ToxicsWatch Alliance (TWA)
To
Drugs Controller General of India
Central Drugs Standard Control
Organization (CDSCO),
Directorate General of Health Services
Union Ministry of Health and Family
Welfare,
Government of India
FDA Bhavan, ITO, Kotla Road,
New Delhi -110002
Date: December 20, 2018
Subject- Seeking ban on carcinogenic asbestos fibers
contaminated Talc powder of Johnson & Johnson and other companies in India
Sir,
This is to draw your urgent
attention towards the relevance of investigative report titled “Johnson &
Johnson knew for decades that asbestos lurked in its Baby Powder” published on
December, 14, 2018 for protecting the human rights of Indians. The
investigation was conducted by Reuters, a 167 year old 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.” It is significant that CDSCO’s
official function includes banning “Drugs and Cosmetics”.
In view of these scientific findings,
I wish to draw your attention towards Schedule S of the Rules [read with Rule
150-A], Drugs and Cosmetics Rules, 1945, Drugs and Cosmetics Act, 1940 (last amended
in 1995). Referring to Standards for cosmetics in finished form fixed by Bureau
of Indian Standards (BIS) for “Skin Powders and Skin Powder for infants”, it is
stated that these “cosmetics in finished form shall conform to the Indian
Standards specifications laid down from time to time by the [Bureau of Indian
Standards (BIS)]”. This standard covers two types of powder, namely, body powder
and face powders. Body powders include products which are commonly known as talcum
powders, dusting powders, toilet powders and deodorant powders. BIS issued has
two separate revised Indian Standard (IS) notifications for Skin Powders and
Skin Powder for Infants namely, IS 3959:2004 and IS 5339:2004. These standards were
originally issued in 1966 and 1969 respectively. Both were first revised in 1978.
The composition of the BIS’s Cosmetics
Section Committee and SkinCare Products Subcommittee which finalized both the standards
is quite revealing. Both the committees have Dr Prashant Abhvankar on behalf of
Johnson & Johnson. In such a backdrop, it is startling that the Indian standards
for the powders make no mention of asbestos mineral fiber although it does provide
for determination of Arsenic, tests for heavy metals etc.
The notification on “Skin
Powder for Infants-Specification”, it is stated that “In composition, skin
powders for infants do not differ greatly from those intended for adults.”
Given the fact that it has
been admitted in the notifications that “No stipulations have been made in this
standard regarding composition of skin powders”, it emerges that the separateness
of the composition of both the adult powders and infant powders is apparently a
fiction for marketing purposes.
It is important to note that both
BIS notifications state that “it is necessary that the raw materials used are such
that in the concentrations in which they would be present in the finished skin powder,
after interaction with other raw materials used in the formulation, they are free
from any harmful effects” but they confine themselves to dermatological safety.
It underlines that “It shall be the responsibility of the manufacturers of skin
powders to satisfy themselves of the dermatological safety of their formulation
before releasing the product for sale.” They maintain a studied silence about harmful
effects of the powder in question on lungs, ovary and other internal organs.
A careful perusal of the relevant
legal provisions, Indians Standards and IITR study reveals the glaring loophole
in the existing legal provisions, given the fact that it has been conclusively
been established in scientific and medical literature that Talc and asbestos
co-exist and safe and controlled use of all kinds of asbestos is impossible. Talc,
like asbestos, is a silicate mineral fiber that has been studied in relation to
cancer risk. Talc refers to
both mineral talc
and industrial mineral
products that are
marketed under the name talc and contain proportions of mineral talc
that range from about 35% to almost 100%. As
it is soft
to the touch
and inert, talc has
been valued for
centuries as a body
powder. Today, it
also plays an important
role in many
cosmetic products, including products for
feminine hygiene and
baby powders, and
provides the silkiness in
blushes, powder compacts and
eye shadows, the
transparency of foundations
and the sheen
of beauty creams. In pharmaceutical products, talc is an important
excipient that is used as a glidant,
lubricant and diluent.
Soap manufacturers also
use talc to
enhance the performance of skin care
products.
The use of body powder has
been prevalent in infants and woman. The use of body powder for feminine hygiene
has been studied. Body powder is applied perineally, on napkins or on
underwear. Dusting of the perineum
after bathing appears
to be the
most frequent single type
of application, but simultaneous uses
have also been
reported. The exposure may
occur as a
result of storing a
diaphram in body
powder or contamination from the
male partner who has used body powder. 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.
During breast implantations, it is possible that talc from surgical
gloves can lead to unwanted encapsulation. 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.”
(Reference: IARC Monographs on
the Evaluation of Carcinogenic Risks to Humans, Evaluation of Carcinogenic
Risks to Humans, Volume 93, Carbon Black, Titanium Dioxide, and Talc,
International Agency for Research on Cancer (IARC), World Health Organization, 2010,
https://monographs.iarc.fr/wp-content/uploads/2018/06/mono93.pdf)
I submit that as per World
Health Organisation (WHO), “All types of asbestos cause cancer in humans
Asbestos (actinolite, amosite, anthophyllite, chrysotile, crocidolite and
tremolite) has been classified by the International Agency for Research on
Cancer as being carcinogenic to humans. Exposure to chrysotile, amosite and anthophyllite
and to mixtures containing crocidolite results in an increased risk of lung
cancer. Mesotheliomas have been observed after occupational exposure to
crocidolite, amosite, tremolite and chrysotile, as well as among the general
population living in the neighbourhood of asbestos factories and mines and in
people living with asbestos workers. The incidence of asbestos-related diseases
is related to fibre type, size and dose and to industrial processing of the
asbestos.” It categorically states that “No threshold has been identified for
the carcinogenic risk of asbestos, including chrysotile. Cigarette smoking
increases the risk of lung cancer from asbestos exposure.”
