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FDA Releases Final Rule for Voluntary “Gluten-Free” Labeling

FDA has released a final rule defining “gluten-free” for voluntary labeling programs. Manufacturers will have one-year after the date of publication (August 5, 2013) of the rule to bring package labels into compliance.  The final rule defines “gluten-free” as meaning that the food either is inherently gluten free; or does not contain an ingredient that is:

1)      a gluten-containing grain (e.g., spelt wheat);
2)      derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or
3)      derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.

Also, any unavoidable presence of gluten in the food must be less than 20 ppm.  The Final Rule’s “Gluten-Free” definition appears to be unchanged from a Proposed Rule defining Gluten-Free was originally released in 2007 and re-opened for comment in August 2011.

Please see the following FDA links related to the final rule:
FDA Press Release on Gluten-Free Labeling Final Rule
FDA Q&A on Gluten-Free Labeling Final Rule
FDA Final Rule on Voluntary Gluten Free Labeling
Source: FMI

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