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This article was originally published in The Tan Sheet

Executive Summary

ALCOHOL-CONTAINING MOUTHWASH CHILD-PROOF CAPS RECOMMENDED by the Consumer Product Safety Commission staff in a recently leased briefing package to CPSC commissioners. In the package, CPSC staff recommended that the commission rant a petition by a coalition of state attorneys general that would require child-resistant packaging for mouthwash products containing over 5% ethanol. The petition was submitted to CPSC in February by 30 states and territories well as the American Academy of Pediatrics, the American Association of Poison Control Centers and the enter for Science in the Public Interest ("The Tan Sheet" March 1, p. 11). The CPSC staff recommended that the level for regulation be based on a maximum total amount of ethanol per package rather than a percentage because of "the potential toxic or lethal dose contained in large volumes of mouthwash with 5% ethanol." CPSC staff specified that if mouthwashes were reformulated to contain no ethanol or less than the regulated level, the products would not be required to use child-resistant caps. The requirement would equalize packaging requirements among mouthwashes with the same ethanol content, the document states, thereby removing the competitive advantage of manufacturers that do not adopt the packaging. The briefing package notes that the incremental cost to manufacturers of using a child-proof cap is low, ranging from one- half to 2" per package. The CPSC staffers cited data showing that since 1984, three children have died from accidentally ingesting mouthwash containing ethanol. From 1978 to July 1993, CPSC's Children and Poisoning (CAP) database showed 65 ingestions of alcohol- containing mouthwash by children under five years old, five of which required hospitalization. The staff also said that the American Association of Poison Control Centers received 10,193 reports of ingestions of the mouthwash by children under the age of six in the last five years. "The number of ingestion incidents is expected to decrease if [child-resistant] packaging were required for mouthwash with ethanol," the document asserts. The commission will hold a briefing on mouthwash CRPs on Nov. 3 and is expected to vote on whether to grant the petition two to three weeks after that. The entire process of finalizing the requirement could take a year, the commission said. In an effort to pre-empt any child-resistant packaging requirements, the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association issued joint voluntary packaging and warning label guidelines for mouthwashes containing over 5% ethanol in June that urged the use of child- proof caps ("The Tan Sheet" June 7, p. 17). Implementation dates for the voluntary program are no later than May 30, 1994 for warning labels; Aug. 31, 1994 to include CRP for at least one size of a product line; and May 1, 1995 for full compliance. Despite the creation of the voluntary program, the briefing package underscores that "a mandatory requirement for special packaging would be advantageous because it would: 1) Apply to all current and future manufacturers of mouthwash products; 2) Ensure that the [child-resistant] packaging used complies with CPSC standards; and 3) Set an appropriate level for regulation of ethanol which would protect children from serious injury or illness." Another attempt to encourage mouthwash manufacturers to use child-proof caps was made by the American Dental Association, which stated in April that it would grant its ADA Seal of Acceptance to products containing over 5% ethanol only if the products have the child-resistant packaging.

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