490 JOURNAL OF COSMETIC SCIENCE
In 2004, Darbre et al. reported that parabens were found in human breast tumors.20 The
implication was that parabens were linked with cancer. These workers indicated that MP
may have been at higher levels than other paraben esters due to its more widespread use
in consumer products or due to its greater ability to be absorbed and/or resist hydrolysis
in body tissues. Unfortunately, no normal tissues were sampled in the subjects tested to
provide reference levels of parabens present in noncancerous tissues.14
The estrogenic activity of MP was already known because Nakagawa and Maldeus had
reported that parabens had estrogenic activity in rat hepatocytes in 1998.21 These workers
found that butylparaben (BP) had the most estrogenic activity of the paraben esters tested.
BP was significantly more estrogenic than MP. Nevertheless, the publication by Darbre and
coworkers shocked the cosmetic industry because it raised a possible link between parabens
and cancer. This was unsettling because parabens had been in use for over 50 years and
were the most used preservative in the cosmetic industry.14
An editorial by Harvey and Everett provided excellent perspective on the report by Darbre
and coworkers, because it explained that parabens have inherent estrogenic activity, and
that estrogen is a major factor in the growth and development of human breast cancer.22
They noted that long-term exposures due to the use of products containing parabens may
contribute to the bioburden of estrogenic materials in the body. Even though the cause-
and-effect relationship between parabens and breast cancer was not established, Harvey and
Everett concluded that unlike environmental exposures that may not be avoidable, individual
use of consumer products with parabens is preventable, and that the removal of estrogenic
formula components would eliminate one potential source of estrogenic materials. Goon,
Leow, and Goh observed that this was unfortunate because perception often becomes reality
to consumers.23 Many companies reacted to this concern by replacing parabens in products
with other preservatives and with multifunctional ingredients that have antimicrobial
activity to meet the perceived consumer demand for products that are safe.
In 2020, The Cosmetic Ingredient Review Expert Panel for Cosmetic Ingredient Safety
reported on the safety of 21 parabens as preservatives in cosmetic products. It was
concluded that “20 of the 21 parabens included in this report are safe in cosmetics in
the present practices of use and concentration described in this safety assessment when
the sum of the total parabens in any given formulation does not exceed 0.8%.”24 They
reported that the available data are insufficient to support a conclusion of safety for BP
in cosmetics.24 Currently, the position of the FDA is that “At this time, we do not have
information showing that parabens as they are used in cosmetics have an effect on human
health.”25 Although MP and PP continue to be popular preservatives in cosmetics, many
manufacturers are formulating products without parabens to avoid consumer perception
that parabens in cosmetics are unsafe.
In 2016, The US FDA issued a final rule establishing that OTC consumer antiseptic wash
products, such as deodorant or medicated soaps, containing certain active ingredients (e.g.,
Triclosan, Triclocarban, etc.) could no longer be marketed.26
Hand and bodywash manufacturers were no longer able to sell antibacterial soap and
washes with antibacterial active ingredients because they did not demonstrate that the
active ingredients were both safe for long-term daily use and more effective than plain soap
and water in preventing illness and the spread of certain infections. Thus, manufacturers
failed to provide data, or the information submitted was not sufficient for the FDA to
determine that these active ingredients are generally recognized as safe and effective.
In 2004, Darbre et al. reported that parabens were found in human breast tumors.20 The
implication was that parabens were linked with cancer. These workers indicated that MP
may have been at higher levels than other paraben esters due to its more widespread use
in consumer products or due to its greater ability to be absorbed and/or resist hydrolysis
in body tissues. Unfortunately, no normal tissues were sampled in the subjects tested to
provide reference levels of parabens present in noncancerous tissues.14
The estrogenic activity of MP was already known because Nakagawa and Maldeus had
reported that parabens had estrogenic activity in rat hepatocytes in 1998.21 These workers
found that butylparaben (BP) had the most estrogenic activity of the paraben esters tested.
BP was significantly more estrogenic than MP. Nevertheless, the publication by Darbre and
coworkers shocked the cosmetic industry because it raised a possible link between parabens
and cancer. This was unsettling because parabens had been in use for over 50 years and
were the most used preservative in the cosmetic industry.14
An editorial by Harvey and Everett provided excellent perspective on the report by Darbre
and coworkers, because it explained that parabens have inherent estrogenic activity, and
that estrogen is a major factor in the growth and development of human breast cancer.22
They noted that long-term exposures due to the use of products containing parabens may
contribute to the bioburden of estrogenic materials in the body. Even though the cause-
and-effect relationship between parabens and breast cancer was not established, Harvey and
Everett concluded that unlike environmental exposures that may not be avoidable, individual
use of consumer products with parabens is preventable, and that the removal of estrogenic
formula components would eliminate one potential source of estrogenic materials. Goon,
Leow, and Goh observed that this was unfortunate because perception often becomes reality
to consumers.23 Many companies reacted to this concern by replacing parabens in products
with other preservatives and with multifunctional ingredients that have antimicrobial
activity to meet the perceived consumer demand for products that are safe.
In 2020, The Cosmetic Ingredient Review Expert Panel for Cosmetic Ingredient Safety
reported on the safety of 21 parabens as preservatives in cosmetic products. It was
concluded that “20 of the 21 parabens included in this report are safe in cosmetics in
the present practices of use and concentration described in this safety assessment when
the sum of the total parabens in any given formulation does not exceed 0.8%.”24 They
reported that the available data are insufficient to support a conclusion of safety for BP
in cosmetics.24 Currently, the position of the FDA is that “At this time, we do not have
information showing that parabens as they are used in cosmetics have an effect on human
health.”25 Although MP and PP continue to be popular preservatives in cosmetics, many
manufacturers are formulating products without parabens to avoid consumer perception
that parabens in cosmetics are unsafe.
In 2016, The US FDA issued a final rule establishing that OTC consumer antiseptic wash
products, such as deodorant or medicated soaps, containing certain active ingredients (e.g.,
Triclosan, Triclocarban, etc.) could no longer be marketed.26
Hand and bodywash manufacturers were no longer able to sell antibacterial soap and
washes with antibacterial active ingredients because they did not demonstrate that the
active ingredients were both safe for long-term daily use and more effective than plain soap
and water in preventing illness and the spread of certain infections. Thus, manufacturers
failed to provide data, or the information submitted was not sufficient for the FDA to
determine that these active ingredients are generally recognized as safe and effective.
