CPSC Votes Safety Closures For Ibuprofen Medicines

The U.S. Consumer Product Safety Commission (CPSC) has voted unanimously to propose mandatory child-resistant closures for over-the-counter ibuprofen medicines. The Commission's proposal for safety closures is in response to increasing numbers of poisonings to young children who accidentally swallow ibuprofen sold in non-child-resistant packaging.

Ibuprofen, a pain-killer and anti-inflammatory medicine, originally was available by prescription only and therefore was required to be packaged with safety closures. Since 1984, however, ibuprofen has been available over-the-counter. When a prescription medicine is granted over-the-counter status by the Food and Drug Administration, the medicine is no longer subject to the child-resistant packaging requirements for oral prescription medicines.

Increased use of ibuprofen since 1984 has resulted in more accidental ingestions by young children. Approximately 29,000 ingestions of over-the-counter ibuprofen by children under age five were reported to poison control centers during the five years following the medicine's over-the-counter availability. The CPSC knows of two deaths of young children who swallowed ibuprofen. Therefore, the CPSC is proposing this regulation in order to require safety closures for over-the-counter ibuprofen.

The CPSC is proposing this Poison Prevention Packaging Act regulation as part of its mission to protect the public from unreasonable risks of injury and death associated with consumer products. Safety packages save lives. For oral prescription medicines alone, CPSC estimates that over 400 children's lives have been saved since 1974. The CPSC is the Federal agency responsible for consumer product safety. Some 15,000 types of consumer products fall within the Commission's jurisdiction and each year these products are involved in an estimated 29 million injuries and 22,000 deaths.