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Comment & Response
March 18, 2020

Endocrine-Disrupting Chemicals in Cosmetics—Reply

Author Affiliations
  • 1Department of Dermatology, University of Pennsylvania, Philadelphia
JAMA Dermatol. Published online March 18, 2020. doi:10.1001/jamadermatol.2019.4661

We thank Drs Gore and Cohn for their interest in our article1 and thoughtful comments. We agree that ongoing research is needed; however, we would like to point out several issues. First, many parabens are, in fact, not banned in the European Union. The European Union has banned 5 longer-chain parabens not because of evidence that they are unsafe, but rather because “no information was submitted by industry for the safety evaluation [of these compounds].”2 All of the most commonly used parabens, including methylparaben, ethylparaben, propylparaben, and butylparaben, along with many others, are considered safe and legal for use as preservatives in Europe.2 Although many researchers in the clean beauty movement have expressed concerns about the potential for endocrine disruption by parabens, studies in rats and yeast cells have shown parabens to be thousands to millions of times weaker than estradiol, an endogenous sex hormone.3 Given that women are exposed to much more potent natural estrogens, along with estrogens in oral contraceptive pills and even phytoestrogens in food, the extremely weak estrogenicity of parabens is unlikely to be meaningful. The Cosmetic Ingredient Review has done an extensive investigation of the scientific literature on paraben safety and has concluded that parabens are safe in personal care products. The US Food and Drug Administration has also concluded that parabens are safe when used in personal care products.4

It is difficult to draw generalizable conclusions when both the method and concentration of exposure that model organisms receive do not replicate human chemical exposure. Despite the fact that our functioning skin barrier limits much of our systemic exposure to chemicals in personal care products, many animal studies,5 including the one cited by Drs Gore and Cohn, rely on protocols in which model organisms are fed or injected with the compound of interest, limiting the generalizability of these studies. Although the 2019 JAMA article by Matta and colleagues demonstrated systemic absorption of sunscreen agents, the authors also highlight “the need for further studies to determine the clinical significance of these findings”6(p2082) and their conclusion that “these results do not indicate that individuals should refrain from the use of sunscreen.”6(p2082)

We accept the fact that long-term exposure to certain concentrations of formaldehyde can lead to health risks, such as allergic contact dermatitis, asthma, irritation, and cancer, in laboratory animals and humans. However, this needs to be kept in the proper perspective, as the amount of formaldehyde found in personal care products is extremely low and is typically a byproduct of the manufacturing process or is released in small amounts from certain preservatives. Because formaldehyde is also an endogenous byproduct of the human metabolism, small amounts of this substance are ubiquitous in our environment, including in textiles, in construction materials, in the air we breathe, and in our bodies. The Cosmetic Ingredient Review has established guidelines for industry on safe limits of formaldehyde in personal care products.

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Article Information

Corresponding Author: Bruce A. Brod, MD, Perelman Center for Advanced Medicine, Department of Dermatology, University of Pennsylvania, 3400 Civic Center Blvd, South Pavilion, Philadelphia, PA 19104 (bruce.brod@pennmedicine.upenn.edu).

Published Online: March 18, 2020. doi:10.1001/jamadermatol.2019.4661

Conflict of Interest Disclosures: None reported.

Rubin  CB, Brod  B.  Natural does not mean safe—the dirt on clean beauty products.  JAMA Dermatol. 2019;155(12):1344-1345. doi:10.1001/jamadermatol.2019.2724PubMedGoogle ScholarCrossref
European Commission. Commission Regulation (EU) No. 358/2014 of 9 April 2014 amending Annexes II and V to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on Cosmetic Products. http://data.europa.eu/eli/reg/2014/358/oj. Accessed February 7, 2020.
Routledge  EJ, Parker  J, Odum  J, Ashby  J, Sumpter  JP.  Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic.  Toxicol Appl Pharmacol. 1998;153(1):12-19. doi:10.1006/taap.1998.8544PubMedGoogle ScholarCrossref
US Food and Drug Administration. Parabens in cosmetics. https://www.fda.gov/cosmetics/cosmetic-ingredients/ingredients/parabens-cosmetics. Accessed November 19, 2018.
Matouskova  K, Jerry  DJ, Vandenberg  LN.  Exposure to low doses of oxybenzone during perinatal development alters mammary gland morphology in male and female mice  [published online August 10, 2019].  Reprod Toxicol. doi:10.1016/j.reprotox.2019.08.002PubMedGoogle Scholar
Matta  MK, Zusterzeel  R, Pilli  NR,  et al.  Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial.  JAMA. 2019;321(21):2082-2091. doi:10.1001/jama.2019.5586PubMedGoogle ScholarCrossref
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