Johnson’s Baby Powder is a popular household hygiene product. For more than 100 years, Johnson & Johnson marketed the talc-based substance as a routine method of maintaining freshness.

Recent investigations into the safety of the lightweight powder led to the discovery of a dark, decades-old secret, but millions of Americans still douse themselves daily.


The Truth

Studies + Science

Regulation Recap

The Next Steps
Long-term use of baby powder can cause cancer and other life-threatening side effects.The link was first discovered in the ’70s when researchers uncovered talcum particles embedded in ovarian tumors.Courts found Johnson & Johnson guilty of hiding data linking talcum powder to ovarian cancer.Knowledge about the controversy is growing, and so are the options for affected families.

 

All About Talc

mt-talcum-final-revaTalcum is a fine white substance that naturally occurs as a combination of magnesium, silicon, oxygen, and hydrogen. Talcum powder is primarily used as a drying agent. It can be found in a number of everyday cosmetics, like body and shower products, feminine hygiene formulas and cosmetics. Johnson’s Baby Powder is among the most widely used talc products.

Johnson’s Baby Powder is dusted on the genitals of women and babies to absorb moisture, treat diaper rash, mask vaginal odor and reduce chafing in sensitive areas. The manufacturer recommends sprinkling it on babies after “every bath and diaper change,” and on your own body “anytime you want skin to feel soft, fresh, and comfortable.”

Johnson & Johnson (J&J) worked to build talcum’s reputation as a safe and effective hygiene method for decades. Family-friendly ads presented the product as “the kindest powder in the world,” perfect for mom, dad and of course, baby. But the truth isn’t so kind.

Johnson’s Baby Powder is a major commodity for the sixth-largest consumer health company in the world, but more than 40 years ago, scientific studies linked its main ingredient to cancer. Until recently, the data has remained buried under the Baby Powder fortune. And because of that, many lifetime users will learn of the risks only after receiving a life-changing cancer diagnosis.

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Studies + Science

Research from the U.S. and Europe shows that extended use of talcum powder carries increased risks. More than 20 studies have investigated an association between the cosmetic powder and ovarian cancer. The link, which was first discovered decades ago, prompted European Union officials to prohibit talc-containing products from entering the market.

In the European Union, talcum is one of more than 1,000 chemicals considered too dangerous for use in human cosmetics. Comparatively, the U.S. Food and Drug Administration (FDA) has only taken action on 11 cosmetic substances.

Inhaling Talc

When Baby Powder is sprinkled on the body, there’s a chance that particles could be swept into the respiratory system through the mouth or nose. Talcum inhalation is problematic for a number of reasons, and children are particularly vulnerable.

Does Talc Contain Asbestos? 

Because talc can be mined from the Earth or produced by industry, it may contain traces of asbestos. In 1976, a study from Mount Sinai Medical Center examined 20 talcum products. The researchers tested baby powders and facial makeup, discovering asbestos, tremolite and anthophyllite asbestos in about half. The Personal Care Products Council mandated that today’s “cosmetic-grade talc must contain no detectable fibrous, asbestos minerals.”

Mesothelioma & Respiratory Conditions

Inhaling talcum impurities can also lead to a condition known as talcosis. Talcosis is a respiratory illness that affects infants exposed to baby powder. Symptoms of talcosis include breathing irregularities, severe wheezing, persistent coughing, and lung irritation. Long-term exposure can lead to serious pulmonary problems, worsening asthma, pneumonia, and even lung cancer.

Ovarian Cancer

Issues associated with talc inhalation are included on Johnson’s Baby Powder labeling, but the increased risk of ovarian cancer remains marred in secrecy.

Research indicates that talc particles can enter the vagina, travel through the uterus and damage the ovaries. The particles can then cause inflammation, pain, and growth of tumor cells. It can take years to clear these contaminants from the body.

In 1971, a British study discovered talcum particles “deeply embedded” in 10 of 13 ovarian tumors. A few years later, in 1982, the link was statistically proven and published in the medical journal Cancer. Researchers continued to find heightened cancer risks throughout the 1980s, finding that talcum use contributed to a 35 percent higher chance of developing the disease.

Later, in 1993, the National Toxicology Program published a report of carcinogenesis studies of talc in rats and mice. The results showed “some evidence of carcinogenic activity” in male rats and “clear evidence of carcinogenic activity” in female rats. European researchers also found a link between talcum and cancer in animal studies.

