We recently wrote about how companies importing dietary supplements, cosmetics, and drugs may need to comply with Consumer Product Safety Commission (CPSC) requirements under the Poison Prevention Packaging Act. But child-resistant packaging is not the only reason FDA-regulated companies need to keep CPSC in mind.
Food, drugs, and cosmetics generally are excluded from the Consumer Product Safety Act's definition of a "consumer product." But CPSC may have jurisdiction over mechanical hazards posed by their packaging. Thus, a mechanical hazard associated with the container of an FDA-regulated product may trigger a duty to report the issue to CPSC under the Consumer Product Safety Act (CPSA).
At a high level, Section 15(b) of the CPSA requires companies to report to CPSC within 24 hours of when the company became aware, or should have become aware, of information reasonably supporting the conclusion that a consumer product they manufacture, distribute, or sell:
- Violates a mandatory standard
- Is defective in a way that could create a substantial risk of injury or
- Even if not defective, creates an unreasonable risk of serious injury or death
Importantly, a duty to report can arise even where there have been no consumer complaints or injuries.
Failure to timely report to CPSC can result in significant civil penalties (and even criminal prosecution). If a company is uncertain whether information is reportable, CPSC permits a reasonable period to investigate—ordinarily no more than 10 working days.
Once CPSC becomes aware of the issue, either through the company's report or other means, CPSC may determine that a recall is appropriate or required. For example, earlier this month, CPSC announced the recall of approximately 2.3 million bottles of Ricky Joy Sour Crush Rolling Liquid Candy. According to the recall press release, "[t]he rolling ball on the recalled candy bottles can detach, posing a risk of serious injury or death from choking hazard." The press release stated that there had been no reported incidents or injuries.
As another example, in 2022, Vichy Laboratoires recalled over 200,000 packages of cosmetic facial serum sold in small glass ampoules. According to the CPSC press release, the glass could weaken over time and break when consumers opened the ampoules, creating a laceration hazard. The press release stated that Vichy received 35 reports of injuries, including one cut requiring stitches.
Reporting does not necessarily mean that CPSC will determine a recall is appropriate. When a company believes a recall is not warranted, we help it make the most compelling argument possible against a recall in its report. But failing to recognize and timely evaluate a potential reporting obligation can create substantial regulatory exposure.
For that reason, FDA-regulated companies should ensure that they have an adequate system in place to evaluate potential hazards affecting their packaging, whether those hazards come to light through consumer complaints, internal testing, or other means.
If you have questions about whether a potential safety issue may trigger a CPSC reporting obligation, or if you would like help setting up a compliance program or filing a report with CPSC, we are happy to help.