A final rule issued by the Food and Drug Administration (FDA), effective August 5, 2014, sets forth a new national standard for the voluntary labeling of food as “gluten-free.” The final rule is intended to benefit the estimated 3 million Americans with celiac disease, a chronic inflammatory disorder of the small intestines triggered by the ingestion of gluten. Continued exposure to gluten can lead to a wide variety of serious health problems in individuals with celiac disease.
Definition of “Gluten-Free” Food
The FDA’s final rule defines “gluten” as the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease. A “gluten-containing grain” is defined as wheat, rye, barley, or their crossbred hybrids (such as triticale, which is a cross between wheat and rye).
A food claimed to be “gluten-free” on its label must not contain an ingredient that is:
·a gluten-containing grain;
·derived from a gluten-containing grain that has not been processed to remove gluten; or
·derived from a gluten-containing grain 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.
"Gluten-free" claims can also appear on the labels of food that inherently do not contain gluten, such as bottled spring water or fresh fruits and vegetables. However, any unavoidable presence of gluten in a food labeled “gluten-free,” whether the food is inherently free of gluten or is made “gluten-free,” must be below 20 ppm gluten. If a food contains 20 ppm or more gluten as a result of cross-contact with gluten-containing grains or other gluten-containing ingredients, it cannot be claimed to be “gluten-free.”
Under the FDA’s final rule, only foods with less than 20 ppm gluten comply with the definition of “gluten-free.” Twenty ppm was selected as the limit because it is the lowest level of gluten that can be reliably detected using scientifically validated analytical methods. Twenty ppm is equivalent to 20 milligrams of gluten per 1 kilogram of food.
Even if a food contains less than 20 ppm gluten, it cannot be labeled “gluten-free” if it is made with any amount of a gluten-containing grain or an ingredient derived from such grain that has not been processed to remove gluten. The FDA’s goals are for “gluten-free” food not to contain any gluten or to contain the lowest amount possible that is less than 20 ppm gluten, and to limit consumers’ confusion as they read the listed ingredients of foods labeled “gluten-free.”
21 C.F.R. Section 101.91, entitled “Gluten-Free Labeling of Foods;” Federal Register, Vol. 78, No. 150, August 5, 2013, Gluten-Free Labeling of Foods Final Rule, available at http://www.gpo.gov/fdsys/pkg/FR-2013-08-05/pdf/2013-18813.pdf. For convenience, the regulation is referred to in this Industry Insight as the FDA’s “final rule.”
Relevance of the “Gluten-Free” Final Rule to Restaurants
The FDA’s final rule technically applies to all FDA-regulated packaged foods, including items sold in packaged form by restaurants. It does not apply to meat, poultry, or egg products regulated by the U.S. Department of Agriculture, or to alcoholic beverages regulated by the U.S. Treasury’s Alcohol and Tobacco Tax and Trade Bureau.
Given the public health significance of “gluten-free” labeling, the FDA says that restaurants making a “gluten-free” claim about their menu and menu board items should be consistent with the requirements of the final rule, even though those items are not in packaged form. The FDA plans to work with the state and local regulators that oversee restaurants to support education and outreach on the appropriate use of the claim “gluten-free” for such restaurant food items.
Key Features of the “Gluten-Free” Final Rule
·Labeling food as “gluten-free” is voluntary: The FDA’s final rule does not require the use of the term “gluten-free” on a food label. If a food subject to the final rule is voluntarily labeled as “gluten-free,” then it must comply with the final rule’s requirements. The FDA believes that voluntary use of the “gluten-free” claim will clearly identify for consumers those foods that meet the FDA’s “gluten-free” standard, and create a level playing field for the sale of those foods.
·Permitted equivalents to “gluten-free” claim: A label stating that a food is “free of gluten,” has “no gluten,” or is “without gluten” must meet all of the requirements for a “gluten-free” claim contained in the FDA’s final rule. The final rule treats all three of these terms as synonymous with the claim “gluten-free.”
The final rule does not define the terms “low gluten” or “very low gluten.” The FDA discourages the use of these claims, and intends to evaluate these claims on a case-by-case basis to ensure that they are truthful and not misleading.
·Other statements about gluten: Statements such as “made with no gluten-containing ingredients” or “not made with gluten-containing ingredients” are not prohibited on food labels, so long as the statements are truthful and not misleading. However, the label of the food that bears any such statements must also state that it is “gluten-free” in order for a consumer to rightly assume that the food meets the standards of the FDA’s final rule.
·Additional language for wheat: Food that bears a “gluten-free” claim (or the permitted equivalent terms listed above) and that also (i) lists wheat as an ingredient, or (ii) states on its label that it “contains wheat” must add an asterisk or other symbol after the word “wheat” that is linked to this nearby statement: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”
·Gluten cross-contact: This phrase is not defined in the FDA’s final rule. Gluten cross-contact generally refers to the unavoidable presence of gluten in a food due to contact with a gluten-containing food (wheat, rye, barley, or their crossbred hybrids).
·No required formats: The FDA’s final rule does not require a “gluten-free” claim to be presented in any particular type size or color, or in any particular location, on a food label. There is no required symbol or third-party certification logo for “gluten-free” claims under the final rule, nor any requirement as to where such a logo should appear. The logo of a gluten-free certification program can be utilized, so long as its use is truthful and not misleading and otherwise complies with FDA labeling requirements.
