Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration

Our plain-English summary of Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration, by S.L. Jacob, E. Cornell, M. Kwa, et al (JNCI Cancer Spectrum, 2018).

The study

• Authors: S.L. Jacob, E. Cornell, M. Kwa, W.E. Funk, S. Xu
• Journal: JNCI Cancer Spectrum
• Published: 2018;2(2):pky012
• Cited by: 14 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

There have been numerous controversies surrounding cosmetic products and increased cancer risk. Such controversies include associations between parabens and breast cancer, hair dyes and hematologic malignancies, and talc powders and ovarian cancer. Despite the prominent media coverage and numerous scientific investigations, the majority of these associations currently lack conclusive evidence. In 2016, the US Food and Drug Administration (FDA) made publically available all adverse event reports in Center for Food Safety and Applied Nutrition's Adverse Event Reporting System (CAERS), which includes complaints related to cosmetic products. We mined CAERS for cancer-related reports attributed to cosmetics. Between 2004 and 2017, cancer-related reports caused by cosmetics represented 41% of all adverse events related to cosmetics. This yielded 4427 individual reports of cancer related to a cosmetic product. Of these reports, the FDA redacted the specific product names in 95% of cancer-related reports under the Freedom of Information Act exemptions, most likely due to ongoing legal proceedings. For redacted reports, ovarian cancer reports dominated (n = 3992, 90%), followed by mesothelioma (n = 92, 2%) and malignant neoplasm unspecified (n = 46, 1%). For nonredacted reports, or those reports whose product names were not withheld (n = 218), 70% were related to ovarian cancer attributed to talc powders, followed by skin cancer (11%) and breast cancer (5%) attributed to topical moisturizers. Currently, CAERS is of limited utility, with the available data having been subjected to significant reporter bias and a lack of supportive information such as demographic data, medical history, or concomitant product use. Although the system has promise for safeguarding public health, the future utility of the database requires broader reporting participation and more complete reporting, paired with parallel investments in regulatory science and improved molecular methods.

In plain English

This commentary included the authors' own analysis of the US Food and Drug Administration's adverse event reporting system, CAERS. The authors searched all cosmetic reports from 2004 to March 2017 for cancer-related terms in the self-reported health effects. Of 10 726 cosmetic adverse event reports, 4427 (41%) were cancer-related. The FDA had withheld product names in 4210 of these (95.1%). Across all cancer reports, there were 3992 ovarian cancer reports (90%), 92 mesothelioma reports (2%) and 46 unspecified malignant neoplasm reports (1%). Among the 218 reports that named a product, talc powders accounted for 153 (70%). Of these talc reports, 141 (92%) were ovarian cancer and 2.1% were malignant mesothelioma. Reporters linked moisturizers to 14 skin cancer reports and 7 breast cancer reports. The authors noted several problems: vague cancer categories, little demographic or medical history information, and likely recall bias around lawsuits over talc products. The authors concluded that CAERS was currently of limited utility and that it was impossible to draw conclusions about causality from it.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Commentary that includes the authors' own analysis of adverse event reports in an FDA database (CAERS)
• Who was studied: All adverse event reports about cosmetics submitted to the FDA's CAERS database by consumers and health care providers from January 2004 to March 2017, extracted May 30, 2017. There were 10 726 cosmetic adverse event reports in total, of which 4427 were cancer-related. Reporters of any adverse event had an average age of 48 years; 84% were female.
• Exposure: Cosmetic products named by reporters, grouped as talc powders, hair products, moisturizers, cleansers, tanning products, or miscellaneous (nail polish, oral products, deodorants, makeup). No fiber types or doses were measured.
• Main results:
  • 4427 cancer-related adverse event reports linked to cosmetics, 41% of all 10 726 cosmetic adverse event reports
  • Product names were redacted in 4210 cancer reports (95.1% of all cancer reports); these were left out of the product-class analyses
  • Of all cancer reports, including redacted ones: ovarian cancer 3992 (90%), mesothelioma 92 (2%), malignant neoplasm unspecified 46 (1%)
  • Of the 218 non-redacted cancer reports, 153 (70%) involved talc powders; within the talc reports, ovarian cancer accounted for 141 cases (92%)
  • Within the talc powder reports, malignant mesothelioma made up 2.1% and malignant neoplasm 1.1%
  • Among non-redacted reports, reporters attributed skin cancer (n = 14, 11%) and breast cancer (n = 7, 5%) to moisturizers
• The authors' conclusion: The authors concluded that CAERS is currently of limited utility because of reporter bias and missing supporting information, and that broader and more complete data collection is needed for it to become a useful cancer epidemiological tool.
• Limitations the authors state:
  • Nonspecific categories such as 'mass' or 'neoplasm malignant' make these reports largely uninterpretable
  • Cancer subtypes were rarely given (only 15 ovarian cancer reports named a subtype), which limits interpretation
  • Demographic data on reporters were limited
  • Without information on other medical conditions and product use, causality cannot be judged from the database
  • Most ovarian cancer reports came after 2015, coinciding with lawsuits over talc products; the authors state that such outside influences likely prompt recall bias

Topics

Medical terms in this study, explained in our Lexicon: Talc, Ovarian Cancer, Mesothelioma, Neoplasm.

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