FDA issues final rule on records required to support “Gluten-Free” claim on fermented or hydrolyzed food

The FDA originally issued a final rule in 2013 defining “gluten free” claims for other foods, but at the time noted that it would undertake separate rulemaking for gluten free claims for fermented or hydrolyzed foods due to concerns about the inability to reliably detect and quantify the presence of gluten in these foods¹. This new rule² builds on the existing standard for “gluten-free” claims, including the 20 ppm limit, but establishes an alternative compliance standard for fermented and hydrolyzed foods, or foods that contain such ingredients, based on recordkeeping. The new final rule establishes that because there is no scientifically valid test method that can reliably detect and quantify the presence of 20 ppm gluten in fermented and hydrolyzed foods, in order to support a “gluten free” claim for such foods, the manufacturer must make and keep records demonstrating adequate assurance that:

1. The food is “gluten-free” in accordance  with 21 CFR 101.91(a)(3) before fermentation or hydrolysis;
2. The manufacturer has adequately evaluated their processing for any potential for gluten cross-contact; and 
3. 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.³  

Thus, although fermented and hydrolyzed foods are still subject to the same substantive standard for gluten-free claims generally, including the 20 ppm limit, records, rather than testing, will be used to determine compliance for these foods. Although the FDA’s final rule details what a company’s records must show about a hydrolyzed or fermented food that bears a “gluten-free” claim, the agency does not prescribe the form the records must take, and there is inherent flexibility in how manufacturers make and keep such records, as detailed further below. The compliance date for the new requirements is August 13, 2021.

Scope of the final rule on “Gluten-Free” labeling of fermented or hydrolyzed foods

Because there is no scientifically valid analytical method to detect gluten in fermented or hydrolyzed foods, the FDA has determined that alternative methods are necessary to verify compliance with “gluten-free” claims on fermented and hydrolyzed foods, as well as foods that contain fermented or hydrolyzed ingredients. Examples of such foods include cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beers, and wine, or hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces, and seasonings, or cocoa beans that are fermented after harvest.⁴   

The final rule applies to all hydrolyzed or fermented foods and ingredients bearing a “gluten-free” claim, even if the starting ingredients are inherently gluten-free. However, fermented or hydrolyzed foods that are also subjected to distillation (e.g. distilled vinegar) are exempt from the recordkeeping requirements applicable to fermented or hydrolyzed foods generally. The FDA recognizes distillation as a process that removes gluten when performed in accordance with good manufacturing practices (GMPs), because distillation inherently removes all protein.  Therefore, the FDA will use scientifically valid analytical methods that can reliably detect the presence or absence of protein fragments in a distilled food, rather than reviewing records to determine compliance. The FDA notes that malt beverages, as defined under the Federal Alcohol Administration Act, do not undergo distillation and therefore are subject to the recordkeeping requirements for fermented or hydrolyzed foods, if a malt beverage bears a “gluten-free” claim. The FDA declined to exempt enzymes from the recordkeeping requirements for fermented or hydrolyzed foods bearing “gluten-free” claims.  

If a food manufacturer sources a fermented or hydrolyzed ingredient that is determined to contain gluten under the new procedure, the ingredient would likely be considered a gluten-containing ingredient by the FDA such that foods formulated with that ingredient would arguably be barred from bearing a “gluten-free” claim.

Final rule prescribes what the records must show, not the form the records must take

The FDA’s final rule requires manufacturers of fermented or hydrolyzed foods that bear a “gluten-free” claim to keep two types of records: 

1. Records providing adequate assurance that the food and ingredients are “gluten-free” in accordance with 21 CFR 101.91(a)(3) before fermentation or hydrolysis (i.e., that the food does not contain any gluten-containing grains or ingredients derived from gluten-containing grains that have not been processed to remove gluten, and any unavoidable presence of gluten is at less than 20 ppm); and 
2. Records demonstrating that the manufacturer has adequately evaluated the potential for gluten cross-contact, and demonstrating the implementation of preventive measures if the potential for cross-contact is identified.

As noted, the FDA does not require that manufacturers make or keep any specific type of record to satisfy either requirement, so there is inherent flexibility for manufacturers to determine the appropriate types of records to either create or maintain from suppliers. Electronic records may be kept to satisfy the requirements of the final rule, but are not required; if electronic records are kept, they must comply with the FDA’s regulations at 21 CFR Part 11. All records must be kept for at least two years after the introduction or delivery for introduction of the food into interstate commerce per 21 CFR 101.91(c)(4). Below we provide a summary of the FDA’s examples of the types of records that could be used to satisfy each of the recordkeeping requirements.

