Gluten-Free Labeling Rules Finalized by FDA—What Do They Mean, and Who Benefits?

by: Peter Olins, PhD on August 5, 2013.

At last, the FDA has taken a stand on how gluten-free foods should be labeled in the U.S.!

The FDA has the unenviable task of balancing the needs to protect the safety of the food supply with the legitimate needs of industry for clear regulations that permit long term planning and allow for successful businesses. Inevitably, some people will feel that they have been either the winners or losers in this compromise. My overall assessment is that the FDA has come out strongly in favor of industry.

Some Background on the Process Used for Arriving at the Final Regulation

It has been clear for decades that the presence of traces of gluten in food (typically from wheat, barley or rye) causes serious health problems for people with celiac disease. An FDA regulation for the labeling of “gluten-free” foods has been in the works since 2007, and has been subjected to updates and extensive public comments. The first draft inspired 2,400 comments, and the updated 2011 draft almost 2,000. The FDA is to be commended for taking the public’s input so seriously. It responded to criticisms and comments on the 2011 draft regulation in great depth.

The FDA had two options for how to arrive at an appropriate standard, either relying on available safety data, or relying on the sensitivity of available assays for gluten content. Since there is no definitive data on a safe level of gluten consumption, the FDA chose to rely on the analytical assay approach. In December 2012, the FDA issued a report in which it responded to criticisms about how it had interpreted the available safety data (Ref. 1).

The final regulation is a 95-page document (Ref. 2), and includes a detailed rationale for how the decision was made. For a simple summary of the decision, the FDA has published a useful Q&A fact sheet (Ref. 3).

Overall, the FDA stood firm on its original position on the scientific questions of safety and testing, but the final rules clarified three things:

1. How the acceptable gluten level is defined
2. What manufacturers need to do in order to comply with the regulations
3. What the FDA enforcement process will be

I think it is fair to say that the final regulation is very favorable for industry.

Key Points From FDA Gluten-Free Regulation

1. The cutoff for a food to be labeled “gluten-free” is the familiar value of “20 ppm”, which is already in use in most other countries.
2. In addition to the term “gluten-free”, permitted alternatives are: “no gluten,” “free of gluten,” or “without gluten”.
3. The regulation covers the following gluten-containing grains: wheat, barley, rye, and grain hybrids (such as triticale).
4. Oats are not included in the regulation (in contrast to the regulation in Canada), so presumably products based on oats can be labeled as “gluten-free”.
5. There will be no FDA-approved logo or image that can be used to signify GF status; instead, labeling will depend on text. Individual groups are still at liberty to devise their own, however.
6. Labeling is voluntary (unlike labeling requirements for food allergens).
7. No specific gluten assay is defined by the FDA. This has the advantage that manufacturers will be able to use superior assays that may be developed in the future, rather than relying on specified methods which may become outdated.
8. The regulation went into effect yesterday, and industry compliance is required by August 5, 2014.

Exceptions to the FDA Ruling

As I mentioned in earlier blogs, fermented or “hydrolyzed” foods (such as beer, soy sauce, sourdough bread) pose a particular challenge for gluten measurement, because the current assay (“Sandwich ELISA”) is poor at detecting gluten in these products (Ref. 4, 5). While some manufacturers have argued for the use of a newer assay (the “R5 Competitive ELISA”), the FDA has concluded that this is not a valid way for measuring gluten in foods (Ref. 6). The FDA clearly had problems with including fermented foods in its current regulation, so it decided to postpone a decision, and issue a new proposed ruling at a later date. In the mean time, it appears that products, such as soy sauce or barley malt extract, can be labeled “gluten-free”, providing they pass the Sandwich ELISA test.

The FDA does not regulate most beers (those that are made from barley malt and hops); instead this is the responsibility of the Tobacco Tax and Trade Bureau. Therefore, the FDA ruling still leaves the question of barley-based beers in limbo, and it remains to be seen whether the TTB will update its regulation on gluten-free labeling of barley-based beers (Ref. 4). The FDA has promised to work with the TTB in order to ensure harmonization between the different agencies, so that consumers are not confused by different “20 ppm” labels.

The FDA also does not regulate meat, poultry or egg products: this is the responsibility of the USDA. Raw meat, fish and chicken are inherently gluten-free, processed foods often include some wheat products. Celiacs should therefore be wary of foods such as sausages or luncheon meats, since there are currently no gluten-free labeling standards that apply.

