Federal Safety Standard for Pacifiers

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.

Continue Reading Recalls in Review: Pacifier and Accessory Recalls