Inadequate Refrigeration of Some Commercial Foods Is a Continued Cause of Foodborne Botulism in the United States, 1994-2021.

Foodborne botulism is a rapidly progressive potentially fatal paralyzing illness caused by the consumption of botulinum neurotoxin, which is most commonly produced by Clostridium botulinum. Refrigeration is the primary barrier to botulinum neurotoxin production in many processed foods. C. botulinum toxin production has occurred and caused botulism in the United States when foods that were not processed to destroy spores of C. botulinum were stored in an anaerobic environment and not properly refrigerated. We identified 37 cases, including 4 deaths, that occurred during 1994-2021 in the United States from 13 events associated with inadequate refrigeration of commercially produced products. In 11 events, the patient stored the product unrefrigerated at home; in 2 events, a product was kept unrefrigerated at the store before the consumer purchased it. In three events, refrigeration instructions were inadequate or not easily accessible (one label printed on outer but not inner packaging, one label not clearly visible, and one label was not in English). The number of people affected per event ranged from 1 to 16. Using enhanced cost estimates for foodborne botulism cases from a published economic model, these events were estimated to cost >$79M. Potential solutions to this recurring problem include the addition of a secondary barrier, such as an acidifier, to prevent botulinum toxin production, and better labeling to convey risks of refrigerated foods that have not been processed to destroy spores of C. botulinum and to decrease the occurrence of improper storage and handling.