Posted: 27 Sep 2018 01:00 AM PDT
FDA announced the establishment of a new policy that provides for the release of lists of retailers that may have received a food subject to a recall. Historically, FDA has not released such information because it is considered confidential commercial information. FDA now has concluded that the publication of such information is necessary in certain circumstances to effectuate a recall, and is therefore authorized under 21 CFR 20.91.
As one step toward implementation of the policy, FDA issued a draft guidance titled Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls (available here). Judging by the guidance, FDA has concluded that it has wide latitude in deciding when to make the lists available. It appears that FDA intends to do so primarily in Class I recall situations where the food being recalled is not easily identified as such, and is still available for consumption (based on its shelf-life). However, FDA might choose to also make the lists available in Class II recall situations “where FDA has issued a public warning or where there is an association with an outbreak of a foodborne illness.” Further, FDA might choose to make the lists available in other situations “when doing so will be of most use to consumers in identifying a recalled food and is consistent with 21 CFR 20.91.” Conversely, FDA might choose not to make the lists available “in cases where doing so would undermine a public health warning (for example, if FDA has warned the public to avoid a specific food commodity in general, and there has only been a limited recall of this food).”
Although the guidance was issued in draft form, the policy essentially is in effect. As noted in FDA’s announcement, the agency made a retailer list available earlier this year during a recall of pre-cut melon associated with an outbreak of foodborne illness.
As one step toward implementation of the policy, FDA issued a draft guidance titled Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls (available here). Judging by the guidance, FDA has concluded that it has wide latitude in deciding when to make the lists available. It appears that FDA intends to do so primarily in Class I recall situations where the food being recalled is not easily identified as such, and is still available for consumption (based on its shelf-life). However, FDA might choose to also make the lists available in Class II recall situations “where FDA has issued a public warning or where there is an association with an outbreak of a foodborne illness.” Further, FDA might choose to make the lists available in other situations “when doing so will be of most use to consumers in identifying a recalled food and is consistent with 21 CFR 20.91.” Conversely, FDA might choose not to make the lists available “in cases where doing so would undermine a public health warning (for example, if FDA has warned the public to avoid a specific food commodity in general, and there has only been a limited recall of this food).”
Although the guidance was issued in draft form, the policy essentially is in effect. As noted in FDA’s announcement, the agency made a retailer list available earlier this year during a recall of pre-cut melon associated with an outbreak of foodborne illness.
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