FDA’s New Policy on Release of Retailer Lists During Food Recalls

The FDA announced a new policy providing for the release of lists of retailers that may have received a food subject to a recall.

September 28, 2018 - Author: Neal Fortin

FDA logo with recall.

The Food and Drug Administration (FDA) announced a new policy providing for the release of lists of retailers that may have received a food subject to a recall. In the past FDA did not released such information because the agency deemed it 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As one step toward implementation of the policy, FDA issued a draft guidance titled Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls. “FDA will primarily focus on those recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals, which are also referred to as Class I recalls,” according to the draft guidance.

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).”

Bill Marler, food safety expert and prominent foodborne illness lawyer, has been advocating for the release of retailer lists for years.

Although the guidance is in draft form, the policy 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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