NCA Stance on Gluten Free Oats

February 2018

Melinda Dennis, MS, RDN and Tricia Thompson, MS, RDN

Oats have always been a controversial and very complex topic in the gluten-free (GF) community. Many controlled, short and long-term studies of adults and children indicate that GF oats are safe for the majority of patients with celiac disease (CD) and Dermatitis Herpetiformis (skin rash). However, a 2017 research paper that reviewed past GF oat studies concluded the following:

“In conclusion, the results of our systematic review evaluating oat safety in adults and children with CD are reassuring, and suggest that noncontaminated oats are tolerated by the great majority of patients. However, our confidence is limited by the low quality and limited geographic distribution of the data. Current evidence suggests that noncontaminated oats can be used in patients with CD but there is still a need for more rigorous data from well-designed RCTs [randomized controlled trials] evaluating the effect of pure oats in the short and long term, in both children and adult patients with CD. Ideally, relevant information regarding the source of oats, including cultivars and amount of oats consumed and compliance to GF diet should be provided.”1

Nevertheless, oats are a popular and important whole grain food, high in fiber, vitamins and minerals, and they have made their way into the GF diet.  Symptoms from eating GF oats may be due to one or more factors, including cross contamination with gluten containing grains, - a large concern.

Until recently, GF oats have been grown and processed under a purity protocol (dedicated GF oats, field, truck, facility and processing) and tested using best current practices. Beginning in 2013, certain GF grain millers started selling mechanically/optically sorted (method of mechanically separating wheat, barley, and rye from standard commodity oats) GF oats and oat-based products to small and large companies.2

The testing process to determine possible cross contamination is the key to choosing GF oats, regardless of the type of protocol used. In general, gluten-free companies will disclose if they are using purity protocol oats. Otherwise, they may say that their information is proprietary.

NCA is more comfortable with the purity protocol process at this time. NCA is not comfortable recommending General Mills Cheerios or Lucky Charms (both mechanically sorted) at this time. NCA feels comfortable with the use of Quaker GF oats (mechanically sorted) at this time given their transparent and very strong testing protocol.

IF you choose to eat GF oats, check the package for clear labeling that the product is labeled gluten-free. Then, NCA recommends that you assess each manufacturer individually regardless of whether they use purity protocol or mechanically sorted GF oats.

Choose your GF oat products based on your comfort level from the information you receive from the manufacturers. You may want to consider the following:

o          “Does the manufacturer disclose whether they use purity protocol or sorted oats?

o          Do they disclose their testing protocols?

o          Do they disclose the assay [test] they use to test oats for gluten contamination?

o          If a manufacturer refuses to disclose their source(s) of oats, testing protocols, including the assay used for testing or responds to you by saying the information is proprietary, the advice of Gluten Free Watchdog is to move on to another company.”3

You can read about different companies’ testing methods on www.glutenfreewatchdog.org at https://www.glutenfreewatchdog.org/news/gluten-free-oats-video-handout-fnce-digid-breakfast-2016/  to decide for yourself.

Here is a list of companies that use the purity protocol process: https://www.glutenfreewatchdog.org/news/oats-produced-under-a-gluten-free-purity-protocol-listing-of-suppliers-and-manufacturers

The decision to include gluten-free oats should be made on an individual basis only when CD is well controlled and after discussion with a celiac clinician.4-5 Talk to your celiac health care team to introduce ANY TYPE of labeled GF oats.5

NCA calls for ALL suppliers and manufacturers to offer consistently safe oats proven to be GF through rigorous and precise testing, transparent process, and evidence of consistent favorable results of <20ppm gluten.6

The situation with GF oats is constantly evolving and NCA’s position statement will be updated as new information becomes available. For more detail, read the BIDMC Position Statement on Oats below.

