary supplement companies in the United States. Representation of a food/dietary supplement ingredient supplier in lawsuits involving fraud allegations based upon ingredient purity/content.
- Counseling medical food companies on compliance matters.
- Drafting FDA Form 483 responses subsequent to dietary supplement inspections.
- Representation of dietary supplement companies subject to challenge before the National Advertising Division of the Better Business Bureau.
- Represented DAVIDsTEA, a provider of loose-leaf teas, pre-packaged teas, tea sachets, and tea-related gifts and accessories, in its proposed $96 million IPO.
- Represented Dunkin' Brands, which operates a chain of coffee and baked goods restaurants, and ice cream specialty stores, in its $778 million, $652 million and $563 million follow-on offerings.
- Represented Keurig Green Mountain, which operates in the specialty coffee industry in North America, in its acquisitions of Van Houtte, Diedrich Coffee, Timothy's Coffees of the World, Tully’s Coffee and Keurig.
- Represented Domino’s Pizza, the leading pizza delivery company in the world, in its $1.7 billion securitized debt offering, its IPO and recapitalization.
- Represented Bain Capital in its acquisition of OSI Restaurant Partners, which includes Outback Steakhouse, Carrabba's Italian Grill, Bonefish Grill, Fleming's Prime Steakhouse & Wine Bar, Roy's, Lee Roy Salmon's, Blue Coral Seafood & Spirits, and Cheeseburger in Paradise restaurants.
- Represented Green Mountain Coffee Roasters in its strategic supply alliances with a one of the world's largest QSR franchisors, and in strategic brand expansions through licensing partnerships and the acquisition of regional roasting and retailing brands.