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

We are all delighted that the Food Labeling legislation is so close to passage. It will probably be a while before it will be fully implemented. Therefore, I thought it might be useful to let the list know about some sources of help which already exist although not in a fully binding way.

In 1996 the FDA Center for Food Safety and Applied Nutrition issued a Letter which was a NOTICE TO MANUFACTURERS
on the Label Declaration of Allergenic Substances in Foods. It  advises  manufacturers that the issue off declaring allergenic materials in foods is being discussed on an international level and states the FDA is studying its labeling requirements. To highlight some points I seem to see in the document.  I note the following:

It reminds manufacturers that for an ingredient to  qualify for the exemption from the required ingredient declaration which provided for incidental additives and processing aids  ---An ingredient  must be present in a food at an insignificant level, and it must not have any technical or functional effect on the finished food. If an ingredient  added to another food continues to have an effect on the finished product ----the ingredient is not an incidental additive and must be declared on the label. ---- also, an amount of an ingredient which can cause an adverse reaction is not insignificant, thus the requirements to meet the exemption from labeling cannot be met.  To see the precise language see
http://www.cfsan.fda?gov?~lrd?allerg&.html

Also The FDA issued a Compliance Guideline for FDA staff. "This does not confer  create rights for,  or obligations on FDA or any private person, but are intended for internal guidance." 

This deals with some of the issues we know about like cross contamination
Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-Contamination of Common Food Allergens. Although only wheat is mentioned other substances can be dealt with CFSCAN/Office of Field Programs for Guidance.
see
http://www.fda.gov/ora/compliance_ref?cpg/cpg?cpg/fod/cpg555-250.htm

Subsequently, Office of Regulatory Affairs of the FDA issued and inspection guide

GUIDANCE ON INSPECTIONS OF FIRMS PRODUCING FOOD PRODUCTS SUSCEPTIBLE TO CONTAMINATION WITH ALLERGENIC INGREDIENTS

This appears to having been developed because the prior letter spoke specifically of ingredients deliberately used, and problems came up which were 

This Guide deals with a number of problems such as:

products that become contaminated with a allergenic ingredient due to the firm's failure to exercise adequate control procedures

due to the nature of the product or the process (for example in the manufacture of chocklate intrim wet cleaning is not practical)

products that have a processing aid that have an allergenic component ( currently they are not exempt form the label declaration)

product containing a flavor ingredient which has an allergenic ingredient ( currently they are not required to label  but they are encouraged to-
  If this takes you to a home page look on the left for inspections or guides
http://www.fda.gov/ora/inspect_ref/igs/Allergy_Inspection_Guide.htm

When one reads these documents, it becomes clear that people have been reporting adverse reactions to products when ingredients do not state that an allergen is present. We should be reporting times when we have adverse reactions when none of the ingredients on the label is wheat, barley, rye or oat.  It would appear that adverse reactions  would be most important to report if the product was labeled Gluten Free. One reports adverse reactions to the closest Field Office of FDA Center for Food Safety and Applied Nutrition. One can look them up easily. We have reported one to our Field Office which happens to be in Massachusetts.

We still need to be aware that some of the language  in these documents refers to IgE mediated allergy. Allergists now claim to cover non IgE reactions as a Class 4 allergy and specifically mention Celiac disease. This would be important to clarify, perhaps it will be discussed at the NIH consensus meeting.

Hope this information is useful.

Irma De Bruyn

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