The FDA regulation does not apply to drugs, which can sometimes contain gluten as a filler, which is a concern for celiacs. However, a proposal for future regulation of drugs is currently being prepared.

Some Concerns About the Final Regulation

Overall, while both consumers and manufacturers will pleased that there is now clear guidance from the FDA, I am personally disappointed by some of the FDA’s decisions and reasoning, and most of the concerns that we raised in 2011 (Ref. 7) were rejected.

• The FDA decided not to set a limit lower than 20 ppm, even though some current assays are commercially available that appear to be able to detect lower levels of gluten. The FDA argued that it was undesirable to have too strict a regulation because it would impose too great a burden on manufacturers, and that this would reduce the availability of GF foods to the public. It’s not clear to me how much evidence there was for this conclusion, or if the FDA was simply bowing to industry pressure.
• Manufacturers are not required to actually test foods that they label as being gluten-free, but they are responsible for providing truthful information. (This is effectively an honor system). I still find this part of the regulation puzzling.
• Manufacturers are free to develop whatever gluten assays they feel are appropriate for their product, providing that they have been “scientifically validated”.
• There are no specific record keeping requirements for manufacturers.
• The FDA chose not to relate gluten content based on serving size: instead, it just relies on concentration. While this may simplify the labeling process, I don’t think it provides the most useful information for the consumer to estimate his/her actual gluten consumption.
• As with any law or regulation, enforcement is always an issue. We are all expected to follow our laws, and businesses are expected to follow regulations. In the case of the FDA, it is well known that its modest budget severely limits its ability to enforce regulations. The FDA stated that, quote: “We enforce our regulations primarily through inspections of food processing facilities, examination of imports, collection and testing of food products on the market, and imposition of enforcement measures as required to protect consumers. Manufacturers are responsible for ensuring that food bearing a “gluten-free” claim is not misbranded for failure to meet the final rule.” I think it is fair to say that it will be up to manufacturers to ensure that their products are labeled accurately, since the FDA has only limited resources for routine testing of foods, and tends to do so only when alerted to a potential problem by the public.

Closing Comments

Any regulation like this is inevitably a balancing act between three broad factors:
1) providing the greatest amount of information for consumers to make safe dietary choices
2) protecting the largest number of people from harm
2) giving latitude to manufacturers, so that any regulations are not overly expensive or hard to comply with

While it is inevitable that such a compromise will leave everyone somewhat dissatisfied, in my opinion, the final regulation is extremely favorable for manufacturers.

The adoption of a 20 ppm standard for gluten-free labeling of foods in the U.S. will clearly provide peace of mind for most consumers, and make life simpler for manufacturers.

References:

Ref. 1: FDA’s Responses to Comments on the Report Titled “Health Hazard Assessment for Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for Gluten.” December 2012 http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM362401.pdf

Ref. 2: Food Labeling; Gluten-Free Labeling of Foods  or https://www.federalregister.gov/articles/2013/08/05/2013-18813/food-labeling-gluten-free-labeling-of-foods

Ref. 3: Questions and Answers: Gluten-Free Food Labeling Final Rule

Ref. 4: Is “Gluten-Free” Beer Made From Barley Malt Safe for Celiacs?

Ref. 5: Gluten-Free Beer: Does Omission Beer Deliver the Goods? — A Simple Guide for the Non-Biochemist

Ref. 6: quote from FDA ruling (Ref. 2): “In comparison to sandwich ELISA-based methods, competitive ELISA-based methods need the presence of a single antigenic epitope. However, without an appropriate reference standard to gauge the response, one cannot interpret the results on a quantitative basis that equates the response to intact gluten [my emphasis]. Evidence in the scientific literature is currently lacking about a scientifically valid competitive ELISA method which confirms that any gluten peptides detected in a food sample can be accurately quantified in terms of ppm intact gluten protein [my emphasis]. Therefore, we do not consider these methods scientifically valid for the purposes of analyzing fermented or hydrolyzed foods to determine compliance with this rule under § 101.9 c “.
and
“As noted in the 2011 notice, a scientifically valid method for purposes of substantiating a “gluten-free” claim for foods matrices where formally validated methods (e.g., that underwent a multi-laboratory performance evaluation) do not exist is one that is accurate, precise, and specific for its intended purpose and where the results of the method evaluation are published in the peer-reviewed scientific literature. In other words, a scientifically valid test is one that consistently and reliably does what it is intended to do.”

Ref. 7: Letter to FDA on Labeling of Gluten-Free Food Products