Review of Delaying the FDA Gluten Free Final Rule

The FDA gluten free final rule is set to go into effect August 5, 2014. United States offices reviewed the financial impact. Learn the Final Regulatory Impact Analysis and the Regulatory Flexibility Analysis.

Currently, there are approximately 5% (or 1,096) products that are labeled gluten free that do not meet the FDA gluten free final rule. The FDA estimates that approximately 19,000 individuals diagnosed with celiac disease consume these foods on a daily basis. Each one of these individual are at risk of consuming 50 mg of gluten daily.

FDA Department of Health & Human Services Logo Used for Review of Gluten Free Final Rule

In August 2013, the FDA issued their final gluten free labeling rule which is scheduled to go into effect next month. It is the job of all United States agencies to take into account any rules that will effect small businesses. The FDA Department of Health & Human Services along with [their?] Economics Staff, Office of Regulatory Policy and Social Sciences, and the Center for Food Safety and Applied Nutrition, issued a new document that was recently published, Final Regulatory Impact Analysis Regulatory Flexibility Analysis.

One of the items considered was whether or not it would be beneficial if the August 5, 2014 compliance date was changed to January 1, 2016. They estimated that it would save manufacturers a combined 1.5 million dollars if they postpone the implementation of this ruling. In addition, the months they do not have to comply with the ruling, they also save another $8.7 million. The overall net amount saved by manufacturers is estimated to be a total of $14.3 million.

Once they took into account that the additional months that people with celiac disease and gluten intolerance would possibly become ill due to consuming unsafe products, they saw that the delay would cost an additional $165 million. Therefore, they concluded that the final loss of health costs outweighed the expenditures of manufacturers.

They also reviewed many other aspects of the final rule such as banning oats in gluten free products, increasing the 20 parts per million (ppm) requirements, and more. Check them out at

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