The talc saga - La Cosmétothèque

Talc is out of time. This ingredient basically dates back to the creation of the Earth’s crust and is used in all kinds of ancient preparations, in particular in the field of beauty and hygiene. Generic and ubiquitous in a great number of sectors, it has been used for countless years in almost all product categories. And yet, the cosmetics industry often forgets about certain episodes involving this ingredient. I recently met young students who had never heard of the Morhange talc case! So, I thought a short reminder of these issues might be relevant

Let’s give a bit of background first. Many articles on the use of this ingredient in cosmetics have already been published, including the following, from La Cosmétothèque.

Today, talc is in the spotlight for various reasons, and it is not the first time. Here is a flashback on a few key events.

The Baumol powder case. The Baumol powder case, as it is often called, is a health scandal which took place in France in 1952. It refers to a “talc” preparation for babies which was contaminated with an arsenic-derived substance, causing about 500 casualties, including more than 80 deaths, mainly in the South-West and Brittany. The original product, the Baumol powder, consisted of a combination of talc powder and zinc oxide with a lavender perfume. This product was designed by the Francam laboratories and had been on the market since 1914. The Daney laboratories, founded in 1947, purchased the business license in 1951. But when they manufactured the product, they accidentally replaced zinc oxide with arsenious anhydride. In addition, the laboratory was found to be negligent with quality control, both of ingredients and finished products. The first health alerts were raised in spring 1952, and the product sale was banned in late October, the same year. The contaminated talc caused approximately 500 casualties, including slightly more than 80 deaths, mainly babies, in different Brittany towns, south of the region.

In 1959, at the end of a trial during which many causes for dysfunction were highlighted, the Director of the manufacturing laboratories was sentenced to prison and to a considerable fine. Annick Le Douget told this story in a book entitled Enquête sur le scandale de la poudre Baumol (1951-1959), la première catastrophe sanitaire française [An investigation into the Baumol powder scandal (1951-1959), the first French health catastrophe], published by Le Douget (Fouesnant, 2016).

The Morhange talc. A similar case occurred a few decades later. This time, it took place in Eastern France, in the 1970s.

If the first observations were made in the Ardennes region as soon as April/May 1972, no explanation was initially found. The symptoms included skin rash, diarrhoea, convulsions, and comas. Eventually, in August, the analyses carried out helped identify a cause associated with the use of a product named “Talc Morhange”, and more specifically with a powerful bactericide it contained in excessive concentrations: hexachlorophene. The investigations revealed the cause of the incident: an operational error led to 38 kg of hexachlorophene, a highly toxic product, being mixed with 600 kg of talc. The concentration of this ingredient was supposed to be very low, but the error resulted in a normal talc can being mixed with the remainder of a can of hexachlorophene thought to contain talc. As a consequence, bottles with an abnormally high bactericide concentration were placed on the market. The Morhange company, which marketed the product, did not have the equipment or competent staff to carry out compliance tests, and neither did the packaging company. The product was applied on the bottom of 204 infants, 36 of whom died! Many of the other victims suffered serious consequences, in particular neurological disorders. Legal proceedings were launched at a criminal court near Paris in October 1979. In 1980, the accused were sentenced to suspended prison terms reduced on appeal, and eventually amnestied a few years later. However, since this incident sort of echoed the Baumol powder scandal, it had a strong impact on cosmetics regulations, as it accelerated their appearance in France, in 1975. Measures directly inspired from this event were added to the text, which was to be used as a basis for the European Directive enacted a few years later (1978).

In the first two examples, talc itself was not involved. The incidents were mainly due to operational errors associated with process control gaps. And yet, today, a pressing issue keeps coming back, which is closely linked to the origin of this material: the presence of asbestos in it.

Talc and asbestos. This issue is far from new – it is even consubstantial with talc. But the case at stake here involves the link between these two substances, which was established in the early 1970s. At that time, talc was widely used and asbestos was a common ingredient in many industrial applications, although the first pulmonary fibrosis cases observed in subjects exposed to asbestos had been described as soon as 1906. The first regulation aimed to reduce the risk of asbestosis was passed after the term asbestosis was introduced in 1927. In 1935, a report suggested the existence of a relationship between the risk of lung cancer and occupational exposure to asbestos. Then, all following studies confirmed the risk of serious disorders, in particular cancers, in employees exposed to asbestos, including a 1960 study on insulators in New York City.

