Today FDA (the Food and Drug Administration – the overlords of our food and drugs), posted their final ruling on what defines “gluten-free” food, according to labeling. I’m posting my highlights that I found most interesting on this post. You can read it all on FDA’s website here. Basically, we’re all doing the Carlton out of sheer joy.

To this ruling I say, HIGH FIVE FDA!

We still have a long way to go with education, awareness and advocacy – but these are all steps in the right direction to keep us safe!

On top of foods labeled “gluten free,” this ruling also applies to food labeled:

• “without gluten”
• “free of gluten”
• “made with no gluten-containing ingredients”
• “not made with gluten containing ingredients”
• and “no gluten”

This ruling is great for those of us who are skeptical of any gluten-free claims that may be on packaging. Without a final legal ruling, how would we know that it isn’t just a marketing claim? 

Here is the meat of the ruling (from FDA.gov on 8/2/2013).

How Does FDA Define ‘Gluten-Free’?

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:

1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
2. an ingredient derived from these grains and that has not been processed to remove gluten
3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.

The regulation will be published Aug. 5, 2013 in the Federal Register, and manufacturers have one year from the publication date to bring their labels into compliance.

I think the most meat of the ruling lives in the Q&A found here. The following are my picks for the most exciting things about the FDA’s ruling. I’ve italicized the exciting parts – nerd alert!

Q: Can a food be labeled gluten-free if it is made with small amounts of a gluten-containing grain or ingredients derived from such grains that were not processed to remove gluten, if the food contains less than 20 ppm gluten?

A: No. A food labeled gluten-free cannot be intentionally made with any amount of a gluten-containing grain (wheat, rye, barley, or their crossbred hybrids like triticale) or an ingredient derived from such grain that was not processed to remove gluten. The goal of manufacturing any food labeled gluten-free should be for the food to not contain any gluten or to contain the lowest amount possible that is less than 20 ppm gluten. One goal of FDA’s regulatory definition of the term “gluten-free” is to limit consumer confusion when reading ingredient lists of foods labeled gluten-free

Q: What does gluten cross-contact mean in the context of the final rule?

A: The term “cross-contact” is not defined in the final rule, but gluten cross-contact generally refers to the unavoidable presence of gluten in a food due to contact with a gluten-containing food (wheat, rye, barley, or their crossbred hybrids like triticale). The U.S. Grain Standards allow commodity grains, legumes, and seeds to contain a small percentage of another commodity grain as a result of commingling during production. The presence of gluten in a grain, legume, or seed that is naturally free of gluten from this type of commingling is an example of cross-contact. The typical practice of crop rotation, as well as the shared use of harvesting and transport equipment and storage silos, often results in gluten-containing grains coming into contact with other grains, legumes, and seeds that are naturally free of gluten. Furthermore, manufacturing facilities that use shared production equipment to produce foods both with and without gluten could result in gluten cross-contact. Any grain other than the gluten-containing grains of wheat, rye, barley, or their crossbred hybrids like triticale can be labeled gluten-free, if it meets the definition, including that the presence of any unavoidable gluten due to cross-contact situations is less than 20 ppm.

***Erica’s side note: They manage to make the phrase “commingling” so dirty here. Le sigh, such is life for most manufacturers.

Q: Are statements like “made with no gluten-containing ingredients” or similarly “not made with gluten-containing ingredients” permitted on labels of foods bearing a gluten-free claim?

A: Yes. Neither the final rule nor FDA’s general food labeling regulations prohibit the use of a statement like “made with no gluten-containing ingredients” or “not made with gluten-containing ingredients” on any food products, provided that the statement is truthful and not misleading. However, unless the label of the food including such a statement also bears a gluten-free claim, consumers should not assume that the food meets all FDA requirements for a gluten-free food.

***Erica’s side note: So we’ll always have to look for the “gluten free” claim on top of “made with no gluten-containing ingredients” claim. “Gluten free” is the key term.

Q: Are advisory statements, such as “made in a factory that also processes wheat products” permitted on labels of foods bearing a gluten-free claim?

