View From the Bottom – Are Medicated Baby Powders Doing More Harm Than Good?

Jennifer Bogo, E: The Environmental Magazine

Lead has been identified by the federal government as the foremost
environmental health threat to American children. Nearly one million children still
have elevated blood lead levels, over four percent of the population. Now,
according to San Francisco's
Center for Environmental Health (CEH), infants may be exposed through the most
unlikely of sources–medicated baby powders.

Testing conducted by the CEH revealed 10 powders to contain trace amounts of
lead (up to three parts per million), under the brand names Ammens, Caldesene,
Desitin, Dr. Scholl's, Gold Bond, Johnson & Johnson, Longs, Mexsana and
Walgreens. Not that these names should necessarily be taboo to parents. The
tests did not actually reveal them to be harmful to children, and several of
these same companies also manufacture lead-free, unmedicated powders. The
common denominator in all of the brands with detectable levels of lead is the element
of medication–the active ingredient zinc oxide, added to treat rashes and
minor skin irritation.

Because the zinc oxide itself is frequently contaminated with lead, the CEH
questions applying the medicated powders directly to the chafed, sensitive area
of diaper rash. Dr. Janet Phoenix of the National Lead Information Center
warns, however, that "putting a product with lead on a child, even if it's
not absorbed through the skin, may still result in ingestion or inhaling powder
that's been dispersed through the air." And although the levels may be
low, all sources of lead exposure are cause for concern, says Phoenix, because the damage incurred is
largely irreversible.

When lead enters the body, it distributes to vital organs, like the brain
and kidney, and accumulates in the bones. The effects range from reduced
mention and lowered intelligence to learning disabilities, behavioral problems,
impaired growth and hearing loss. Developmental delays in lead-exposed children
have been shown to persist until at least age 5. Several factors place children
at greater risk: high hand-to-mouth activity, a nervous system that is still
developing, and certain dietary deficiencies, like those of calcium and iron,
which increase absorption of lead from the gut.

The CEH filed suit against the manufacturers of the powders, and several
retail distributors, including RiteAid, Safeway and three online Internet drug
stores (Drugstore.com, More.com and PlanetRx.com) for silently exposing
consumers, especially children, to lead. The CEH claims the companies are in
violation of California's
Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act
of 1986, which identifies chemicals known to the state to cause cancer or
reproductive harm. Lead is listed for both.

Risky Business

But the question is not whether the lead content is legal. Lead is actually
already in a lot of products, says Allen Halper, compliance officer in the Food
and Drug Administration (FDA)'s Office of Cosmetics and Colors. For instance, zinc
oxide is also used as a color additive in cosmetics, and lead acetate appears
in Grecian Formula, a hair coloring product. What California's Proposition 65 might instead
determine is whether the levels of lead warrant action such as product
labeling. "The key issue is that parents have a right to know," says
Michael Greene, CEH director.

There are currently 455 carcinogens and 255 developmental chemicals listed
under the Act, and for many of these, levels of safety have been established
that determine whether a product necessitates a warning. If no legal level has
been set, it's left to industry to prove through testing that the product
doesn't impose unreasonable risk. According to a spokesperson for the
California Environmental Protection Agency's Office of Environmental Health and
Hazard Assessment, if deemed necessary, the powders would carry a label similar
to this: "Warning: Contains a chemical known to the state of California to
cause cancer, birth defects or other reproductive harm."

Although the lawsuit was raised under California
law and technically applies only to products marketed within the state, the
baby powders are medicated, and are therefore regulated as a drug by the FDA.
The FDA is aware of the suit, and according to an agency spokesperson, will
next evaluate the scientific data that the report was based upon, and determine
if the products contain enough lead to designate a health hazard. Under a
worst-case scenario, the FDA may then issue its own warning, which could
ultimately lead to the powders being reformulated, or removed from the market
altogether.

But that's an outcome many in the industry don't consider justified. The
legal action itself is, according to a recent statement by Johnson &
Johnson, based on "exaggerated unscientific claims that only unnecessarily
alarm consumers." Bristol-Myers Squibb is prepared to vigorously defend
any type of claims against Ammens Medicated Powder, says spokesperson Jane
Kramer. And according to Clay Selland, vice president of Longs Drug Stores, "The
manufacturers assure us that their products are safe and meet all national
standards of purity. These have been put on babies for 75 years, and the
products are on the shelf of every retailer in the country."

Double Exposure

The products' ubiquity is not necessarily reassuring to everyone. "Lead
in baby powder falls in the same category as the multitude of stupid
inexcusable sources of lead," says Don Ryan, executive director of the Alliance to End Childhood
Lead Poisoning. "The bottom line is that there is no excuse for lead to be
used in any kind of consumer products. But," he emphasizes, "it is
important to focus media attention on the overwhelming heart of the problem.
Lead paint in housing eclipses all these other sources."

According to the Department of Housing and Urban Development, 64 million
homes, two thirds of American housing, still contain lead from lead-based
paints which, as it deteriorates, lands in dust on flat surfaces, toys and
floors. And despite lead being phased out of gasoline in the 1980s, it still
persists in the soil, especially in urban areas of high automotive traffic.
Drinking water is another common source, because of lead pipes in older
plumbing. In fact, excessive lead exposure in young infants has been traced to
reconstituted infant formula, reports a study in the journal Clinical
Pediatrics.

Although blood lead levels have dropped since the 1970s, so has the
acceptable blood lead level in children set by the Centers for Disease Control
and Prevention (CDC)–it dropped from 30 to 25 micrograms per deciliter (mcg/
dL) in 1985, and again from 25 to 10 mcg/dL in 1991. Evidence has accumulated
that lead negatively affects children at levels of exposure much lower than
previously suspected. According to the Agency for Toxic Substances and Disease
Registry, no safe level has yet been found for children. Effects have been
reported to begin at levels as low as 4mcg/dL (the current limit for accurate
blood lead measurement).

"I know of no cases reported where the powder is implicated as the
source of exposure," says Jerry Hershovitz of the Lead Poisoning
Prevention Center at the CDC. "Overwhelmingly, the majority of exposure
comes from lead-based paint, dust and soil with chalkings from lead exteriors
and auto exhaust. That's where the major problem is and where attention needs
to be focused." However, Hershovitz adds, "If a consumer has any
concern, it's always better to err on the side of safety."

The CEH agrees. "Our goal is for these companies to take the lead our," says Greene. "In the meantime, we recommend that parents read the labels and see if the powders contain zinc oxide, and not use those powders if they are concerned about lead, which every parent should be." CONTACT: Center for Environmental Health, (510594-9864, www.cehca.org; Alliance to End Childhood Lead Poisoning, (202)543-1147, www.aeclp.org; National Lead Information Center, (800)LEAD-FYI.

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