Kelley Drye

Attorneys & Professionals 

Sarah Roller

Partner Email vCard
Washington, D.C.
Phone: (202) 342-8582
Fax: (202) 342-8451

Sarah Roller, J.D., R.D., M.P.H., is a partner in the firm’s Washington, D.C. office and chair of the Food and Drug Law practice. She focuses her practice on the representation of U.S. and global companies and industry trade organizations engaged in the development, manufacture, import, export, distribution and marketing of foods, beverages, dietary supplements, functional foods, nutraceuticals, medical foods, cosmetics, medicines, and other personal health care and wellness products domestically and abroad.

Ms. Roller assists companies in the development of legal risk management strategies and compliance programs designed to minimize risk at the outset and avoid the costly setbacks associated with regulatory enforcement. In addition to ensuring that product formulations and ingredients meet Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and other applicable safety requirements, Ms. Roller leverages her multidisciplinary background in law, human nutrition, food science and public health to ensure that product benefit claims disseminated through labeling, print and Web advertising, social marketing and other promotions are adequately substantiated by scientific evidence. Ms. Roller also has experience representing clients in complex legal, policy and enforcement matters before federal and state agencies, providing integrated counseling services spanning the legal, regulatory and legislative arenas.

Specifically, Ms. Roller provides legal advice, strategic counsel and recommendations to clients relating to the production, distribution, importation, marketing and recall of food and beverage products, functional foods, dietary supplements, cosmetics, ingredients, packaging and related emerging technologies, including irradiation, biotechnology, cloning and nanotechnology. She represents clients in legal, policy and enforcement matters arising before federal and state governmental bodies, including the U.S. Congress, FDA, Federal Trade Commission (FTC), USDA, and the Department of Health and Human Services (DHHS). She also advises global companies regarding the production, importation, distribution and marketing of food products and components and the associated regulatory issues involved at the international, federal and state levels.

Ms. Roller determines the adequacy of scientific evidence to substantiate product benefit claims, and defends clients when the adequacy of claim substantiation is challenged by governmental bodies, competitors or consumers. She represents clients in connection with FDA enforcement matters, including warning letters, inspections, product seizures and import detentions, and advises clients in conducting product recalls, whether self-initiated or performed at the request of the FDA. In addition, she counsels clients in litigation matters in which product safety, marketing practices and promotional claims are challenged under federal or state laws.

Ms. Roller develops self-regulatory guidelines for food industry organizations with respect to product marketing practices and claim substantiation. She counsels clients with respect to food marketing practices directed to children and youth, and legal and policy developments surrounding obesity and diet-related public health concerns that are emerging at the international, federal and state levels.

Ms. Roller prepares citizen petitions, health claim petitions, health claim notifications, nutrient content claim petitions, temporary marketing permits, competitor complaints, model legislation, model rules, self-regulatory guidelines, briefing papers, testimony, press releases and other written and oral statements on behalf of client companies and trade organizations. She also communicates with the press and representatives of medical, scientific and public interest organizations.

In addition, Ms. Roller serves on medical, scientific and regulatory advisory boards providing strategic counsel to companies and trade organizations with respect to the development of new products and marketing initiatives.

A veteran of Capitol Hill, Ms. Roller previously spent five years working as a Life Sciences Policy Analyst for the U.S. Congress with the Congressional Research Service. She also previously served as a clinical research nutritionist with the Mt. Sinai Hypertension Trial conducted by Mt. Sinai Hospital and the University of Minnesota.

Representative Experience

Successfully represented a cooperative association of 450 family-owned dairies, maker of the best selling brand of butter in the Western U.S., in a class action filed in the Los Angeles Superior Court, alleging that the labeling of certain of their dairy products were false and misleading in violation of the California Unfair Competition statutes, as well as the Consumer Legal Remedies Act.  Judge dismissed the case with prejudice on federal preemption grounds.

Developed successful health claim petition resulting in FDA approval of claims concerning walnut consumption and the reduced risk of heart disease.

Defended a beverage marketer in an FTC investigation concerning substantiation support for advertising claims promoting beverage consumption benefits in promoting cardiovascular health and wellness.

Served as co-counsel representing the leading dairy processor trade association in response to allegations that it had misled consumers about the benefits of dairy products.

Served as co-counsel on behalf of a coalition of dairy processors and retailers in a lawsuit alleging that they failed to adequately warn milk consumers about lactose intolerance.

International Dairy Foods Ass’n v. Amestoy, 92 F.3d 67 (2d Cir. 1996)
Served as co-counsel to plaintiffs in challenging a state law on First Amendment grounds that required labeling for milk derived from animals treated with the first FDA-approved animal drug from recombinant DNA, where the labeling could not be justified on consumer deception or public health grounds.

Developed and coordinated multidisciplinary regulatory and legislative strategy on behalf of a food company to support FDA and USDA enforcement of food ingredient safety and labeling standards applicable to meat products.

Facilitated the evaluation of legal standards and procedures in several European countries in support of an international launch strategy for a new ingredient product on behalf of an international supplier of ingredients for food and dietary supplement products.

Conducted regulatory compliance due diligence assessment and prepared report making findings and recommendations with respect to FDA and FTC requirements and similar state law requirements for a global, Fortune 100 food company.

Memberships & Associations

Institute of Medicine of the National Academies (IOM) Food Forum, member 

American Bar Association, Antitrust and Consumer Law Section, Administrative Law and Regulatory Section, Section of Science & Technology Law

American Society for Law, Medicine, and Ethics

American Public Health Association

Institute of Food Technology, Food Laws and Regulations Section Executive Committee, at large member

American Dietetic Association, Dietitians in Business and Communication Section, practice group member

Professional Activities

Frequent lecturer for Food and Drug Law Institute (FDLI) programs

Served on the FDLI planning committee for the first international meeting of the Institute, held in Beijing, China in 2011

Monograph Series, FDLI, Editorial Advisory Board 2010-present

Food and Drug Law Journal, FDLI, Chair, Editorial Advisory Board, 2006-2007

Registered Dietitian, 1981-present

Honors & Awards

Recognized nationally as a leading practitioner in the Food & Beverages: Regulatory & Litigation area by Chambers USA, 2007-2016.

The Best Lawyers in America© (Woodward/White, Inc.), FDA Law, 2014-2017.

Recognized as a leading attorney in Food and Drugs practice area by Washington D.C. Super Lawyers, 2016.

Recommended in US Legal 500 for her work in the Marketing and Advertising area, 2010 and 2011.

Practice group ranked National Tier 2 for FDA Law in the U.S. News & World Report and Best Lawyers 2011-2012 report of Best Law Firms.

Recipient of the Burton Foundation Award for Legal Achievement for the Food and Drug Law Journal article titled "Promoting Functional Foods and Nutraceuticals on the Internet," 2000, with Harold J. Feld.

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December 7, 2016

Medical Foods: FDA’s Guidance, Substantiation Standards, and a Survey of Enforcement and Litigation Risk

FDLI's Enforcement, Litigation, and Compliance Conference: for the Drug, Medical Device, Food, and Tobacco Industries