FDA Issues Warning Letters for making drug claims on Cosmetic Products
FDA has always used warning letters as an effective compliance mechanism to let companies know that they have violated the laws and to tell them what corrective action they need to take. Over the years, FDA has issued a number of warning letters directed to cosmetic establishments. These were mainly related to unauthorized drug claims made for products marketed as cosmetics, improper marketing of medical devices as cosmetics and safety violations due to illegal use of color additives. FDA has issued many firms warning letter citing claims made on label or other promotional materials for products.
As per the FD&C Act any product use to diagnose, mitigate, treat or prevent disease or to affect the structure or Function of Human body is regarded as a Drug. Any product which makes such claims will be considered as a Drug product.
The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
FDA does not pre-approve cosmetic products or ingredients, with the important exception of color additives. However, cosmetic firms are responsible for marketing safe, properly labeled products; using no prohibited ingredients; adhering to limits on restricted ingredients, not making any claims or misguiding the consumers. Any claim that is stated on the product Labeling, in advertisement, on the internet or in any of the promotional material by a cosmetic firm for the product may lead to the product being classified as drug and warrant a Warning letter. The below example will give a better idea about claims that make Cosmetic product a Drug.
- Massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product claims to relieve muscle pain, it’s a drug.
- A fragrance marketed for promoting attractiveness is a cosmetic. But if it claims to help consumer sleep or quit smoking it will be considered a Drug
A Cosmetic Firm is fully responsible for the Data they produce on the label and other Promotion materials. Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. The company has to follow combination OTC drug/cosmetic labeling. For example,
- The drug ingredients must be listed alphabetically as “Active Ingredients,” followed by cosmetic ingredients, listed in descending order of predominance as “Inactive Ingredients.”
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