Reducing Risk for Slack-fill Packaging Lawsuits: Part Two

Last month’s article concluded with this distinction: a defense strategy is reactive. Instead, a proactive approach—with its focus on lawsuit avoidance—should be a component of packaging management.

Slack Fill Packaging Lawsuits

Avoidance rests on compliance with federal regulations, which preempt state regulations if there is meaningful variance. The federal regulations are the Food, Drug, and Cosmetics Act (FDCA) and the Code of Federal Regulations Title 21 (21CFR §100.100). The FCDA establishes misleading fill levels as misbranding.

21CFR §100.100 defines slack-fill as the difference between a container’s capacity and its contents. 21CFR §100.100 further establishes misleading fill-levels as occurring when the container doesn’t allow a view of the contents and contains non-functional slack-fill. 21CFR §100.100 deems slack-fill as non-functional if it does not fall under any of six exemptions.

If the slack-fill in question offers product protection, is required by machinery, accounts for product settling, or performs a specific task, it’s exempted. Also, if the slack-fill in the container functions in product preparation, presentation, or is reusable; or if the brand is unable to increase contents or reduce container size, it’s exemtped.

Evaluating a company’s exposure to slack-fill lawsuits can be straightforward, much like a flowchart or a box-checking list. Does the packaging disallow a view of the contents? Is there slack-fill? Is the slack-fill non-functional? When all answers are, “Yes,” a company needs to decide on a course of action.


Read article   

Read Part One of Sterling Anthony’s Series on slack-fill lawsuits.


One course of action is not to do anything at all. The risk of such a decision is product specific. For example, a company might regard an established brand with a history of repeat purchases as prima facie evidence that consumers are not being misled by alleged slack-fill.

Pharmaceutical Innovations Report
Discover the latest breakthrough packaging technologies shaping the pharmaceutical sector. This report dives into cutting-edge innovations, from smart containers that enhance patient safety to eco-friendly materials poised to transform the industry’s sustainability practices. All from PACK EXPO. Learn how forward-thinking strategies are driving efficiency and redefining what’s possible in pharma packaging.
Learn More
Pharmaceutical Innovations Report
Annual Outlook Report: Sustainability
The road ahead for CPGs in 2025 and beyond—<i>Packaging World</i> editors review key findings from a survey of 88 brand owners, CPG, and FMCG readers.
Download Now
Annual Outlook Report: Sustainability