J&J’s decision may curb talcum powder, asbestos items’ production

ToxicsWatch Alliance (TWA) demands stoppage of manufacture, sale and use of all brands of toxic talcum powder and all asbestos based products in India

Johnson & Johnson

Mumbai: Johnson & Johnson, a multinational medical devices, pharmaceutical and consumer packaged goods manufacturing company, which proposed $8.9 billion settlement to resolve years-long lawsuits claiming that its talcum powder products caused cancer, has submitted an application to Maharashtra Food and Drug Administration (FDA) to stop the production of the baby powder at its Mulund plant, Mumbai.

This application for withdrawal of license dated 22 June, 2023 and its announcement dated August 11, 2022 is of deep relevance for the public health of present and future generation of Indians. In 1947, Johnson & Johnson expanded into India, marketing Johnson’s Baby Powder. In September 1957, Johnson & Johnson incorporated as a legal entity in India. The production in its first manufacturing facility began in 1959 at the Johnson & Johnson India plant in Mulund, Mumbai, for Johnson’s Baby Powder and other specialized products.

In 1968, the company introduced the Stayfree brand to India. In a situation wherein talcum powder of this company has reached almost every household in India, the revised settlement amount backed by more than 60,000 parties. who have filed lawsuits alleging harm from talcum powder merits attention of Indian victims. The lawsuits filed against it allege that its talcum powder caused users to develop ovarian cancer and mesothelioma. These damage claims contributed to drop in sale of baby powder compelling the company to stop selling its talc-based products.

ToxicsWatch Alliance (TWA) had filed complaint regarding ongoing exposure of Indians to hazardous asbestos mineral fibers contaminated talcum powder of Johnson & Johnson with the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Union Ministry of Health and Family Welfare on May 27, 2020. TWA had drawn the attention of CDSCO towards the announcement dated May 19, 2020 by Johnson & Johnson, a multinational company headquartered in New Brunswick, New Jersey, USA stating that it will discontinue sale of its Talcum Powder products in North America.

This announcement was aimed at safeguarding the health of residents and citizens of North America but not the residents and citizens of India. Such doublespeak and double standard of these transnational corporations in matters of public health in general and children’s health in particular merits urgent intervention of the CDSCO.

Responding to TWA’s complaint, DGCI has informed TWA that “in India, the import, manufacture, distribution and sale of cosmetics is regulated under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder. Schedule ‘S’ of the Drugs and Cosmetics Rules, 1945 specifies that the cosmetics in finished form shall conform to the India Standards specifications laid down from time to time by the cAs far as the asbestos in talcum powder is concerned, it is to mention here that asbestos is already prohibited to be used in the cosmetic products as per the Indian Standards IS 4707 Part 2:2017. Further, recently, the BIS has amended Indian Standard, IS 1462 “Talc for Cosmetic Industry- Specification”, with regard to the requirement and test method for the absence of asbestos.

Subsequently, on August 11, 2022, Johnson & Johnson announced that “As part of a worldwide portfolio assessment, we have made the commercial decision to transition to an all-cornstarch-based baby powder portfolio. As a result of this transition, talc-based JOHNSON’S® Baby Powder will be discontinued globally in 2023.”

Prior to this in April 2022 when Johnson & Johnson’s shareholders voted against a proposal to stop sales of the talc baby powder in India and other non-North American markets, TWA and Ban Asbestos Network of India (BANI) had accused shareholders of Johnson & Johnson of practicing double standard and racism. In a classic case of double standard and racism, US shareholders of Johnson & Johnson had agreed to stop sale of asbestos laden talc powder in North America but had acquiesced to continue sale of toxic talc to countries like India. It is inhuman and immoral to knowingly expose humans to killer asbestos fibers. The claim of Johnson & Johnson that its “Baby Powder is safe, does not contain asbestos, and does not cause cancer” is an exercise to save itself from liabilities emerging out of fatal diseases caused by the consumers of its asbestos laden talc powder.

In this regard it is relevant to recall that responding to questions about safety of talcum powder and whether talc contains harmful contaminants, such as asbestos, in January 2022, USA’s Food and Drugs Administration (USFDA) released a White Paper and technical appendices on testing methods for asbestos in cosmetic products containing talc. Talc is an ingredient used in many cosmetics, from baby powder to blush.

CDSCO should stop the continued sale of existing inventory through retailers.

A study titled “Asbestos in commercial Indian talc” published in the American Journal of Industrial Medicine states that “this product study of various talcum powders marketed to combat prickly heat, purchased from Indian retailers both over‐the‐counter and online, demonstrates the ease of general population access to such products and the potential for significant exposure to asbestos. The analytical results of this study confirm that asbestos exposure of the Indian and potentially greater Southeast Asian populations is not limited to traditional occupational settings.”

