Finally, FDA Sets Guidelines for Gluten Free Labeling

Gluten free

My four year old son was diagnosed with gluten intolerance and possible Celiac disease when he was 18 months old. In a matter of a few weeks his weight dropped from 25 to 19 pounds, putting him at the weight of an average 8 month old baby. He was severely dehydrated from constant diarrhea, his skin had broken out into a horrible rash, he drooled uncontrollably, and was cranky and lethargic. At first he was tested for various parasites and illnesses, but it wasn’t until I mentioned that Celiac disease runs in my mother’s side of the family that his doctor considered the possibility. Since my son was so sick and continuing to lose weight at such a rapid pace, his doctor decided to take him off gluten immediately as a test, rather than wait for a biopsy. Within a few days of removing gluten from his diet, my son’s health had returned to normal and he regained 3 of the 6 pounds he had lost.

Before Diagnosis
Before Diagnosis – Christmas 2010

A few months later we tried the gluten challenge, which involves eating gluten after a period of being gluten free.  My son reacted quickly to the gluten.  He immediately suffered bloating, diarrhea, dehydration, and weight loss.  His doctor agreed with us that continuing with a gluten challenge for a biopsy was not an option for him at such a young age. As a result, our doctor has diagnosed him with Celiac based on his symptoms and reaction to gluten, but we have yet to confirm it via biopsy. When he’s a bit older, we’ll try the gluten challenge again. We have gone through an elimination diet with him to be certain that it is in fact gluten and not another food that he is reacting to, and the results were the same.

As it stands today, my son’s physical reaction to even the smallest amount of gluten consumption causes symptoms that include rashes, sinus issues, stomach pains, mood swings, lethargy, and diarrhea. They last for almost two weeks, put him in a considerable amount of pain, and embarrass him when he has trouble controlling his bowels. He’s starting school this year. I don’t want him missing days because he has accidentally eaten something that contains gluten. I never want my son to experience these symptoms again, so I am extremely careful about what I purchase or allow to be brought into my home.

But purchasing gluten free food in the United States hasn’t been easy for consumers.  It’s not that there’s a shortage of goods labeled gluten free.  The problem has been that seeing “gluten free” on a product wasn’t a guarantee that the product was actually gluten free.  There was no standard defining “gluten free.” Any company could claim a product was gluten free without actually testing for the presence of gluten, making some products that were labeled as such unsafe for someone with Celiac disease or gluten intolerance to consume.

I experienced this firsthand when I made my son a dish using breadcrumbs that were gluten free, but had been produced in a facility that also produced items containing wheat. While the breadcrumbs were made with gluten free flour, the cross-contamination from the machines added gluten to the product. My son was sick for two weeks, unable to attend daycare or even leave the house without a diaper.

This is why I am excited about the FDA’s recent decision to set guidelines for gluten free labeling. According to the new definition, a product must contain less than 20 parts per million (20ppm) of gluten to be able to be called gluten free. The 20ppm rule is on par with the standards in many countries around the world, including the European Union and Canada, although is not as strict as the regulations in New Zealand or Australia. The FDA states that they chose that level because current scientific technology that can detect levels lower than 20ppm is not reliable enough to be used as the standard. Furthermore, many researchers claim that for most people with Celiac disease, ingesting up to 20ppm of gluten is not enough to cause adverse health effects.

On a Gluten-Free Diet - 2012
On a Gluten-Free Diet – 2012

According to the new guidelines, a product must meet one of three criteria before it can be labeled gluten free in the United States. The product must either be inherently gluten free, or not be made with gluten containing grains that have not been processed to remove gluten. If a grain that contains gluten has been processed to remove the gluten, the detectable amount must be under 20ppm. Finally, any product with an unavoidable presence of gluten must test less than 20ppm. However, the regulation does not apply to all products. Notably exempt is alcohol, so for example, beer claiming to be gluten free does not fall under the new regulation. Also important to note is that labels don’t have to reflect the new standards for another year, so products on shelves today may not yet adhere to the new labeling standards.

The rules are not perfect, and there is much debate about whether 20ppm is an acceptable threshold. I understand the argument that “gluten free” should mean no gluten is present in a product, period. There is logic to the argument that if someone consumes several products with low, but still detectable amounts of gluten over a short period of time, they may actually be consuming unsafe amounts of gluten overall, all under the guise of “gluten free.”

While I don’t disagree with this, I still believe the new rules are a good thing and a big step forward. Knowledge is power, and with the new guidelines the consumer at least has the assurance that the product labeled gluten free has been tested and complies with the maximum levels of gluten allowed. Just like with any product, consumers are free to choose not to buy packaged goods that claim to be gluten free, and focus on foods that are naturally gluten free. My personal stance lies somewhere in the middle.

I don’t often purchase packaged or processed food for my son, but I do like to know that when I choose to buy him any such product, I can be assured that what I’m buying has less than 20ppm. I understand that there may still be small amounts of gluten in the product, and I make a decision whether to purchase an item or not based on the information I have and what I know about my son.

Of course, I don’t view the new FDA ruling as a signal that it’s okay to start purchasing processed gluten free foods. The fundamentals of a healthy gluten free diet remain the same, but the regulations make it easier for those who choose to purchase foods labeled gluten free to do so with confidence.

Kathleen Sperduti
Kathleen Sperduti

Kathleen Sperduti is the mother of a gluten free little boy who starts kindergarten this fall. She blogs at Celiac Baby! where she offers tips, recipes, menu plans, travel advice, and product reviews for living life gluten free. Visit her at

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