References:
1. Pinto Sanchez MI, et al. Safety of adding oats to a gluten-free diet for patients with celiac disease: systematic review and meta-analysis of clinical and observational studies. Gastroenterology. 2017 Aug;153(2):395-409. https://www.ncbi.nlm.nih.gov/pubmed/28431885

  1. Gluten Free Watchdog. https://www.glutenfreewatchdog.org/news/the-gluten-free-oats-situation-why-it-is-such-a-sticky-wicket/. October 30, 2015.
  2. Gluten-Free Watchdog. https://www.glutenfreewatchdog.org/news/gluten-free-watchdog-updated-position-statement-on-oats/. January 13, 2017.
  3. Stance on Gluten-Free Oats. Celiac Center, Beth Israel Deaconess Medical Center., 2017. See below for full statement.
  4. Dennis M, et al. Medical Nutrition Therapy Encounter Process for Celiac Disease. Celiac Disease Toolkit. Chicago, IL: American Dietetic Association, 2011.
  5. North American Society for the Study of Celiac Disease. Summary Statement on Oats. http://www.nasscd.org/files/Oats-Statement-NASSCD-April-2016(1).pdf

***************************

Oats

Celiac Center, Beth Israel Deaconess Medical Center Statement on Oats

May 2016

Oats have always been a controversial and very complex topic in the gluten-free community. They were originally discouraged from use in the gluten-free diet due to mistaken concerns that they were toxic themselves; concerns over issues with contamination came later. Until recently, gluten-free oats that have been grown and processed under a purity protocol (dedicated gluten free oats, field, truck, facility and processing) and tested using best current practices have been the only oats labeled gluten-free and recommended for the gluten-free community.

News of the relatively new mechanically/optically sorted oats methodology and its use by General Mills (Cheerios) and Quaker Oats has been widespread since last year.  In recent months we have come to learn that certain gluten-free grain millers have been mechanically sorting oats and selling them to manufacturers (both large and small companies) of gluten-free oats and oat based products since 2012.1  We have also learned that it is nearly impossible to tell by the food label whether the oats used in a product are grown under a gluten-free purity protocol or are mechanically sorted (per Gluten Watchdog, referenced in the paragraph below) or are a combination of both types.

Although this method of mechanically separating wheat and barley from regular oats is promising, there can be a risk of cross contamination. At this time, it is not clear that the testing measures are sufficiently rigorous to consistently and sufficiently identify gluten contamination in all cases. In addition, different companies are using different testing methods, some more stringent than others.  For this reason, GlutenFreeWatchdog.org, an independent program which performs independent testing on gluten-free foods and provides online results, recommends that each manufacturer using this methodology must be assessed on an individual basis.

We, as clinicians, feel more comfortable with the gluten-free oats grown under the purity protocol process at this time. However, we recognize that some companies may be doing a good job at consistently providing mechanically sorted gluten-free oats. We encourage our patients to look into how the gluten-free oats you may choose to purchase are grown, processed, and tested to confirm that they are indeed gluten-free.  Tricia Thompson of GlutenFreeWatchdog.org has written extensively on this topic. We encourage you to read the information on Glutenfreewatchdog.org about Cheerios, Quakers, and the companies that are using mechanically sorted versus purity protocol oats so that you can determine your own comfort level.  Keep in mind that some companies are using a combination of both purity protocol oats and mechanically sorted oats. Talk to your celiac health care team to help you make an informed decision about what choices may be best for you.

We believe best practices methodology, rigorous and precise testing, and transparency of gluten-free testing data are necessary to ensure the safety of gluten- free oats.2 We are optimistic that the millers and companies using the mechanically sorted oats will come up with a solution to offer consistently safe oats and oat-based products that are proven to be gluten-free, be transparent about their process, and provide evidence of consistent favorable results. We also acknowledge that cross contamination is a concern regardless of the type of oat that is eaten – purity protocol or mechanically sorted. Therefore, rigorous and precise testing is the most important key to determining the safety of gluten-free oats.

Please note: the decision to include gluten free oats in a patient’s gluten-free diet should be discussed first with his/her doctor.2 The anti-TTG antibody should be monitored before and 3-6 months after introducing any gluten-free oat containing product to monitor for celiac disease re-activation. Oats and products containing oats should only be eaten if they are labeled gluten-free.

