<<Disclaimer: Verify this information before applying it to your situation.>>


It is understandable that some may see the lack of inclusion of the many
species of wheat in the Food Allergen Labeling and Consumer Protection Act
(FALCPA) as an oversight.  Comments that such an oversight means that no
scientists were involved in the drafting of the law or that the FDA just
wasn't paying attention are completely without merit.  FDA staff, including
their scientists, provided technical assistance throughout the process of
drafting the legislation, as it moved through committee, and then onto final
passage.  Other scientific experts with extensive credentials in research
relating to food allergies were also consulted.  How do I know this?  Our
predecessor group, the American Celiac Task Force worked closely with the
House and Senate staff, to ensure that concerns of the celiac community were
addressed (as best as possible) in the Food Allergen Labeling and Consumer
Protection Act.   


This law was a major change for the vast majority of food manufacturers.
Companies understand why it was passed - to help prevent allergic reactions
and deaths attributed to accidental ingestion of known allergens in food.
Similarly, they are very aware of the potential liability if a product is
mislabeled.  


 


The relevant definition in FALCPA (21 U.S.C. 321) states:  


 


(qq) The term ''major food allergen'' means any of the following: (1) Milk,
egg, fish (e.g., bass, flounder, or cod), Crustaceanshellfish (e.g., crab,
lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat,
peanuts, and soybeans.

(2) A food ingredient that contains protein derived from a food specified in
paragraph (1) . . . (emphasis added)


 


Spelt contains "protein derived from" wheat.   Rather than spell out a dozen
or so names for the species in the genus Triticum, the drafters used the
phrased noted previously.  By doing so, a similar laundry list for the 7
other allergens was not included in the statute.  


 


Companies in food manufacturing know that the FDA routinely provides
guidance to the industry on new laws and regulations. These guidance
documents are updated as needed.  In the case of FALCPA, four separate Q&A
documents were prepared.  Each one building on the former based on questions
presented to the FDA.  


 


In October 2006, less than 10 months after FALCPA went into effect, the FDA
provided industry guidance on what is considered 'wheat:'    


Section 201(qq) includes "wheat" in the definition of major food allergen.
What is considered "wheat" for purposes of section 201(qq)? 

The term "wheat" in section 201(qq) means any species in the genus Triticum.
Thus, for the purposes of section 201(qq), wheat would include grains such
as common wheat (Triticum aestivum L.), durum wheat (Triticum durum Desf.),
club wheat (Triticum compactum Host.), spelt (Triticum spelta L.), semolina
(Triticum durum Desf.), Einkorn (Triticum monococcum L. subsp. monococcum ),
emmer (Triticum turgidum L. subsp. dicoccon (Schrank) Thell.), kamut
(Triticum polonicum L.), and triticale ( x Triticosecale ssp. Wittm.). 

http://www.cfsan.fda.gov/~dms/alrguid4.html#update

There have been instances where a food manufacturer knew a product was
mislabeled and sent it to market, in other cases it appears to have been
oversight.  In both cases the consumer is placed at risk.   At this point in
time, 3 years after FALCPA went into effect, neither should be acceptable.  

 

Andrea Levario

American Celiac Disease Alliance 

 


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