As a result, the presence of asbestos in the environment was measured and characterized. As a matter of fact, due to its origin, asbestos is quite similar to talc: it is a natural contaminant of talc, which means the origin of the presence of asbestos in talc is not anthropogenic, but natural. Talc is a mineral whose particles usually form plaques, but sometimes appear as long, thin fibres resulting in fibrous talc. Just like other materials containing asbestos, talc can be contaminated, since, from a geological standpoint, talc and asbestos can naturally form alongside one another. Research shows that depending on the production deposits it comes from, talc can contain other fibrous or non-fibrous minerals, in particular mineral fibres with chemical structures similar to those of the six mineral fibres classified as asbestos fibres in the regulatory sense. A few mines from which talc is extracted are blamed.

Asbestos fibers in Talc

In the early 1970s, the discovery of asbestos in talc, but especially of talc in ovary tumoral tissues of adults created a situation which is still not completely solved. This observation led to many studies being conducted. Following certain publications, in 1976, well aware of the issue, the Cosmetic, Toiletries and Fragrance Association (CTFA), the American association of cosmetics manufacturers, established specifications for a new product they called “cosmetic talc”. With this term, the association aimed to make a distinction between “cosmetic talc” and “industrial talc”. The idea was that talc manufacturers and users would use this term as part of their activities. But then, there were discussions among experts about the limits and validity of the characterization methods suggested. Sensitivity limits and the relevance of certain techniques were at the heart of debates. Lobbying effects were also reported, and as is often the case when no consensus is reached, the discussions considerably limited the conditions of application of the methods. The situation remained unsolved for many years, due to disputes between experts.

It seems that the least that should be done would be to implement a strengthened quality assurance policy taking into account these notions. That is what leading talc producers and many users have been advocating, including the J&J group in the cosmetics industry. Lastly, since other substances can replace the ingredients at stake for these complementary uses, it would have been wiser to plan a substitution. Failing that, the situation remained unchanged, which is why things are still the way they are in 2019. If hazard seems to be characterized, it still remains to determine the risk. Indeed, if the effects of asbestos cannot be denied, the roles of talc and of the use of talc-based products in the cases described are less clear. And if it has been established that specific talc origins may be involved, talc’s responsibility in finished products remains to be confirmed. All this creates an explosive mixture for many players – and it is pretty hard to have an objective opinion.

Baby Powder J&J.

Following this story about asbestos, talc was once again put in the spotlight when an event known as Baby Powder Johnson & Johnson occurred. While this product has been on the market for many decades, it all started in 2011, when Gloria Ristesund, an American woman who had used talc manufactured by the pharmaceutical group almost on a daily basis for decades as an intimate hygiene product, developed an ovarian cancer. To her, only the talc produced by the giant group could be responsible for it. She filed a complaint against J&J, and after countless legal episodes, an American jury sentenced Johnson & Johnson to pay her a 55-million-dollar compensation. According to the jury, the group had not provided their customers with enough information on the cancer risk related to the use of talc. This is one of the reproaches that had been made to the hexachlorophene manufacturer in the Morhange talc case. Of course, there is no link between the two cases. The group is subject to many other legal proceedings. This year, J&J was sentenced to pay a compensation of more than 37 million USD to six other plaintiffs who accused the J&J Baby Powder of causing mesothelioma, a form of lung cancer. Despite this, J&J say they have been exonerated in two trials on asbestos in California, and one in Missouri. On Friday, October 18, 2019, the pharmaceutical & hygiene product group announced the recall of 33,000 talc bottles in the US, after the FDA found asbestos traces in them. In a press release, the company emphasizes the fact that they decided this recall “in an excess of caution […], following a test performed by the FDA showing the presence of minute levels of contamination by chrysotile asbestos (no more than 0.00002%, i.e. 0.02 ppm!!) in samples taken from a bottle purchased online.The company recently reported that it is working with the FDA to develop more relevant tests. In addition, an external cause of industrial contamination was mentioned.

