Manufacturers of decongestant products containing imidazolines will get a one-year stay of enforcement from the Consumer Product Safety Commission’s (CPSC’s) new rule requiring child-resistant (CR) packaging for any over-the-counter or prescription product that contains the equivalent of 0.08 milligrams or more of an imidazoline in a single package. The Commission approved the rule on November 20, 2012, and it takes effect one year from the date of publication in the Federal Register.
Although topical and nasal administration of imidazolines evidently result in little absorption by the general circulation system of the human body, if they are ingested orally, imidazolines are absorbed, which can lead to severe life-threatening consequences, such as central nervous system depression and adverse cardiovascular effects. CSPC has determined that availability of 0.08 milligrams or more of an imidazoline in a single package, by reason of its packaging, is such that special packaging must be used to protect children younger than 5 from serious personal injury or illness due to handling or ingestion.
CPSC states that it received five comments with none opposing the proposed rule. Several requested more time to package products in CR packaging while two sought a stay of enforcement 12 months beyond the proposed 1-year effective date of a final rule. See CPSC Staff Briefing Package and Draft Rule, November 8, 2012.