In 2013, the FDA issued the gluten-free final rule, which addressed the uncertainty in interpreting the results of current gluten test methods for fermented and hydrolyzed foods in terms of intact gluten. Due to this uncertainty, the FDA has issued this proposed rule to provide alternative means for the agency to verify compliance for fermented or hydrolyzed foods labeled “gluten-free” based on records that are made and kept by the manufacturer.
Questions & Answers
1. What is FDA proposing?
On November 18, 2015, the Food and Drug Administration published a proposed rule in the Federal Register to establish requirements for fermented, hydrolyzed, and distilled foods or ingredients that are labeled as “gluten-free.” We propose to amend FDA’s regulations on gluten-free labeling of food in title 21 of the Code of Federal Regulations (21 CFR), section 101.91, to establish compliance methods for these types of foods that bear a voluntary “gluten-free” labeling claim. In an August 5, 2013 final rule, FDA established section 101.91 to define the term “gluten-free” for voluntary use in the labeling of foods. However, the final rule identified uncertainty with the compliance methods established in the final rule for fermented, hydrolyzed, or distilled foods or ingredients.
2. Does FDA propose that fermented, hydrolyzed, or distilled foods that meet the definition of “gluten-free” be required to bear the “gluten-free” claim?
No. This proposed rule would not require any “gluten-free” labeling. A manufacturer may voluntarily label its product as “gluten-free” if the food bearing the label meets the applicable requirements in 21 CFR 101.91. The Food Allergen Labeling and Consumer Protection Act of 2004 directed the Secretary of the U.S. Health and Human Services to define and permit the use of the term “gluten-free” in the labeling of foods.
3. Will fermented, hydrolyzed, or distilled foods labeled as “gluten-free” still have to meet the requirements of the gluten-free food labeling final rule?
Yes. Hydrolyzed, fermented, or distilled foods voluntarily bearing the “gluten-free” claim will also still have to meet the requirements of the gluten-free food labeling final rule, including the definition of “gluten-free,” which means that they are either inherently gluten-free or they do not include any of the following:
- Ingredients that are gluten-containing grains
- Ingredients derived from a gluten-containing grain that have not been processed to remove gluten
- Ingredients derived from a gluten-containing grain that have been processed to remove gluten if use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food
In either case, any unavoidable presence of gluten must be less than 20 ppm.
4. What are potential benefits of this rule to consumers?
Standardizing the requirements for use of the term “gluten-free” will help assure consumers with celiac disease that the foods labeled as “gluten-free” meet a clear standard—one that is established and enforced by FDA—on the meaning of “gluten-free.”
5. What are potential benefits of this rule to industry?
A standard description of the requirements for manufacturers who wish to use the “gluten-free” claim for hydrolyzed, fermented, or distilled foods will help establish a level playing field among manufacturers of products labeled “gluten-free” and a clear understanding of the requirements for a food to bear a “gluten-free” claim.
Yes. The FDA accepted public comments starting November 18, 2015. The comment period is now closed. View submitted comments in docket folder FDA-2014-N-1021.
Fermented and Hydrolyzed Foods
7. What are fermented foods?
A fermented food is one that has undergone a process that typically involves the conversion of complex organic compounds, especially sugars and other carbohydrates, to simpler compounds such as lactic acid and ethyl alcohol. This process is referred to as fermentation. During fermentation, proteins are broken apart into smaller groups of amino acids known as peptides. Examples of fermented foods include beer and yogurt.
8. What are hydrolyzed foods?
A hydrolyzed food is one in which a food’s chemical components—such as proteins—are broken into smaller organic compounds by reaction with water. These reactions are often accelerated by enzymes. Examples of hydrolyzed foods include hydrolyzed soy protein and hydrolyzed wheat protein.
9. What additional requirements does FDA propose to verify a “gluten-free” claim on hydrolyzed or fermented foods?
Because the current gluten tests do not adequately detect and quantify gluten in fermented and hydrolyzed foods or ingredients, FDA proposes that, in order to make a “gluten-free” claim, manufacturers of these foods would have to make and keep records to show all of the following:
- The food meets the definition for “gluten-free” in 21 CFR 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis.
- The manufacturer adequately evaluated the processing for any potential for gluten cross-contact.
- Where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.
These records could include test results conducted by the manufacturer or an ingredient supplier, a certificate of analysis, or other appropriate verification documentation for the food or each ingredient used in the foods.
