NEWS from CPSC

U.S. Consumer Product Safety Commission

CPSC Proposes To Require Child-Resistant Packaging For Mouthwash Containing Ethanol

WASHINGTON, DC -- The U.S. Consumer Product Safety Commission (CPSC) voted to propose mandatory child-resistant packaging for mouthwash containing 3 grams or more of ethanol (alcohol) in a single retail package. The Commission must finalize a regulation under the Poison Prevention Packaging Act before the child-resistant packaging would be required.

CPSC knows of three deaths since 1984 to children under 5 years of age who drank mouthwash containing ethanol. The Commission estimates that from January 1987 through November 1993 there were 1,670 mouthwash poisoning cases treated in hospital emergency rooms.

Commission Chairman Ann Brown said, "The accessibility and appeal of mouthwash may increase the probability of poisoning by children. I know that child-resistant packaging is a little harder for adults to open, but think about it -- every time you use it you may be saving a child's life."

Two industry trade associations announced a voluntary program to use child-resistant packaging and warning statements for mouthwash containing 3 grams or more of ethanol. Child-resistant packaging has been very effective in reducing deaths and injuries associated with accidental ingestion of medicines and household chemicals. CPSC estimates that child- resistant packaging for aspirin and oral prescription medicine saved the lives of about 700 children since the requirements went into effect in the early 1970's. However, this success story has not eliminated the poisoning problem in America. In 1990, 49 children under age 5 died from accidental poisoning with medicines or household chemicals. Nearly a million consumers called poison control centers about actual or "near-miss" child poisonings last year.

The Commission's proposed rule will be published in the Federal Register soon. After considering comments from interested parties, the Commission must take another vote on whether to issue the regulation. Mouthwash containing 3 grams or more of ethanol could be required to be in child-resistant packaging in 1995.

CPSC's mission is to protect the public from unreasonable risks of injury and death associated with consumer products. The Commission's objective is to reduce the estimated 28.6 million injuries and 21,700 deaths associated each year with the 15,000 different types of consumer products under CPSC's jurisdiction.

STATEMENT OF COMMISSIONER MARY SHEILA GALL ON PETITION 93-1 PROPOSING CHILD-RESISTANT PACKAGING FOR MOUTHWASH CONTAINING ETHANOL

May 3, 1994

I have voted to publish in the Federal Register a notice informing the public of the Commission's intent to establish a mandatory special packaging standard for mouthwashes. Packages which contain three grams or more of absolute ethanol per package would be covered regardless of their size.

The petitioners had requested that such a standard be established for mouthwashes in which ethanol comprised more than 5~ of the product. I do not believe that this approach provides adequate protection for small children. Ingestion of approximately twenty six ounces of mouthwash containing 5% ethanol will kill a 22 pound child. Ingestion of less than this lethal dose may cause hypoglycemia, metabolic acidosis or hypokalemia, any of which can have severe effects.

The first line of protection for young children is the individuals who are caring for them. Parents and child care providers MUST act responsibly in keeping these products out of the reach of small children, regardless of whether the packages have child-resistant closures. However, mouthwashes are familiar products that can be fairly characterized as presenting a hidden hazard to consumers. Ethanol comprises between 5% and 7% of most beers and 12% to 14% of most wines. By comparison, most of the popular adult mouthwashes contain between 14% and 27% ethanol. Parents and others who care for children may be unaware of the high ethanol concentration in these products. Since mouthwashes are often sold in large sizes, I believe that the proposed level will provide an essential margin of safety for young children by bringing all sizes of mouthwashes containing toxic doses of ethanol within the purview of the standard.

Through its associations, industry has established a voluntary packaging and labeling program. Originally conceived at the petitioner's proposed level of greater than 5% ethanol, industry has modified its program to bring it into line with the Commission's proposal. We expect nearly full compliance by May of 1995. These actions are commendable and I look forward to implementing this important safety measure.