Nobody wants to live in a classless society. And, nobody at FDA or USDA wants to manage classless recalls. Indeed, when it comes to food safety, we should be all about “class.”

USDA recalls are usually classified as they occur. Whenever FDA-regulated products are recalled, however, the Center for Food Safety and Applied Nutrition (CFSAN) typically will take days or weeks to assign a classification to a recall. As a result, when initiating a recall, FDA-regulated companies do their level best to predict how CFSAN will classify the recall. In many cases it’s like playing blackjack, and trying to predict the next card the dealer will unveil. Gambling on characterization is important to most food companies, because recalls can be defined as Class I, Class II or Class III, and each characterization usually dictates a different result.

A Class I Recall involves a situation in which “there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” When a recall is characterized as a Class I Recall, the FDA will post a formal public recall notification on the FDA website and will typically expect the company involved to issue a press release.

A Class II Recall involves a situation in which “the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” In turn, a Class III Recall involves “a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.” When a recall is characterized as Class II or Class III, FDA will not usually issue any public notification. Put differently, the recall is only carried forward to the retail level and consumers in most cases will not be informed.

How a recall is classified is usually important to a food company. If a recall is characterized as a Class II or a Class III, there will be no adverse publicity and the company can avoid public scrutiny.

I’ll admit it: I’m a nerd, and I have been tracking food product recalls daily for a long time. Over the course of the last 20 years, there have been precisely 3,070 Class I, Class II and Class III Recalls involving undeclared “Big Eight” allergens. Of those, 2,572 have involved FDA-regulated products and 498 have been USDA-regulated products.

While, in the past, most recalls for undeclared allergens have historically been characterized by USDA and CFSAN as “Class I,” we are now seeing an emerging trend in the last few years in which the agency is increasingly characterizing recalls involving undeclared allergens as “Class II” or “Class III.” In 2020, for example, 34 FDA-supervised recalls involving wheat, 26 involving soy, 24 involving tree nuts, 20 involving milk, eight involving peanuts, seven involving eggs, five involving fish, and 1 involving shellfish, were characterized as “Class II.” On the USDA side of the aisle, we see similar trends as well.

So, kudos to FDA and USDA for carefully assessing the underlying facts for each circumstance involving undeclared allergens and making a reasoned determination as to the actual risk. There were 421 recalls in 2020. With only those recalls which create higher risk for consumers being publicized, consumers will likely pay more attention to the recalls that matter most, as opposed to being desensitized when constantly hearing about recalls with lesser significance. Let’s hope that as we move deeper into 2021, these trends continue.

Stay classy, FDA and USDA.

Stay Classy, FDA and USDA

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