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NDMA/CTFA VOLUNTARY CRP GUIDELINES FOR ALCOHOL-CONTAINING MOUTHWASHES

This article was originally published in The Tan Sheet

Executive Summary

NDMA/CTFA VOLUNTARY CRP GUIDELINES FOR ALCOHOL-CONTAINING MOUTHWASHES will apply to all mouthwashes containing more than 5% alcohol by volume under a program announced by the two industry groups on June 3. "Mouthwash manufacturers will move as quickly as practicable to comply with the voluntary program and will begin shipping mouthwashes with child-resistant packaging by Aug. 31, 1994," the Nonprescription Drug Manufacturers Association and the Cosmetic, Toiletry and Fragrance Association said in a joint press release. The program also includes voluntary consumer label warning statements that: urge that the mouthwash be kept "out of the reach of children"; recommend that a health professional or poison control center be contacted immediately in the event of accidental overdose; and advise that children under age six should not use the product. NDMA and CTFA acknowledged that the program is "in response to concerns typified most recently by a request for action from a number of state officials." Attorneys general from 29 states petitioned the Consumer Product Safety Commission in late February to require child-proof packaging for all mouthwashes containing more than 5% alcohol ("The Tan Sheet" March 1, p. 11). Citing data from the American Association of Poison Control Centers, the petition to the CPSC said that poison control centers received 10,193 reports from 1987 to 1991 of ingestions of alcohol-containing mouthwashes by children under age six, including 329 ingestions that required "some form of treatment" and 40 ingestions with outcomes that "were life-threatening or resulted in permanent injury." Three deaths of young children were reported. NDMA and CTFA have set an implementation date for voluntary compliance of the labeling components of the program for May 30, 1994. The CRP target date "for at least one size (or SKU)" is Aug. 31, 1994 and the goal for full compliance "with all aspects of the program" is May 1, 1995. Under the program, package labeling for mouthwashes containing more than 5% alcohol will state: "Keep [this and all drugs] out of the reach of children." The two associations noted that the bracketed phrase "will not appear in labeling of mouthwashes making only cosmetic (non-drug) claims, since cosmetics are not drugs." In addition, labeling will bear the statement: "Do not use in children under 6 years of age." Product labeling also will state: "In case of accidental overdose [or, in case of accidental ingestions; or, in case of accidental misuse; or, if an amount considerably larger than used for rinsing is swallowed; or similar phrase(BRACKET), seek professional assistance or contact a poison control center immediately." NDMA and CTFA said that mouthwash products making only cosmetic claims should use one of the bracketed phrases or a "substantially equivalent phrase" instead of "overdose." NDMA and CTFA said that mouthwash labels will continue to "bear the appropriate statements for disclosure of the alcohol content of affected products." In addition, the two groups note that the Poison Prevention Packaging Act of 1970 allows one SKU to be exempt from CRP requirements if they bear the statement: "This package for households without young children." Procter & Gamble issued a separate June 3 release on the childproof packaging program, announcing plans for its Scope mouthwash. In addition to developing child-proof packaging for Scope, P&G is modifying the product's label to encourage proper storage of the product. The current label cautions against use of Scope for children under six. The new label additionally will advise that the product be kept out of childrens' reach. P&G said it will offer consumers replacement bottles with child-resistant closure through a toll free number while the new Scope packaging is under development and is producing a free informational booklet on the safe use of various household products. P&G also "reaffirmed its commitment" to "reducing the alcohol content of Scope over time." The company said that "although the alcohol level of Scope is already well below the level of other leading brands of mouthwash . . . it will further reduce the alcohol content of Scope while still providing an effective and consumer-preferred mouthwash." Warner-Lambert is in the process of changing packaging for its Listerine and Listermint mouthwashes to child-proof bottles. The company said the effort was initiated in February. W-L also said it intends to comply fully with the program as described by NDMA and CTFA.
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