WITHDRAWN: Reporting adverse events related to cosmetic products

JAAD ONLINE: NOTES & Reporting adverse events related to cosmetic products To the Editor: As the regulatory body for cosmetics in the United States, the US Food and Drug Administration (FDA) depends on dermatologists and other medical professionals to alert us of health issues they are seeing in their patients that may be related to cosmetic products. The Federal Food, Drug, and Cosmetic Act defines cosmetics as articles that are rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body to beautify, cleanse, promote attractiveness, or alter the appearance. Unlike drugs, cosmetics are not reviewed or approved before marketing. The law does not require cosmetic manufacturers to provide to the FDA safety data on their products or to report adverse events that they receive. Therefore, we rely heavily on the clinical observations and case information that health care professionals can provide, but only 1% to 3% of all the reports we receive come from health professionals. Because cosmetic-related adverse events often result in skin irritation, allergic reactions, and hair loss, we believe that health care professionals play a critical role in helping the FDA receive appropriate reports, containing critical medical information and descriptions of findings. The FDA will use these data to help identify safety trends associated with cosmetic products and ingredients and take action to address safety issues. Both health professionals and consumers can report adverse events to the FDA via MedWatch (https:// www.fda.gov/Safety/MedWatch/default.htm) or by

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contacting the FDA District Office Consumer Complaint Coordinator in their area (http://www.fda. gov/Safety/ReportaProblem/ConsumerComplaint Coordinators/). We appreciate the extra time and effort it takes for health professionals to compile and submit such reports, but they are extremely valuable in helping us identify signals of potential safety issues, which can help protect others from injury. Linda M. Katz, MD, MPH Center for Food Safety and Applied Nutrition, US Food and Drug Administration, College Park, Maryland Funding sources: None. Statements and opinions expressed in the articles and communications herein are those of the author(s) and not necessarily those of the Editor(s), Publisher, or Academy. The Editor(s), Publisher, and Academy disclaim any responsibility or liability for such material and do not guarantee, warrant, or endorse any products or services advertised in this publication, nor do they guarantee any claim made by the manufacturer of such products or services. Correspondence to: Linda M. Katz, MD, MPH, Center for Food Safety and Applied Nutrition, US Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740-3835 E-mail: [email protected] http://dx.doi.org/10.1016/j.jaad.2016.07.062

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