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The notification of a new publication from FDA or USDA rarely elicits eager reading from the food industry, as it is generally about a new rule or guidance document, enforcement issue, or other such directive to be added to the facility’s to-do or don’t-do list of processes. But as is appropriate for this week of Thanksgiving, the food industry can be thankful for thisnotification of some recent kudos from FDA. In an online FDA discussion of the three-year impact of the gluten-free labeling standard, which requires that a food labeled as gluten-free have less than 20 ppm of gluten, it was said that: “the food industry took this seriously and did an exceptional job with the new labels.” (Kudos to you all!) The commendation is borne out by a sampling FDA did earlier in the year which showed nearly 100% of food labeled as gluten-free was indeed gluten free. In fact, in its sampling of products, only one of more than 250 products labeled as gluten-free was considered to be mislabeled, giving the industry a commendable 99.5% compliance rate. And even that is a low tally, because when the product that was found to be out of compliance in the sampling was recalled, subsequent FDA sampling did not find levels of gluten that violated the regulation. Interestingly, the kudos from the non-FDA official in the discussion also extended to the agency for “the fact that the FDA spelled out exactly what was required.” I think that virtually all of us in the industry agree that FDA should be commended when it spells out exactly what is required. While we may balk at new regulations, they are certainly easier to follow when we know exactly what is expected. Such clarity also seems to have an extensive reach, as it was further stated in the discussion that: “Consumers feel much more confident in the products they buy these days. And manufacturers are producing more gluten-free food products than ever before, now that they have clear guidelines that level the playing field for companies producing gluten-free food products.” While there continues to be controversy over the advisability of the singular consumption of gluten-free foods by those who think they are allergic or intolerant or believe it to be a healthy choice, for people with celiac disease, the unknowing consumption of gluten can cause very serious health problems. Because of this, FDA does intend to continue its field staff inspections of products labeled as gluten-free. And, if a label is found to be in violation of requirements, FDA would contact the company, giving them an opportunity to make the appropriate corrections, while working together to recall any mislabeled products on the market. So, to interject one note of caution: be sure you are as careful with your gluten-free products, ingredients, and processes as you are with other allergens, i.e., preventing and testing for any potential cross-contact, ensuring correct label application, etc. Accidental contact and mislabeling – due to mishandling, poor storage practices, equipment sharing without proper cleaning, etc. – are much more frequently the cause of contamination and recalls than are any purposeful actions. As a final thought for the FDA, can we use what we learned from setting gluten thresholds to the setting of other allergen thresholds? I know the food industry would be very happy to have allergen thresholds set to help them better manage risks. We all know this is not a new issue – nor a new request from me. But just maybe, we can put this as a high priority for 2018, to at least get serious about having a discussion on how to set realistic, manageable and public health protective thresholds for other major allergens. In the spirit of Thanksgiving, I wish to commend all my colleagues in the food industry for the care you take in all your food safety processes and practices, and thank you for being a part of the Acheson Group family, even if that’s only by reading and sometimes applying these weekly words of (what I hope you find to be) helpful insight. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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