What Does "Gluten-Free" Really Mean?

[psawyer]

What does "gluten-free" really mean?

In the US, we don't really know. Under the FALCPA legislation, the FDA was supposed to propose a rule by 2008, and implement it in a timely manner. 2010 is almost over, and the debate continues.

Any rule must be able to be enforced, which means there must be a test to ensure compliance. No test can ever prove the negative that there is ZERO gluten. The most sensitive test available today can detect 5 parts per million (ppm), but it is quite costly. A less expensive (but not cheap) test can detect 20 ppm.

Contamination can occur at any point on the supply line, not just at the final production facility. This means that even a "gluten-free" facility could receive an ingredient already contaminated. A person entering the "gluten-free" facility could carry bread crumbs, or some other source of gluten, into the plant.

The questions that the FDA has to resolve are:

1. How much gluten can be in a "gluten-free" product? 5 ppm? 20 ppm? 200 ppm? The EU has recently moved from 200 ppm to 20 ppm, BTW.

2. Can any of that gluten be from an intentional ingredient, or must there be no intentional ingredients that contain any gluten from any source?

My understanding is that the FDA is leaning toward 20 ppm with no intentional gluten included. It is the latter part that is still being debated. Can sprouted barley or wheat grass be included provided the finished product tests below 20 ppm?

I have already mentioned it, but it bears repeating: there is always some risk of contamination. It cannot be eliminated. It can be tested for, but the tests have costs and limits. The best test can only detect 5 ppm.

Since there is no regulated definition of "gluten-free" at this time, it can mean whatever the company wants it to mean. Sadly, it means whatever the plaintiff's attorney can convince the jury it means. This is why many major corporations who produce products which are, in fact, gluten free refuse to label them as such, and if asked, will cite that there is a risk of contamination (see above). If asked to "guarantee" anything about the gluten-free status of their products, they will (correctly) refuse to do so--as stated above, the best guarantee possible is "less than 5 ppm" and they can only do that if they actually test.

[kareng]

Good explanation, Peter.

Another thing to consider are the companies that say the product is gluten-free but don't test. They make a product that likely is as gluten-free as any tested product. For example, we have some small companies that make products like hummus or sausages or dips/ salsas. They don't use any gluten containing products in those kitchens or in the product. They put gluten-free on the packages but testing would make an already expensive product, more costly. If they are required to test to call it gluten-free, they won't.

Makes me a little sad but I know that without an official law, there will be people carelessly labeling things gluten-free. And companies afraid to say gluten-free without a legal standard.

Do you know, would every batch of a food product be tested or just a percentage of product?

[Skylark]

Sampling in general is a surprisingly complex issue. Do you test by the batch, if so, at the start or end? Do you test ingredients or finished product? How many tests do you need? How homogeneous is your food? Will one test catch traces of contamination somewhere else in a 500 unit run?

Legislators have to deal with this. Take the example of someone here who found a wheat chex in a box of rice chex. Likely the other boxes on that production run were perfectly fine. There are probably logs showing the gluten-free status of the flours, and the GMP cleaning of equipment. Does a company get fined for having problems with one product out of hundreds of thousands of boxes? At what point is it too risky to label anything gluten-free because of sampling issues?

[bbuster]

  On 11/3/2010 at 2:13 AM, Skylark said:

Legislators have to deal with this.

and that's where it gets REALLY scary!

[psawyer]

  On 11/3/2010 at 2:20 AM, bbuster said:

and that's where it gets REALLY scary!

Health and politics together.

[Skylark]

  On 11/3/2010 at 2:27 AM, psawyer said:

Health and politics together.

Add a lawyer into the mix and it really becomes messy.

[psawyer]

Also, we have a discussion forum here:

Gluten-Free Foods, Products, Shopping & Medications

Discussions regarding which mainstream products are gluten-free and which are not.

In that forum, we talk a lot about foods which are, in fact, free of gluten, but which are not so labeled.

Many food manufacturers use GMP and label clearly all sources of gluten in their ingredient lists. For legal liability reasons, they won't say that their products are "gluten-free" but that does not mean that they aren't.

Click here for an interesting article by Danna Korn about when "not gluten-free" does not really mean "not gluten-free."

