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:
- 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].
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:
- 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].
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:
- 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)].
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--
- 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. 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
Cosmetics
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