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Recalls and Draft Guidance for Industry

April 13, 2018

The Food and Drug Administration (FDA), U.S. Department of Health and Human Services and the Office of Regulatory Affairs (ORA) developed a Draft Guidance for Industry and FDA Staff. This Guidance was created as non binding recommendations to reflect the FDA’s current thinking and for the purpose of providing industry and FDA staff with guidance on use, content and circumstances for public warnings or notifications in addition to the type of information that needs to be included in a public warning and the parties responsible for issuing such a warning.


FDA will evaluate each individual situation with regards to the circumstances and severity of potential recalls and warnings. Upon making a determination about the recall, FDA will update their weekly FDA Enforcement Report. Information on all recalls are listed in the FDA Enforcement Report even if they are not urgent situations that present serious risks, but the purpose of the report is not necessarily for alerting the public about risks of a product being recalled. Depending on the circumstances, alerts about risks regarding recalled products are generally done through public warnings or public notifications.


Public warnings are usually recommended for Class I Recalls due to the urgency and severity of the risks, but certain circumstances may also prevent the warning if it is seen as not beneficial to the public. Firms will typically issue their own public warning, but FDA may issue a supplemental warning under various situations, such as if a recall or public warning is not prompt or effective.


Firms are usually given the first opportunity to issue public warnings during recalls and the FDA will review and comment on recall strategies that the firm developed. There are also certain circumstances where firms may choose to issue public warnings without FDA review and the FDA will release a supplemental warning if necessary. However, there are also scenarios where the FDA may issue a public warning on its own, such as if the firm’s warning is ineffective.


Public warnings should include (1) information to help identify recalled products, such as lot numbers, expiration dates, etc., (2) geographic areas and dates of distribution, (3) The reason for recall and a description of the defects and risks associated, (4) name and contact for the recalling firm, (5) instructions for consumers and users, (6) quantity and nature of risks associated with product, and (7) descriptions of symptoms of illnesses. Furthermore, Public warnings should also include a headline containing the brand name, type of product and hazard that caused the recall. While the above points are essential to the warning, it is also important to keep the warnings concise and free of any firm promotion or statements that appear to minimize the hazard.  Public warnings may be perceived as deficient if they do not include the aforementioned points, but also if the warning is deemed insufficient in reaching a target audience.


Firms and the FDA will utilize various methods to alert the public of a recall, including press releases, which are most commonly recommended by FDA, and posting on FDA, company or social media websites. It is important to note that the method for distribution of the press release should match that of the distribution of the product. For example, if the product was one that was disseminated online, then it is vital that the public warning is available on the same platform. While firms will usually announce the removal of a FDA regulated product before the FDA, FDA may post information and announcements on https://www.fda.gov/Safety/Recalls/default.htm if they believe their content is factually correct or beneficial. However, the recalls found on this page are limited. If an individual seeks to find information on major product recalls, they can find it at https://www.fda.gov/Safety/Recalls/MajorProductRecalls/default.htm. However, this list is also limited, but all recalls can be found in the FDA Enforcement Report.


References: https://www.fda.gov/downloads/Safety/Recalls/IndustryGuidance/UCM592851.pdf



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