The following article was written in 1989 to alert consumers to the danger of poisoning from artificial nail removers containing acetonitrile, a substance that has caused injury and death, particularly among children. At that time, special child-resistant packaging for such products was under consideration.
In 1990, child-resistant packaging became a requirement for all household glue removers in liquid form containing more than 500 milligrams of acetonitrile in a single container. This includes artificial nail removers. The Consumer Product Safety Commission (CPSC) enforces this requirement under authority of the Poison Prevention Packaging Act (15 U.S.C. 1471-1476). However, the fact that a product is in "child-resistant" packaging does not mean that a child could not possibly open it.
"CPSC's requirement for child-resistant packaging is an important protection to consumers in homes with young children. We support this regulation. However, because packaging alone does not guarantee safety, we still urge consumers to keep these products out of the reach of children," says Linda M. Katz, M.D., director of FDA's Office of Cosmetics and Colors.
Like any cosmetic product that may be hazardous if misused, it is important for these artificial nail removers to carry an appropriate warning on the label, along with directions for safe use. For one acetonitrile product intended for non-cosmetic use -- a one-ounce container of 98% acetonitrile with a restricted-flow nozzle -- CPSC requires the following warning information:
"WARNING: MAY BE FATAL IF SWALLOWED. FLAMMABLE. IRRITATING TO SKIN AND EYES.Contains Acetonitrile. Avoid contact with skin and eyes. Avoid prolonged breathing of vapors. Keep away from open flame. If swallowed, call poison control center or emergency room immediately. For skin and eye contact, flush area thoroughly with water and seek medical attention. Keep out of the reach of children."
In late 1987 in Los Angeles, 12 hours after swallowing a mouthful of solvent used to remove sculptured artificial fingernails, a 16-month-old toddler died of cyanide poisoning.
In fall of the same year in Utah, a 2-year-old boy was rushed to the emergency room for rigorous intensive care after his parents found him in bed vomiting, moaning and unresponsive, an open bottle of the same sculptured nail remover by his side. Once again, a child's curiosity had resulted in cyanide poisoning.
Sculptured nails are acrylic artificial fingernails that are glued onto the real nail. It takes a special glue remover to remove these fake long nails. However, some brands of sculptured nail removers are extremely poisonous when swallowed. FDA warns: Keep them out of the reach of small children.
These products contain 98 percent to 100 percent acetonitrile, a chemical that breaks down into cyanide when swallowed. Studies show that 150 milligrams of acetonitrile--about 1/200 of an ounce--will kill 50 percent of laboratory rodents that are given the chemical, says Heinz Eiermann, director of FDA's division of colors and cosmetics.
Toby Litovitz, M.D., who heads the American Association of Poison Control Center's data collection committee, would like to see acetonitrile-containing sculptured nail removers withdrawn from the market. However, despite the fact that the product is poisonous if swallowed, FDA does not have the authority to restrict its sale unless the injury results from using the product according to directions. Since the product is not intended to be swallowed, FDA cannot take it off the market. Regulation falls through the loopholes of federal health and safety laws.
For instance, the Federal Hazardous Substances Act, which covers household products such as cleaners, prohibits the sale of substances that contain concentrations of cyanide greater than 25 parts per million. Acetonitrile contains 4,000 to 80,000 parts per million of a cyanide equivalent, according to Litovitz. But, under the Federal Food, Drug, and Cosmetic Act, sculptured nail removers are not considered household products, but cosmetics. And the Hazardous Substances Act, which is enforced by the Consumer Product Safety Commission, doesn't cover cosmetics. No comparable law exists that would ban a cosmetic that is dangerous for other than its intended use.
At the very least, Litovitz is calling for child-resistant packaging of sculptured nail removers. The products now come in glass bottles with screw-on caps, easy for a child to open. Also, says Litovitz, she knows of at least one brand that is dyed purple and smells like grapes, further inviting childhood misuse.
Last December, Litovitz and colleague E. Martin Caravati, M.D., published a paper in the Journal of the American Medical Association calling attention to poisonings from acetonitrile cosmetics. They cited the two cases mentioned earlier. Since then there have been others, Litovitz says, although none resulted in death: Another 2-year-old suffered convulsions after swallowing a small amount of sculptured nail glue remover, and an adult woman became comatose after a suicide attempt involving the substance. At least three others--all children--have escaped with little or no harm after swallowing nail remover containing acetonitrile.
The highly poisonous glue remover is available not just professionals, but to anyone. In the JAMA article, Litovitz and Caravati reported that the "highly toxic, cyanide generating product" was purchased by parents of the victims at wholesale-retail beauty supply outlets. Similar products also are marketed in supermarkets and drugstores.
In January, FDA sent a memo to its district office in Los Angeles, where firms marketing these products are located. The memo instructed investigators to collect samples and labeling of acetonitrile-containing products. Seven sculptured nail glue removers were specifically cited in the memo. "Of special interest," it said, "is any warning or caution statement made in the labeling and promotion of the products."
Scientists in FDA's division of colors and cosmetics in Washington, DC, have reviewed the samples collected in the field, finding that these products do contain nearly 100 percent acetonitrile.
Labels on the packaging caution: "Poisonous--Do not ingest," "Poisonous & Flammable. Do not swallow or inhale. . .Keep away from children," or "Do not take internally." FDA's Eiermann says that if a nail remover containing acetonitrile "didn't have any cautionary statement, then the agency probably could take action." But the statements on the packages appear "conspicuously as compared to other words" on the label, therefore meeting the minimum requirements of the Code of Federal Regulations.
The responsibility for requiring child-resistant packaging lies with the Consumer Product Safety Commission under the Poison Prevention Act. Under that law, child-resistant containers may be required for products that can cause serious personal injury or illness because of the way the substance is packaged.
CPSC is reviewing a petition that child-resistant packaging be required for acetonitrile-containing products, says Alan Brauninger, an attorney at the commission. The petition was submitted by the Cosmetic, Toiletry and Fragrance Association, which represents the cosmetics industry.
Concern about the safety of sculptured nails and their accessories is not new. Last year, FDA Consumer published an article warning of possible infections, allergic reactions, fingernail loss, and other problems caused by sculptured nails, especially when used improperly ("Artificial Fingernails: Apply with Caution," February 1988).
FDA continues to monitor sculptured nail products and to warn consumers to read product labels and keep poisonous substances out of the reach of small children.
Dale Blumenthal is a member of FDA's public affairs staff.
U. S. Food and Drug Administration
FDA CONSUMER, June 1989