FDA reopens comments on gluten-free labeling

By Caroline Scott-Thomas

- Last updated on GMT

Related tags: Gluten-free foods, Gluten-free diet, Coeliac disease, Wheat

FDA reopens comments on gluten-free labeling
The Food and Drug Administration (FDA) has reopened comments on its proposed thresholds for gluten traces in products labeled as gluten free – four years after it originally proposed the guidelines.

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.

Deputy commissioner for foods Michael Taylor said: “Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance. We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”

In a conference call on Tuesday, celiac expert Dr. Alessio Fasano of the Center for Celiac Research at University of Maryland said he considered that the 20ppm threshold would be a safe level for those with celiac disease. The FDA also said that it would make available the scientific research indicating the safety of the 20ppm threshold on its website.

The proposed rule is also in line with international regulation on labeling thresholds for gluten in gluten-free foods. 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 also 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 United States suffers from celiac disease, an autoimmune disorder with symptoms triggered by consumption of gluten, the protein found in wheat, rye, barley and spelt – yet only around 40,000 to 60,000 Americans have been diagnosed.

The move to reopen the proposal for comments comes just weeks after two US Senators, Ron Wyden (D-OR) and Patrick Leahy (D-VT), sent a letter to FDA commissioner Margaret Hamburg urging prompt action on gluten-free labeling laws and an explanation for the delay.

Comments and suggestions about gluten-free labeling can be made online at www.regulations.gov​, citing docket number FDA-2005-N-0404.

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7 comments

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How can zero ppm of gluten be enforced?

Posted by aklap,

Current testing technology will only detect down to 5 ppm. If testing can not go to zero, how would the FDA enforce a zero ppm rule?

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Gluten Free should mean be completely free of ALL gluten

Posted by Affected Family,

My whole family is terribly affected by any amount of gluten no matter how small. Any amount ingested causes terrible reactions such as; lethargy,acne,rashes,nausea, and I shall not list the lengthy rest due to personal nature involving the restroom.

It is not acceptable nor truthful to slap a label on anything reading gluten free if it is not. Any amount of gluten should make the label unusable to any product that even contains a very small amount of gluten. 1/2 ppm to 20ppm it is all the same it contains gluten the ppm matters not. For a lot of us not any amount is safe to consume. This label should only be used for our protection.

Because of this "helpful" label my 4 yr old daughter got "gluted" last weekend and was extremely sick the entire weekend! She was staying with her Nana and Nana is very aware of her condition. (In fact Nana along with many others inc medical field helped us figure out she also was intolerant to any amount of gluten). Nana purchased something reading gluten free on "helpful" label. It was not.

Needless to say it ruined her whole weekend with Nana. She is still suffering from reactions. Nana and I are both extremely angry this "helpful" label is on anything that contains even the smallest amount of gluten. Either get the gluten out or remove the label.

We customers who are affected by this have the right to demand if the label says gluten free then the product had better be 100% gluten free. If it isn't then do NOT use the label because our lives and health depend on it. If the label cannot be used truthfully and safely for our protection then do not use it. It is very unhelpful and harmful to us. If no one is protecting us then we cannot afford to buy any more of these products. Take into account first those of us who depend on these labels to protect us. This will never go away or be "cured" no matter how much we want it to. It is actually growing with countless new cases being diagnosed daily!

I am a member of a huge Celiac/gluten intolerant forum group and I always inform others on the reactions that came from what product and then I never buy the product again. They also take note and follow suit.

We protect each other by informing each other about what is going on since we cannot rely on any truth to protect us from this. It is your responsibility to protect us so why are you failing in your responsibility?

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20ppm

Posted by Concerned Dad,

Not being a food scientist, 20ppm is not very meaningful. I know that for my 40+ year old daughter she needs only to ingest a tiny amount of soy sauce as an example to have a reaction. What is the ppm of wheat/gluten in 5 grams of soy sauce?

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