Over the last twelve months, we have seen a significant uptick in Consumer Product Safety Commission (CPSC) recalls of products that do not have required child-resistant closures. Under the Poison Prevention Packaging Act (PPPA), child-resistant packaging is required for prescription drugs, over-the-counter drugs, dietary supplements, and cosmetics that contain chemicals listed in CPSC's regulations. Since 1992, CPSC has conducted 28 recalls for PPPA violations. Six of these recalls occurred since November of last year, and five were of products that contained lidocaine with concentrations of 4-5%. (The only other recall of a product containing lidocaine that failed to use child-resistant packaging was in 2015.) The increase in such recalls suggests that CPSC's Office of Compliance and Field Operations has been conducting a targeted enforcement effort of PPPA requirements, focusing, at least initially, on products containing lidocaine.
The recall remedy the firm elects in this situation may also affect the commercial availability of certain types of products going forward, as two recent cases illustrate. On September 25, 2018, CPSC announced a recall of Desert Harvest's Relévum Skin Repair Cream. The cream originally came with a removable pump dispenser. The recall remedy is a replacement child-resistant twist-off cap that does not have the pump functionality. It now appears that Desert Harvest has discontinued the pump dispenser in favor of a child-resistant cap. On October 1, 2018, CPSC announced a recall of UberScientific's UberNumb cream and spray. The cream is currently being sold with a child-resistant twist-off cap. The spray, however, has been taken off the market completely. Consumers who bought the spray can obtain either a refund or a replacement cream. Some consumers - especially those who use lidocaine to reduce arthritis pain - may find that the inability to purchase the spray version makes the product less convenient to use.
There are many factors that go into CPSC's decision on whether to ask a firm to conduct a consumer-level recall for PPPA violations. The actual potential hazard posed by a product containing a certain substance is an obvious consideration, as is the probability that the product is likely to still be used in the home. If products have a short shelf-life or are likely to be used quickly, it may be easier for companies to convince CPSC that a consumer-level recall is unnecessary, and that correcting future production would suffice.
Companies with potentially noncompliant products should expect tight timeframes for reporting to CPSC, negotiating a recall if necessary, and bringing new products into compliance. Because child-resistant packaging requirements are enshrined in mandatory regulations, firms that learn of a failure to comply must of course consider their obligation to file a report to CPSC under Section 15(b) of the Consumer Product Safety Act (CPSA). From our work in this area, we have also seen that it takes time to source appropriate child-resistant closures that are technically suitable for the package, can be implemented on existing product packaging lines, and meet cost considerations. Companies that determine that their existing product packaging fails to meet child-resistant requirements are well-advised to begin the search for alternative packaging or closures at the same time they prepare their reports to the CPSC.
For more information, contact Sheila A. Millar at millar@khlaw.com or +1 202.434.4143.
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