“To summarise the evidence in favour of an association, a very large number of studies have found that women who used talc experienced excess risks of ovarian cancer; some results were statistically significant and some were not,” according to the Journal of Epidemiology and Community Health. “There was some indication in the cohort study of an increase in serious tumours.”

The studies, which found a small but existent association between talcum powder and ovarian cancer, remained largely unpublicized because they weren’t strong enough to prove direct causation.

1890
Fred B. Kilmer, J&J’s scientific director, invents talcum powder.
Vault Guide to the Top Consumer Products Employers
1971
Talcum particles “deeply embedded” in 10 of 13 ovarian tumors.
The Journal of Obstetrics and Gynaecology of the British Commonwealth
1982
Link between talc use and ovarian cancer statistically proven.
Cancer
1992
Lifetime genital perineal talc use may increase the risk for ovarian cancer.
Obstetrics & Gynecology
1992
Survey showed an increased risk observed for exposure to talc on sanitary napkins.
Gynecologic Oncology
1993
Carcinogenesis studies reported “clear evidence of carcinogenic activity” in female rats.
The National Toxicology Program
1994
Consumer Labeling Initiative requests warnings or discontinued use of talc.
Cancer Prevention Coalition
1996
Condom manufacturers stop using talc due to women’s health concerns.
Jersey Journal
1997
Genital talc use is associated with a 50 percent increased risk of ovarian cancer.
American Journal of Epidemiology
2003
Scientific review finds a 33 percent increased risk of ovarian cancer.
Anticancer Research
2006
Talcum is classified as a 2B carcinogen.
World Health Organization, International Agency for Research on Cancer
2016
Talc use may result in a 33 percent increased risk of ovarian cancer.
Epidemiology
2017
Federal investigation focused on talc and ovarian cancer.
U.S. Food and Drug Administration

 

According to the Center for Disease Control and Prevention, about 20,000 U.S. women are diagnosed with ovarian cancer each year. More than 14,000 women in the United States will die from this disease.

In a study published in 1999, researchers estimated that talcum powder could be the cause of about 10 percent of ovarian cancer cases in the United States. The Foundation for Women’s Cancer asserts that “while ALL WOMEN ARE AT RISK FOR OVARIAN CANCER, some women have a personal or family history that may further substantially increase their risk.”

Ovarian cancer will affect 1 in 70 women in the United States over their lifetime and is the deadliest gynecologic cancer (FWC).

When talcum powder is added to the mix, the risk could increase by about 35 percent—which means one in 50 women may develop talc-related cancer.

“Balanced against what are primarily aesthetic reasons for using talc in genital hygiene, the risk-benefit decision is not complex,” the 1999 study authors said. “Appropriate warnings should be provided to women about the potential risks of regular use of talc in the genital area.”


Regulation Recap

U.S. Food and Drug Administration

Talcum products are classified as cosmetics, which means they aren’t subject to Food and Drug Administration (FDA) review. The FDA allows the manufacturer to test their products before introducing them to market. It’s the manufacturer’s responsibility to properly label them as safe for use.

“Cosmetic companies have a legal responsibility for the safety and labeling of their products and ingredients, but the law does not require them to share their safety information with FDA,” according to the Food and Drug Administration website.

However, in 2009, the FDA did send samples to a lab called AMA Analytical Services, Inc. (AMA) of Lanham, MD to test if the talc used in the consumer products contained asbestos. The agency’s survey, which only included four samples, did not find asbestos contamination.

“The survey found no asbestos fibers or structures in any of the samples of cosmetic-grade raw material talc or cosmetic products containing talc. The results were limited, however, by the fact that only four talc suppliers submitted samples and by the number of products tested,” according to the FDA’s Talc section of its website.

“For these reasons, while FDA finds these results informative, they do not prove that most or all talc or talc-containing cosmetic products currently marketed in the United States are likely to be free of asbestos contamination.”

FDA Office of Women’s Health Investigation

The Food and Drug Administration Office of Women’s Health (OWH) is now investigating the link between talcum powder, ovarian cancer and other health issues. The Office of Women’s Health (OWH) is the agency’s internal arm, focused on better understanding female wellness through a combination of research, development and outreach.

Created in 1994, OWH influences the FDA’s regulatory decisions to inform women about potential health risks. The mission of the OWH is to “protect and advance the health of women through policy, science, and outreach.” 

