16 CFR Part 1700 - POISON PREVENTION PACKAGING

The Consumer Product Safety Commission (“CPSC,” “Commission,” or “we”) is proposing a rule to require child-resistant (“CR”) packaging for any over-the-counter or prescription product containing the equivalent of 0.08 milligrams or more of an imidazoline, a class of drugs that includes tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline, in a single package. Imidazolines are a family of drugs that are vasoconstrictors indicated for nasal congestion and/or ophthalmic irritation. Products containing imidazolines can cause serious adverse reactions, such as central nervous system (“CNS”) depression, decreased heart rate, and depressed ventilation in children treated with these drugs or who accidentally ingest them. Based on the scientific data, the Commission preliminarily finds 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 is required to protect children under 5 years old from serious personal injury or illness due to handling, using, or ingesting such a substance. We are taking this action under the Poison Prevention Packaging Act of 1970 (“PPPA”). 1 1 The Commission voted 4-0 to publish this notice in the Federal Register . Commissioner Robert S. Adler issued a statement, which can be found at http://www.cpsc.gov/pr/statements.html.