U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Cosmetics and Colors
July 29, 2002


FDA Recall Policy for Cosmetics

A recall is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, such as seizure [Title 21 of the Code of Federal Regulations (CFR), section 7.3(g)] FDA strongly recommends that firms become familiar with the complete guidelines, including the components of a recall strategy, in 21 CFR Part 7. The following is an introduction.

What is FDA's role in a recall?

FDA has no authority under the FD&C Act to order a recall of a cosmetic, although it can request that a firm recall a product. However, we do have an active role in recalls. For example:

What is a cosmetic firm's responsibility in a recall?

Under the guidelines in 21 CFR Part 7, you are expected to do the following:

How can a cosmetic firm make the recall process easier and more effective?

The best way to minimize the burden of product recalls is to do a thorough job of preventing product adulteration and misbranding to begin with. But in case a recall does become necessary, companies can minimize the damage by being prepared in advance. The following are some tips:

What should a cosmetic firm do to prevent similar problems?

In addition to the corrective actions of removing a violative product from the market and either destroying it or bringing it into compliance, you should take the kind of corrective actions that prevent a similar problem from occurring in the future. For example, you should-- These are some of the things an FDA investigator will look for if we conduct an inspection related to a recall. To learn more about what to expect during a recall-related inspection, you may check FDA's Investigations Operations Manual, Subchapter 810. To learn more about FDA's policies and procedures regarding recalls, you may check FDA's Regulatory Procedures Manual, Chapter 7, "Recall Procedures" (available in PDF).



See also FDA Recall Policies


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