Johnson & Johnson Reformulating Personal Care Products To Remove Cancer Causing Chemicals

Years of public pressure has finally pushed Johnson & Johnson to ratchet up its efforts to remove several chemicals from its product formulations that have been documented as known carcinogens, hormone disruptors, and environmental hazards.

Photo courtesy of medicsindex.net.

Much of the pressure has come from an effort by the Campaign for Safe Cosmetics in cooperation with the American Nurses Association, Physicians for Social Responsibility, and about 20 other parent and health groups asking the company for healthier changes to its product formulations.

Among the early complaints against the company, the Campaign for Safe Cosmetics wrote a letter to Johnson & Johnson citing a report issued by the nonprofit coalition – No More Toxic Tub: Getting Contaminants Out of Children’s Bath and Personal Care Products – which documented laboratory tests that found chemicals including formaldehyde and 1,4-dioxane (both highly toxic in large amounts) in Johnson’s Baby Shampoo and other products made by the company.

Both formaldehyde and 1,4 dioxane are considered to cause cancer in animals and listed as probable human carcinogens by the U.S. Environmental Protection Agency.

Johnson & Johnson makes popular global brands including Aveeno, Neutrogena, Johnson’s Baby Shampoo, Clean & Clear, Johnson’s Lubriderm, RoC, as well as local and regional brands like Sundown in Brazil, and Le Petit Marseillais in Europe.

As part of the ongoing dialogue, Susan Nettesheim, vice president of product stewardship and toxicology at Johnson & Johnson, responded in a letter to the campaign, saying, “While we would still disagree with the science and conclusions in your letter and report, we want you and those who count on our products everyday to understand our commitment to safety.

“Our products always meet and often exceed the standards of the agencies around the world responsible for the safety of personal care products in the markets where they are sold. But we understand that the bonds of trust we have with the people who use our products often means going beyond safety alone.”

Nettesheim went on to say, “We listen to consumers, and respond to their needs and values, and their desire for products that are more sustainable and gentle on both people and the environment. We are continually making changes.”

Johnson & Johnson is in the process of reformulating its baby and adult personal care products to remove the following chemicals: formaldehyde-releasing preservatives, diethylphthalate (DEP), and triclosan.

Formaldehyde-Releasing Preservatives

Formaldehyde is a commonly used preservative in the personal care industry, though Johnson & Johnson says that, “We never add formaldehyde directly to our products. Instead, we use what are known as formaldehyde-releasing preservatives, which release tiny amounts of methylene glycol, the alcohol form of formaldehyde, over the shelf-life of a product,” adding that, “This means that all of our products stay significantly below the levels considered safe by regulators.”

Getting told the levels of formaldehyde are low hasn’t been consoling to health and consumer groups.

The National Cancer Institute  (NCI) has found that, “When formaldehyde is present in the air at levels exceeding 0.1 parts per million, some individuals may experience adverse effects such as watery eyes; burning sensations in the eyes, nose, and throat; coughing; wheezing; nausea; and skin irritation. Some people are very sensitive to formaldehyde, whereas others have no reaction to the same level of exposure.”

In an industrial setting, the NCI did a study whose results showed that workers employed at plants that used or produced formaldehyde showed “a possible link between formaldehyde exposure and death from cancers of the blood and lymphatic system, particularly myeloid leukemia.”

The NCI study also found that “the risk of myeloid leukemia was 78 percent higher among industrial workers with the highest peak exposures compared to those with the lowest peak exposures,” adding that, “studies of humans exposed to inhaled formaldehyde have (also) shown higher rates of damage to their chromosomes.”

In response to concerns, Nettesheim said, “We have begun providing new formulas with alternatives to formaldehyde-releasing preservatives and expect to finish this process in our hundreds of baby products around the world (by about early 2014), and sooner for our baby shampoos.”

Johnson & Johnson said, “We have introduced new product formulations for consumers who prefer natural products, such as Johnson’s Natural, a line that is 98 percent natural and contains no formaldehyde releasing preservatives or 1,4 dioxane.”

The company continued that, “In addition, we will phase out formaldehyde releasers in adult products, making rare exceptions for adult products only when alternatives are not feasible or safe in formulations with other ingredients.”

The Campaign for Safe Cosmetics advises consumers to avoid products that contain formaldehyde releasing preservatives such as quaternium-15, DMDM hydantoin, diazolidinyl urea and bronopol; and ethoxylated chemicals such as sodium laureth sulfate, PEG-100 stearate, and polyethylene.

Diethylphthalate (DEP)

Diethylphthalate (DEP) is part of a group of chemicals called phthalates, which according to the U.S. Food and Drug Administration, are “used in hundreds of products, such as toys, vinyl flooring and wall coverings, detergents, lubricating oils, food packaging, pharmaceuticals, blood bags and tubing, and personal care products, such as nail polish, hair sprays, soaps and shampoos.”

Johnson & Johnson added that, “In the cosmetics industry, phthalates give hairspray a flexible film, help fragrances last longer, and make nail polish products resistant to chipping. Diethylphthalate (DEP), a low-weight phthalate, is the only phthalate that we use, and you will find it in a few of our adult products at tiny levels as fragrance components.”