The office investigates cancers, cardiovascular disease, chronic illness and other reproductive health threats across a woman’s lifespan. OWH breaks down their focus into eight categories, including: 

  • Breast Cancer/Mammography
  • Cancer
  • Device Safety
  • Sex Differences
  • Bioinformatics/Data Mining
  • Cardiovascular Disease
  • Pregnancy/Reproductive Health
  • Women in Clinical Trials

OWH grants funds to support one-to-two-year studies in the focus areas. The agency’s talcum study, spearheaded by FDA Director of Cosmetics Nakissa Sadrieh, is called “Non-clinical mechanistic studies in addressing ovarian cancer risk from talc use in cosmetics.”

“Although some epidemiologic and animal studies have examined the relation between talc and ovarian cancer, talc’s effects on female genital system tissues have not been adequately investigated,” Sadrieh wrote on the FDA website.

Sadrieh’s research aims to better understand long-term risks related to talcum exposure, which she believes is of “particular interest to women’s health.” A major goal of Sadrieh’s work is to “fill some of the existing data gaps, in the molecular and genetic events associated with early ovarian oncogenesis, as these are largely unknown.”  

She added that the results could “prove to be useful as possible experimental models for further mechanistic studies in ovarian carcinogenesis.”

Researchers have suspected that talcum may cause cancer since the ‘70s. New FDA research will hopefully uncover conclusive talc-cancer evidence, spark regulatory restrictions on talcum powder, and assert that women’s health is a top priority.

Cancer Classifications

A number of petitions for more stringent labeling of talc-containing products have been directed to the FDA. The first request came from the Public Citizen Health Research Group in 1978. The agency responded with the belief that all talc-related dangers were caused by asbestos contamination.

A few years later, in 1983, a consumer rights group directed a second petition to the FDA, which was shot down. The Cancer Prevention Coalition (CPC) took up the cause in 1994, prompting the FDA to forcibly add warnings to talcum powder labeling. The CPC tried again in 2008, but both petitions were denied by the FDA.

The National Toxicology Program (NTP), comprised of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the FDA, began investigating talc in 2000. Five years later, the substance was withdrawn from review due to “considerable confusion over the mineral nature and consequences of exposure to talc.” The NTP has not revisited the issue.

However, other groups have. The World Health Organization’s International Agency for Research on Cancer (IARC) lists talcum as a ‘2B possible human carcinogen.’ In addition, the American Cancer Society warns women “that talcum powder might cause cancer in the ovaries if the powder particles (applied to the genital area or on sanitary napkins, diaphragms, or condoms) were to travel through the vagina, uterus, and fallopian tubes to the ovary.”

J&J’s Marketing

J&J ads from 1965 and 1980. Ebony magazone ad: Gaslight Ad Archives (VIA BLOOMBERG)
J&J ads from 1965 and 1980. Ebony magazine ad: Gaslight Ad Archives (VIA BLOOMBERG)

Many people find it hard to believe that a product used to soothe a baby’s skin could cause cancer. It’s important to remember that manufacturers are given the freedom to come up with their advertising strategies, in addition to influencing what’s added to the labeling.

Despite their kingpin status, consumers may still picture Johnson & Johnson as the down-home business from their youth. Johnson & Johnson marketed talcum powder as an essential part of the family healthcare routine. Slogans such as “A sprinkle a day keeps odor away,” and “Your body perspires in more places than just under your arms” graced their ads for decades.

Johnson & Johnson is a power player in the industry, with various indications of its size and reach, including:

  • The world’s sixth-largest consumer health company
  • The world’s most comprehensive medical devices business
  • The world’s sixth-largest biologics company
  • And the world’s fifth-largest pharmaceuticals company

Now, Johnson & Johnson boasts a net worth $65 billion dollars. In 2015, Fortune Magazine listed J&J as the most admired in the pharmaceutical industry. With 265 companies present in more than 60 countries, it’s nearly impossible to enter a drug store without finding something manufactured by the corporate giant.

J&J’s Data Denial

Johnson & Johnson worked to suppress the data linking talcum to ovarian cancer on a number of occasions. In 1982, Dr. Daniel Cramer, the gynecologist and Harvard Medical School professor who led the talc study published in Cancer, received a visit not soon after. A senior J&J scientist “spent his time trying to convince me that talc use was a harmless habit,” Cramer said, according to court documents found on Fair Warning.

While the J&J scientist attempted to downplay the results, Cramer said he “spent my time trying to persuade him … that women should be advised of this potential risk.”