Records demonstrating the food or ingredients are Gluten-Free prior to hydrolysis or fermentation

The FDA recognizes that the records kept to provide adequate assurance the ingredients/food were gluten-free prior to fermentation or hydrolysis a will vary based on the degree of likelihood of cross-contact, but underscores that this assessment must be undertaken for all fermented and hydrolyzed foods bearing a “gluten-free” claim, even if the starting ingredients are inherently gluten-free. The FDA states:

"For example, a manufacturer of fermented or hydrolyzed foods from non-gluten-containing grains, legumes, or seeds that are susceptible to cross-contact with gluten-containing grains bearing the “gluten-free” claim may choose to obtain a CoA from the ingredient suppliers or test the ingredients before fermentation and maintain records of the test results. A manufacturer of products bearing the “gluten-free” claim made from inherently gluten-free ingredients, such as milk, or fruit, that have low probability of cross-contact with gluten-containing grains may be more likely to use other appropriate verification documentation."⁵ 

The FDA lists the following as examples of appropriate records to satisfy the first set of recordkeeping requirements: test results, certificates of analysis (CoAs), or “other appropriate verification documentation for each of the ingredients used in the food.”⁶ Appropriate records could also include test results on the food itself, rather than the ingredients, before fermentation or hydrolysis. The FDA confirms in the preamble that the final rule does not require ingredient testing.⁷ However, the FDA also states that it would expect manufacturers as a part of their routine operations, to test their food or ingredients with sufficient frequency to ensure that the gluten level in the food or in each ingredient is below 20 ppm before fermentation or hydrolysis.⁸ The agency also states that “alternatively,” manufacturers can rely on records from suppliers, such as CoAs, to determine each ingredient is below 20 ppm gluten. The FDA also provides that “for ingredients received from outside suppliers, manufacturers may document a visit to a supplier’s facility, a review of supplier’s records, or a review of written documentation from a supplier to verify the gluten-free status of these ingredients prior to hydrolysis or fermentation.”⁹    

Records of evaluation for potential cross-contact with Gluten and implementation of preventative measures

The manufacturer of any fermented or hydrolyzed food bearing a “gluten-free” claim must make and keep records demonstrating adequate assurance that the manufacturer has “adequately evaluated their processing for any potential for gluten cross-contact,” and, if such potential is identified, records demonstrating adequate assurance that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process.”¹⁰  

The assessment of the manufacturer’s processing for potential gluten cross-contact entails a case-by-case evaluation of the manufacturing process to determine if there is a known or reasonably foreseeable risk of cross-contact with gluten-containing grains. The FDA is clear in the final rule preamble that the potential for cross-contact needs to be evaluated for all fermented ingredients bearing a “gluten-free” claim, even if the food is gluten-free prior to fermentation, because the agency “cannot exclude the possibility that the food could be exposed to gluten due to cross-contact.”¹¹ One comment requested that the FDA require records to support a “gluten-free” claim on a fermented or hydrolyzed food only when the potential presence of gluten or gluten-containing grains was “known or reasonably likely,” mirroring the FDA’s hazard analysis requirements.¹² The FDA rejected this request, making a distinction between the standard for a food safety hazard analysis, and that for the gluten free final rule.¹³ Therefore, even if the outcome of the manufacturer’s assessment of its processing for potential gluten cross-contact is that cross-contact with gluten is not known or reasonably likely, the manufacturer must still maintain records documenting this assessment. If such a potential is identified, the manufacturer must keep records to demonstrate that measures have been implemented to prevent the introduction of gluten into the food during the manufacturing process.  

The FDA states that the manufacturer is best-suited to undertake this assessment of potential gluten cross-contact and implement preventative measures, but that the supporting records could include: 

• Records of test results conducted by the manufacturer or an ingredient supplier, CoA, or other appropriate verification document for the food itself or each of the ingredients used in the food; or 
• Information on growing practices and product segregation.

The FDA was asked to clarify whether “documentation providing general information on the commodity and regional growing practices in countries of origin would be sufficient to meet the ‘gluten-free’ claim requirements”, and the FDA responded that the agency “would accept information on growing practices and product segregation as records to meet the requirements of this final rule.”¹⁴ 

Compliance date and updates to methods to detect Gluten in fermented or hydrolyzed foods

The effective date of the rule is October 13, 2020, but the compliance date is August 13, 2021.¹⁵ The FDA states that once the agency identifies a scientifically valid method that can accurately detected and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for a food manufacturer to make and keep these records to support the “gluten-free” claim, and FDA would identify such a change through a guidance document or other appropriate means, such as changing the regulations, if warranted.¹⁶

If you have any questions on the records required to support a “gluten-free” claim on a fermented or hydrolyzed food, or any other matter, please do not hesitate to contact us.

References 

¹ FDA Final Rule, Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods, 85 Fed. Reg. 49240 (Aug. 13, 2020). 

² 21 CFR § 101.91; see also FDA Final Rule, Food Labeling; Gluten-Free Labeling of Foods, 78 Fed. Reg. 47154 at 47165 (Aug. 5, 2013). 

³ Final rule at 21 CFR § 101.91(c)(2).

⁴ 85 Fed. Reg. 49240 at 49241-42.

⁵ Id. at 49244.  

⁶ 85 Fed. Reg. 49240 at 49245.

⁷ Id.

⁸ Id. at 49245. 

⁹ Id.

¹⁰ 21 CFR § 101.91(c)(2)(ii)-(iii). 

¹¹ Id. at 49245. 

¹² Id. at 49250. 

¹³ Id. 

¹⁴ Id. at 49244-49245 (emphasis added).

¹⁵ Id. at 49254; see also final rule correction (to be published in September 9, 2020 Federal Register) correcting the effective date to October 13, 2020. https://s3.amazonaws.com/public-inspection.federalregister.gov/2020-19569.pdf 

¹⁶ 85 Fed. Reg. 49240 at 49249. 

Authored by Martin Hahn, Veronica Colas, and Samantha Dietle.