The findings of this study “imply that the asbestos‐related medical and public health implications to consider will need to extend to persons of both genders and all ages among this population group. This study’s confirmation of an underappreciated source of asbestos exposure, through personal care products, also highlights the risk that anyone within breathing range of these aerosolizeable, contaminated, talcum products incurs.” The authors of the study observe, “”Until asbestos is also viewed as a hazard in India and banned, there will still be considerable risk to health.” There is a need to identify the source of their talc supply as well. (Reference: Fitzgerald S, Harty E, Joshi TK, Frank AL. Asbestos in commercial Indian talc. American Journal of Industrial Medicine. 2019; 1‐8. https://doi.org/10.1002/ajim.22969)

The World Health Organisation (WHO)’s International Agency for Cancer Research (IARC) has recognized the presence of asbestos in talcum powder. IARC Monograph on the Evaluation of Carcinogenic Risks to Humans on Carbon Black, Titanium Dioxide, and Talc (2010) refers to the presence of asbestos in talcum powder. It also refers to “Use of talc for feminine hygiene”. The use of body powder for feminine hygiene can be estimated from the prevalence reported for controls in case–control studies that investigated the association between the use of cosmetic talc for feminine hygiene and the risk for ovarian cancer. It refers to exposure to respirable dust during the use of talcum powders on the face, body and babies. Talc is used as a surface lubricant on the majority of condoms manufactured; contact with condoms may also represent a direct means of exposure of the female genital tract to talc. Exposure to talc can also occur during surgical procedures when using powdered gloves. Talc particles were observed in the navels of small children, in the testes, on the vocal cords, in the urinary bladder tract and after removal of varicous veins. Besides this the Food Chemical Codex (2003) provides specifications for food-grade talc, including the statement that “talc derived from deposits that are known to contain associated asbestos is not food grade.”

Under the voluntary guidelines initiated in 1976, the Cosmetic, Toiletry, and Fragrances Association stated that all cosmetic talc should contain at least 90% platy talc (hydrated magnesium silicate) that is free from detectable amounts of fibrous, asbestos minerals. Meanwhile, some 67 countries have banned all kinds of asbestos. World Health Organisation (WHO)’s recommendations have established the infectious nature of Covid-19, the same WHO has underlined that “All types of asbestos cause lung cancer, mesothelioma, cancer of the larynx and ovary, and asbestosis (fibrosis of the lungs).”

(Reference: https://www.who.int/ipcs/assessment/public_health/asbestos/en/ and https://www.who.int/news-room/fact-sheets/detail/asbestos-elimination-of-asbestos-related-diseases)

Fitzgerald S et al observe, “With products of this nature being readily available and appealing to both genders, it is necessary to consider what the potential health risks and burdens of disease are for millions of exposed women of childbearing age and the children for whom they provide care. IARC has confirmed the causal association of asbestos with ovarian cancer and other cancers”.

The CDSCO must undertake the enviro-occupational health audit of the workers who handle asbestos laden talcum powder in the manufacturing facilities of talcum powder products in general besides the health audit of the communities who are in the vicinity of such factories and recommend adequate compensation for those who are exposed to the carcinogenic mineral fibers and are suffering from asbestos related diseases. This will be also relevant for assessing the harm which the unsuspecting consumers continue to face. These consumers include all judges, legislators, officials, their children and grandchildren and the residents of India.

An investigative report titled “Johnson & Johnson knew for decades that asbestos lurked in its Baby Powder” was published on December 14, 2018 is noteworthy for protecting the human rights of Indians. The investigation was conducted by Reuters, an international news agency headquartered in London. This investigative report is consistent with the findings of a study by India’s Industrial Toxicology Research Centre (IITR), Lucknow, a constituent laboratory of Council of Scientific & Industrial Research (CSIR), Ministry of Science and Technology, Government of India on “Exposure risk to contaminants in pharmaceutical and cosmetic powders” has found that “There are different types of cosmetic powders such as body powder, baby powder, face powder, eye shadow and powdered blush as well as pharmaceutical powders available in the market. Both the sexes of all age groups are using these powders. These are talc – based. Talc is a mineral product and often contaminated with asbestos fibres.”

