August 16, 2017

August 16, 2017

Subscribe to Latest Legal News and Analysis

August 15, 2017

Subscribe to Latest Legal News and Analysis

August 14, 2017

Subscribe to Latest Legal News and Analysis

GNC Slack Fill Settlement

  • Slack fill” cases are on the rise across the U.S.  Slack fill is the empty space between products and their packaging. Companies can be challenged for including “nonfunctional slack fill” in product packaging under both the Federal Food Drug and Cosmetic Act (“FDCA”) and state unfair business practice statutes (particularly in California).  At the federal level, 21 C.F.R. §100.100 of FDA’s regulations provides that a food is “misbranded” if “its container is so made, formed or filled as to be misleading.”  Section 100.100(a) further provides that “a container that does not allow the consumer to fully view its contents shall be considered to be filled as to be misleading if it contains nonfunctional slack-fill.”

  • On October 9, 2015, a class-action lawsuit was filed against GNC Holdings Inc. (GNC) for allegedly deceptively packaging its Whey Protein products, including AMP Amplified Gold Whey Protein, AMP Amplified Wheybolic Extreme, and 100% Whey Protein products. The complaint alleged that the containers for these products were opaque and contained approximately 40% empty space in violation of the FDCA and California state consumer laws. (Gioia et al v. GNC Holdings, Inc., Case No. 15-cv-2273, S. D. CA.). In defending itself, GNC argued that “the products’ containers specifically stated the amount of product on the label . . . the labels contain the products’ net weight, serving size and the number of servings contained within each container. Thus, consumers are receiving the exact amount of product disclosed.” The plaintiffs countered that GNC’s arguments justifying the slack fill were inappropriate as they revolved around factual issues that should be resolved on a motion for summary judgment.

  • On March 17, 2017, GNC and the putative class of consumers agreed to end the slack fill lawsuit.

  • Slack fill lawsuits are an increasing source of litigation exposure for marketers of FDA-regulated food and dietary supplement products. Given the duration of this case and the fact that the court did not dismiss the complaint per GNC’s request in earlier proceedings, this lawsuit demonstrates that marketers of FDA-regulated food and dietary supplement products should not assume that simply disclosing on a label the amount of product contained in a package will result in the quick dismissal of a slack fill suit.  Instead, consumer perception may be viewed as a fact-intensive inquiry requiring further discovery and summary judgment proceedings.  While settlement of such claims are certainly an option (and the path chosen here), manufacturers should seriously consider vigorous defenses against these claims given a number of favorable decisions to date.

© 2017 Keller and Heckman LLP


About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...