Gluten-Free Labeling Rules Finally Head To The White House

After like a million petitions gluten free labeling is finally headed to the White House 🙂

“New rules dictating what foods can be labeled “gluten free” have arrived at the White House for final review, according to federal records. 

The Food and Drug Administration (FDA) has been working on the labeling requirements for gluten-free foods since 2005. The regulation has been named “economically significant,” meaning it has a cost of $100 million or more on the economy.

On Monday, the rule headed to the White House’s Office of Information and Regulatory Affairs (OIRA), which it will need to pass through before being enacted.” –

How Is The FDA Proposing To Define The Term “Gluten-Free”?

FDA proposes to define the term “gluten-free” to mean that a food bearing this claim in its labeling does not contain any one of the following:

*An ingredient that is a prohibited grain

*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, if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food or 20 ppm or more gluten

What Is The FDA’s Proposed Definition For “Prohibited Grain”?

FDA is proposing to define the term “prohibited grain” to mean any one of the following grains:

*Wheat, meaning any species belonging to the genus Triticum

*Rye, meaning any species belonging to the genus Secale

*Barley, meaning any species belonging to the genus Hordeum

*Crossbred hybrids of wheat, rye or barley (e.g., triticale, which is a cross between wheat and rye)

Will Foods That Meet The Definition For “Gluten-Free” Be Required To Bear A “Gluten-Free” Claim?

No. FDA is proposing to define the term “gluten-free” for voluntary use in the labeling of foods. In other words, once a final federal definition of the term is in effect, if a manufacturer wishes to label his product as “gluten-free,” it may do so at its own discretion, but only if the food bearing the label meets the proposed regulatory definition.

Alessio Fasano, M.D. Explains The Reasoning Behind The 20 Parts Per Million Threshold

3:02 “Gluten free products have been consumed for decades and decades with no clear evidence of harm” – Alessio Fasano, M.D.

3:18 “Thresholds of twenty parts per million are safe for the vast majority of individuals” – Alessio Fasano, M.D.

4:35 “Is it true that 20 ppm is safe for everybody? Of course not because as usual in human biology there is always the exception” – Alessio Fasano, M.D.

4:54 “To put this in a context, our studies demonstrated that You need to eat more than a pound of gluten free products cross contaminated with 20 parts per million a day to have some side effects” – Alessio Fasano, M.D.

Original image source:

Is 20 Parts Per Million Low Enough?

5:20 “Why then we don’t go to 5 parts per million, where maybe most of the products may eventually satisfy the criteria, because thats too risky it doesnt give any flexibiliy to the producers of the marginal error that is intrinsic in the assay the assay is not perfect it has a 20-30% margin error so what an assay can test safe today may not be safe the next day of the same product. – Alessio Fasano, M.D.

5:30 “Let me make an example, lets say that producers ”X” put on the market a gluten free brownie that has 3 parts per million so it tests safe today, the same product can test 7 ppm tomorrow due to just the variability of the assay and not because there has been an increase in gluten in this product” – Alessio Fasano, M.D.

What About Oats?

FDA did not include oats as one of the “prohibited grains” in its proposed definition of the term “gluten free” for the following reasons:

*There is no consensus among nutrition experts or authorities on the unconditional exclusion of oats from the diet of individuals with celiac disease. For example, the following celiac disease experts/authorities do not support the unconditional exclusion of oats: The National Institutes of Health, the American Dietetic Association, and some celiac disease research/treatment centers.

*Research data suggest that the majority of individuals with celiac disease can tolerate a daily intake of a limited amount (e.g., 50 grams) of oats that are free of gluten from wheat, rye, barley or their crossbred hybrids.

*Oats are reported to add variety, taste, satiety, dietary fiber, and other essential nutrients to the diet of individuals with celiac disease and may make their diet more appealing.

*Allowing oats free of gluten from wheat, rye, barley or their crossbred hybrids, to bear a “gluten-free” labeling claim would make it easier for consumers to identify such oats in the marketplace and may serve as an incentive for more manufacturers to produce such oats.

Source: FDA

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