Senators urge FDA action on gluten-free labeling

By Caroline Scott-Thomas

- Last updated on GMT

Related tags Wheat Coeliac disease

Senators urge FDA action on gluten-free labeling
Two US Senators have sent a letter to the Food and Drug Administration (FDA) urging prompt action on gluten-free labeling laws, after a proposed rule on tolerable gluten thresholds for gluten-free foods has languished for more than four years.

Defining a tolerable threshold level for gluten presence in gluten-free foods was included as part of the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. In 2007, the FDA proposed that gluten should be labeled at anything over 20mg per kg (20ppm); foods labeled gluten-free containing more than this amount would be considered misbranded. Many companies are already voluntarily using this standard, but the rule has yet to be finalized.

U.S. Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) sent their letter to FDA Commissioner Dr. Margaret Hamburg asking for an explanation for the delay.

They wrote: “We ask that you provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation.”

Greater awareness of celiac disease – an autoimmune disorder with symptoms triggered by consumption of gluten, a protein found in wheat, rye, barley and spelt – has led to more people being diagnosed, and the only treatment currently available is complete avoidance of gluten.

The introduction of FALCPA labeling regulations mandating the labeling of gluten aimed to make this easier for those with gluten sensitivity, but research​ has suggested that consumers are confused by the wide variety of advisory labels as organizations have developed their own standards.

“The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of ‘gluten free’ standards and labels provided by 3rd party groups. This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be.” ​Senators Wyden and Leahy wrote.

Most recently, Quality Assurance International (QAI) and the healthcare nonprofit National Foundation for Celiac Awareness (NFCA) created a “Certified Gluten-Free” label with a tolerable upper threshold of 10ppm. The organizations released the certification scheme last month, and claim that it is independent and science-based, verified through inspections and product testing.

In Europe, the Codex Commission approved 20ppm as an accepted threshold for gluten in 'gluten-free' products in 2008, in the first update to guidelines since 1983. The limit was hugely cut from 200ppm to 20ppm – and it claims this level is considered to pose no risk to celiac sufferers. It said that the reason for the change is that low levels are more easily attainable than 25 years ago due to technological advances allowing for more accurate detection of minute gluten traces.

The US government estimates that around one in 133 people in the country suffer from celiac disease, yet only around 40,000 to 60,000 Americans have been diagnosed.

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Author response

Posted by Caroline Scott-Thomas,

@Meran ni Cuill
Thank you for your comment. When there are more up-to-date statistics available, I would certainly be interested in seeing them. Right now, however, the official government estimate is one in 133. It's also the figure cited by the Celiac Disease Foundation.

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Number of sufferers is not correct for our times

Posted by Meran ni Cuill,

"1 in 133"? That number is from a 1948 study. New numbers will be coming in, more to the tune of 1 in 30. And that doesn't count the gluten sensitive either.
please do more research before touting numbers.

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FDA Definition of Gluten free

Posted by Barbara B,

The FDA is trying come up with an amount of gluten that is acceptable to be listed as gluten free. My concern is, if I should consume that product that has even a littel gluten...which has been labeled gluten free because the FDA deems it safe, what if I consume that product 3 times every day because I'm getting the meessage that it's OK? Add up that little amount of gluten. Anyone with Celiac Disease will know it is NOT gluten free. I would suggest that if the manufacturer "thinks" there's just a little bit of gluten, then they should not be allowed to put gluten free on their labels. Gluten free means NO GLUTEN...not even a little bit. Let's see who the FDA caters to on this issue. Probably like they do with the drug's more about money than health these days with the FDA!!

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