10. How long would manufacturers need to keep these records?
Under the proposed rule, for hydrolyzed and fermented foods labeled as “gluten-free,” the manufacturer would have to keep the records described above for at least 2 years after the food enters interstate commerce. Manufacturers would have to provide those records to us for examination and copying during an inspection upon request.
11. Are the proposed recordkeeping requirements the same for all hydrolyzed or fermented foods and foods containing hydrolyzed or fermented ingredients?
Yes. The proposed requirements are the same. However, the specific types of records that would provide adequate assurance for hydrolyzed or fermented ingredients with a high likelihood of gluten cross-contact, such as grains and legumes, may vary from those expected for ingredients with a lower likelihood of gluten cross-contact, such as dairy.
12. If the hydrolyzed or fermented food or a food containing a hydrolyzed or fermented ingredient is inherently gluten-free, would the proposed requirements apply to those inherently gluten-free foods that bear the “gluten-free” claim?
Yes. FDA proposes that any manufacturer of a hydrolyzed or fermented food or a food containing hydrolyzed or fermented ingredients would have to follow the requirements even if the food was inherently gluten-free—that is, it does not contain a gluten-containing grain or an ingredient derived from a gluten-containing grain. The extent of the records necessary will depend on the food, the ingredients, the manufacturing process, and other foods processed in the plant. (See question 11.)
13. What is an example of a hydrolyzed or fermented food product that would still not be permitted to bear the “gluten-free” claim in its labeling under this proposed rule?
Fermented or hydrolyzed soy sauce made from gluten-containing grains would not be permitted to bear a “gluten-free” claim, unless the grains were processed to remove gluten and the use of the ingredient resulted in the presence of less than 20 ppm gluten in the food. If, however, the soy sauce was made using a roasted grain that does not contain gluten, then it would be permitted to bear the “gluten-free” claim if it meets the other requirements of the gluten-free labeling rule.
14. Why are beers being considered in this proposed rule?
Beers are fermented beverages and we specifically noted in the gluten-free labeling final rule that these products would be addressed in this proposed rule and that we were exercising enforcement discretion with regard to certain beer products pending completion of the rulemaking process.
Beer is derived from fermented malted cereal grains; most commonly malted barley or wheat, which are gluten-containing grains. Beers that meet the definition of “malt beverages” in the Federal Alcohol Administration Act are subject to the labeling requirements of the Alcohol and Tobacco Tax and Trade Bureau (TTB). Malt beverages are described as being made with both malted barley and hops. Beers made with malted barley and no hops or with malted barley substitutes (such as sorghum) and hops are subject to FDA labeling requirements. An example of a beer subject to FDA labeling requirements is sorghum beer.
Under the proposed rule, beers that are not made from gluten-containing grains would be permitted to bear the term “gluten-free” if they meet the provisions of 21 CFR 101.91. (See questions 3 and 9.)
15. What are distilled foods?
Distilled foods are formed as a result of a purification process that involves heating a liquid such that volatile components with lower boiling points are vaporized and recovered separately from nonvolatile components with higher boiling points. The remaining nonvolatile compounds, whose boiling points were too high to undergo vaporization, are removed from the distilled food. Examples of distilled foods include some vinegars and distilled water.
16. Why are distilled foods and ingredients being considered in this proposed rule?
The proposed rule would clarify that, in most cases, it is unlikely that gluten will be present in a distilled food because distillation is a purification process that separates volatile components like alcohol and flavors from nonvolatile materials like proteins and sugars. However, this would depend on the adequacy of the distillation process. Scientifically valid methods to measure the protein content should find no detectable protein present and thus no gluten in distilled ingredients or distilled products.
17. What requirements does FDA propose for distilled foods labeled “gluten-free”?
We propose that a manufacturer use a scientifically valid method to measure protein content and should find no detectable protein present in the distilled food or ingredient. No detectable level of protein would indicate an absence of gluten. When choosing a method to verify the absence of protein, sensitivity of the method is one of the factors to consider. The method’s sensitivity should have a limit of detection as close to zero as possible.
18. Can distilled foods made from ingredients derived from gluten-containing grains be labeled as “gluten-free”?
Yes. Since proper distillation is capable of removing all proteins, including gluten, it would be considered as a “process to remove gluten.” Thus, an ingredient that is derived from a gluten containing grain that has been properly distilled would be allowed to be used in a food bearing the “gluten-free” claim since the ingredient would meet the requirements of 21 CFR 101.91.