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On Aug. 5, 2013, the Food and Drug Administration (FDA) issued a final rule defining the labeling requirements for a product claiming to be “gluten-free.” Manufacturers will have one year from the date of issuance to ensure their labels are compliant. Although the FDA has provided limited guidance concerning “gluten-free” claims in the past, the publication of this final rule marks the first time manufacturers and consumers will have a definitive regulatory definition of the term “gluten-free.”
Background
“Gluten” refers to proteins that can be found in wheat, barley, rye and similar grains. Gluten-free products and the proper labeling of such foods are important to individuals suffering from celiac disease, who are at risk for health problems if they consume gluten. In its commentary surrounding the new rule, the FDA expressed concern that “different and inconsistent amounts of gluten in foods with 'gluten-free' labeling result in the inability of those individuals with celiac disease who adhere to a gluten-free diet to avoid exposure to gluten at levels that may result in adverse health effects.”
The Food Allergen Labeling and Consumer Protection Act of 2004 gave the Secretary of Health and Human Services the authority to “define and permit the use of” the food-labeling term “gluten-free.” In 2007, the FDA issued a proposed rule defining “gluten-free” and allowing for the term's voluntary use on food labels. The subsequent comment period elicited numerous inquiries and requests for developing a standard, national definition of “gluten-free.”
Pursuant to the new FDA rule, products claiming to be “gluten-free” must contain less than 20 ppm (parts per million) of gluten. Scientific tests cannot reliably detect gluten levels below this threshold, which is why the standard level of 20 ppm was chosen. Most individuals with celiac disease are able to tolerate foods with this trace amount of gluten. The FDA also explained that using a more stringent definition of “gluten-free” would result in the removal of many food items from the market that satisfy the less than 20 ppm standard, and would discourage the introduction of new “gluten-free” products that could not meet the gluten limit. The FDA considers reducing the widespread availability of “gluten-free” foods to be “detrimental” to individuals with celiac disease “who are already challenged by the complexities of adhering long term to a gluten-free diet.”
The Guidelines
Manufacturers will also be able to use “gluten-free” on their labels if the food does not contain: 1) any ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains; 2) any ingredient derived from these grains that has not been processed to remove gluten; and 3) any ingredient derived from these grains that has been processed to remove gluten, if it results in the food containing 20 or more ppm gluten. Foods which, by nature, do not contain any gluten, such as fruits, vegetables and bottled spring water, may make the claim “gluten-free” as well, without having to include any qualifying language. Foods making the claims “without gluten,” “no gluten,” and “free of gluten” must also adhere to these guidelines.
Very few of the other items in the 2007 proposed rule were included in the final rule. For example, the FDA declined to define the terms “low-gluten,” “very-low gluten,” or other tiered labeling claims because the agency determined that there was no scientific basis for these claims. Additionally, the final rule specified no technical requirements for gluten-free labeling statements, including size, conspicuousness, or placement of the statement. The FDA also explicitly declined to establish the use of any universal symbol, logo, or standardized print format to identify a gluten-free food. Impact on Litigation
Litigation and Regulatory Action
In the past, once the FDA has sent a warning letter to a manufacturer to take corrective action concerning product labeling, consumers have filed private suits on the basis of this action. Litigation concerning food labeling claims has been especially prevalent in states with consumer-friendly false advertising laws, such as California and New Jersey.
The new FDA rule likely will help protect manufacturers from many of these consumer lawsuits because they now have a threshold level of gluten that may still legally be allowed in a product. Therefore, even if gluten is found in a product marketed as “gluten-free,” so long as that trace amount is less than 20 ppm, consumers should not be able to bring false advertising claims against the food manufacturer.
Nevertheless, because there is a final rule by the FDA setting the threshold gluten level, manufacturers would be unwise to skirt this rule and label their products as “gluten-free” if indeed they contained more than 20 ppm of gluten. The FDA also discourages making claims on labeling about the gluten content of foods other than the approved terms and would evaluate any and all statements under the sections on misbranding of the Food, Drug, and Cosmetic Act (sections 403(a)(1) and 201(n)).
If manufacturers are in violation of these rules, the FDA may consider the products to be misbranded and take regulatory action against offending companies. In addition, if a food label claims that the product is “gluten-free” but uses the term “wheat” in its ingredient list or has a separate “contains wheat” statement on the label, it will be deemed misbranded unless its labeling “also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a 'gluten-free' claim.”
In terms of monitoring gluten levels, the FDA does not mandate that manufacturers use a specific test or methodology to determine whether their products contain gluten levels of 20 ppm. The FDA concluded that by requiring a specific analytical method in the final rule, manufacturers would be deterred from developing new and advanced testing methodologies. However, the FDA did note that it will employ two enzyme-linked methods to monitor compliance: 1) R-Biopharm: Food and Feed Analysis; and 2) Morinaga Institute of Biological Science: Wheat Protein ELISA Kit (Gliadin).
Moreover, pursuant to the final rule, manufacturers may develop their own analytical tools for determining gluten content and whether gluten levels fall below the 20 ppm threshold. Manufacturers may also use third-party organizations to certify or otherwise verify the gluten content of their foods to confirm that their “gluten-free” products do indeed meet the standard definition of “gluten-free.” Companies wishing to go through the certification process may do so voluntarily; the FDA final rule does not mandate this.