The aim of the IITR study “was to investigate the safety of such powders being sold in the market, initially by analyzing the asbestos content. Five branded samples of talcum powder were analysed and all were found contaminated with asbestos fibres. Asbestos fibre contamination in these powders ranged from 10.3 – 15.4%. Fibre length study on two samples revealed that asbestos fibres were 22.8 – 34.7%, 48.2 – 55.1% and 17.1 – 22.1% in the range of <10µm, 10 – 20µm, and > 20µm, respectively. The study indicates risk of human exposure to asbestos through the use of naturally contaminated talcum powder. It is noteworthy that asbestos takes many years to cause asbestosis and carcinogenic malignancies which are irreversible. It also necessitates a regular monitoring and surveillance on all the cosmetic and pharmaceutical powders being marketed for asbestos contamination.” This has been published in the Annual Report Annual Report 2005-2006 of IITR. IITR is accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL) for chemical and biological testing and is recognized for GLP (Good Laboratory Practice) toxicity testing. (Reference: http://www.itrcindia.org/ITRC_Annual_Report_2005-06.pdf )

The investigation by Reuters corroborates the findings of IITR. This recent investigation was undertaken in the wake of three verdicts in New Jersey, California and St. Louis awarding compensation to plaintiffs who blamed asbestos-tainted Johnson & Johnson talc products for their mesothelioma, a type of cancer that develops from the thin layer of tissue that covers many of the internal organs. The connection between asbestos exposure and mesothelioma was discovered in the 1970s. The third verdict was a watershed in in St. Louis: The 22 plaintiffs were the first to succeed with a claim that asbestos-tainted Baby Powder and Shower to Shower talc, a longtime brand the company sold in 2012 that caused ovarian cancer, which is much more common than mesothelioma. The jury awarded them $4.69 billion in damages. Most of the talc cases have been brought by women with ovarian cancer who say they regularly used Johnson and Johnson talc products as a perineal antiperspirant and deodorant. The inclusion of ovarian cancer besides mesothelioma has broadened the potential liability of Johnson & Johnson.

The Reuters investigative report refers to the findings of Dr. Irving J. Selikoff who had conclusively established a link between the inhalation of asbestos particles and lung-related ailments in the 1960s itself that paved the way for ban on asbestos of all kinds in some 60 countries. Dr. Selikoff was the director of the Environmental and Occupational Health Division of Mount Sinai Hospital in New York. It is significant that Ms Lisa Girion of Reuters has shared the official documents on the basis of which she has made these startling claims in her investigative report.

(Reference: https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/)

It is noteworthy that the Terms of Reference dated October 25, 2010 issued by Union Environment & Forests Ministry for a proposed Asbestos cement sheet and accessories manufacturing unit of 1,80,000 Tonnes Per Annum capacity at Narsimharaopalem Village, Veerulupadu Tehsil, Krishna District, Andhra Pradesh by M/s Sahyadri Industries Limited made reference to “talc and chrysotile”.

Prior to the Reuters report, a 2014 paper published in the International Journal of Occupational and Environmental Health titled “Asbestos in commercial cosmetic talcum powder as a cause of mesothelioma in women” by Ronald E Gordon et al concluded “we found that a specific brand of talcum powder contained identifiable asbestos fibers with the potential to be released into the air and inhaled during normal personal talcum powder application. We also found that asbestos fibers consistent with those found in the same cosmetic talc product were present in the lungs and lymph node tissues of a woman who used this brand of talc powder and developed and died from mesothelioma. This study was published in October 2014.

(Reference: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4164883/)

CDSCO’s intervention is required in the light of the judgment of Supreme Court in Consumer Education and Research Centre (CERC) Vs Union of India (1995 AIR 922, 1995 SCC (3) 42) that recognized right to health as part of right to life and had directed central and state governments to revise their law related asbestos in keeping with fresh resolutions of International Labour Organisation (ILO). ILO’s asbestos related resolution of June 2006 is relevant in this regard (Reference: https://www.ilo.org/safework/info/standards-and-instruments/WCMS_108556/lang–en/index.htm . The ILO resolution was followed by a joint publication of WHO and ILO titled “Outline for the Development of National Programmes for Elimination of Asbestos-Related Diseases” published in December 2007. It creates a logical compulsion for urgent remedial action.

(Reference: https://www.ilo.org/global/topics/safety-and-health-at-work/resources-library/publications/WCMS_108555/lang–en/index.htm)

All the manufacturers of asbestos based brands and products and government regulators need to draw lessons from why Johnson & Johnson is stopping the manufacture of talcum powder in India and across the world.

It is noteworthy that TWA had filed a complaint with the NHRC dated May 26, 2020, on the subject of “Doublespeak and Double Standards of Johnson & Johnson cause of ongoing exposure of Indians to hazardous asbestos mineral fibers contaminated Talcum Powder”, NHRC had passed an order dated 13 July 2020 addressed to the Secretary, Ministry of Health and Family Welfare. The order reads: “This complaint be transmitted to the concerned authority for such action as deemed appropriate. The authority concerned is directed to take appropriate action within 8 weeks associating the complainant/victim and to inform them of the action taken in the matter.”

Instead of waiting for all the companies to withdraw their licenses for manufacture of asbestos-laden talcum powder products-both baby powder and adult powder and asbestos based products, the CDSCO and the ministry of health must act in compliance with the NHRC’s order to prevent preventable diseases and deaths by banning these products along with all asbestos based products with immediate effect.

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