Statement from FDA Commissioner Scott Gottlieb, M.D.:
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.
Based on this new policy, moving forward the FDA intends to publicize retail consignee lists for food recalls when the food is not easily identified as being subject to a recall from its retail packaging, or lack thereof, and if the food is likely to be available for consumption. Some examples of this may include foods sold directly to consumers with no universal product code or UPC, or bar code. This might include deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually.
The new draft guidance also states that the FDA may disclose retail consignee lists in certain recall situations, including when a recalled food is related to a foodborne illness outbreak and where the information is most useful to consumers. For example, the FDA might release retailer information for a packaged food that was distributed in a particular geographic region or through a particular online retailer if providing that information could help consumers protect their health and wellbeing from a recalled food potentially purchased at one of these establishments.
In recent months, we’ve already begun taking actions that align with this approach.
For example, this summer the agency released detailed retail distribution information by state during a recall of pre-cut melon associated with an outbreak of Salmonella infections so consumers could better identify where the recalled food may have been purchased. The draft guidance released today, provides greater transparency on our intention to regularly use this approach in these and other scenarios.
We believe that providing retailer information for certain recalls will also improve the efficiency of recalls by helping the public to identify and focus on the foods that are recalled. It’s important to note that in sharing this information, the FDA may also not be able to fully verify the accuracy or completeness of the information it receives from recalling companies or distributors, and information may change over time.
Identifying retail locations can be complex. It can involve obtaining information from multiple parts of the supply chain, including the recalling company and intermediate distributors. But we also know this information can be very important to consumers. Knowing where a recalled product was sold during the most dangerous food recalls can be the difference between a consumer going to the hospital or not. While we can’t prevent every illness, we can make sure we provide information to consumers to prevent more people from becoming sick from a recalled or hazardous food product.
Availability of this new draft guidance is the second in a series of policy steps we’re taking as part of a broader action plan to further improve our oversight of food safety and the recall process. Earlier this year, I committed the agency to further improve our recall processes because I believe that consumers should have actionable information for protecting themselves from recalled FDA-regulated products.
As part of these commitments, we took an important step in January when we released a draft guidance on public warnings for consumers. It outlined situations where the FDA and firms would publicize public warnings to help carry out a recall. All of these actions are a part of our overall efforts to ensure more comprehensive and timely information reaches consumers. The agency has since been communicating sooner and more often on food safety issues that pose serious threats to the health of consumers. For example, the FDA issued a public warning earlier this year on imported crab meat from Venezuela as soon as we knew there were Vibrioillnesses in several states associated with that product.
Assisting food producers in having effective recall practices in place, as well as taking immediate action to address unsafe products, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital consumer protection mission. I take these obligations very seriously.
We’re committed to doing our part in ensuring that recalls by firms are initiated, overseen, and completed promptly and effectively to best protect consumers; and that consumers have useful and timely information about recalled products. We’ll use all of our tools to carry through on this commitment.
We continue to assess how best to execute our authorities during food-related emergencies and build on our commitments to consumers. The new draft guidance issued today represents yet another meaningful step to improve our recall processes. We’ll continue to seek out opportunities for improved processes, education and awareness. And we constantly strive to learn from every recall, and every issue, so that we can help to prevent future outbreaks and limit their impact when they do occur.
I remain committed to investing in the FDA’s food program, building on our successes, and to applying the FDA's food safety expertise to protect American families and keep our Nation safe.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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