Not sure many people will understand anything about this! Since then, the case has been in the hands of experts with opposing views, and it is quite tricky to make a well-informed opinion. Although in Europe, this issue has not been discussed, it still remains that talc is at the heart of an episode which will inevitably mark the history of consumer goods and is likely to have consequences on the history of this ingredient.

Mineral makeup. This concept has been very trendy for over a decade, but it was born much before it was introduced as new. Talc is also much related to this phenomenon, in which it has played a significant role. But in what way? As mentioned in the “Talc and asbestos” section, in the 1970s, talc was at the heart of discussions on its use. And yet, much earlier, in the 30s, the use of face powders had also been controversial, given their blocking, harmful effects on the skin. These scandals resulted in the development of micronization techniques and of the bite test (an empirical assessment of the particle size distribution of powders). Be it as it may, discussions gradually focused on these issues and led to debates about powders themselves. In the late 70s, there was a wave of “talc-free” products in which talc was replaced with supposedly less suspicious materials. Unsurprisingly, a few brands did not hesitate to use this artefact to position themselves on original segments, as could be seen with an emerging brand known as Bare Escentuals. In 1976, its founder Diane Richardson opened a first store in Los Gatos, near San Francisco, California. The small store sold beauty products, some of which contained a 100% natural mineral powder sold by weight, which, according to her, helped conceal skin problems like rosacea and scars and suited sensitive skins. The product was not that successful, though. In 1994, the brand was purchased by Leslie Blodgett. Aware of the oddness of the product, bulk powders, she decided to target women with skin problems who she thought would find it difficult to use other products on the market and developed a powder called Bare Minérals. The brand became Bare Minerals in 1997.

As regards formulas, Diane Richardson wanted to create products free from what she called the “seven deadly skins”: perfume, talc, alcohol, mineral oil, preservatives, emulsifiers, and colourants. So, her standard banned the use of talc, which was replaced with ingredients like Mica. The other base ingredients included titanium oxide, bismuth oxychloride, and zinc oxide. This philosophy became the credo of mineral makeup, a concept which soon boomed: its positioning and legitimacy were strengthened when it was sort of introduced as the “makeup” answer to “organic cosmetics”. That is how it settled in the cosmetics landscape. Later, fears over talc eased and its use stopped being questioned. However, the brand kept developing and the concept of mineral makeup lasted, growing alongside more standard positionings. Countless products were designed as part of this trend, although the formulation concept was no longer systematically complied with. Bare Minerals is now part of the Shiseido group, who keep developing these concepts and products in similar ranges.

Conclusions:

This is how talc got – probably much involuntarily – involved in a series of stories that impacted the world of beauty. At the end of the day, although there are many examples in which talc was actually not suspicious, if only given the astronomical quantities of talc-based products sold all across the world for decades, it was indirectly related to disastrous contaminations which long altered its reputation. As we have seen with various examples, it was not the ingredient that was at stake, so we should beware of lumping different things together.

As regards the presence of asbestos, it should be reminded that it is part of the material’s composition. We are not dealing with deliberate additions, here – absolutely no serious brand uses asbestos. Besides, this issue is related to that of traces of elements of various origins in natural substances. It does not mean these products are particularly hazardous, as can be seen with the outstanding trend of clay-based products, where clay has naturally been contaminated by infinitesimal traces of heavy metals. The way certain players “overreact” – authorities, the media, consumer associations… – might actually seriously threaten the future of this ingredient. Will stricter quality control processes calm things down? To be continued…

Well, if we do not know where we are going, we can at least know where we come from. That is what this article was meant to show.

Thanks for reading it.

Jean Claude LE JOLIFF

Thanks :

–Laurence Bacilieri, for her intimate knowledge of the American market.
– Jean Marc Giroux, expert toxicologist / pharmacologist, for helping me understand.
– All those who helped me by reading the different episodes.

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