CPSC Proposes CR Packaging for Minoxidil
CPSC adopts a staff policy stating that droppers and sprayers must be child resistant and senior friendly.
The Consumer Product Safety Commission (CPSC) has proposed that over-the-counter products containing 14 mg or more of minoxidil be sold in child-resistant (CR), senior-friendly (SF) packaging. The ruling means that droppers and metered finger sprayers that attach to primary containers after opening must be easy for senior adults to use yet difficult for children. The proposed rule marks the CPSC's adoption of the staff's long-standing interpretation that special packaging requirements, including CR packaging, extend to applicators.
The rule is unusual in that all primary containers for topical minoxidil already have continuous-threaded CR closures. However, CPSC is concerned about droppers or sprayers that replace closures once original containers are opened.
CPSC took action because toxicity data show that minoxidil causes serious illness and injury to children. What's more, minoxidil use is increasing. According to CPSC, retail sales of the topical solution reached $200 million last year. About 8 million packages were sold.
While developing the proposed regulation, CPSC confronted the issue of whether applicators fall under the CR/SF umbrella. The Poison Prevention Packaging Act of 1970 (PPPA) defines package as the immediate container that holds a substance and the container in which any substance is used or stored. CPSC concluded that PPPA's wording about use, along with the history of the statute, gave it the authority to regulate applicators.
The proposed rule appeared in the March 17, 1998, Federal Register (pp. 13019–13025). If finalized as is, the rule would require CR/SF packaging for products containing 14 mg or more of minoxidil in a single package. The regulated dose level should help protect children under 5 years of age from serious injury or illness.
The rule also requires that droppers and finger sprayers be child resistant and senior friendly. Droppers aren't a problem—8 out of 13 droppers examined by CPSC were found to be CR/SF. Finger sprayers, however, are another matter. CPSC found eight products on the market with non-CR finger sprayers. For a sprayer to be child resistant, children must find it difficult to remove the sprayer from the container or use it to deliver an amount above the regulated level. To date, there are no finger sprayers that meet these requirements. One manufacturer does have a prototype that may pass CR/SF testing protocols, but it will take at least 12 months for the firm to finish engineering and testing.
A package is considered to be child resistant if it cannot be opened by at least 85% of a panel of 200 children in the first 5 minutes and 80% after the full 10-minute test. For a package to be considered senior friendly, 90% of 100 adults ranging in age from 50 to 70 years must be able to open a package within 5 minutes. Then they must be able to open an identical closure and secure or close it in 1 minute.
CPSC knows that the development of CR/SF applicators could take time. The proposed rule calls for an effective date 6 months after publication of the final rule for primary closures and droppers and 12 months for metered finger sprayers.
The commission also proposed a temporary stay of enforcement for finger sprayers to give manufacturers a reasonable amount of development time. However, as in the past with other rules, CPSC has been adamant that companies make every effort to meet the deadline. Because no language about an extension appeared in the Federal Register, it is reasonable to assume that CPSC will be as strict with sprayers as it was with closures. Companies that ask for an extension must have proof that a sprayer could not be ready in time.
The comment period for the proposed regulations ends this June 1. Send comments to the Office of theSecretary, CPSC, Rm. 502, 4330 East West Hwy., Bethesda, MD 20814-4408. E-mail comments to firstname.lastname@example.org.
For more information, contact CPSC's Division of Poison Prevention and Scientific Coordination at 301/504-0477, fax 301/504-0025.