Manisha Reddy
Senior Editor
Loyola University Chicago School of Law, J.D. 2019

In September 2018, the Food and Drug Administration (“FDA”) announced a new policy that provides for the release of a list of retailers that have received a food subject to recall. In the past, the FDA did not release such information because the agency deemed it confidential commercial information. The lack of information on the part of the FDA has been a huge detriment to the public. Prior to the new guidance, the public would only find out information about the particular food that was being recalled, not where this recalled food was available for purchase. The public was told just to stop purchasing that recalled food, whether it be romaine lettuce or beef, even if there were retailers who were selling non-contaminated products. This procedure not only hurts the public but also has a huge financial effect on those retailers who are not selling contaminated or recalled products. The FDA has effectuated a new guidance because they have found that such information is necessary to enforce a recall and to ensure public safety.

Old Protocol

The new guidance is authorized under 21 CFR 20.91. Although the guidance is currently only in draft form, the policy is in effect. The guidance first took effect earlier this year after the FDA made a retailer list available during a recall of pre-cut melon associated with an outbreak of Salmonella. Prior to this new guidance, when a food recall was initiated the FDA would work with companies to publicize labeling information, product descriptions, lot numbers, as well as photographs and geographic or retail-related distribution information. But the FDA has realized that consumers require additional information to protect themselves and their health. The FDA touted that the reason for keeping information confidential was because there was certain supply chain information between supplier and retailer that was required to be kept confidential.

New Guidance

The new draft guidance provides greater transparency and creates a better relationship between the consuming public and the FDA. The draft guidance states that “FDA will primarily focus on those recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious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.” Experts have been advocating for a release of retailer lists for years. The FDA has only required the release of retailers for Class I recall situations but are also considering making the list available in Class II recall situations. A Class II recall is one where the FDA has issued a public warning or where there is a product associated with an outbreak of a food-borne illness. Not only is the FDA considering requiring the release in Class II situations but also in other situations where doing so will be of great use to consumers in identifying a recalled food and is of course consistent with 21 CFR 20.91.

We Need More Protection

The announcement of the new draft guidance in September is the second step in a series of policy steps the FDA has taken as part of a broader plan to improve its oversight of food safety and the recall process. The first draft guidance issued in January created an outline of situations in which the FDA would publicize warnings to help carry out a recall. Both drafts are part of a necessary movement in which the FDA is taking steps to increase their transparency with the consuming public. The new guidance is not perfect, the FDA still has discretion on what information is released, when the information is released, and the information is only released if the FDA determines it to be a significant threat. While it is understandable that the FDA should have discretion in determining the severity of an outbreak, and it is unnecessary to frighten the public without thorough research and information, more needs to be done to ensure the safety of consumers. While the United States has some of the most stringent food safety laws, the CDC estimates that 1 in 6 Americans, roughly 48 million people get sick from food-borne illnesses in the United States each year. Of those 48 million, 128,000 were hospitalized and 3,000 people died of a food-borne disease last year. More needs to be done to protect these preventable deaths, whether that means new guidances or more stringent food safety laws, the FDA needs to take initiatives to protect the public that depends on them.