If you have decided to consume any type of gluten-free oats, please consider the following:

  • Gluten-free oats can add diversity, fiber, and many nutritional benefits to the gluten-free diet and, overall, we find them well tolerated by our patients. However, although gluten-free oats appear to be safe in the vast majority of individuals with celiac disease, there is evidence that, in some individuals, the protein in oats (avenins) can trigger an immune response similar to gluten. Some people may need to avoid oats due to a food allergy to oats.  Others may experience symptoms due to an intolerance to the increase in fiber or due to food intolerances (e.g. Fermentable Oligo-saccharides, Disaccharides, Mono-saccharides and Polyols in oat products).3,4 For these reasons, close monitoring by a healthcare professional experienced in celiac disease/NCGS is recommended during introduction of oats into a gluten-free diet.

  • Currently, we recommend that newly diagnosed patients avoid consumption of oats until it can be clearly demonstrated that their celiac disease is well controlled. Good control is demonstrated by the complete resolution of symptoms (diarrhea, other symptoms of malabsorption or DH skin rash) and a normal tissue transglutaminase level (IgA tTG). At that point, under physician guidance, the gradual addition of uncontaminated labeled gluten-free oats up to 50 grams/day (a little more than ½ cup dry rolled oats or ¼ cup steel cut oats)5 may be attempted. Patients are advised to drink adequate water if they are adding gluten-free oats to their diet since they are high in fiber.

  • Follow-up with the patient’s gastroenterologist should occur within three to six months after the addition of oats into the gluten-free diet.

  • Patients are advised to diligently maintain routine follow-ups with their medical team.

  • Patients with persistent symptoms and/or an elevated anti-TTG antibody level should avoid all gluten-free oats and oat products until these symptoms and/or level have substantially improved and they have followed up with their medical team.

  • Patients who develop new symptoms that seem to correlate with gluten-free oat ingestion should follow up with a physician who is expert in the monitoring of celiac disease/NCGS to determine whether gluten exposure or an alternative diagnosis can account for these symptoms.

  • The Food and Drug Administration (FDA) advises consumers with complaints related to potential gluten contamination from a product to contact MedWatch, the FDA’s Adverse Event Reporting System by phone: 800-332-1088 (choose option #4 to speak to a representative) or online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home. Keep the product’s box or package to report the batch/lot number to the representative.

Even before the Cheerios recall in the fall of 2015, we recognized that some patients were having issues with oats and that there was a need for better data on oat contamination and the safety of oats in celiac disease in the United States. Nearly all clinical trials done to date on this topic are from Europe.

Nothing is risk free.  Cross contamination is always a concern. We hope the gluten-free community will work together to continue to understand and improve the safety of the gluten-free food supply.  We are in favor of methodologies and rigorous testing measures that will ensure the final product consistently guarantees less than 20ppm gluten.  The safety of oats in the gluten-free diet is a constantly evolving, multi-faceted, and complex issue and we look forward to reviewing new data as it arises.

The information on Glutenfreewatchdog.com can help patients stay current on the oats situation in the United States.

NCA Stance on Gluten Free Oats

For a list of companies following the purity protocol as well as comments from several companies using mechanically sorted oats, see: https://www.glutenfreewatchdog.org/news/oats-produced-under-a-gluten-free-purity-protocol-listing-of-suppliers-and-manufacturers/

Update as of May 18, 2016: https://www.glutenfreewatchdog.org/news/gluten-contamination-levels-of-oat-products-labeled-gluten-free-summary-test-results-from-gluten-free-watchdog/

References:

  1. Gluten Free Watchdog. https://www.glutenfreewatchdog.org/news/the-gluten-free-oats-situation-why-it-is-such-a-sticky-wicket/. October 2015.
  2. North American Society for the Study of Celiac Disease. Summary Statement on Oats. http://www.nasscd.org/files/Oats-Statement-NASSCD-April-2016(1).pdf
  3. Lundin KE, et al. Oats induced villous atrophy in coeliac disease. Gut 2003;52:1649-52.
  4. Arentz-Hansen H, et al. The molecular basis for oat intolerance in patients with celiac disease. PLoS Med 2004; Oct;1:84-92.
  5. Dennis M, Kupper CR; Lee AR, Sharrett MK, Thompson T. Medical Nutrition Therapy Encounter Process for Celiac Disease. Celiac Disease Toolkit. Chicago, IL: American Dietetic Association, 2011.