The government of Canada is considering measures that would prohibit or restrict the use of talc in some products. After reviewing the latest science and producing a draft screening assessment, the government "proposes that inhaling loose talc powders and using certain products containing talc in the female genital area may be harmful to human health."
The announcement was made Wednesday on the Health Canada website.
The draft screening assessment will be published in the Canada Gazette, Part I, and will be open for public comment for 60 days, until February 6, 2019. The Risk Management Scope , which outlines the possible measures to manage the risks identified in the draft screening assessment, will also be open for public comment for the same 60-day period.
The final screening assessment and risk management approach will take into consideration any comments and new evidence received during the consultation period, the announcement notes.
No action, such as warning labels or a ban, will be taken until this final assessment is published, according to news reports.
The document notes that the draft assessment did not identify human health risks of concern from oral exposures, including talc in food and drugs; dermal exposures such as the application of talc-containing products to skin; or inhalational exposures from dry hair shampoo or pressed powder products, such as cosmetics like eye shadow and blush.
However, the assessment did identify two exposure scenarios of potential concern to human health.
One was inhalation of fine particles of talc during the use of loose powder, self-care products (eg, body powder, baby powder, face powder, foot powder), potentially resulting in damage to the lungs.
The other scenario of concern was exposure of the female perineal area, which includes the genitals, to self-care products containing talc (eg, body powder, baby powder, diaper and rash creams, genital antiperspirants and deodorants, body wipes, bath bombs), as this type of exposure has been associated with ovarian cancer in studies of the human population, the document notes.
Move Comes Amid Great Controversy, US Lawsuits
The move from Canada comes amid a growing controversy, as well as fiercely fought court battles in the United States, over whether use of talc in the female genital area contributes to ovarian cancer.
The controversy is over whether talc itself is a carcinogen, and the issue is complicated because talc is sometimes contaminated with asbestos (the two sometimes occur naturally together).
The scientific community has not reached a consensus.
A recent review appearing in the European Journal of Cancer Prevention ( Eur J Cancer Prev. 2008;17:139–146.) concludes that "data collectively do not indicate that cosmetic talc causes ovarian cancer." The heterogeneity in the perineal dusting studies has raised important concerns over the validity of the exposure measurements, and the lack of a consistent dose–response effect limits making causal inferences. Perhaps more importantly, it is unknown whether external talc dust enters the female reproductive tract, and measures of internal talc exposure such as talc-dusted diaphragms and latex condoms show no relationship with ovarian cancer risk. Talc is not genotoxic, and mechanistic, pathology and animal model studies have not found evidence for a carcinogenic effect, the journal adds.
However, a recent review in Epidemiology ( Epidemiology. 2018;29:41–49 ), concluded that "in general, there is a consistent association between perineal talc use and ovarian cancer." This was based on a meta-analysis of observational studies that included at least 50 cases of ovarian cancer, and looked at 24 case–control studies (13,421 cases) and three cohort studies (890 cases, 181,860 person-years).
In the US, thousands of lawsuits have been filed by individuals, or the families of deceased individuals, alleging that ovarian cancer was caused by the use of talc products such as Baby Powder and Shower-to Shower manufactured by Johnson & Johnson. The company is reported to be facing more than 10,000 plaintiffs.
Many of the lawsuits that have already taken place have found for the plaintiffs, but not all.
For example, a jury in Missouri ordered Johnson & Johnson to pay $72 million in damages to the family of Jacqueline Fox, who died from ovarian cancer. However, in two cases juries on appeal overturned multimillion dollar awards: Gloria Ristesund of South Dakota was originally awarded $55 million in 2016, but in June the verdict was overturned. In August 2017, a jury in Los Angeles awarded $417 million to Eva Echeverria, but that verdict was overturned 2 months later.
A lawsuit in October 2018 involving a New Jersey woman cleared Johnson & Johnson of liability in a case of mesothelioma and the company’s baby powder product.
In one of the most recent cases, Johnson & Johnson was ordered in July to pay $4.7 billion to 22 women and their families, who claimed that asbestos in the company's talc products led them to develop ovarian cancer. The company said the verdict was 'fundamentally unfair' and says that its talc products do not contain asbestos.
Talc–Asbestos Connection Explained
Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen, explains the Food and Drug Administration. It also notes that asbestos, another naturally occurring silicate mineral, may be found in close proximity in the earth, and so mining sites should be selected carefully. "Unlike talc, however, asbestos is a known carcinogen," the agency notes.
The FDA says that "it continues to investigate and monitor reports of asbestos contamination in certain cosmetic products," and notes that talc is used in many cosmetic products, including baby powder and makeup such as powder blush and eye shadow.
The American Cancer Society explains that asbestos does sometimes occur naturally in talc, but guidelines issued in the US in 1976 called for the removal of asbestos from commercial talc products.
However, many consumer groups note that this is an area that is not officially regulated, and report that makeup products sold in the United States that have been found to contain asbestos/talc. Consumer groups also point out that talc in cosmetics has been removed by the European Union, but is still allowed in the United States.
The American Cancer Society also emphasizes that it is important to distinguish between the two. Talc that contains asbestos is generally accepted as being able to cause cancer if it is inhaled. However, the evidence about asbestos-free talc is less clear, it notes.
It also cites the conclusions made by the International Agency for Research on Cancer (IARC), which is part of the World Health Organization (WHO).
The IARC classifies talc that contains asbestos as "carcinogenic to humans."
Based on the lack of data from human studies and on limited data in lab animal studies, IARC classifies inhaled talc not containing asbestos as "not classifiable as to carcinogenicity in humans."
As there is limited evidence from human studies showing a link to ovarian cancer, IARC classifies the perineal (genital) use of talc-based body powder as "possibly carcinogenic to humans."
The US National Cancer Institute says that the "the weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer. "
Medscape Medical News © 2018
Cite this: Canada Says Talc May be 'Harmful to Human Health' - Medscape - Dec 07, 2018.