See the attached statement released Wednesday (9/26/18) by the FDA. This statement is from the FDA Commissioner Scott Gottlieb, M.D regarding the agency’s decision to release the names of retailers who may have received recalled products. The FDA statement focuses on their mission to address public health and safety concerns and to help ensure the consumer is aware of various recalled products and where they may have been sold.
While this may seem like stunning news, I want to describe the FDA recall process for you. During a recall situation, the FDA investigator and the district recall coordinator collect information from the recalling firm regarding the product in question, including the appearance of the product, the reason for the recall, and the distribution lists for the affected lots. The FDA staff will likely collect samples of the product label and photographs of the product packaging including the bottles, secondary cartons, and master cases. These photos may be used in FDA press releases.
Distribution lists were always collected by the FDA during the management of a recall. The difference with the recent statement is that now the FDA may publicly disclose the retailers who may have received the recalled goods. Previously, these distribution lists were only available to the FDA staff.
As investigators, we were tasked with verifying that those on the distribution list received the recall notice from the responsible firm, and that they followed the recall instructions. This process is called a recall audit check. If the recalled products were distributed to a retailer, we would go to the store shelves before we identified ourselves to the store’s management. We would independently verify that the recalled product lot(s) was not available to consumers. Then we would speak to the management and confirm they received the notice, determined where the affected product was stored, and how it was marked/labeled to ensure it was not inadvertently placed back on the store shelves.
I hope this helps give you a better understanding of the process. If you have any questions, please feel free to contact us at UNPA. We would be happy to help.
---------- Forwarded message ----------
From: McDermott, Catherine <Catherine.McDermott@fda.hhs.gov>
Date: Wed, Sep 26, 2018 at 8:00 AM
Subject: Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA commitment to disclose retailer information for certain food recalls to improve consumer safety
To: "McDermott, Catherine" <Catherine.McDermott@fda.hhs.gov>
Please see today’s FDA Commissioner statement regarding disclosing retail information related to certain food recalls:
Americans depend on the U.S. Food and Drug Administration to help ensure that the foods they buy and consume are safe. When we learn that potentially dangerous food products may be available in the U.S. marketplace, we must move quickly and efficiently to remove these food products from the market.
Our teams routinely work with food producers on voluntary recalls, and when necessary and where applicable, mandate recalls in order to keep people from getting sick or being harmed. We recognize that an important part of the recall process is also arming consumers with actionable information that they can use to avoid potentially contaminated food products. We’re committed to providing consumers with more information to take these actions. This is an area where we see more opportunity to improve the FDA’s role in protecting public health. To promote these goals, we’re advancing an important new policy.
When a food recall is initiated, the FDA typically works with companies to publicize labeling information, product descriptions, lot numbers, as well as photographs and geographic or retail-related distribution information. The aim is to enable consumers to identify whether they have the recalled product and take appropriate actions. That often includes discarding the product or returning it to the place of purchase.
The agency has not traditionally released lists of specific retailers where recalled foods may have been purchased. This is because certain supply chain information is confidential between the supplier and retailer. Moreover, in most cases, information publicized by the recalling company is sufficient to allow consumers to identify and avoid recalled product. But there are some cases where additional information about the retailers selling potentially harmful product may be key to protecting consumers such as when the food is not easily identified as being subject to a recall from its retail packaging and the food is likely to be available for consumption. It is particularly important in situations where the product has already been linked to foodborne illness. In these situations, providing retailer information can help consumers more quickly and accurately recognize recalled product and take action to avoid the product or seek assistance if they’ve already been exposed.
We recognize the importance of providing consumers with actionable information related to recalled food products. That’s why today the FDA issued new draft guidance that describes situations when disclosing retail information for products undergoing recalls is appropriate. The draft guidance outlines the circumstances when the FDA intends to make public the retail locations that may have sold or distributed a recalled human or animal food. These circumstances will particularly apply in situations associated with the most serious recalls, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals.
Entire statement can be found at the link below,