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Monday, April 25, 2011


Cosmetic products have become an unavoidable part of human beings. Food, Drug, and Cosmetic Act defines “cosmetics” as products that are intended to be applied to the body “for cleansing, beautifying, promoting attractiveness, or altering the appearance.” But the legal definition includes items such as face and body cleansers, deodorants, moisturizers and other skin lotions and creams, baby lotions and oils, hair care products, dyes, conditioners, straighteners, perms, makeup, hair removal creams, nail polishes, shaving products, perfumes and colognes, face paints and temporary tattoos and permanent tattoos and permanent makeup. Countries have different list of such products. So, you must contact the Food, Drug and Cosmetics regulatory authority before identifying a marketed product as “Cosmetic”.


  Regarding FDA, most of these products don’t require FDA approval before they’re sold in stores, salons, and at makeup counters. So consumer feedback is one of FDA’s most important resources when it comes to identifying problems of such products. If you’ve had a negative reaction to a cosmetic product as listed above,then you must report it to the Food and Drug Administration (FDA), if you resides under the jurisdiction of FDA. Most of the countries maintain their own reporting system, which you can get information from health authorities in your country.


How and what to report

Consumers should contact FDA if they experience any sort of undesired effect while using a cosmetic even if they fail to follow specific instructions by the company on using the product.

When you contact FDA for reporting an undesired effect, then you must include the following information such as

  • the name and contact information for the person who had the reaction;
  • the age, gender, and ethnicity of the product’s user;
  • the name of the product and manufacturer;
  • a description of the reaction—and treatment, if any;
  • the healthcare provider’s name and contact information, if medical attention was provided; and
  • when and where the product was purchased

 MedWatch, FDA’s problem-reporting program, on the Web  is the easy and quick method to report by consumers. Alternatively you can contact over telephone at 1-800-332-1088; or contact the consumer complaint coordinator in your area.

What FDA do on such a report from consumer

FDA enters the information into a database of negative reactions based on the feedback provided by the consumer. There is nothing to worry about this as the identity of consumer who reported the problem will remain confidential. FDA scientists and experts review the issue and try to find similar issues being reported from other consumers. If they identify this as a serious issue, then actions could be depending upon the product and the problem that may range from issuing a consumer safety advisory to taking legal action.

Source: FDA's Consumer Updates page

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