Later, when the Cancer Prevention Coalition petitioned the FDA in 1994, the agency responded with the claim that it lacked enough evidence to mandate warnings. Johnson & Johnson refused to voluntarily add warnings to the label. According to Fair Warning, they had been working with Personal Care Products Council (formerly CTFA) on the Talc Interested Party Task Force to find holes in studies linking talc to ovarian cancer two years prior.

In 1997, another scientist, a toxicologist named Alfred P. Wehner, spoke out against Johnson & Johnson’s attempts to bury the research. He sent the corporation two letters, later obtained by FairWarning, in March and September of 1997, urging them to acknowledge the biological significance of the studies.

“There are at least 9 epidemiological studies published in the professional literature describing a statistically significant (albeit weak) association between hygienic talc use and ovarian cancer,” Wehner wrote in a letter. “Anybody who denies this risks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence to the contrary.”

Talcum Powder Lawsuits

Despite numerous attempts to compel Johnson & Johnson to update talc product labeling, the company has yet to comply. As a result of increasing talc-linked cancer diagnoses, the corporation has been pulled into federal court proceedings. More than 4,800 women have sued Johnson & Johnson, imploring the company to inform consumers of the risks.

Feb. 2016
Estate of Jacqueline Fox v. Johnson & Johnson et al.
$72 Million Verdict | Case number ED104580
Nov. 2016
Giannecchini v. Johnson & Johnson et al.
$70 Million Verdict | Case number 1422-CC09012-01
Feb. 2017
Swann v. Johnson & Johnson
Case number 1422-CC09326-01
May 2017
Gloria Ristesund v. Johnson & Johnson
$55 Million Verdict | Case number 1422-CC09012-01
Oct. 2017
Michael Blaes et al. v. Johnson & Johnson et al.
Case number 1422-CC09326-01

Anti-Talc Advocacy

Mothers relied on Johnson’s Baby Powder to soothe their babies, depended on the cosmetic powder to care for their most vulnerable parts, and trusted in J&J household name.

Families also believed the FDA would sound the alarm about potentially dangerous products. But they didn’t.

Teaming Up Against Talc

Media outlets and consumer advocacy groups are tracking the impact of talc products, sparking new investigations and speaking out against Johnson & Johnson. Bloomberg’s exposé on Johnson’s Baby Powder brought the controversy to the forefront, informing a whole new audience.1000px-Bloomberg_logo.svg

Nonprofits like FairWarning and the Campaign for Safe Cosmetics work to inform the public about the risks of everyday talcum use. The CSC has taken a strong stance, urging consumers to “Avoid personal care and cosmetic products that contain talc if used in the pelvic area. Choose companies that certify their talc is free of asbestos.”

Detailed investigations and renewed attention have led to helping women fighting ovarian cancers. For many of these women, a dash of baby powder was a normal part of the morning routine. Brigades of activists and successful legal campaigns have mandated that the corporation pays millions of dollars in restitution.

Talcum Powder Abroad

In the Republic of the Philippines, the Food and Drug Administration warned consumers to be aware of the possible risk of using talcum powder products present in hygiene items and cosmetics. The Philippine FDA published a consumer advisory on their website, intended for both consumers and manufacturers. The agency reitereated that talcum powder must meet the safety standards set by the ASEAN Cosmetic Directive (ACD).

Manufacturers using talc are required to comply with labeling and prove their products do not contain any traces of asbestos. The warning reminds consumers to avoid putting any talc powders near the faces of children in order to avoid talc inhalation. The FDA has also reached out to the Philippine Cancer Control Program of their Disease Control and Prevention Bureau (DCPB) to review “cancer registry relevant to [talc in products].”

Join the Movement

Talcum products have forever altered the lives of thousands of women and their families. Many of these women have shared their stories to prevent others from being injured by the everyday cosmetic, while others have demanded J&J provide medical assistance.

Connect with a community of advocates fighting the dangers of talcum powder today.

Check out related MedTruth articles:

Cosmetic Safety App Rates Johnson’s Baby Powder

Judges Support Survivors of Talcum Powder Cancer

Does Baby Powder Contain Asbestos?

Jury Awards $417M in California Talcum Powder Lawsuit

What Happened in the California Talcum Ovarian Cancer Trial

How to Lower Your Risk of Ovarian Cancer

5 Talcum Powder Alternatives

Philippine FDA Warns of Talc in Cosmetics

 

This article was updated on May 30, 2018.