FDA Issues New Gluten-Free Labeling Rule
Posted in Legal Bites
FDA Issues New Gluten-Free Labeling Rule

The FDA recently published a final rule to establish requirements for “gluten-free” labeling for fermented, hydrolyzed and distilled food.  The rule will go into effect on October 13, 2020, with a compliance date of August 13, 2021.

Federal regulations define the term “gluten-free” to mean that the food bearing the claim does not contain: (1) an ingredient that is a gluten-containing grain; (2) an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten; or (3) an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or inherently does not contain gluten, and that any unavoidable presence of gluten in the food is below 20 ppm gluten. A food that bears the claim “no gluten,” “free of gluten” or “without gluten” in its labeling and fails to meet the requirements for the “gluten-free” claim will be deemed to be misbranded.

This final rule amends the regulation to provide alternative means for the FDA to verify compliance based on records that are maintained by the manufacturer of the fermented or hydrolyzed food bearing the “gluten-free” claim and made available to us for inspection and copying.

The new rule covers foods such as yogurt, sauerkraut, pickles, cheese, green olives, FDA-regulated beers and wines, and hydrolyzed plant proteins used to improve flavor or texture in processed foods such as soups, sauces and seasonings. This rule does not change the definition of "gluten-free" but establishes compliance requirements for these specific categories of foods.

The regulation does not require manufacturers to place the voluntary "gluten-free" claim in any specific location on the food label. Manufacturers may choose where they place a "gluten-free" claim on their food labels, provided that the claim does not interfere with other FDA-required labeling information and meets all other applicable statutory and regulatory requirements.

Any food product bearing a “gluten-free” claim must comply with FDA regulations and will be subject to FDA inspections and testing. 

The FDA claims that the uniform definition and required conditions for its use will allow consumers with celiac disease to choose foods with greater confidence.

The FDA has provided questions and answers on the labeling here.

  • Pooja S. Nair
    Partner

    Pooja S. Nair is a business litigator and problem solver with a focus on the food and beverage sector. She advises food and beverage clients, startups and other businesses on a comprehensive range of issues, including employment ...

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