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Nearly All Tested Gluten-Free Food Products Meet FDA Standards

A new compliance survey shows over 99 percent of gluten-free foods meet FDA standards.

A new FDA compliance survey shows over 99 percent of gluten-free foods meet FDA standards. Photo: CC--a.mina 07/10/2017 - For anyone with celiac disease or gluten intolerance who was wondering how well food manufacturers are complying with FDA standard for gluten-free labeling, or wondering exactly how gluten-free is my gluten-free food, some early answers are in, and the news looks good.

A recent report by the agency indicates that the vast majority of food manufacturers are getting it right, and, correcting where they do get it wrong.

The FDA's final rule for compliance in gluten-free labeling was August 5, 2014. To gauge compliance in gluten-free food labeling, the agency conducted a sampling assignment of products labeled "gluten free" from July 2015 to August 2016.

The compliance testing is an important part of the FDA's mission to ensure that products labeled on or after the compliance date are properly labeled as "gluten-free."

In all, the agency's team analyzed more than 250 types of products, and tested 702 individual samples in the categories of cereals, grain bars, and flours.

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Their complete survey showed that just five samples from one product source contained gluten in excess of the regulatory limit of 20 parts per million (ppm). That left the overall gluten-free product-based compliance rate above 99.5 percent.

The good news here is that producers major gluten-free food products are doing a very good job of following FDA labeling standards. Also, the manufacturer of the samples that showed gluten levels above 20 ppm carried out a voluntary recall, conducted an extensive root cause analysis, and immediately implemented additional corrective actions to prevent recurrence.

Follow-up testing by the FDA showed acceptable levels of gluten.

This is the first hard data the FDA has gathered regarding compliance with gluten-free labeling standards. To see such high levels of compliance and responsiveness by manufacturers is encouraging.

Read the Analytical Results of FY2015/16 Gluten-Free Food Product Sampling. SOURCE: welcomes your comments below (registration is NOT required).

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4 Responses:

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said this on
11 Jul 2017 1:48:02 PM PST
I am very glad to hear this. My concern prior to the FDA ruling of 20 ppm on 8-5-14 effective date was that some companies were not consistent or confused. The label standard 20ppm appeared to give it some needed clarity. The companies who were founded by celiacs or had relatives or employees that were celiac seemed to grasp the importance prior to 8-5-14. I'm glad to hear they are testing and keeping watch that there is compliance with the labeling standards, that more companies understand and are taking the proper GMP' s, testing , and food industry guidelines that GF requires.

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said this on
18 Jul 2017 3:29:16 AM PST
This headline is very misleading. It implies that 99% of the gluten free products on the shelves are safely below the 20ppm standard. But this is total lie. The only thing that this “study” shows is that OF THE LIMITED LIST of products TESTED, 99% of them are actually within the legal definition of gluten free. That cannot be extrapolated to ALL PRODUCTS. What actions has the FDA taken against those who produce products that are above the standard? They are the ones with the power to ensure that this legal definition of gluten free is followed. What has the FDA done to ensure that 100% of products labeled gluten free are within the standard? Just testing them does nothing to keep celiacs safe from harm. What difference does it make to anyone that most products are within the legal standard? If the one dangerous products is being used by people, then they are getting sick and having their bodies damaged in a very serious way. That damage leads to starvation and cancer and death. Gluten Free Watchdog has evidence of products that are well about the standard. When they contacted the FDA, the report was ignored. 7 months later one dangerous product is still allowed to be marketed with the gluten free label and the dangerously high PPM. Then we have General Mills who advertises that their products are safe for celiacs. Yet, their testing process is very flawed. And people are still being made very ill by their gluten free oat four. This is very disappointing. I expected this site to be helpful to celiacs. Apparently, the news here is just more sensationalism.

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said this on
18 Jul 2017 11:21:12 AM PST
We are just reporting an FDA press release that is relevant to our readers.

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said this on
19 Jul 2017 7:23:33 AM PST
I agree with your assessment. I remember seeing the 4 to 5-foot amber waves of grain waving in the wind. Modern wheat differs from its origins as the result of intense cross-breeding (hybridization) programs. "The crops are neither physically nor genetically like its old self." Modern wheat (grown in 99 percent of the world’s wheat fields) is dubbed "dwarf wheat." The FDA was made aware of the changes in the wheat gluten content, but did not require further research regarding the effects of gluten protein increase on humans. Modern wheat exceeds the 1960's content by 17 times. I ate wheat, barely and rye for over half- a-decade before the 2008 variation hit the grocery shelves. Modern wheat is an assault on the health of many thousands of people. Celiac enteritis, celiac encephalopathy, celiac steatorrhea, gluten-sensitive enteropathy, celiac related dermatitis hepetiformis, and gluten ataxia are a few of the modern wheat era diseases that are captured by the W.H.O. Most of the above disease listing are NEW disease occurrences that have been added to the disease reporting statistics. An estimated 1% of the world population has celiac disease alone. Keep in mind, that for many persons, it takes up to 14 years from the start of symptomology to receive a confirmed diagnosis. Physicians now consider “modern wheat” as exacerbating: fibromyalgia, irritable bowel syndrome, dementia, rheumatoid arthritis and diabetes. Think back for a moment. When did your first heart of the term: gluten? When did you first hear the news media attack on: gluten? When did you first hear comedian jokes and advertisements poking fun at persons who did not consume gluten?

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