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FDA requirements for reporting adverse events with Cosmetics

MedWatch Form can be used for reporting Adverse Events with Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes and tattoos

What is CAERS?

CFSAN Adverse Event Reporting System

The CFSAN Adverse Event Reporting System (CAERS) is a database that contains information on adverse event and product complaint reports submitted to FDA for foods, dietary supplements, and cosmetics. The database is designed to support CFSAN's safety surveillance program.

How a Product Can Be Considered Both a Cosmetic and a Drug

OTC drugs are often marketed side by side with cosmetics, and some products qualify both as cosmetics and as OTC drugs. This may happen when a product has two intended uses, with ingredients intended to do two different things. For instance, a shampoo is a cosmetic, since its intended use is to cleanse the hair. An anti-dandruff treatment is a drug, because its intended use is to treat dandruff. Consequently, an anti-dandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims.

 

 

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