title: Survey of undeclared soy allergen levels in the most frequently recalled food categories with or without precautionary labelling.
abstract: A comprehensive study was designed to determine the frequency and levels of soy allergen in packaged bakery and snack food products. A representative sample of products with no soy allergen disclosed on the label was analysed using two widely used enzyme-linked immunosorbent assay (ELISA) methods. Samples were chosen that either had no soy identified on the product label or which had a soy precautionary statement. Among 558 bakery and snack products, soy protein was detected in 17% of the products using the Neogen (NE) kit and 11% of the products using the Elisa Systems (ES) kit. The disagreement rates between kits were 8.8% for bakery products and 3.3% for snack products. Overall soy protein was detected at higher frequency in bakery products than in snack foods. Among 284 bakery samples, soy protein was detected in 25% of the samples with no precautionary statement and 19% of the samples which had a precautionary statement. Among 274 snack samples, soy protein was detected in 11% of the samples with no precautionary statement and 9% of the samples which had a precautionary statement. The sample repeatability was at an acceptable level (< 9%) for each method and food commodity. The reproducibility between kits was 23% for bakery foods and 36% for snack foods. None of the bakery (21) and snack (6) products without precautionary labelling (measured level > 5 ppm) had a higher level of soy protein per serving compared with the eliciting dose10 (ED10) of 10.6 mg for soy allergic patients. But the level of soy protein per serving may be clinically relevant to a subpopulation of soy allergic patients if a more stringent eliciting dose is applied. These findings emphasise that suitable detection methodologies and references doses are crucial for labelling accuracy and the safety of soy allergic consumers.
authors.affiliation: a Center for Food Safety and Applied Nutrition , United States Food and Drug Administration (USFDA) , Laurel , MD , USA.
authors.forename: Sefat E
authors.initials: SE
authors.lastname: Khuda
authors.affiliation: a Center for Food Safety and Applied Nutrition , United States Food and Drug Administration (USFDA) , Laurel , MD , USA.
authors.forename: Girdhari M
authors.initials: GM
authors.lastname: Sharma
authors.affiliation: a Center for Food Safety and Applied Nutrition , United States Food and Drug Administration (USFDA) , Laurel , MD , USA.
authors.forename: Dennis
authors.initials: D
authors.lastname: Gaines
authors.affiliation: a Center for Food Safety and Applied Nutrition , United States Food and Drug Administration (USFDA) , Laurel , MD , USA.
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Do
authors.affiliation: a Center for Food Safety and Applied Nutrition , United States Food and Drug Administration (USFDA) , Laurel , MD , USA.
authors.forename: Marion
authors.initials: M
authors.lastname: Pereira
authors.affiliation: c Joint Institute for Food Safety and Applied Nutrition , University of Maryland , College Park , MD , USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Chang
authors.affiliation: b Center for Food Safety and Applied Nutrition , United States Food and Drug Administration (USFDA) , College Park , MD , USA.
authors.forename: Martine
authors.initials: M
authors.lastname: Ferguson
authors.affiliation: a Center for Food Safety and Applied Nutrition , United States Food and Drug Administration (USFDA) , Laurel , MD , USA.
authors.forename: Kristina M
authors.initials: KM
authors.lastname: Williams
mesh_terms: D000485:Allergens / Q000032:analysis*; D004797:Enzyme-Linked Immunosorbent Assay; D005506:Food Contamination / Q000032:analysis; D005515:Food Labeling; D006801:Humans; D030262:Soybean Proteins / Q000032:analysis*; D013025:Glycine max / Q000737:chemistry*; D011795:Surveys and Questionnaires
chemical_list: D000485:Allergens; D030262:Soybean Proteins
keywords: ELISA; Food allergy; allergen labelling; precautionary labelling; soy allergen