Tort and Insurance Law
What's in the Package: Food, Beverage, and Dietary Supplement Law and Litigation—Part I
Jordan Lipp, Ed Hafer
Tort and Insurance Law articles provide information concerning current tort law issues and insurance issues addressed by practitioners representing either plaintiffs or defendants in tort cases. They also address issues of insurance coverage, regulation, and bad faith.
William P. Godsman of the Law Office of William Godsman, Denver—(303) 455-6900, willgodsman@gmail. com
About the Authors
Jordan Lipp is a partner with Davis Graham & Stubbs, LLP—(303) 892-7471, email@example.com. Ed Hafer is an associate with Davis Graham & Stubbs, LLP-(303) 892-7254, firstname.lastname@example.org.
This two-part article discusses the regulatory framework applicable to the food, beverage, and dietary supplement industries. It also addresses Colorado law on personal injury claims resulting from consumption of food products and on false advertising/labeling claims regarding food products.
Food, beverage, and dietary supplement litigation is a hot topic in Colorado and throughout the nation. The listeriosis outbreak in 2011, originating from Jensen Farms in Holly, Colorado, has spawned a plethora of litigation. In 2012, Colorado had the first "popcorn lung" consumer plaintiff verdict in the nation, which resulted in a multi-million-dollar award.1 Nationally, there has been significant media coverage of the false-claim style class action suits, especially regarding energy drinks and food labeling claims of products as "all natural," "organic," and similar statements. Indeed, one prominent law professor has predicted that food law will become as big as environmental law over the next decade.2
This article explores Colorado law on the various issues that arise in litigation by consumers against the manufacturers, producers, distributors, and retailers of foods, beverages, and dietary supplements.3 Because the various food-related industries are highly regulated, the first part of this article provides an overview of the regulatory framework applicable to foods, beverages, and dietary supplements. This discussion includes: (1) a description of important terminology necessary to understand the regulations; (2) a review of the governmental agencies that regulate the food, beverage, and dietary supplement industries; and (3) a review of the various administrative enforcement and voluntary actions involving these industries. The article next examines Colorado law as it relates to litigation alleging a physical injury as a result of the consumption of foods, beverages, and dietary supplements. This includes an analysis of the typical claims and defenses—both common law and statutory—that are particular to the food-related industries, as well as a discussion of the peculiar issues involving personal injury litigation resulting from individuals who are intoxicated. Part II of this article, which will be published in the August 2014 issue, will examine Colorado law as it relates to litigation alleging false advertising/labeling types of claims against food, beverage, and dietary supplement manufacturers. This discussion will include the typical claims and defenses in this arena of litigation—both common law and statutory—as well as the class action issues that arise in this litigation.
The Regulatory Framework
The food, beverage, and dietary supplement industries are highly regulated industries that engage in interstate commerce. To understand related litigation, it is important to understand the basic regulatory framework that applies to the industries. In turn, a brief examination of the statutory definitions and categories of "food," "dietary supplements," "beverages," and "alcoholic beverages" is necessary for a practitioner to understand the regulatory schemes that apply to these items. Moreover, because many lawsuits involve arguments or facts related to recalls and administrative enforcement actions, this article describes the basics of such actions.
Although one might assume it is obvious what is "food" and what is not "food," there are numerous statutes and a fair amount of case law on the exact scope of what is considered to be "food." The general federal statutory definition of "food," which in part is somewhat tautological, is: "(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article."4 This definition is broader than the commonsense definition of food, because it includes such items intended to be processed into food or items that are no longer fit for consumption.5 Indeed, the term "components" has been interpreted broadly, so, for example, green coffee beans, before roasting, are considered food.6 The definition of food includes alcohol,7 though as discussed below, alcohol has its own regulatory framework. Colorado's primary statutory definition of food is virtually identical to the federal definition, but other Colorado statutes provide slightly different definitions of food.8
A "dietary supplement" is
a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient [listed above].9
Moreover, a dietary supplement cannot be represented for use as a conventional food or as a sole item of a meal or diet, and it must be labeled as a dietary supplement.10
Dietary supplements are not synonymous with drugs. Rather, dietary supplements are distinct from drugs, because drugs are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.11 From a regulatory perspective, the difference between a product being classified as a dietary supplement as opposed to a drug is enormous. Drugs must go through a stringent premarket approval process with the U.S. Food and Drug Administration (FDA) that is time-consuming and expensive and involves extensive investigations.12 On the other hand, the regulation of dietary supplements is much more akin to the regulation of food. As long as the dietary supplement does not contain a new dietary ingredient, there is no premarket approval process for dietary supplements.
Nevertheless, it is important to note that although foods and dietary supplements are similarly regulated, they are not treated precisely the same. Among other things, dietary supplement labels can make certain claims food labels cannot, and they are exempt from food additive provisions of the law.14 Foods also should be distinguished from drugs, because even if there is "an article that happens to be a food but is intended for use in the treatment of disease," it is classified as a drug for regulatory purposes.15
Beverages fall within the food category as opposed to the dietary supplement category,16 but that is not to say that all products in the liquid form are categorized for regulatory purposes as foods as opposed to dietary supplements.17 Distinguishing between whether a liquid product meant for consumption is a food or dietary supplement can be difficult. "Beverages" are liquid products that are intended to quench thirst or provide fluid (for example, water, soda); provide nutritional value (for example, milk, orange juice); provide taste and aroma (for example, hot cocoa); or some combination of the foregoing.18 On the other hand, dietary supplements in the liquid form are items that one takes in a manner consistent with other dietary supplements (for example, one tablespoon three times a day).
Under federal statute, alcoholic beverages are defined as "any beverage in liquid form which contains not less than one-half of one percent of alcohol by volume and is intended for human consumption."20 Colorado defines an alcoholic beverage as a "fermented malt beverage or malt, vinous, or spirituous liquors" except for certain confectionery containing alcohol.21 Each of these individual products, in turn, must contain one-half of one percent alcohol by volume, or more, to be considered alcoholic beverages.22
Multiple governmental agencies regulate foods, beverages, and dietary supplements at both the federal and state level. At the federal level, the Food, Drug, and Cosmetic Act (FDCA) gives the FDA primary authority...