Gluten Free & More

GF&M: The issue has been raised that how researchers tested for gluten-both the method and the laboratory used-could have affected results. How important are these testing details? Tricia Thompson: There's no established protocol for testing gluten in foods-and supplements fall under broad category of foods. I don't know if a lot of people understand that. There are a wide variety of tests and, unfortunately, they're not all equal. Some manufacturers use testing that's outdated, in my opinion. The FDA doesn't require manufacturers to test products they label gluten-free-that goes for foods and supplements. Since it doesn't require testing, FDA also doesn't provide manufacturers with any guidelines about testing. FDA says only which tests it will use the--sandwich R5 ELISA and the Morinaga wheat protein ELISA. Testing is very technical and can be tricky to understand but I think it's important to try to explain. The sandwich R5 ELISA can't detect gluten that's been hydrolyzed or broken down. Probiotics contain ingredients that are hydrolyzed, so the sandwich assay won't work. For probiotics, you need to use what's called the competitive R5 ELISA. This assay is able to detect gluten fragments. But FDA doesn't recognize this test for quantifying ppm of gluten. The same may be true for the method the Columbia research team used, which is called mass spectrometry. So we're a bit stuck because when you're testing products like probiotics that contain hydrolyzed ingredients, the sandwich R5 ELISA doesn't perform well. Whether the FDA will act on findings resulting from mass spectrometry or the competitive R5 ELISA is questionable. In addition to which test is used, results are affected by how a food or supplement sample is extracted, prepared and mixed. So, as you can see, testing is very complex. GF&M: By drawing attention to trace levels of gluten, the study seems to call into question the 20 ppm threshold. Should we be rethinking this level? Tricia Thompson: Let's step back a bit. I don't think this study should have us rethinking it. That said, we do have a validated assay in the sandwich R5 ELISA that has a lower limit of quantification of 5 ppm, so we can quantify gluten at that lower level. From testing we've done at Gluten-Free Watchdog, we know that the vast majority of manufacturers can and are producing products that test at or below 5 ppm. One of the reasons FDA set the 20 ppm threshold was over concern that manufacturers may have difficulty complying with lower levels and this would result in decreased availability of gluten-free foods. But clearly, that's not been the case. GF&M: It's been suggested that taking multiple capsules per day of a probiotic containing trace amounts of gluten could cause a problem for celiacs. Does this differ from eating multiple servings of bread or cereal that each contains traces of gluten? Tricia Thompson: 20 ppm is a proportion. You can look at 20 ppm as being the same as 20 milligrams in one kilogram--or 2.2 pounds of food. So if you eat one ounce of a food that contains just under 20 ppm gluten, you've eaten a little over a milligram of gluten. But keep in mind you have to eat the entire ounce. It's easy to eat an ounce of cereal or bread-typically we eat multiple ounces of these foods at once. But how many probiotics does it take to equal one ounce? I'm not sure but it's a lot. So the amount you eat matters. You're going to get a lot more gluten from gluten-free cereal, muffin or pasta that contains close to 20 ppm versus a probiotic that contains close to 20 ppm, simply because of the difference in the amounts eaten. GF&M: This study gets at the issue of trust. In the U.S., can we trust a gluten-free label? Tricia Thompson: I've been running the food-testing service, Gluten-Free Watchdog, for four years now. At the three-year point, we published data that showed 95 percent of gluten-free products tested below 20 ppm gluten and 87 percent tested below 5 ppm. Is it the case that all 100 percent should test below 20 ppm gluten? Yes. But 95 percent is pretty good. And we've found there tends to be defined group of reasons the products test high. For example, manufacturers unaware of gluten contamination issues with oats. It is rarely the case that the manufacturer is intentionally being lax. GF&M: What steps can consumers take to help ensure their probiotics are gluten-free? Tricia Thompson: First of all, any consumer with a gluten-related disorder should only be using probiotics labeled gluten-free. If they have concerns, they should contact the manufacturer and ask the following: (1) Are any of the bacterial strains in your product grown on a gluten-containing medium like wheat or barley? I don't want to alarm anyone but sometimes gluten-containing grains are used in the growth media. (2) If the answer is yes, ask about testing protocols. The manufacturer should be testing with the competitive R5 ELISA since gluten contamination in a probiotic will likely be hydrolyzed. (3) Ask if they run a "spike recovery" to make sure nothing in that bacteria is interfering with gluten detection. It can be difficult to get a straight answer from a manufacturer's helpline. It's probably not because they don't want to provide the info but because the representative simply doesn't know. You can always reach out to Gluten-Free Watchdog, (glutenfreewatchdog.com) for help. GF&M: At Gluten-Free Watchdog, will you be testing probiotics? Tricia Thompson: Yes. We'll either be testing just a few as part of our regular weekly testing or, because of all the interest in probiotics, we may do more extensive testing-ideally 20 gluten-free probiotic brands. Unfortunately, we don't have enough money in the coffers for this extensive testing. So we've reached out to the gluten-free community for pledges to help fund this. We need additional support to take this on. GF&M: Do you provide brand names? Tricia Thompson: Yes, Gluten-Free Watchdog provides the subscribers with the names of products tested and exact testing results. As far as the larger gluten-free community, we'll release a general statement as to the levels that we found and more background information as to why we think we're seeing what we're seeing. Gluten Free & More magazine will be covering this topic in more detail in an upcoming issue. For more about Gluten-Free Watchdog, visit glutenfreewatchdog.com.