What is the new FDA concern regarding the safety of cosmetics?

July 1, 2015

Cosmetic products are an interesting category because the cosmetics industry is self-regulated. This is in direct contrast to drugs that are carefully regulated by the FDA.

Zoe Diana Draelos, MDCosmetic products are an interesting category because the cosmetics industry is self-regulated.  This is in direct contrast to drugs that are carefully regulated by the FDA.  Actually, there is only one type of product that escapes all government regulation and this is soap.  With the current climate mandating increased government oversight of many activities, including banking and home mortgages and health insurance, it is not surprising that cosmetic products are coming under increased scrutiny.  At present, when a new cosmetic active is introduced, the industry collects its own safety data and, when convinced that the ingredient causes no risks to the consumer, the ingredient is placed in a new formulation. Most of the new ingredients that are utilized in cosmetic formulations are botanically derived, many of them found as foods, and are thus felt to be safe. In a recent meeting with the FDA, the cosmetics industry proposed a model for continued self-regulation with some more rigidly described standards for safety.  

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The FDA did not feel that this model was sufficient and suggested that new cosmetic ingredients might need to go through the same application model currently used for drugs.  In other words, cosmetic ingredients would need to file a document similar to the IND (Investigational New Drug) that is currently required for research on new medications. This idea has been highly controversial in cosmetics manufacturing because the cosmetic industry is driven by the rapid introduction of new ingredients and a very short lead time from development to launch for new products.  This would dramatically slow down the new ingredient introduction process and increase the cost. Exactly what will be done to insure cosmetic product safety at this time is still undetermined.

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