A recall is a firm's removal or correction of a marketed product that FDA considers to be in violation of the laws we administer and against which we 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?
- What is a cosmetic firm's responsibility in a recall?
- How can a cosmetic firm make the recall process easier and more effective?
- What should a cosmetic firm do to prevent similar problems?
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:
- We monitor the progress of a recall [21 CFR 7.53]. In addition to reviewing firm status reports, we may conduct our own audit checks at wholesale or retail customers to verify the recall's effectiveness.
- We evaluate the health hazard [21 CFR 7.41] presented by the product under recall and assign a classification to indicate the degree of hazard posed by a product under recall [21 CFR 7.3(m)]:
- Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
- Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
- If we believe that public notification is necessary, we assure that either FDA or the firm issues the public notification [21 CFR 7.42(b)(2)]. If the firm is unwilling to issue a press release, or unduly delays issuing a press release, we will issue one. FDA also issues general information about recalls through a weekly publication, the FDA Enforcement Report [21 CFR 7.50], which provides information on all recalls that have been assigned a classification.
- If we request a recall, we develop a recommended strategy for each recall that sets forth how the Agency expects it to be carried out and the necessity for any press release. If the firm develops a recall strategy, we review and comment on that strategy [21 CFR 7.42(a)(2)].
- We make sure that the product is destroyed or suitably reconditioned [21 CFR 7.55].
Under the guidelines in 21 CFR Part 7, you are expected to do the following:
- You should notify your customers. The content, format, and extent of notification should be commensurate with the hazard presented by the product and the recall strategy developed for the product, as detailed in 21 CFR 7.49.
- When you initiate a recall, you should notify the appropriate FDA district office [21 CFR 7.46(d)].
- You should submit periodic recall status reports to the appropriate FDA district office so that we may assess the progress of the recall [21 CFR 7.53]
- If FDA or your firm determines that a public warning is necessary, you should submit such a statement and plan for its distribution to FDA for review and comment [21 CFR 7.42(b)(2)].
- You should conduct effectiveness checks, as described in 21 CFR 7.42(b)(3).
- You are responsible for the disposition of the recalled product, whether the product is destroyed or brought into compliance [21 CFR 7.55].
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:
- Maintain a contingency plan for initiating a recall in accordance with the recall regulations. Refer to 21 CFR Part 7 to determine the steps you need to incorporate into this plan [21 CFR. 7.59(a)].
- Assign production lot or batch numbers. Lot numbering is not required by law for cosmetics. However, it allows you to determine whether some or all lots of a product need to be recalled. If the products do not have lot numbers, it may be necessary to recall all product on the market, since it will most likely be impossible to identify the specific production runs involved [21 CFR 7.59(b)].
- Maintain adequate distribution records to facilitate location of products being recalled. Maintain them for a period of time exceeding the shelf life and expected use of the product [21 CFR 7.59(c)].
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--
- determine why the violation occurred,
- determine what changes you should make to keep the problem from happening again, and
- implement those changes.
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 (PDF 2.26 MB). To learn more about FDA's policies and procedures regarding recalls, you may check FDA's Regulatory Procedures Manual, Chapter 7, "Recall Procedures."
- FDA Authority Over Cosmetics
- Guidance & Regulations
- How FDA Evaluates Regulated Products: Cosmetics
- Key Legal Concepts: Interstate Commerce, Adulterated, and Misbranded
Updated July 29, 2002. This document is current. It is updated only as needed.