·No mandated testing or recordkeeping: There is no specific method required by the FDA’s final rule to determine that gluten levels in a food do not exceed the FDA’s 20 ppm threshold. No analytical testing or recordkeeping is required by the final rule, but food bearing a “gluten-free” claim must meet its requirements. To ensure compliance with the final rule, recommended practices include as necessary:
Analyzing food or food ingredients for gluten, whether in–house or through employment of a third-party laboratory,
Obtaining gluten analysis certificates from suppliers of ingredients,
Participating in a third-party gluten-free certification program, and/or
Documenting processes for preparing gluten-free items (i.e., maintaining records of gluten analysis or certificates, developing protocols and procedures for preventing cross-contact, implementing staff training, analyzing results of gluten testing, etc.) in case there is any question about a food item labeled “gluten-free.”
·Preemption: The FDA’s final rule preempts state and local requirements to the extent that they define and permit the use of the claim “gluten-free” or the permitted equivalent terms listed above. Other state or local labeling requirements concerning statements or warnings about gluten are not preempted by the final rule.
Additional FDA Rulemaking
The FDA plans to issue a proposed rule to address fermented or hydrolyzed foods or foods which contain fermented or hydrolyzed ingredients (for which there are no scientifically valid methods for measuring compliance with the FDA’s 20 ppm gluten threshold) as well as gluten-free labeling of beer.
Legal Considerations for Restaurants Making “Gluten-Free” Claims
A packaged food product labeled “gluten-free” that fails to comply with the FDA’s final rule would be deemed misbranded under the Federal Food, Drug, and Cosmetic Act, which is enforced by the FDA and by California through its Sherman Food, Drug and Cosmetic Law. The final rule is technically not applicable to unpackaged restaurant food such as menu and menu board items. However, the FDA has stated that it will monitor any reported information about unpackaged food claimed to be “gluten-free,” such as food served in restaurants, and share any complaints received about such food with its state and local government partners.
When packaged food labels are challenged by consumers as false and misleading, the cases are frequently litigated under California’s unfair competition, false advertising, and consumer legal remedies statutes and accompanying common law theories. Those cases demonstrate the courts’ reliance on guidance, letters, and other information from the FDA in evaluating challenges to claims made about food. It is too early for a customer to have challenged a “gluten-free” claim made about an unpackaged restaurant menu or menu board item and for a court to have evaluated the legal theories for such a challenge. The FDA’s final rule could in any event provide a court with a standard by which to evaluate a “gluten-free” claim about a restaurant menu or menu board item.
The FDA’s final rule may also be relevant to a restaurant’s compliance with the federal Americans with Disabilities Act (ADA). Under the 2008 amendments to the ADA, a food allergy or sensitivity that substantially limits a major life activity such as eating or a major bodily function may qualify as a disability under the ADA. Although there are no court cases directly addressing celiac disease, the U.S. Department of Justice (DOJ) addressed celiac disease in a December, 2012 settlement with Lesley University. The DOJ’s guidance about the settlement states that individuals with food allergies who have significant or severe responses to certain foods, including those with celiac disease, have a disability under the ADA. The settlement required gluten-free and allergen-free food to be made available to students with celiac disease and food allergies and required other changes to assist students with celiac disease and food allergies to participate in the mandatory school meal plan.
A public accommodation such as a restaurant is required by the ADA to make reasonable modifications for a customer with a disability, but it is not required to fundamentally alter the nature of its services. In the guidance about the Lesley University settlement, the DOJ made the distinction between the ADA obligations of a university with a mandatory school meal plan and those of a restaurant that serves the general public. The DOJ observed that the ADA does not require every restaurant serving food to the public to provide gluten-free or allergen-free food, to change its menu, or to provide different foods for particular dietary needs.
Rather, in order to accommodate customers with celiac disease or food allergies rising to the level of a disability under the ADA, a restaurant may have to take reasonable steps such as answering questions from customers about menu or menu board item ingredients, or omitting or substituting certain ingredients upon request if the restaurant usually does this for other customers. Another reasonable step might be preparation of a “gluten-free” menu or menu board item. In the event that a customer with celiac disease contended that he or she has a disability under the ADA and challenged the reasonableness of a restaurant’s modifications to its services, a court could rely on the FDA’s final rule to evaluate whether the restaurant had prepared a “gluten-free” food item for that customer.
Labeling food as “gluten-free” is voluntary. Neither packaged food nor unpackaged restaurant menu and menu board items are required to be labeled “gluten-free.” Food items regulated by the FDA, sold in packaged form by a restaurant, and labeled “gluten-free” must comply with the final rule. For the reasons outlined above, it is advisable that a restaurant also comply with the final rule when it claims that a menu or menu board item is “gluten-free,” even though the final rule does not technically apply to unpackaged restaurant food.
Additional information about “gluten-free” labeling is available on the FDA’s website, which is www.fda.gov.The advice of competent legal counsel should be obtained, as needed, for specific wordings and situations. This report should not be viewed as legal advice or as a legal opinion of any kind.
This report was prepared by Tour-Sarkissian Law Offices, LLP.
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