On March 3, 2022, the U.S. Food & Drug Administration (FDA) issued a guidance, “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff,” to help companies prepare for voluntary recalls. Part 7 of Title 21 of the Code of Federal Regulations describes how manufacturers and distributors of FDA-regulated products can voluntarily recall violative products.[1] Recalls can be undertaken voluntarily by firms in the distribution chain, including manufacturers and distributors. FDA may also request recalls under “urgent situations.”[2]
To determine whether or not to recommend a recall, FDA will assemble an ad hoc committee to perform a health hazard evaluation that considers the following factors:
- whether the product has already caused injury,
- whether conditions exist that could create a clinical situation that could expose people to harm,
- assessment of how the hazard impacts different segments of the population,
- seriousness of the harm,
- likelihood of the harm,
- consequences of the harm.[3]
The guidance is intended to help companies prepare to remove products from the market quickly and effectively where necessary. FDA’s guidance also encourages companies to voluntarily initiate recalls when there is a risk to the public, and even do so before completing internal investigations as to the cause of the problem. The guidance also discusses the necessary steps companies can take prophylactically to develop internal systems to reduce the time a recalled product remains on the market, like product coding, internal trainings, and record-keeping procedures. Companies should also be proactive in conducting “Mock Recalls” so they can practice their ability to trace product both forward and backwards.
Companies can reduce the risk to the public by developing internal plans for recalls. As pointed out by FDA, an additional benefit of developing robust recall procedures is that they help the entire supply chain in the event of a recall. For instance, a developed recall plan can help to inform downstream suppliers, wholesalers, or vendors, if a product is recalled. FDA also recommends that companies should utilize electronic communication to provide updates to interested parties.
In Sec. 117.139 of Title 21 FDA outlines the regulatory requirement for a Recall Plan for food with a hazard requiring a preventive control:
(a) You must establish a written recall plan for the food.
(b) The written recall plan must include procedures that describe the steps to be taken and assign responsibility for taking those steps to perform the following actions as appropriate to the facility:
(1) Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;
(2) Notify the public about any hazard presented by the food when appropriate to protect public health;
(3) Conduct effectiveness checks to verify that the recall is carried out; and
(4) Appropriately dispose of recalled food – e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.”
FDAImports has a long history of efficiently and successfully navigating FDA’s requirements and systems, including developing robust recall plans and procedures. If you need assistance initiating voluntary recalls or understanding the impact of FDA’s new guidance on your existing recall procedures, please contact us today for help.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
[1] 21 CFR 7.1.
[2] 21 CFR 7.40(b).
[3] 21 CFR 7.41(a), et seq.
