FDA Guidelines for Gluten-Free Labeling are Frightening for Celiacs

FDA Guidelines for Gluten-Free Labeling are Frightening for Celiacs

Last year, the United States Food and Drug Administration (FDA) issued a final ruling on the definition of “gluten-free” on food labels for food manufacturers who desire to market products as “gluten-free”. The ruling came after years of delays and much frustration for members of the celiac community who have been in need of a national standard for the meaning of gluten-free of prepackaged foods for a very long time.

The FDA gave food manufacturers desiring to label their products as gluten-free a full year to come into compliance with the new ruling, which officially goes into effect August 5, 2014. The law requires foods labeled gluten-free to meet all of the requirements of the new definition, including that foods labeled gluten-free contain less than 20 parts per million (ppm) of gluten.

Other stipulations in the new law indicate foods labeled gluten-free cannot contain ingredients made from a gluten-containing grain that have not been processed to remove gluten. The ruling also states that if a food does contain ingredients made from a gluten-containing grain and has been processed to remove gluten, that food must still test less than 20 ppm gluten.

Now, with the August 5th deadline just around the corner, the FDA has issued guidelines designed to help small businesses comply with the gluten-free labeling regulations. While this is a terrific idea, in theory, the reality is that this document is frightening for those of us with celiac disease.

The document consists of an introduction about the creation of the guidelines for defining gluten-free on food labels, as well as a bit of background about celiac disease. This is followed by a series of questions and answers that provide explanations about what gluten-free will mean on food labels, information on testing and what may happen if a food is incorrectly labeled as gluten-free but fails to meet the requirements.

The guidance is weak and leaves much to the interpretation of the food manufacturer when it comes to how foods are tested for gluten content, stating there are “scientifically valid methods” such as “certain enzyme-linked immunosorbent assay (ELISA) based methods” that can be reliable.

Manufacturers NOT Required to Test for Presence of Gluten?!

Even worse than the loose testing guidance is the statement that manufacturers are not required “to test for the presence of gluten in your starting ingredients or finished foods labeled “gluten-free.” The document goes on to state that manufacturers are “responsible for ensuring that foods bearing a gluten-free claim meet our [FDA] requirements, including that any unavoidable gluten present in a food labeled gluten-free is less than 20 ppm.” The FDA also encourages manufacturers to “use effective measures to ensure that any foods labeled as “gluten-free” comply” with the definition of gluten-free. 

It’s all downhill from there and this “guidance” from the FDA is certainly a shocking reminder there is much work to be done in terms of regulations in the food industry to protect individuals who have celiac disease.

Tell the FDA What You Think of These Guidelines!

The FDA opens comments today for members of the public to comment on the guide. You can share your thoughts with the FDA online here. If you prefer to submit a written comment, send those to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2005-N-0404.

Every voice matters, and I encourage you to let yours be heard!

Be well and be informed…

This post originally  appeared on GlutenFreeGigi.com.


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