August 19, 2022

Volume XII, Number 231

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Georgia Court Finds Dietary Supplement Labeling Claim within FDA’s Jurisdiction

  • On June 24, the Court of Appeals of Georgia held that Plaintiff Shawn Smith’s deceptive product labeling case raised questions best left to the FDA.

  • By way of background, in 2016, the FDA issued warning letters to seven companies stating that methylsynephrine used in the companies’ dietary supplements does not meet the definition of a “dietary ingredient” under the Federal Food, Drug, and Cosmetic Act (FDCA), rendering any product containing this ingredient and labeled as a “dietary supplement” misbranded. Relying on these letters, Smith sued Hi-Tech Pharmaceuticals under the District of Columbia Consumer Procedures and Protection Act for misleading consumers by “omitting that methylsynephrine is an unapproved drug that has been linked to adverse health events.” The state trial court dismissed the case with prejudice on grounds that the claims were preempted by the FDCA and raised issues within the FDA’s jurisdiction.

  • On appeal, a panel of judges found that the claims were not subject to preemption. However, they affirmed the trial court’s determination that the claims fall within the FDA’s primary jurisdiction because the questions require the agency’s expert determination of dietary ingredients.  The plaintiff argued that the warning letters describe the FDA’s final position that methylsynephrine does not qualify as a dietary ingredient; however, holding that the warning letters are only “regulatory letters [that] do not constitute final agency action,” the Court of Appeals remanded to the trial court to decide whether a stay or dismissal without prejudice is appropriate.

  • An attorney for the plaintiff reports that there is no indication the FDA plans to reconsider the questions at issue because there is no “pending agency action.” Keller and Heckman will continue to monitor this litigation.

Nicholas Prust, Natalie Rainer, and Frederick Stearns also contributed to this article.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 180
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About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office
Associate

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

202-434-4237
Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

202-434-4222
Jill M Mahoney Associate Attorney Keller Heckman
Associate

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

202-434-4184
Richard Mann Partner Keller Heckman DC
Partner

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

202-434-4229
Paula S. Pastuskovas San Francisco Food and Drug Attorney Keller and Heckman
Associate

Paula Pastuskovas counsels domestic and international clients on regulatory and compliance matters in food and drug law. She assists clients in obtaining regulatory clearances for food additives and food-contact materials from the U.S. Food and Drug Administration (FDA), Health Canada, and other comparable international agencies. She advises clients on food labeling, ingredient, and substantiation issues. 

As a resident of the firm’s San Francisco office, Paula also advises companies on compliance with California’s state and local laws. This...

415-948-2830
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