By Jack C. Henning
Dillingham & Murphy
LLP, San Francisco, California
Product liability refers to the legal rules concerning who is responsible for defective or dangerous products. Entities in the chain of distribution of products that allegedly cause harm to people can be sued under state law theories of negligence, strict liability, or breach of warranty. However, manufacturers of products also need to worry about federal and state law theories concerning misleading product containers and the concept of “slack-fill.” Have you purchased a box of candy at a movie theater and found it only half-full of product? Have you opened a bag of chips while watching a football game and found the top half-full of air? That is slack-fill, and if you are a manufacturer, you face potential liability regarding the empty space in the container.
What is Slack-Fill? Slack-fill refers to the difference between the capacity of a product container and the amount of product in the container. It essentially is the empty space in a container. Slack-fill is not always an evil thing that subjects manufactures to potential litigation. Manufacturers only need to worry about “nonfunctional slack-fill,” which will be addressed later in this article.
Who Can Sue and Concerning What Products? The Food, Drug, and Cosmetic Act (FDCA) provides that a food, drug, or cosmetic is misbranded and violates the Act if the container is misleading. 21 U.S.C. §§ 343(d) (foods), 352(i)(1) (drugs), 362(d) (cosmetics). The Act does not use the words slack-fill. In the early 1990s the FDA determined that the FDCA’s provisions were not being adequately enforced in relation to foods. Therefore, the FDA developed food-specific slack-fill regulations that are found in 21 C.F.R. § 100.100(a). These regulations apply only to food containers. For drugs and cosmetics there remains the previously mentioned general statutory prohibition concerning “misleading” containers.
21 C.F.R. § 100.100 does not include a private right of action, so individual consumers do not have a cause of action. However, some state consumer protection laws and state common law theories do allow consumers to sue, including regarding items other than food, drugs, and cosmetics. The consumers typically argue that these causes of action incorporate or mirror the standards found in the FDCA and its regulations.
Slack-fill cases typically are brought as class actions, but they historically have had problems getting certified. Also, to the extent the plaintiffs seek injunctive relief regarding changes to containers, the plaintiffs generally lack standing because standing to pursue prospective relief requires a showing of imminent future injury. How can there be imminent future injury if the product has been purchased once and the plaintiff knows what to expect in the future?
Functional vs. Nonfunctional Slack-Fill: The Food and Drug Administration and state consumer protection laws are intended to prevent consumers from being misled regarding the amount of product in a container. 21 C.F.R. § 100.110(a) 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.”
Slack-fill is functional and therefore not a problem if its presence is related to one of the following safe harbors: (1) it protects the contents of the container; (2) it is present due to the requirements of the manufacturing process; (3) it is the result of unavoidable product settling during shipping and handling; (4) it is required for the container to perform a specific function such as where the container plays a role in the preparation or consumption of a food; (5) the product consists of a food packaged in a reusable container that is part of the presentation of the food and has value which is independent of its function to hold food; or (6) there is an inability to increase the level of product or to further reduce the size of the container, such as where some minimum container size is necessary to accommodate required labeling, discourage theft, or facilitate handling. 21 C.F.R § 100.110(a). If the empty space (i.e., slack-fill) is due to something other than one of these six reasons listed in this regulation, then the empty space is nonfunctional slack-fill and a potential problem for the manufacturer.
Examples of The Six Safe-Harbors:
- Cotton that fills the top of a container of food supplements protects the supplements from damage and therefore falls within the first safe harbor.
- The second safe harbor is machine and application specific and applies in some situations when the process of bringing together the product and the container requires a certain level of slack-fill.
- Boxes of your favorite breakfast cereal like Lucky Charms settle during shipment, but are sold by weight and not by volume, so they fall within the third safe harbor.
- Some containers of soup include space to add hot water so the soup can be made in and eaten from the containers, so they fall within the fourth safe harbor.
- The fifth safe harbor includes those holiday season tins that contain food. The tins are intended for further use after the food is consumed and usually end up being used by your grandparents to hold nuts and bolts or old buttons.
- In some situations, expensive products are sold in small quantities (e.g., your mom’s expensive bottles of fragrance) and a container with no slack-fill might not be practical, so the container potentially falls within the sixth safe harbor.
Even if slack-fill does not fall within one of these safe harbors and is nonfunctional, the case is not over. Many state consumer-protection statutes and state common-law theories require not only a regulatory violation, but also a showing that reasonable consumers would be misled or deceived by the container.
Recent Legislative Changes In California: An increase in the number of slack-fill suits resulted in at least one state taking action. California slack-fill cases commonly are based upon Sections 12606 (non-food products) and 12606.2 (food products) of the California Business and Professions Code. Neither statute creates a private right of action, but they serve as a foundation for claims under California’s Unfair Competition Law and Consumers Legal Remedies Act, which provide that no container shall be filled as to be misleading and that a container that does not allow the consumer to fully view its contents shall be considered to be misleading if it contains nonfunctional slack-fill.
In September of 2018 now former California Governor Jerry Brown signed California Assembly Bill 2632, which provides that consumer product manufacturers cannot be deemed to have violated California’s slack-fill laws when the product’s exterior packaging contains information that clearly communicates the amount and size of the product in the container. The legislation provides clarity (1) against enforcement for a container with a discrete number of products and that clearly illustrates the actual size and number of such products on the exterior of the container along with the appropriate size/weight/count information; (2) against enforcement for packaging that contains a clearly and conspicuously labeled “fill line;” and (3) against enforcement when the method of product commerce does not allow a customer to see or handle a container prior to purchase. As for the last point, if you did not see the container before the purchase, then you could not have been misled by the container.
Conclusion: There are steps manufacturers can take to protect themselves from slack-fill litigation. Make sure your container is not misleading to a reasonable consumer acting reasonable under the circumstances. Each time you redesign your container evaluate the likelihood of an allegation of deception. If you can design your container so the consumer can see the amount of product, there should be no opportunity for claimed deception. If the consumer cannot see the amount of product, ensure that the container prominently displays the net weight, serving size, and number of servings. Listing this information might offset any potential misrepresentations arising from non-functional slack-fill. Some cases hold that the laws do not protect consumers for their failure to read labels. Finally, adding a “fill line” indicator also can be beneficial.