Mon. Jul 26th, 2021

Recalls in Review: A monthly spotlight on trending regulatory enforcement issues at the CPSC.

Although members of the House and Senate don’t agree on everything lately, they have come together in efforts to ensure safety of products intended for use by infants and small children.  In today’s installment of “Recalls in Review,” we look back at CPSC regulatory actions involving Pacifiers and Pacifier Accessories.

A pacifier rule was first proposed by the Food and Drug Administration in 1972 before the Federal Hazardous Substances Act was transferred to the CPSC.  The CPSC has regulated pacifiers and pacifier accessories regularly since 1976, when the Commission proposed a substantially revised regulation after investigations by CPSC staff revealed at least eight infant deaths associated with pacifiers.  Pacifiers must now comply with the Federal Safety Standard for Pacifiers, 16 CFR Part 1511, and the U.S. Toy Standard, ASTM F963-17.  And although pacifier clips do not fall under the definition of “pacifiers” in the safety standard, they must still meet separate children’s product safety requirements, such as the Small Parts regulation (16 CFR Part 1501).  Additionally, pacifiers may not be sold with any ribbon, string, cord, or similar attachment.

At least sixty-six pacifier-related products have occurred to date, with thirty-two of the recalls occurring since 2001.  Enforcement has been roughly consistent over the years; the largest number of recalls in any single year totaled six recalls in 2009.

Pacifier-related recalls have targeted pacifiers (80% of all pacifier-related recalls), pacifier clips (9%), paired pacifiers and clips (2%), pacifier holders (6%), and other children’s products that incorporate pacifier clips (3%).

According to information provided by the CPSC recall announcements, the approximately eighty-two percent of pacifier-related recalls address the risk of an infant choking on the pacifier.  Pacifier-related recalls have also been conducted to address strangulation hazards (8%), suffocation hazards (6%), excessive levels of lead, excessive levels of nitrosamines, and injury posed by safety pins.

The most common remedy offered by recalling firms is a refund of the purchase price (68% of the recalls).  Less often, the remedies offered may include replacement with a compliant product (20% of the recalls), choice between a refund or replacement product, or mere instructions to discard the noncompliant product.

Despite the consistent regulation of pacifiers since the 1970s, the only civil penalty that has been issued involving pacifiers occurred in 1998.  The pacifiers at issue could allegedly crack, permitting the nipple to detach from the shield, which posed a choking hazard to children.  The recalling firm agreed to pay a penalty of $150,000 to settle allegations that it obtained information sufficient to conclude that the pacifiers contained a defect that could create a substantial product hazard but failed to report the defect to the CPSC as required by the Consumer Product Safety Act.

The CPSC has also issued at least twenty-eight notice of violations (“NOV”) to manufacturers and retailers relating to pacifiers since 2013.  The vast majority of the notices cite violations of the Federal Safety Standard for Pacifiers, although some cite tracking label violations, children’s product certificate violations, small parts violations, and violations of the federal limits on lead in children’s products.  The most frequently requested corrective action is a stop sale (68%), followed by correct future production (29%), and consumer level recall (3%).

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About Recalls in Review:  As with all things, but particularly in retail, it is important to keep your finger on the pulse of what’s trending with consumers.  Regulatory enforcement is no different—it can also be subject to pop culture trends and social media fervor.  And this makes sense, as sales increase for a “trending” product, the likelihood of discovering a product defect or common consumer misuse also increases.  Regulators focus on popular products when monitoring the marketplace for safety issues.

As product safety lawyers, we follow the products that are likely targets for regulatory attention.  We share our observations with you through Recalls in Review.