Are Medicated Baby Powders Doing More Harm Than Good?
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 ones with detectable levels of lead is the element of medication—the active ingredient zinc oxide, added to treat rashes and minor skin irritation.
Because zinc oxide itself is frequently contaminated with lead, applying the medicated powders directly to the chafed, sensitive area of diaper rash may be of particular concern. 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 attention 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.
But the question is not whether the lead content is legal. Lead is actually already in a lot of products, says Allan 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 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 a warning itself, 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.”
The products' ubiquity is not necessarily reassuring to everyone. “Lead in baby powder falls in the same category of 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 majo
r 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.”
“Our goal is for these companies to take the lead out,” 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.”