The 13 August 2021 compliance date for the U.S. Food and Drug Administration’s (FDA) final rule1 establishing recordkeeping requirements for foods bearing “gluten-free” claims that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients is approaching. Because of the resources needed to establish these records, we encourage manufacturers to start planning now to ensure compliance by August.
Although foods that are fermented, hydrolyzed, or contain fermented or hydrolyzed ingredients remain subject to the same substantive standard for “gluten-free” claims as other foods generally2, the FDA has established an alternate method of compliance with the “gluten-free” standard for fermented and hydrolyzed ingredients and foods focused on recordkeeping based on the lack of scientifically valid test methods to reliably detect and quantify the presence of 20 ppm gluten in fermented and hydrolyzed foods or ingredients.3 Importantly, in addition to finished foods that are fermented or hydrolyzed, the FDA’s final rule captures any food bearing a gluten-free claim that contains a fermented or hydrolyzed ingredient even if the finished food is not itself fermented or hydrolyzed, such as a product containing chocolate derived from fermented cocoa beans or a snack product containing cheese.
FDA recordkeeping requirements for “gluten-free” fermented or hydrolyzed foods and ingredients
The FDA’s new rule establishes that in order to support a gluten-free claim on fermented and hydrolyzed foods or foods containing fermented or hydrolyzed ingredients, a manufacturer must make and keep records demonstrating adequate assurance that:
- The food is “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 less than 20 ppm);
- The manufacturer has adequately evaluated their processing for any potential for gluten cross-contact; and
- 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.
Examples of foods and ingredients that would trigger the FDA’s recordkeeping requirements (if in a finished product bearing a “gluten-free” claim) include, but are not limited to, cheese, yogurt, vinegar, sauerkraut, pickles, green olives, beer, malt beverages, wine, hydrolyzed plant proteins used to improved flavor or texture in processed foods, cocoa beans that are fermented after harvest, and enzymes.
The FDA’s final rule prescribes what the records must show, not the form the records must take. There is inherent flexibility for manufacturers to determine appropriate types of records to either create or maintain from suppliers in order to comply with the FDA’s rule. For a more detailed summary of examples of records FDA stated would satisfy the requirements of the final rule, see our previous post here.
Although the rule is not overly prescriptive with respect to the specific type of records that must be kept, the resources needed to collect and maintain these records could be substantial. Depending on the number of hydrolyzed or fermented ingredients a manufacturer uses in its “gluten-free” foods or foods that are fermented or hydrolyzed and labeled as “gluten-free,” there could be a significant number of suppliers or entities in the supply chain to connect with and receive documentation from, or review existing documentation to determine whether sufficient to satisfy the FDA’s requirements for purposes of this rule.
We will continue to monitor developments regarding “gluten-free” claims. If we can provide any assistance regarding compliance with these or other requirements, please contact us.