[GlutenFreeManna]

I think that rather than regulate the use of the term "gluten free" they should require that all gluten ingredients are disclosed. They already have to disclose wheat in the US as it is one of the 8 major food allergens. It seems like it would not be too hard to require disclosure of barely and rye as well. I'm not so sure how I feel about shared facility/shared equipment statements. Right now it's voluntary to put that statement on a product. It would be nice if companies claiming gluten free status had to disclose shared equipment/shared facilites. I think that requiring a gluten free company to state whether they make their product on shared equipment MIGHT motivate more campanies to make their items in Gluten free facilities and lead to fewer instances of CC. But I suppose it could also backfire and lead to fewer companies willing to make something gluten free.

[psawyer]

Requiring disclosure of rye and barley (and perhaps oats) would be a positive step.

The question about contamination remains. Should it be a requirement to test for gluten in the ingredients and/or finished product to be able to claim "gluten-free" on a label.

In Canada, there is a rule, and it is clear. No product may be labeled or represented as "gluten-free" unless:

1. It contains no ingredient derived from wheat, rye, barley or oats;

2. The fact that it is "gluten-free" must be a distinguishing factor of that product. You can market gluten-free bread, but not gluten-free carrots (unless you say something like, "Carrots are naturally gluten-free" or "These carrots, like all carrots, are gluten-free.);

3. Nutritional information about each serving is provided on the package label.

So, in Canada, we at least know what gluten-free means. It refers only to intentional ingredients, says nothing about possible contamination, and does not prescribe a level of testing for enforcement.

Canada is considering amendments to the rule which might, among other changes, make it legal to sell gluten-free oats.

FDA, please decide on a meaning so all manufacturers know what the game is. Until you do, so many companies that produce gluten-free products are afraid to say that they are, in fact, gluten-free.

[Skylark]

There is a need for gluten-free oats, and ever since Tricia Thompson came out with that cross-contamination study, I have started buying my grains from Bob's Red Mill. Bob's states that everything they label gluten-free is batch tested and made in their gluten-free facility, which gives me some measure of comfort. It would be really upsetting if new legislation made it illegal for Bob's to label their tested flours gluten-free.

I think ideal legislation would allow all flours that could be mixed with wheat in harvest, storage, transport, or processing to be tested and labeled as gluten-free. I can determine if a bag of bulk grain is gluten-free by sorting through it (unless it's oats) but I cannot determine if my bag of millet or teff flour is gluten-free without an ELISA.

[munchkinette]

  On 11/3/2010 at 1:45 AM, psawyer said:

What does "gluten-free" really mean?

In the US, we don't really know. Under the FALCPA legislation, the FDA was supposed to propose a rule by 2008, and implement it in a timely manner. 2010 is almost over, and the debate continues.

Any rule must be able to be enforced, which means there must be a test to ensure compliance. No test can ever prove the negative that there is ZERO gluten. The most sensitive test available today can detect 5 parts per million (ppm), but it is quite costly. A less expensive (but not cheap) test can detect 20 ppm.

Contamination can occur at any point on the supply line, not just at the final production facility. This means that even a "gluten-free" facility could receive an ingredient already contaminated. A person entering the "gluten-free" facility could carry bread crumbs, or some other source of gluten, into the plant.

The questions that the FDA has to resolve are:

1. How much gluten can be in a "gluten-free" product? 5 ppm? 20 ppm? 200 ppm? The EU has recently moved from 200 ppm to 20 ppm, BTW.

2. Can any of that gluten be from an intentional ingredient, or must there be no intentional ingredients that contain any gluten from any source?

My understanding is that the FDA is leaning toward 20 ppm with no intentional gluten included. It is the latter part that is still being debated. Can sprouted barley or wheat grass be included provided the finished product tests below 20 ppm?

I have already mentioned it, but it bears repeating: there is always some risk of contamination. It cannot be eliminated. It can be tested for, but the tests have costs and limits. The best test can only detect 5 ppm.

Since there is no regulated definition of "gluten-free" at this time, it can mean whatever the company wants it to mean. Sadly, it means whatever the plaintiff's attorney can convince the jury it means. This is why many major corporations who produce products which are, in fact, gluten free refuse to label them as such, and if asked, will cite that there is a risk of contamination (see above). If asked to "guarantee" anything about the gluten-free status of their products, they will (correctly) refuse to do so--as stated above, the best guarantee possible is "less than 5 ppm" and they can only do that if they actually test.

Do you have any sources for this? I'm trying to track down some documents or websites regarding the labeling rules, and where they stand at this point.

[psawyer]

Open Original Shared Link

[munchkinette]

  On 11/10/2010 at 11:18 PM, psawyer said:

Open Original Shared Link

Thanks! I'm writing a paper for one of my biology classes. I've learned a lot over the past 5 years about this stuff, but I have no idea where to cite the sources.