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, skincare products, medicines, medical devices, health IT and other health care products.

Ms. Roller provides legal counsel on regulatory compliance and legal risk management strategies, enabling clients to clients to make sound business decisions in a manner that maintains compliance and minimizes the risks that stem from regulatory missteps, government enforcement and related legal and business risks.  Ms. Roller leverages her multidisciplinary background in law, human nutrition, food science and public health to help clients ensure that their products are safe, their labeling and marketing claims are accurate and substantiated, and their systems for managing domestic and foreign supply chains, facilities, manufacturing and U.S. product distribution and recall comply with U.S. requirements.  Ms. Roller has substantial experience representing companies and industry trade associations in complex regulatory and public policy matters involving FDA, USDA, TTB, CBP, FTC and the U.S. Congress.  She also defends companies in enforcement matters brought by federal and state regulatory agencies, and in litigation matters involving product safety, labeling or marketing claims.

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

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

International Bar Association - Product Law and Advertising Committee, Life Sciences and Healthcare Committee

Academy of Nutrition and Dietetics - Dietitians in Business and Communication Section

American Public Health Association

Institute of Food Technologists

Professional Activities

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

FDLI Global Committee, Member 2015-present; Serve on the Food Drug Law Institute

FDLI Global Conference Planning Committee – 2010-2011 (conference held in Beijing, China in 2011)

FDLI, Monograph Series and Primer Editorial Advisory Board -  2010-2016.

FDLI Food and Drug Law Journal, Editorial Advisory Board, Member 2002-2007; Chair 2006-2007

Officer, Products Law and Advertising Committee, International Bar Association 2016 - present

National Academies of Sciences, Engineering and Medicine, Food and Nutrition Board, Food Forum, Member 2011 - present

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