sion. Some submissions focused on the tides (i.e., elements of protein) in the in-identity of the native ingredient itself gredient. In such cases, it proved difficult
without necessarily considering the iden- to demonstrate absence of allergenic
tity of the ingredient in the finished “protein” in the ingredient. The teams
product, which is the form of ingredient also noted poor descriptions of the
to which potentially allergic consumers method of manufacture or degree of hy-would be exposed. Similar problems drolysis of some ingredients. This lack of
were found when the constituent pro- information diminished the team’s con-teins of a particular ingredient were not fidence in the identity and characteriza-clearly characterized. Since allergens are tion of the ingredient.
proteins, it is difficult to demonstrate Standards, Methods, and Data Quality.
whether a food ingredient is allergenic or The teams found that notifiers and peti-not when there is limited information tioners often relied on existing standards
on or definition of proteins or protein and assays associated with food allergy
structures from the allergenic food that were inappropriately applied to ad-source in the ingredient. Some submis- dress exemption criteria. As an example,
sions noted trace amounts of large pep- with notifications related to extensively
Ingredient Major food Scientific information/
description allergen evidence presented
FALN Extensively hydrolyzed Milk Processing reduces protein content
001 casein (EHC) Hypoallergenica
Negative immunoassay results
Negative animal model results
hydrolyzed casein (EHC), the designation that these ingredients met the “
hypoallergenic” standard was used to
support the assertion that the ingredient
did not contain allergenic protein. “
Hypoallergenic” is a standard defined by
the American Academy of Pediatrics for
milk-derived infant formula. This standard is based on results from food challenge trials in infants and implies 90%
certainty, with 95% confidence, that a
milk-allergic infant will not react to the
infant formula ingredients. 5 However,
this standard does not necessarily mean
that no infant will react to these ingredients, nor that that the ingredient would
be non-allergenic. Examples in the scien-
Key deficiencies
002
EHC
Milk
Processing reduces protein content
Hypoallergenic
Negative immunoassay results
Negative animal model results
003
Starter growth media
Soy
Processing reduces protein content
Reduced binding in immunoassay
004
Vita Spelt®
Wheat
Taxonomically different from
FALCPA-defined “wheat”b
Tolerated by wheat allergic individuals
005
Anhydrous lactitol and
lactitol monohydrate
Lyophilized probiotic
cultures
Deep sea fish extract
Milk
Negative immunoassay results
Starter growth media
(FALN 003 resubmission)
‘Hypoallergenic’ does not equal ‘non-allergenic’
Case reports of allergic reactions to EHC not addressed
Processing not well defined
Trace protein content potentially allergenic
Animal model and immunoassay not validated
for allergenicity assessment
‘Hypoallergenic’ does not equal ‘non-allergenic’
Case reports of allergic reactions to EHC not addressed
Processing not well defined
Trace protein content potentially allergenic
Animal model and immunoassay not validated for
allergenicity assessment
Poor characterization of ingredient
Analytical methods and assay poorly described
Immunoassay not validated for allergenicity assessment
(in addition, assay is positive)
All species in the same genus (i.e., Triticum) as “wheat”
present risk for wheat allergic individuals
No analysis of protein differences between species
Tolerance study has serious flaws in design
Immunoassay not validated for this purpose
Other methods suggest presence of milk protein
Processing not well defined
Immunoassay not validated for this purpose
Poor characterization of ingredient and processing
Trace protein content potentially allergenic
Gadc1 allergen does not represent all fish allergens
Inconsistent test results
Consumer reports of adverse reactions not discussed
Poor characterization of ingredient
No method for guaranteeing consistent protein levels
in finished product
Analytical methods poorly described
Immunoassay poorly characterized and not validated
DBPCFC study has serious flaws in design
Consumer complaint monitoring not described
006 Milk Processing reduces protein content
Negative immunoassay results
007 Fish Processing reduces protein content
Negative immunoassay for one
major fish allergen (i.e., Gadc1)
Reduced binding in another
immunoassay
FALP Soy Enhanced discussion of processing
001 Negative immunoassay results
Ingredient tolerated in individuals by
DBPCFCc
No evidence of allergic consumer
complaints despite commercial use
and monitoring
002 Soy lecithin used as Soy Withdrawn and resubmitted as
processing aid FALP 003 (pending)
Table 1. Inventory of Food Allergen Labeling Notifications (FALN) and Petitions (FALP) as of 7-31-08
aInfant formula standard as defined by the American Academy of Pediatrics5 • b“Wheat” interpreted to represent ‘common wheat’ ( Triticum aestivum)
cDouble-blind, placebo-controlled food challenge
