I have put off writing this post for over a month because my thoughts and opinions on the matter have not been clear. I have concluded that there is no easy answer, but I believe that you all need to be aware of what is going on with labeling, so I will attempt to present the information to you.
Thanks to the efforts of 1in133.org, the Food and Drug Administration (FDA) is moving forward on establishing a law for the use of the term”gluten free” on labels. As part of this effort, the FDA has opened the comment period on their proposal. That comment period ends October 3rd. You can find information about how to comment near the end of this post.
The Proposed Level of Less Than 20 Parts Per Million (ppm) Gluten
For some time now I have not been happy with the proposed level of less than 20 ppm of gluten being allowed in products labeled as gluten free. I fully understand that zero gluten is not only impossible to test for, but it is essentially impossible to attain in processed foods. There is too much gluten in this world, and some degree of contamination is going to happen during manufacturing, processing, and/or transportation.
It is my understanding that the European standard has been 20 ppm since 2008. Other countries, in particular Australia and New Zealand, require no detectable gluten.
I am not convinced that 20 ppm is safe for people with celiac disease. The problem is that there have not been enough studies done on this topic. One study done by the Center for Celiac Research only included 13 people and lasted only three months. While not insignificant, that is a pretty small and short study. I would like to see more extensive studies done.
I have to be honest and say that my main concern over the 20 ppm standard is not scientifically based, but rather based on experiences. Some people might scoff at that, but when you are a sensitive celiac, it is frustrating when people don’t take you seriously. Most people who are sensitive know when they have ingested gluten because the symptoms are distinct from symptoms that they get from other food intolerances or viruses.
For years I was a very sensitive celiac. Now I am more sensitive than some, but not as sensitive as others, and definitely not as sensitive as I used to be. However, I have always heard and read that we cannot base what is okay for us to eat on our symptoms because some people with celiac have no immediate symptoms from ingesting gluten. So even though I am less sensitive, I try to be just as careful as I was previously.
Now I have a son who is gluten free, and although he tested negative for celiac, he is just as sensitive to gluten as I used to be. I have tried products that are tested to the proposed 20 ppm and he reacts to them. Sometimes I get mild reactions too. Products that are tested to 10 ppm, he seems to do okay with. I know of other individuals who are the same.
So yes, my distrust of 20 ppm is based on personal experience and the experiences of others I know and read about. One of my concerns is that there are people who are not “sensitive” in terms of outward reactions who are reacting internally (villi damage) to these same products that some people show outward reactions to. I’m simply not convinced that 20 ppm is safe.
Despite my opinion on the proposed standard, I was prepared to support it simply because it is better than no law at all. It is a starting place, but then the FDA opened the comment period which gives me an opportunity to say what I really think. They also released a safety assessment….
The FDA Safety Assessment
The FDA released a Safety Assessment. It is a very long report which I cannot summarize here. I will quote one statement from page 46 (CD=celiac disease GFD=gluten free diet):
“In sum, these findings indicate that a less than 1 ppm level of gluten in foods is the level of exposure for individuals with CD on a GFD that protects the most sensitive individuals with CD and thus, also protects the most number of individuals with CD from experiencing any detrimental health effects from extended to long-term exposure to gluten.”
You read that correctly. The FDA found that based on studies that have been conducted, a level of 1 ppm protects the most number of people with celiac disease.
If you are interested, you can also read an external peer review of the safety assessment.
Safety-Based Approach vs. Analytical Method Approach
Basically, the FDA has two ways of approaching how they set the standard for gluten-free labeling. The safety-based approach would mean recommending a level based on the lowest amount of gluten considered toxic. The analytical method approach would be based on the sensitivity of testing methods. So, even though 1 ppm may protect the most number of people, there are no tests available that can reliably test foods to 1 ppm.
The FDA is proposing to use the analytical method approach. You can read more about their concerns regarding a very low threshold in the next section.
Doctors in the celiac community, including Dr. Fasano and Dr. Guandalini support the analytical method approach. You can find out more at 1in133.org: What the Experts Are Saying About FDA’s Labeling Proposal.
