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FDA Issues New Rules on Gluten Labeling

The U.S. Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it “gluten- free,” “without gluten,” “free of gluten” and “no gluten.”  The rule applies to all FDA-regulated alcohol beverages, which include wines (and ciders) below 7 percent alcohol by volume, and malt beverages that are not made with both barley and hops; but does not apply to alcohol beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops.  The notice includes a commitment by the FDA to work with TTB to harmonize labeling issues.  The two agencies consult as needed under an interagency Memorandum of Understanding, and TTB may develop new guidance based on the FDA final rule.

For brewers, FDA intends to issue a proposed rule on gluten-free labeling of hydrolyzed and fermented foods (like beer).  This rule will address compliance when analytical methods are not available because the food is fermented or hydrolyzed or contains fermented or hydrolyzed ingredients.  FDA intends to address the “gluten-free” labeling of beers subject to FDA’s labeling requirements in that proposed rule.

In light of this, FDA will exercise enforcement discretion with respect to the requirements for “gluten-free” labeling for beers subject to FDA labeling requirements.  This will extend to beers that currently make a “gluten-free” claim and that are:  (1) made from a non-gluten-containing grain or (2) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten.  This enforcement discretion pertains only to these beers subject to FDA labeling requirements that make a “gluten-free” claim as of August 5, 2013 pending completion of the rulemaking process with respect to fermented or hydrolyzed products.  To the extent that a beer manufacturer wants to make a new gluten-free claim that is not present on a label as of August 5, 2013, they should contact FDA regarding the possible expansion of FDA’s consideration for the exercise of enforcement discretion related to such labeling.

FDA expects beer manufacturers using a “gluten-free” claim to take appropriate measures to prevent cross-contact with gluten-containing grains during production, processing, storage or other handling practices.  Last, FDA notes that beer manufacturers whose beers are subject to FDA’s labeling requirements can make claims about the beer being processed to reduce gluten provided such statements are truthful and not misleading.  FDA cites as examples the statements in TTB’s interim policy on gluten content statements (“Product fermented from grains containing gluten and [processed or treated or crafted] to remove gluten.  The gluten content of this product cannot be verified, and this product may contain gluten.”)

For those interested in the application of FDA’s final rule to gluten-free claims about other FDA-regulated products, one of the criteria for using the claim “gluten-free,” is a gluten limit of less than 20 parts per million (ppm) in the food.

Gluten means the proteins that occur naturally in wheat, rye, barley and crossbreeds of these grains and that may cause adverse health effects in persons with celiac disease.

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:

  1. an ingredient that is any type of wheat, rye, barley or crossbreeds of these grains;
  2. an ingredient derived from these grains and that has not been processed to remove gluten; and
  3. an ingredient derived from these grains and that has been processed to remove gluten, if the use of that ingredient results in the food containing 20 or more parts per million (ppm) gluten.

Labels for foods such as bottled spring water, fruits and vegetables, and eggs can state “gluten-free” if they inherently do not have any gluten.

The FDA regulation also preempts States and subdivisions from establishing any law or regulation that differs from FDA’s requirements for the definition and use of the claim “gluten free,” “no gluten,” “free of gluten” and “without gluten.”   The rule is scheduled to take effect in one year, i.e., in or about August, 2014.

Finally, as noted, FDA has said that it will continue to work with TTB and the U.S. Department of Agriculture (USDA) on the issue of gluten-free food labeling to harmonize the requirements for foods labeled gluten-free among the agencies whenever possible.

© 2020 McDermott Will & Emery

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About this Author

Marc E. Sorini Alcohol Distribution Attorney McDermott Will law firm
Partner

Marc E. Sorini is a partner in the law firm of McDermott Will & Emery LLP and is based in the Washington, D.C. office.  He heads the Firm’s Alcohol Regulatory & Distribution Group, where he focuses on regulatory and litigation issues facing the alcohol beverage industry and non-beverage alcohol users.

Marc's alcohol beverage practice covers licensing, labeling, advertising, trade practices, distribution, import-export, formulation and excise taxation.  He has represented alcohol beverage suppliers before federal and state courts, the Alcohol &...

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Arthur R. Rosen, Tax Planning Litigator, McDermott Will Emery, New York Law Firm
Partner

Arthur R. Rosen is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s New York office. His practice focuses on tax planning and litigation relating to state and local tax matters for corporations, partnerships and individuals. Formerly the Deputy Counsel of the New York State Department of Taxation and Finance, as well as Counsel to the Governor’s Temporary Sales Tax Commission and Tax Counsel to the New York State Senate Tax Committee, Mr. Rosen has held executive tax management positions at Xerox Corporation and AT&T. In addition, he has worked in accounting and law firms in New York City.

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Christopher Lahiff, Attorney, McDermott Law Firm
Partner

Christopher M. Lahiff is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Washington, D.C. office.  He focuses his practice on matters regarding the regulation of pesticides by the U.S. Environmental Protection Agency as well as of food by the Food and Drug Administration and the U.S. Department of Agriculture.

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