FDA Posts Guidance for Small Businesses on 'Gluten-Free' Labeling Claims
The Food and Drug Administration recently finalized a new guide to assist small businesses in compliance with the agency’s gluten labeling regulations. FDA’s rule on labeling food “gluten-free” only allows foods that do not contain gluten or that contain less than 20 ppm of gluten to make the claim (see 13080213). Compliance with the new requirements is required by Aug. 5, after which any foods that are mislabeled “gluten-free” will be considered by FDA to be misbranded.
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According to the guidance, the rule does not require testing to ensure that a food labeled “gluten-free” is under the 20 ppm threshold. But the labeler is required to ensure that any foods that make the gluten-free claim meet FDA’s requirements, and testing is one way to achieve that. The guidance cites “certain enzyme-linked immunosorbent assay” (ELISA) based methods as an example of a reliable method for testing whether gluten content is below 20 ppm. FDA also said labelers can request certificates of gluten analysis from ingredient suppliers or participate in a third-party gluten-free certification program.
FDA says it discourages use of claims other than gluten-free like “low gluten” or “very low gluten,” which are not defined by agency regulations. If such claims are used, FDA will evaluate them on a case-by-case basis to determine whether the claim is truthful and not misleading, it said.