Imidazoline Childproof Packaging Deadline Extended Six Months, Potentially More
This article was originally published in The Tan Sheet
Executive Summary
The Consumer Product Safety Commission followed its staff’s recommendation to extend the deadline for six months, through May 10, 2105, and to consider requests for additional six-month extensions on a case-by-case basis.
The Consumer Product Safety Commission extends its deadline for adding childproof packaging for nasal decongestants, eye drops and other products that include 0.08 mg or more of an imidazoline ingredient per package to May 10, 2015, and allows firms to request further extensions.
The commission followed its staff’s recommendation to extend the deadline for six months and to consider requests for additional six-month extensions on a case-by-case basis, according to a Nov. 12 statement on the CPSC website.
The change followed by comments by OTC manufacturers and the Consumer Healthcare Products Association on its 2012 final rule requiring compliance by Dec. 10, 2013, but allowing a one-year extension if a firm made timely notification to the commission. Stakeholders pointed out that the amount of time needed to implement some packaging changes is affected by a requirement for FDA approval (Also see "In Brief" - Pink Sheet, 17 Dec, 2012.).
As a “conditional stay of enforcement,” the final rule also required timely notification to the commission if a firm expected not to be ready by the December 10, 2014, deadline for compliant packaging. The same notification requirement is in place the May 2015 deadline. The rule also requires quarterly updates to the commission on firms’ progress toward compliance.
The commission says 12 firms provided timely notice and met conditions for stay of enforcement through December, and eight of them indicated they likely will not be able to comply with the requirements and are seeking an extension of the conditional stay. The other four expect to have their packaging compliant before the expiration of the conditional stay.
According to the CPSC’s pending Federal Register notice announcing the changes, four of the five manufacturers of ophthalmic products containing imidazoline ingredients marketed in the U.S. advised commission staff they need additional time to comply; and four of seven manufacturers of nasal products containing the ingredients need additional time to produce either squeeze spray or metered pump spray bottles.
In briefing materials
for the commission members, CPSC staff said they based their recommendation on the expectation that most manufacturers of imidazoline-containing products will be compliant within the additional six-month conditional stay of enforcement. “Extending the stay for six months rather than a longer period of time such as one year will mean that compliant products will be available on the market sooner,” CPSC staff stated.
The commission proposed the requirement in January 2012, saying the safeguard is needed to protect children under 5 years from serious injury or illness, such as central nervous system depression, decreased heart rate and depressed ventilation, due to accidental or unsupervised ingestion or overdose of the vasoconstrictors (Also see "CHPA Requests Extension To Childproof Imidazoline Product Packaging" - Pink Sheet, 16 Apr, 2012.).
‘Diligence’ Required For Extensions
The CPSC briefing materials state that in addition to adhere to conditions of the stay, requests for six-month extension beyond May 10, 2015, will be evaluated on criteria including whether firms:
- demonstrate to CPSC staff “continued efforts to meet the deadline”
- initiate “open dialogues with staff regarding the unanticipated delays in the design and production of special packaging for their products”
- provide “supporting documentation that, in staff’s opinion, demonstrates … diligence in meeting the deadlines.”
CPSC also will consider whether a firm’s “difficulties in obtaining packages that pass the child-resistant and senior-friendly testing requirements and in implementing the requirements were not reasonably foreseeable.” Problems such as contract packagers experiencing delays linked to obtaining automation equipment from foreign suppliers are among the reasons for extensions that the commission will consider reasonable.
The briefing document also points out that the commission’s decisions on additional extensions will consider that it “is important to have continuity in the availability of products containing tetrahydrozoline, naphazoline, oxymetazoline, and xylometazoline” to cause vasoconstriction of blood vessels in the eye or in nasal tissue.
“Without extending the stay, these products will be in violation of the [child-resistant] packaging rule. If companies pull their non-compliant products from retail shelves, a shortage of imidazoline-containing ophthalmic and nasal product could result,” according to the commission staff.