A Multistate Outbreak of Niacin Toxicity in School Age Children Associated with an Infused Rice Product

Fields, Angela; Fields, Angela

Sunday, July 26, 2015

Exhibit Hall (Oregon Convention Center)

Stelios Viazis , U.S. Food and Drug Administration/CORE Network , College Park , MD

Allison Wellman , U.S. Food and Drug Administration/CORE Network , College Park , MD

Angela Fields , U.S. Food and Drug Administration-CORE Network , College Park , MD

Alyssa Clendenin , FDA , College Park , MD

Tracy DuVernoy , FDA, CFSAN , College Park , MD

Stefano Luccioli , U.S. Food and Drug Administration-CFSAN , College Park , MD

Doug Heitkemper

Matthew Wise , Centers for Disease Control and Prevention , Atlanta , GA

Michael Schwartz

Jacqueline Barringer , 3Morgan County Health Department , Jacksonville , IL

Alicia Lepp , 4North Dakota Department of Health , Bismarck , ND

Linda Gaul , Texas Department of State Health Services , Austin , TX

Kari Irvin , U.S. Food and Drug Administration/CORE Network , College Park , MD

Introduction: Beginning in December 2013, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state and local partners investigated an outbreak of gastrointestinal illness and rash in school age children caused by niacin toxicity linked to consumption of an infused rice product.

Purpose: The purpose of the investigation was to identify the vehicle responsible for the outbreak and take appropriate actions to protect public health.

Methods: The majority of cases reported headache, nausea, and a rash on ears, neck, arms, face or trunk. FDA reviewed records and production information from the manufacturing firm. Samples of leftover and uncooked infused rice product collected from school locations, a distributor, and manufacturer were tested for niacin (nicotinic acid) and iron levels.

Results: A total of 81 cases from 3 states were identified; 91% of cases were school age children. Both male and female students were affected equally; most spontaneously recovered within 90 to 120 minutes. Samples of leftover cooked rice and product from the same lot as rice consumed at one of the schools contained 1.4 – 4.4 mg/g nicotinic acid, approximately 1000 times higher than expected, and 2.8 – 2.9 mg/g iron, 100 times higher than expected. Samples of product obtained from other schools did not have elevated levels of niacin or iron, indicating a potential issue with the application of a vitamin mixture during processing of the infused rice product. Based on laboratory findings, niacin toxicity from consumption of the infused rice product was determined to be the cause of illnesses in case patients.

Significance: Laboratory findings, combined with epidemiologic information and findings from the manufacturing facility led the firm to voluntarily recall the infused rice product produced in 2013. Subsequently, the firm investigated and revised their vitamin mixture application process to prevent future issues.

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