(Reference: Elimination of
asbestos related diseases, Updated March 2014 https://www.who.int/ipcs/assessment/public_health/Elimination_asbestos-related_diseases_EN.pdf)
Given conclusive evidence
about impossibility of safe and controlled use of all kinds of asbestos, it is
indefensible that 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 (<0 .5="" span="" style="mso-spacerun: yes;">
of fibrous, asbestos
minerals under the voluntary guidelines it had initiated in
1976, Indian Standards remain so backward that it does not even make a
mention of asbestos in its notification on Skin Powders. It has adopted Ostrich
policy with regard to the grave health hazards from asbestos of all kinds.
It is apparent that Indians
Standards and legal provisions have remained blind to numerous possibilities of
exposure. It emerges from it that health hazards from Talc is confined to skin
powder alone. Studies have found the harmful effects of asbestos laden Talc
powder.
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 <10 10="" 20="" and="" m=""> 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, a
132 year old multinational medical devices, pharmaceutical and consumer
packaged goods manufacturing company headquartered in New Brunswick, New
Jersey, USA.
Earlier, British Medical
Journal (BMJ) published an article titled “Jury awards $4.7bn damages against
Johnson & Johnson in talcum cancer case” published in the renowned British
Medical Journal (BMJ). As per BMJ’s article, “More than 9000 former US talcum
customers have lodged suits against the company. Most claim damages for ovarian
cancer, but some allege that using the product led them to develop
mesothelioma. The award is by far the biggest yet against Johnson and Johnson in
litigation relating to talcum powder and the first case in which plaintiffs
alleged that asbestos in talcum powder caused their disease. The verdict was
handed down in the Circuit Court of the City of St. Louis.
((Reference: BMJ 2018; 362
doi: https://doi.org/10.1136/bmj.k3135)
I submit that this
investigative report is of deep relevance for the public health of present and
future generation of Indians given the fact that Johnson & Johnson company
has admittedly been in India for last 70 years. The company has brought many
products in consumer healthcare, medical devices and pharmaceuticals. 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 introduces the Stayfree brand
to India. A situation emerged wherein Johnson & Johnson reached almost
every household in India.
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/)
I wish to point out that in a
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/)
This investigation by Reuters
reveals that “Johnson & Johnson developed a strategy in the 1970s to deal
with a growing volume of research showing that talc miners had elevated rates
of lung disease and cancer: Promote the positive, challenge the negative. That
approach was summed up by a J&J applied research director in a “strictly
confidential” March 3, 1975, memo to managers of the baby products division,
which used the talc in J&J’s signature Baby Powder. Its approach reads:
“Our current posture with respect to the sponsorship of talc safety studies has
been to initiate studies only as dictated by confrontation,” the memo said. “This
philosophy, so far, has allowed us to neutralize or hold in check data already
generated by investigators who question the safety of talc.” It reveals that
scientific ghostwriters have been hired for long to hide evidence of “cancer
concern associated with exposure to talc.” Based on an Italian study, one such
ghost authored article that appeared in the Journal of Occupational and
Environmental Medicine, in 1976 found no mesothelioma, the signature cancer of
asbestos exposure. The Italian study in question has been updated three times –
in 1979, 2003 and 2017 – “confirming the lack of association between exposure
to asbestos-free talc, lung cancer and mesothelioma.” The investigative
underlines that Johnson & Johnson got a lot of mileage out of the study. It
was cited in a review article titled “The Biology of Talc,” published Nov. 1,
1976, in the British Journal of Industrial Medicine.
(Reference:
https://pdfs.semanticscholar.org/77df/7030e57e91ee73c8e313d6b54e0ea0b7c498.pdf)
In addition to dozens of
published studies, the review cited unpublished research, including one
experiment that used a doll as a proxy for infants and that supported the
company’s position on the safety of talc. It didn’t disclose that Johnson &
Johnson had commissioned the unpublished research. The author of the review
article concluded that the “concern that has been expressed about the possible
health hazard from consumer exposure to cosmetic talc is unwarranted … There is
no evidence that its normal use poses a hazard to health.” The author was
Hildick-Smith, the Johnson & Johnson physician executive who had overseen
the Italian study and played a key role in the company’s talc safety research.
The article did not disclose his Johnson & Johnson connection, identifying
him only as a Rutgers University Clinical Assistant Professor of Pediatrics.
In a related event I submit
that I was a panelist at a Round Table Conference on Issues Related to Asbestos
Use in India held at India International Centre, New Delhi on December 21,
2009, wherein Dr Iqbal Ahmad, a scientist from IITR, Lucknow said that there
are many different sources of asbestos exposures which need to be looked at. He
identified talc (powder) as a major source which has asbestos contamination and
exposes a large section of population, especially children and women. Talc is
used in several industries as raw material. He said that we do have numbers of
talc based cosmetic powders in India. China is the largest producer of talc.
Some 47 companies which used to procure Chinese talc powder had to recently
withdraw their product from market in South Korea due to high asbestos
contamination.
In view of the above, I seek your
urgent intervention to ensure complete stoppage of ongoing exposure of Indians
to carcinogenic asbestos fibers contaminated Talc powder of Johnson &
Johnson and other companies in India.
Thanking You
Yours faithfully
(Dr Gopal Krishna, LLB, PhD)
Director, ToxicsWatch Alliance (TWA)
E-mail:krishnaruhani@gmail.com
Web:www.toxicswatch.org
