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Waiting For 'gluten-Free' Label Rules

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Waiting for 'Gluten-Free' LabelRules


Foods labeled"gluten-free" line the shelves of special sections in conventionalgrocery stores and natural food stores alike. But what exactly does this labelmean?

Groups such as the Gluten FreeCertification Organization, the Celiac Sprue Association, the Canadian CeliacAssociation and the National Foundation for Celiac Awareness each suggestdifferent guidelines to establish a gluten threshold level.

The U.S. Food and DrugAdministration (FDA) does not yet have a rule for gluten-free labeling. Itproposed one in 2007 - that foods could be marketed as gluten-free if theycontain less than 20 parts per million (ppm), or 20 milligrams perkilogram of gluten. That's consistent with labeling rules from CodexAlimentarius, which is also used in Europe.

The FDA acknowledges that the term"free" does not necessarily mean that a food contains none of aparticular substance. For example, foods labeled as cholesterol-free foods maycontain up to 2 mg of cholesterol.

Four years have elapsed since FDAproposed its labeling rules for gluten and a decision on whether toaccept them has yet to be made. The agency recently re-opened a60-day comment period - which ended in October - to get new input on theguidelines. Now the food and restaurant industry and those in the celiacand gluten intolerant community anxiously await the agency's decision.

Gluten is found in wheat, barleyand rye and therefore in foods processed using these grains. The proteincomponents of gluten (gliadins and glutelins) can trigger an autoimmunereaction in some people called celiac disease, the most common food-sensitiveintestinal problem. According to the FDA, approximately 1 percent of theAmerican population has the inherited digestive disorder.

For those who can't tolerategluten, it can be hard to know what to trust when it comes to processed foods,or even some medicines or vitamins. If a celiac ingests gluten in a high enoughconcentration, it can cause deterioration of the small intestine when theimmune system attacks the villi lining the small intestine. It can also lead toother digestive problems and malabsorption of nutrients.

Registered Dietitian TriciaThompson from Massachusetts has gotten a lot of questions from consumers aboutthe safety of so-called gluten-free foods. Over time, she says, ithas become harder to justify the 20 ppm threshold - which FDA hassaid is the minimum level at which gluten can be reliably and consistentlydetected - because many manufacturers are already producing foods with glutenamounts well under that level. It's now possible to precisely test amounts asminute as 5 ppm, she notes.

Thompson believes that if the FDAlowers the allowable limit of gluten it shouldn't affect food cost oravailability adversely. While she believes that the less-than 20 ppm glutenlevel is probably safe for the majority of people with celiac disease, shehopes that the FDA will consider lowering the 20 ppm rule - if not to5, perhaps to 10 or 15 ppm to help ease the minds of those who believethey react to very low levels of gluten.

Peter Olins, a PhD biochemist whoruns the website ultimateglutenfree.com,agrees. In his comment on the FDA recommendation, Olins wrote, "Currently,it appears that a level of 5 ppm gluten can be reliably measured, and we see nobenefit in setting a higher threshold."

Olins also thinks an alternative tothe ppm measure would be to instead label the amount of gluten per servingmeasurement. Such a change would increase the number of foods that can beclassified as gluten-free, because of small serving sizes.

"A label such as 20 ppm glutenis really a measure of concentration; however, it seems most likely that thetoxicity of gluten is related to total daily quantity ingested, notconcentration," Olins said in his letter.

He notes that people are alreadyused to measuring calories by individual food servings.

While Thompson can see thereasoning behind this, she fears it could prove to be unworkable formanufacturers. According to her research, different batches of the same foodcan contain different amounts of gluten. If labels gave specific informationabout the amount of gluten per serving, it could not be trusted to be uniformacross batches. Therefore manufacturers would need to produce many differentlabels for their foods.

One issue confusing the glutenlabeling debate is the FDA's own Health HazardAssessment, published in May 2011, which listed TolerableDaily Intake (TDI) values so low that critics say people with celiac diseasewill be afraid to eat. The safety assessment found that TDI for gluten to be0.4 milligrams per day for "adverse effects on the intestinal mucosa"and 0.015 milligrams per day for adverse effects on clinical symptoms.

In a post onThompson's website, she calls many of the TDI estimates"ridiculously low" and notes that based on those numbers, people withceliac disease would have to limit themselves to less than a 1 ounce slice ofbread containing 20 ppm of gluten each day to prevent intestinal damage, andfar less to prevent clinical effects. The FDA also seems to doubt the numbers,and tentatively concluded that "based on the [levels of concern]identified in the safety assessment approach, the Agency should not usethat approach in defining 'gluten-free' because the estimation of risk toindividuals with celiac disease associated with very low exposure levels may beconservative and highly uncertain."

In her comment to the FDA, Thompsonsaid the regulators should consider "explaining in much more detail whythey believe the findings of the Health Hazard Assessment to be conservativeand highly uncertain. An explanation may help decrease anxiety among those whoare very concerned about the published TDI values."

"They need to explain toconsumers why they don't have a lot of confidence [in the TDI values],"Thompson says. "They owe it to consumers to decrease fear ... so thatconsumers are confident in the proposed gluten threshold level of less than 20ppm gluten."

Olins also wants more informationfor consumers. On items that are labeled as gluten-free, he would like to see atext box warning that the food may in fact contain trace amounts of gluten.

"This approach would providethe best 'truth-in-labeling,' and would satisfy the needs of theconsumer/physician/dietitian in selecting appropriate foods," Olins saysin his letter.

In a jointsubmission to the docket, the Celiac Sprue Association (CSA)commented on the proposed labeling rules, along with the Celiac DiseaseFoundation, Gluten Intolerance Group of North America, Canadian CeliacAssociation and the National Foundation for Celiac Awareness. Theirrecommendation, which is posted on the CSA website, supports a single definitionof gluten-free, saying a dual definition of gluten-free and low-gluten would beconfusing.

A study publishedin June by the Journal of the American Dietetic Association, titled"Gluten Contamination of Grains, Seeds, and Flours in the UnitedStates," found that nine out of 22 inherently gluten-free products, suchas corn or millet, contained mean levels of gluten varying from 8.5 ppm to2,925 ppm. The 13 other products had gluten levels below 5 ppm.

Given those findings, the ADAJournal said, "Gluten contamination of inherently gluten-free grains,seeds, and flours not labeled gluten-free is a legitimate concern. The FDA maywant to modify their proposed rule for labeling of food as gluten-free,removing the requirement that gluten-free manufacturers of inherentlygluten-free grains, seeds, and flours must state on product labels that allfoods of that type are gluten-free."

Stephen King, press liaison for theFDA's Center for Food Safety and Applied Nutrition, said in an email that theagency is reviewing the comments and evaluating the information to determine ifany changes need to be made to the rule.

At this point, predicting which waythe agency is leaning, King says, "would be speculative."

King says the process is ratherinvolved, but the agency hopes to see the rule published within three months ofthe comment period close, though that depends on the time it takesto review comments, and whether the rule needs to be edited.

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What is it with pHD biochemists and gluten issues ?

Olins also thinks an alternative tothe ppm measure would be to instead label the amount of gluten per serving measurement. Such a change would increase the number of foods that can be classified as gluten-free, because of small serving sizes.

There is NO STANDARD for serving sizes, either, in the United States. There is a plethora of single serving packages that contain "one and a partial" servings, to give the illusion of the foodstuff being lower calorie.

He notes that people are already used to measuring calories by individual food servings.

And they screw it up ALL THE TIME! <_<

I would be infuriated if they did this.

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