The CPSC is proposing to require child-resistant packaging for any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more in a single package of an imidazoline, a class of drugs that includes tetrahydrozoline, naphazoline, oxymetazoline and xylometazoline. According to the CPSC, imidazolines are a family of drugs that are used a decongestants in eye drops and nasal products. Topical and nasal administration of imidazolines results in little absorption into the general circulation but oral ingestion can lead to systemic effects and cause serious adverse reactions such as central nervous system depression, decreased heart rate, and depressed ventilation in children treated with these drugs or who accidentally ingest them. Based on the scientific data, the CPSC has preliminarily found that the availability of 0.08 milligrams or more of an imidazoline in a single package, by reason of its packaging, is such that special packaging is required to protect children under five years of age from serious personal injury or illness due to handling, using or ingesting such a substance.
The Poison Prevention Packaging Act authorises the CPSC to establish standards for the special/child-resistant packaging of any household substance if (i) the degree or nature of the hazard to children in the availability of such substance, by reason of its packaging, is such that special packaging is required to protect children from serious personal injury or serious illness resulting from handling, using or ingesting such substance, and (ii) the special packaging is technically feasible, practicable and appropriate for such substance. In this particular case, the CPSC has preliminarily determined that special packaging for household products containing imidazolines meets the above conditions.
Special packaging is designed or constructed to be significantly difficult for children under five years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for “normal adults” to use properly. Household substances for which the CPSC may require child-resistant packaging include foods, drugs or cosmetics, as defined in the FD&C Act. The PPPA also allows the manufacturer or packer to package a non-prescription product subject to special packaging standard in one size of non-child-resistant packaging only if the manufacturer or packer also supplies the substance in child-resistant packages of a popular size and the non-child-resistant packages bar conspicuous labelling stating: “This package for households without young children.”
Interested parties may submit comments on this proposal by 9 April.
In other CPSC news, the Chronic Hazard Advisory Panel (CHAP) on phthalates and phthalate substitutes will hold a teleconference on 1 February and an additional public meeting on 15-17 February. Interested parties may listen to the CHAP’s teleconference but will not have the opportunity to ask questions, comment or otherwise participate in that proceeding or in the subsequent meeting. As directed by the Consumer Product Safety Improvement Act, the CHAP on phthalates studies the effects on children’s health of all phthalates and phthalate alternatives as used in children’s toys and child care articles. The panel’s review had to be completed within 18 months of its appointment (by mid-October 2011), and no later than 180 days thereafter (by mid-April 2012) the panel must report to the CPSC on the results of its review and its recommendations regarding any phthalates (in addition to those permanently banned by the CPSIA) that should be declared hazardous substances.
