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Cosmetics Sold to Consumers with No FDA Screening

The U.S. Food and Drug Administration has no regulatory authority over cosmetics across consumer markets. Certain ingredients are prohibited regardless of product type, but there is no FDA pre-market approval required to sell cosmetics to consumers.

As stated on the website:

“In general, except for color additives and those ingredients that are prohibited or restricted by regulation, a manufacturer may use any ingredient in the formulation of a cosmetic, provided that–
• the ingredient and the finished cosmetic are safe under labeled or customary conditions of use,
• the product is properly labeled, and
• the use of the ingredient does not otherwise cause the cosmetic to be adulterated or misbranded under the laws that FDA enforces.”

While color additives demand FDA inspection all other ingredients in a formula are only subject to companies’ internal safety and testing regulations. Cosmetic firms and manufactures are responsible to ensure the safety of their product. This is accomplished in part by thorough ingredient testing to gather a comprehensive understanding of the cosmetic’s active and inactive ingredients. Manufacturing quality assurance and any necessary failure analysis studies should also be performed to preserve a product’s quality.

Cosmetic firms and manufactures are not required to have any sort of FDA license to operate; however, the FDA does encourage all companies to participate in the Voluntary Cosmetic Registration Program (VCRP).  This program alerts the FDA to any new products released and provides information such as products ingredient lists as well as distributor and manufacturer information. This voluntary program in conjunction with independent panels such as the Cosmetic Ingredient Review (CIR) assists in the monitoring of cosmetics currently on the market. In addition to reviewing recorded information the FDA can inspect cosmetic manufactures per the FD&C Act to ensure compliance with the law.

Though the FDA monitors cosmetics in these ways, if a product is found to be harmful to consumers or to violate safety and labeling laws the Administration does not have the authority to demand a recall. What they can do, and what action can be expected will be discussed in a future post.
This lack of external requirements constitutes the primary operating differences for cosmetics versus other monitored consumer goods. Cosmetic firms must, however, still submit to branding and adulteration legal restrictions. In light of this, manufactures of cosmetics should fully equip themselves to know the legal requirements specific to cosmetics and develop practices to ensure compliance. As part of this effort in product safety, firms should employ formulation testing to verify labeling and take measures to protect against product contamination.