A: Yes. The final rule does not prohibit the inclusion of an advisory label statement, such as “made in a facility that also processes wheat,” on foods labeled gluten-free, provided that the statement is truthful and not misleading. FDA would need to evaluate food labels on a case-by-case basis to determine whether a specific advisory statement included along with a gluten-free claim would be potentially misleading to the consumer. However, any food whose label bears a gluten-free claim, regardless of whether it also has an advisory statement, must meet all the requirements of the final rule.

****Erica’s side note: So with a “gluten free claim,” even with this advisory statement, the product still has to be under 20ppm? I’m interested to learn more about this one. Obviously I’d love to have any company that manufacturers in the same facility to test all of their products for gluten – that would open the doors for me to eat from many different manufacturers.

Q: Why didn’t FDA adopt zero ppm gluten rather than less than 20 ppm gluten as one of the criteria for a food labeled gluten-free?

A: FDA used an analytical methods-based approach to define the term gluten-free and adopted < 20 ppm gluten as one of the criteria for a food labeled gluten-free because the agency relies upon scientifically validated methods for enforcing its regulations. Analytical methods that are scientifically validated to reliably detect gluten at a level lower than 20 ppm are not currently available. 

In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects.

****Erica’s side note: I know that many of you will be upset about the 20ppm and you’ll tell me that you are affected by anything under 20ppm and the cumulative effects on the body at 20ppm is a problem, etc. – BUT 20ppm is better than anything over 20ppm! Until we can reach ZERO GLUTEN GLOBAL (from Rodney Ford’s book), 20ppm is all I can ask for. Obviously I’d love to have all of these products to test at under 20ppm – in my perfect world they would all test at 0!

Q: Are manufacturers required to test for gluten to make a gluten-free claim on their food labels?

A: No. The final rule does not specifically require manufacturers to test for the presence of gluten in their starting ingredients or finished foods labeled gluten-free. However, manufacturers are responsible for ensuring that foods bearing a gluten-free claim meet the requirements of the final rule. Among other requirements, this means that any unavoidable gluten present in a food labeled gluten-free is less than 20 ppm. Manufacturers may choose to use effective quality control tools to ensure that any foods they label gluten-free do not contain 20 ppm or more gluten, such as:

• conducting in-house gluten testing of starting ingredients or finished foods,
• employing a third-party laboratory to conduct in-house gluten testing,
• requesting certificates of gluten analysis from ingredient suppliers, or
• participating in a third-party gluten-free certification program.

****Erica’s side note: So they don’t REQUIRE testing, but the food is REQUIRED to be under 20ppm? Either way, I’m doing a happy dance. If the food is under 20ppm, I will be happy.

Q: What gluten test methods should a manufacturer use if it elects to analyze its foods labeled gluten-free to ensure compliance with the final rule?

A: Manufacturers who elect to analyze their foods for gluten can select the test methods most appropriate for them, considering the type of foods they manufacture. Manufacturers are not obligated to use any one specific method to check for gluten in their foods. FDA recommends the use of scientifically valid methods in order for the gluten test results obtained to be reliable and consistent. Conducting gluten testing using a scientifically valid method is an effective tool manufacturers can use to ensure that their foods labeled gluten-free do not contain 20 ppm or more gluten.

Q: Does the final rule apply to gluten-free claims made for foods served in restaurants, including cafeterias and buffets? 

A: With respect to restaurants, FDA guidance suggests that any use of an FDA-defined food labeling claim (such as “fat free” or “low cholesterol”) on restaurant menus should be consistent with the respective regulatory definitions. This same approach would be followed with respect to “gluten-free” claims made in restaurants and other retail food service establishments.

***Erica’s side note: While they can’t really regulate the restaurants, I really dig the fact that FDA is trying to tell restaurants that “gluten free” SHOULD BE GLUTEN FREE! I’d love to see this expand and for kitchen certifications become more common practice in order to comply. Please? Pretty please?

…

So what are your initial thoughts on the FDA final ruling? Was there something that you found that was exciting or confusing? What are you interested in learning more about?

PS stay tuned to NFCA’s FDA page for updated information including a free webinar about what all of this means here.

Tagged: celiac, celiac disease, FDA, Food and Drug Administration, gluten free