FDA Issues Final Rule On Meaning and Use of “Gluten-Free” Claims – Some Fermented Beverages Will Get Clarification Later

The FDA’s
recent publication of a final rule defining “gluten-free”
for voluntary
food labeling provides some finality to those wondering whether the 20 parts
per million (ppm) level proposed for product qualification in using terms like “gluten-free”
would become the mandated level – it has.

In addition to
limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow
manufacturers to label a food “gluten-free” if the food does not
contain any of the following:

ingredient that is any type of wheat, rye, barley, or crossbreeds of these

ingredient derived from these grains and that has not been processed to remove

ingredient derived from these grains and that has been processed to remove
gluten, if it results in the food containing 20 or more ppm gluten

such as bottled spring water, fruits and vegetables, and eggs can also be
labeled “gluten-free” if they inherently don’t have any gluten.

Under the new rule, a food label that bears the claim
“gluten-free,” as well as the claims “free of gluten,”
“without gluten,” and “no gluten,” but fails to meet the
requirements of the rule would be considered misbranded and subject to
regulatory action by FDA.

The compliance date for the foods labeled gluten-free to
meet the rule’s requirements is one year from the rule’s publication.  While the FDA has said that it will be issuing separate guidance on testing methods for fermented foods, it is unlikely that this separate guidance would include some drastic difference from the definitions set forth in this rule.

on the FDA’s website
promises that the FDA will work with the TTB and USDA
to harmonize labeling requirements.

As stated above regarding a mentioned additional rule for fermented foods (see Comment 15 and the Response to Comment 15 in the Federal Register (linked above))  there’s no word yet on whether this ruling changes any of the
requirements in the TTB’s
2012-2 ruling: Interim Policy on Gluten Content Statements in the Labeling and
Advertising of Wines, Distilled Spirits, and Malt Beverages
 – especially the requirements for providing
assay results with label approval applications for products wanting to make
claims that they were “Processed or Treated or Crafted” to remove gluten – which appear to be a driving factor in Comment 15 and its response.  The Comment and Response does say that at least for FDA Labeling governed beers, there will be further guidance in the fermented foods ruling… this may hold true for other FDA governed fermented beverages as well.

Ashley Brandt

Hi there! I’m happy you’re here. My name is Ashley Brandt and I’m an attorney in Chicago representing clients in the Food and Beverage, Advertising, Media, and Real Estate industries. A while back I kept getting calls and questions from industry professionals and attorneys looking for advice and information on a fun and unique area of law that I’m lucky enough to practice in. These calls represented a serious lack of, and need for, some answers, news, and information on the legal aspects of marketing and media. I've got this deep seeded belief that information should be readily available and that the greatest benefit from the information age is open access to knowledge... so ... this blog seemed like the best way to accomplish that. I enjoy being an attorney and it’s given me some amazing opportunities, wonderful experiences, and an appreciation and love for this work. I live in Chicago and work at an exceptional law firm, Goldstein & McClintock, with some truly brilliant people. Feel free to contact me at any time with any issues, comments, concerns… frankly, after reading this far, I hope you take the time to at least let me know what you think about the blog and how I can make it a better resource.

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