The company tells consumes that, “Despite DEP’s strong safety record, we understand that because it is so tied to other phthalates in public discussion, the best way to keep your confidence is to not use it at all.

“To give you peace of mind, all our baby products worldwide are now phthalate-free, and will remain so. As for adult products, in 2006 we stopped using DEP in new adult products, and we are committed to phasing it out of all our adult products.”

On the issue of the health effects of phthalates, the FDA treads carefully, saying, “It’s not clear what health effects, if any, phthalates have on health. An expert panel convened from 1998 to 2000 by the National Toxicology Program, part of the National Institutes of Health, concluded that reproductive risks from exposure to phthalate esters were minimal to negligible in most cases.”

Finding a stronger correlation between phthalates and reproductive health risk, a study – Prenatal Phthalate Exposure is Associated with Childhood Behavior and Executive Functioning – was conducted as a collaboration between Mount Sinai, Cornell University, and the U.S. Centers for Disease Control and Prevention.

Dr. Stephanie Engel, a lead author in the study and an associate professor of preventative medicine at Mount Sinai School of Medicine, said, “The government instituted regulations limiting certain phthalates in things like toys that young children put in their mouths, but even with that, it’s their mothers’ contact with phthalate containing products that cause prenatal exposure.

“The phthalates that we found most strongly related to neurodevelopment were those commonly found in cosmetics, perfumes, lotions, and shampoos. Current U.S. regulations do not address these kinds of phthalates.”

Engel also illustrated in more technical terms, saying, “We found a striking pattern of associations between low molecular weight phthalates, which are commonly found in personal care products and disruptive childhood behaviors, such as aggressiveness and problems with attention.”

Another issue of concern is that even if you’re trying to avoid phthalates by reading product labels, it won’t be possible in the case of fragrances.

The FDA says, “Consumers can tell whether some products contain phthalates by reading the ingredients declaration on the labels of such products.

“However, the regulations do not require the listing of the individual fragrance ingredients; therefore, consumers will not be able to determine from the ingredient declaration if phthalates are present in a fragrance.”

On Johnson & Johnson’s position on fragrances, the company tells its consumers that, “While fragrance formulations are considered proprietary, we want you to know some of the ingredients that we don’t put in our fragrances.”

The company says that it doesn’t use any of the following ingredients in new baby or adult products and is phasing them out altogether, with priority given to baby products. They are:

• Animal-derived ingredients
• Nitromusks and polycyclic musks
• Tagetes
• Rose crystal
• Diacetyl
• DEP

Triclosan

Triclosan is a commonly used antibacterial ingredient in consumer products worldwide. Johnson & Johnson said, “In recent years, some questions have been raised about the potential environmental impact of triclosan.”

The company further tells its consumers that, “We have set a goal to phase out triclosan in our beauty and baby products. None of our infant or baby products worldwide contain triclosan and we are looking to eliminate it in our adult products in order to give you peace of mind.”

The FDA says that triclosan isn’t currently known to be hazardous to humans, but “animal studies have shown that triclosan alters hormone regulation.”

Another concern the FDA is looking at is that, “Other studies in bacteria have raised the possibility that triclosan contributes to making bacteria resistant to antibiotics.”

In light of these studies, the agency says that it’s “engaged in an ongoing scientific and regulatory review of this ingredient,” but currently, “does not have sufficient safety evidence to recommend changing consumer use of products that contain triclosan.”

If consumers are looking to avoid triclosan, the FDA explains that, “If a cosmetic contains triclosan, it will be included in the ingredient list on the product label.”

1,4 dioxane

In addition, to removing chemicals from its formulations that are potentially hazardous to human health, Johnson & Johnson said that it will also work to reduce the amounts of 1,4 dioxane in its products.

1,4 dioxane is a compound that is a byproduct of the process that makes cleansers mild and nonirritating. 

The FDA gives further background, saying, “Concerns were initially raised in the 1970s, when studies at the NCI found an association between 1,4 dioxane and cancer in animals when 1,4 dioxane was administered in high levels in the animal feed.

“However, the levels in cosmetics (such as lotions) are far lower than those found to be harmful in feeding studies, and for the most part, the types of products in which it is found (in cosmetics) are only in contact with the skin for a short time.”

The FDA does admit that it cautions cosmetics manufacturers, “alerting them to the health concerns and how to minimize 1,4 dioxane.”

To ease consumer concerns, Johnson & Johnson said that it is reducing 1,4 dioxane in its baby product to what it considers “the lowest reliably measureable level, 1 to 4 ppm. In our adult products, we are reducing 1,4 dioxane to below 10 ppm,” which the company considers “lower than levels considered safe by regulators around the world.”

In general though, consumers have to be careful and be their own advocates in making sure the cosmetics they use are safe. The FDA’s legal authority over cosmetics is different from other products regulated by the agency, such as drugs and medical devices.

Cosmetic products and their ingredients are not subject to FDA premarket approval authority, with the exception of color additives. Cosmetic firms are responsible for substantiating the safety of their products and ingredients.

Manufacturers are not required to register their cosmetic establishments, file data on ingredients or report cosmetic-related injuries to the FDA, but the agency can take regulatory action if it has information to support that a cosmetic is “adulterated,” meaning somehow contaminated or tainted, or has been misbranded.

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