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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.
7 comments (Comments are now closed)
How can zero ppm of gluten be enforced?
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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Posted by aklap
07 August 2011 | 04h26
Gluten Free should mean be completely free of ALL gluten
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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Posted by Affected Family
05 August 2011 | 22h49
20ppm
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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Posted by Concerned Dad
05 August 2011 | 21h25
Gluten is Gluten, in any amount
I'm gluten intolerant and any speck of gluten ingested sets my body into reaction mode. It isn't fun; rashes, acne, lethargy, and the list gets grosser and goes on and on. And it isn't just a few hours, it takes up to two weeks for my system to balance out again. Any trace of gluten and I react.
While I respect that the FDA wants to create a guideline to make it easy for manufacturers to mass produce gluten-free foods, I also imagine manufacturers would like customers to keep buying their food. As someone who reacts to any amount of gluten, I know that when I try a product and I react, I strike it from my purchase list immediately and I share my reaction and negative experience with the product to anyone and everyone I know.
I hope the FDA works quickly to create stringent guidelines that take into account the needs of gluten-free eaters first. This gluten-free change in the way we eat isn't going away, it isn't a fad, it is growing, and we all deserve to live and thrive with happy tummys.
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Posted by Marisa Voorhees, The Food-Sensitive Foodie
05 August 2011 | 17h20
FDA Action on Gluten- labeling
May daughter and I discovered 8 years ago that we both had Celiac Disease. If my daughter consumes the slightest bit of gluten, the following day she has several, painful mouth sores that can take up to 2 weeks to heal. If a friend of mine who also has CD consumes a tiny bit, she instantly has to vomit. All this to say is I don't believe the FDA should allow any gluten...not even a tiny bit...to be labeled gluten-free. If some products have a small amount and are allowed to be labeled gluten free, it could lead to us consuming many products in one day with just a little bit of gluten, adding up to a lot of gluten at the end of the day. The regulation should be ZERO gluten in order to be labeled gluten free. If the manufacturer isn't sure of how little gluten there is in their products, then it should not be labeled gluten free. Check the stats..Some people are more sensitive than others and in some cases (and you can check this out) 1/8th of a teaspoon can cause enough damage to take 6 months to heal. So, just a little is far from safe. Thank you for taking this very seriously. We suffer alot trying to adere to a gluten free diet. This is not easy and if our foods are going to poison us because there is "only a little" bit of gluten, then many, many, many people are going to suffer.
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Posted by Barbara B.
05 August 2011 | 04h45
Disclousure is so important
The problem with the 1 in 133 statistic is that so many more suffer without being able to identify gluten as the problem. On top of that so many doctors are unwilling to see that gluten intolerance is just as serious as Celiac Disease.
We also should consider those who are only allergic to wheat, they would benefit greatly if food and drug manufacturers had guidelines and mandates to disclose whether or not their products contain wheat and other gluten products.
I wish the FDA would stop dragging their feet and get this done already.
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Posted by Joy
05 August 2011 | 04h44
Gluten amounts
I am gluten intolerant and suffer all day long if I ingest gluten. I am loosing two days each week if I am not completely careful. I also have become lactose intolerant caused by my gluten problem. Further, I am allergic to sulfites and sulfates, and it seems to me that processed foods are the major problem all the way around. The big guys who make processed foods are making products that are killing us. I believe pasturized milk is another problem over time. Please note.
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Posted by Elaine Maes
03 August 2011 | 23h53
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