FDA ensures safety of Cosmetic Products Using Adverse Event Reports to Monitor Cosmetic Safety!!

Cosmetics are a broad category of products that, by law, are intended to, among other things, cleanse or alter appearance. Per Linda Katz, M.D., MPH, director of the FDA’s Office of Cosmetics and Colors “Every person uses some cosmetic product on a given day, be it shampoo, mouthwash, a moisturizer or deodorant”

On Tuesday, Dec. 6, 2016, FDA announced that it is making public certain data that the agency’s Center for Food Safety and Applied Nutrition (CFSAN) receives about adverse events associated with the use of its regulated products, which include cosmetics. The goal of CFSAN’s Adverse Event Reporting System (CAERS) is to collect data on some of the problems reported when using these products.

FDA does not have the legal authority to approve cosmetics products and their ingredients, other than color additives, before they go on the market and so FDA monitors cosmetics on the market through an adverse event report (AER) filed by a consumer, manufacturer, or health care professional. An adverse event could be any problem experienced when using a cosmetic product to ensure that they are safe to consumers.

Due to increase in number of AER associated with Talcum powder FDA is currently collecting latest scientific literature and are conducting laboratory research study to determine a link between talc and ovarian cancer. FDA has posted an alert for consumers and healthcare providers about AER associated with the use of hair-care products: Statement on FDA Investigation of WEN by Chaz Dean Cleansing Conditioners

FDA is hoping that making the safety data available to public will increase transparency and will result in more detailed and complete reports that will help FDA to more rapidly identify red flags about a possible safety issue with product. FDA encourages consumers and health care providers to report any safety or other issue associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. The problems can be reported at Reporting Serious Problems to FDA

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