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U. S. Food and Drug Administration
FDA Consumer
June 1989
ARTIFICIAL NAIL REMOVER POSES POISONING RISK
by Dale Blumenthal
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sculptured nail removers withdrawn from the market.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.
SMELLS LIKE GRAPES
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.
READ THE LABEL
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.
CHILD-RESISTANT PACKAGES
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.
KEEP AWAY FROM CHILDREN
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
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