Personally, I don’t have a problem with using the analytical method approach. Setting a limit that can’t be tested makes no sense. However, I don’t believe that limit has to be 20 ppm. There are certification programs that test to 5 ppm and 10 ppm, so I believe it is possible to test to a level lower than 20 ppm. However, the FDA states:
“At the current time, FDA is not aware of any analytical methods that have been validated to reliably and consistently detect gluten below 20 ppm.”
Regarding two testing methods (the FDA recommends the ELISA method), the Gluten-Free Certification Program which tests to 10 ppm has this to say on their FAQ page:
“Research to be published shortly suggests that both ELISA and Skerritt may have weaknesses that can be complimented by using both methods. We feel that by using both methods, we are able to more accurately assure GF status.”
I understand that the FDA would want to use a method of testing that they are sure about. I would like to see them look into it further, though.
The Federal Register – Proposed Rules
You can read the Federal Register dated August 3, 2011. In it, the FDA states,
“To the extent it is possible to do so and protect public health, we believe that we should set a gluten threshold level for ‘‘gluten free’’ labeling that best assists most individuals with celiac disease in adhering life-long to a ‘‘gluten-free’’ diet without causing adverse health consequences.”
“Most individuals” is a key phrase. It sounds like they have decided that protecting everyone, including the most sensitive people, is just not realistic nor beneficial overall, and I’m not necessarily arguing that point.
The FDA has proposed that the term “gluten-free” would mean that the food does not contain:
- “an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains”
- “an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten”
- “an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 ppm or more gluten in the food”
- 20 ppm or more gluten
- In the Federal Register, the FDA lists concerns they have about setting a threshold that is much lower than 20 ppm. Their concerns include:
- Some manufacturers might discontinue labeling their products as gluten free because they could not meet the lower level.
- Other companies might be discouraged from producing foods labeled gluten free for the same reason.
- There could be a significant increase in the cost of gluten-free foods.
- It could negatively affect the trade of gluten free foods and therefore affect the availability of gluten free foods.
Dr. Fasano addresses these issues in his article In Defense of 20 Parts Per Million and in this video (in case you’re tired of reading). One important point that Dr. Fasano makes is that there is a margin of error for the tests that are done to determine the level of gluten in a food. If the threshold is very low, then a product might be under that threshold one day, but the exact same product could test higher the next day and be over the threshold.
Australia and New Zealand have two terms they use on foods, “gluten free” and “low gluten.” While “gluten free” means no detectable gluten, “low gluten” means less than 200 ppm. The FDA would like comments regarding the use of the term “low gluten” in the US, both whether the term should be used and if so, what the threshold should be.
The general consensus from what I have read is that a “low gluten” label would not be helpful and would likely cause confusion.
How Will I Comment?
As I said a the beginning, I don’t think there is an easy answer to this. I understand the reasons for going with an analytical method approach, and I understand the reasons for not wanting to set a threshold that is extremely low.
However, because I feel that 20 ppm may be too high, I will communicate that my preference is to set the threshold at 10 ppm. I don’t believe that level is as restrictive as 5 ppm would be, but it would provide a higher degree of safety. I understand that would be contingent upon a testing method or methods that are accurate. Even if they decide to go with 20 ppm at this point, I hope they would consider a lower level in the future if better testing or more information about testing becomes available.
Regarding how that will affect the importing of gluten-free foods, it seems to me that there are many companies here in the US who produce gluten-free foods, and the number seems to be growing all the time.
I will also let the FDA know that I do not support a “low gluten” category for foods.
In addition, if you read through the Federal Register, there are a number of points on which the FDA wants comments. I will comment of some of these, but will not take the time to spell is all out here. While there is an option below to sign a pre-written comment, I think you should at least read through the Federal Register yourself and then consider leaving your own comment.
How You Can Comment
The FDA wants to hear from you! Please let them know what you think and why. You can find complete commenting information in the Federal Register. To comment online, go to regulations.gov then:
1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”
Another option is to electronically sign a comment written by the American Celiac Disease Alliance. If nothing else, it may be helpful to you to read their comment.