What Do New FDA Gluten-Free Labeling Laws Mean?

It’s finally here! The day for which we, the “let’s be gluten-free” people, have been waiting: the FDA has finally laid down the law for gluten-free labeling. So what does that mean for us? One one hand, we can breathe a little easier: the law has been passed. On the other, our struggles are just beginning: the law isn’t enough, has many pitfalls hidden within and doesn’t go into full effect for a whole year.

Breaking News: FDA sets standard for “Gluten-Free” Find out what this means in a detailed article on GlutenFreeGluten.com

20 Parts per Million

The new labeling requires all products that carry a label referring to a gluten-free status (such as “gluten-free,” “no gluten,” “free of/from gluten” or “without gluten”) be tested to prove said product contains less than 20 ppm (parts per million) of gluten. The FDA rests it’s decision based on the fact that 20 ppm is the most reliable industry standard for testing (you can see my diatribe on 20 ppm being too high here). But by the FDA’s own findings, 20 ppm is too high for people that are “highly sensitive.” Here’s what the FDA stated on their website* before the law was passed: “Based on the data and other variables included in the analysis, the safety assessment resulted in an estimate that a level of 0.01 ppm gluten in food would be protective of even the most highly sensitive individuals with CD.” So should we be happy about 20 ppm? It’s better than rampant contamination, but still more than enough to get most Celiacs sick.

The hemming and hawing the FDA has done on this topic of 20 ppm is a bit sad. Here’s what they have on there current Q ‘n’ A about gluten labeling: 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?
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. “

Why can’t the FDA follow what either the GIG (Gluten Intolerance Group) and the Celiac Sprue Association (CSA) have already implemented? The GIG has a Gluten Free Certification Organization  which will only allow less than 10 PPM of gluten. And the CSA has a limit of less than only FIVE PPM to allow manufacturers to display the CSA Recognition Seal. There are tests (like the RIDASCREEN, Ingensa and Neogen tests) that can test much lower than 20 PPM. The FDA itself has documented that there are currently at least EIGHT tests for gluten that can test under 10 PPM and actually three tests that go as low as THREE PPM (Source: the FDA’s document “Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food” and then check the very hidden  and scroll down the the “Appendix 4” table for gluten-specific findings).

So why 20? Why must we settle for “kinda sick” when we eat 20ppm foods when we could go as low as 3?!  (see more in my article “What’s an Acceptable Level of Gluten” here).

Ruling won’t really help us for a year

Manufacturers won’t be held liable for a full year after the findings are published in the Federal Register, which is on their website with a publication date of this coming Monday, August 5th, 2013. So this new ruling won’t help us for just over a year – products can still not be tested, be contaminated or just plain full of gluten and the FDA won’t do anything until the official compliance date, which would seem to be August 5th, 2014. Here’s what the FDA says about enforcing the new gluten-free labeling law:
6. What is the effective date of the final rule and what is the compliance date?
The final rule becomes effective 30 days after publication in the Federal Register. Manufacturers will have a year after the date of publication of the rule to bring package labels into compliance. After this date, any food product labeled “gluten-free” that does not meet the criteria established in the final rule, including a food that contains 20 ppm or more gluten, would be deemed misbranded and would be subject to regulatory enforcement action.

So until the end of next summer, I’m still not going to trust any gluten-free label without doing my homework and researching all new products. And even then, we have to be careful about the wording they use on labels (see “Caution” section below)

Must all foods that are Gluten-Free be labeled as such?

This ruling does not force manufactures to label any and all gluten-free foods as “gluten-free.” So whole, unprocessed foods like meats and veggies and fruits don’t have to have a label or anything. This ruling just means that if a manufacturer wants to denote a product’s gluten-free status, then it must adhere to the FDA’s requirements (after Aug 5, 2014) of containing less than 20ppm.

Does this ruling impact dining out in restaurants?

Not really. The FDA doesn’t have any specific requirements for restaurants. It seems that in the Labeling section of the Gluten-Free Q ‘n’ A that restaurants are free to continue to use the term “gluten-free” without regard to contamination or actual ingredients containing gluten. The FDA merely “suggests” that using the “FDA defined term” of “gluten-free” should now be consistent with the 20 ppm.

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

It seems to me that the inclusion of the word “suggests” means that they are saying they’re not directly regulating the gluten-free status of restaurants. So I’d have to say that this new gluten-free labeling does not have any impact on eating out. Sad. But it just doesn’t seem very safe, if you ask me.

New label to look for?

Nope. The FDA doesn’t provide a universal label, graphic or logo to denote a gluten-free status. There’s a whole slew of new information on the labeling (what wording to look for, what to avoid, where to look) on the Q ‘n’ A section of the FDA’s Gluten-Free Labeling Ruling, sections 7-11. But basically, there’s nothing new to look for.

Continue to use caution!

Well, isn’t this interesting… and a bit disconcerting! Even with the new FDA ruling on the status of “gluten-free” meaning 20ppm, manufacturers can still be sneaky. Products can claim “made with no gluten containing ingredients” or “not made with gluten-containing ingredients” but be contaminated over 20 ppm and not be in violation of gluten-free labeling laws. Here’s what the FDA says about that:

12. 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?
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.
So basically, as long as the product doesn’t say “gluten-free” on it, it can be contaminated well beyond what the FDA requires (20ppm) but not be in violation of the labeling rule.

Oh – and get this one: there is no requirement to tell us if a product is manufactured in a facility that also processes wheat. It’s completely voluntary.

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

Granted, with the 20ppm ruling, contamination should be caught – provided the product contains one of the five regulated statements (see “Wording” above). But if they don’t state “gluten-free” on a product then they don’t have to test and therefore a “may contain” or “processed in a facility with wheat” statement would be very helpful. It seems to me that ANY product that could be contaminated with gluten should be required to state that fact. (Here’s what the FDA says about these advisory warnings – go to page 10)

Safe, regulated wording

As always, there are loopholes for manufacturers to take advantage of (as detailed above). But once the compliance date of Aug 5, 2014 is hit, the FDA will regulate the following words, making anything labeled with them safe down to 20ppm.

FDA Regulated “Safe Words”


no gluten

free of gluten

without gluten

free from gluten

All in all, this ruling is a great step forward in our gluten-free world. (Well, in a year when the compliance date is hit anyway.) With the passing of these new labeling rules we’ve been transported from a lawless, Gluten-Free Wild West to a nice little town that has a mild-mannered, FDA sheriff who wants to put the gluten behind bars. Well… kinda. But hey, it’s better than nothing!

What do you think about the new ruling? We’ve been waiting a long time for this – I’d love to hear what you think!


Check out the official FDA pages here:

FDA: Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food and scroll half way down and look for the section “D. Gluten Threshold: Evaluation and Findings”
FDA Allergen Food Facts
* source: quote found in Question 11 in the Q ‘n’ A segment on the proposed gluten guidelines

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