Preemption of State Law
The FDA has also made clear that its new rule preempts any state law defining the limits of gluten to be contained within a product. Section 101.91(d) of the new rule declares that a “State or political subdivision of a State may not establish or continue into effect any law, rule, regulation, or other requirement that is different from the requirements in” 101.91 for the definition and use of the term 'gluten-free,' as well as the terms 'no gluten,' 'free of gluten,' or 'without gluten.'”
Pursuant to the Supremacy Clause of the U.S. Constitution, “state laws that interfere with or are contrary to Federal law are invalid.” Further, if the preemptive action is within the scope of an agency's delegated authority and represents a “reasonable accommodation of conflicting policies that were committed to the agency's care,” preemption is warranted. See United States v. Shimer, 367 U.S. 374, 383 (1961). Here, different state requirements concerning “gluten-free” and its related claims would be “contrary to the Congressional directive for [FDA] to define and permit use of the term 'gluten-free.'” Thus, even if a state has a threshold lower than 20 ppm of gluten for foods to be considered “gluten-free,” manufacturers would still be protected by the FDA's rule setting the standard at 20 ppm, and their labeling claims should not be considered misbranding.
In addressing the preemption issue, the FDA noted the need for “national uniformity” in the meaning of the term “gluten-free.” The agency remarked that if states established multiple definitions of what it means to be “gluten-free,” individuals with celiac disease “would not be able to rely on that term to understand the amount of gluten the food may contain and thereby use the term to identify appropriate dietary selections.”
Standardizing the term “gluten-free” prevents consumer confusion and allows those with celiac disease to make educated purchasing choices. Preemption would also occur with respect to labeling language concerning gluten if a state requirement is “found to obstruct the federal purpose articulated in this rule.
Despite this language, it should be noted that preemption has proven to be a thorny issue in the past for other similar labeling claims. There exist other FDA regulations that allow manufacturers to round down nutrient values to zero, despite the presence of small amounts of the nutrient (e.g., if a serving contains less than 0.5 g of trans fat, the content, when declared, can be expressed as zero). This has prompted several state law suits that argue labeling claims such as “0 g Trans Fat” are inherently misleading to consumers when, in fact, the product contains some trans fat. Similar issues may also arise around “gluten-free” labeling claims, where products do, in fact, contain small traces of gluten (but less than 20 ppm). Although the final rule establishes a federal limit of 20 ppm, there are no absolute assurances that all gluten-related state claims will be preempted by this new federal law.
Also, according to the final rule, preemption may arise if a state or local requirement is found to obstruct the federal purpose of the rule, but state or local requirements are only preempted to the extent that they are different from the rule's requirements. In order to ensure that consumers ' particularly those who suffer from celiac disease ' have confidence to identify and purchase gluten-free products, state requirements could not change the 20 ppm threshold or otherwise establish different requirements related to the use of the terms “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” However, this does not mean that additional state or local labeling requirements or warning statements would be preempted. For example, a state could require a statement about the health effects of gluten consumption on persons with celiac disease or information regarding processing methods.
Additionally, not all state laws regulating gluten are automatically preempted by this final rule. The FDA further explained that the rule preempts state law narrowly and only applies to the terms “gluten-free,” “no gluten,” “free of gluten,” and “without gluten.” State law regulating other claims or warnings concerning gluten would not be affected. For more information, see 21 C.F.R. ' 101.91.
Chris Gunnels is a Senior Associate and Aliyya Haque is an Associate with Alston & Bird LLP in Atlanta. They focus their practices on product liability, mass tort, and class action defense.
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On Aug. 5, 2013, the Food and Drug Administration (FDA) issued a final rule defining the labeling requirements for a product claiming to be “gluten-free.” Manufacturers will have one year from the date of issuance to ensure their labels are compliant. Although the FDA has provided limited guidance concerning “gluten-free” claims in the past, the publication of this final rule marks the first time manufacturers and consumers will have a definitive regulatory definition of the term “gluten-free.”
Background
“Gluten” refers to proteins that can be found in wheat, barley, rye and similar grains. Gluten-free products and the proper labeling of such foods are important to individuals suffering from celiac disease, who are at risk for health problems if they consume gluten. In its commentary surrounding the new rule, the FDA expressed concern that “different and inconsistent amounts of gluten in foods with 'gluten-free' labeling result in the inability of those individuals with celiac disease who adhere to a gluten-free diet to avoid exposure to gluten at levels that may result in adverse health effects.”
The Food Allergen Labeling and Consumer Protection Act of 2004 gave the Secretary of Health and Human Services the authority to “define and permit the use of” the food-labeling term “gluten-free.” In 2007, the FDA issued a proposed rule defining “gluten-free” and allowing for the term's voluntary use on food labels. The subsequent comment period elicited numerous inquiries and requests for developing a standard, national definition of “gluten-free.”
Pursuant to the new FDA rule, products claiming to be “gluten-free” must contain less than 20 ppm (parts per million) of gluten. Scientific tests cannot reliably detect gluten levels below this threshold, which is why the standard level of 20 ppm was chosen. Most individuals with celiac disease are able to tolerate foods with this trace amount of gluten. The FDA also explained that using a more stringent definition of “gluten-free” would result in the removal of many food items from the market that satisfy the less than 20 ppm standard, and would discourage the introduction of new “gluten-free” products that could not meet the gluten limit. The FDA considers reducing the widespread availability of “gluten-free” foods to be “detrimental” to individuals with celiac disease “who are already challenged by the complexities of adhering long term to a gluten-free diet.”
The Guidelines
Manufacturers will also be able to use “gluten-free” on their labels if the food does not contain: 1) any ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains; 2) any ingredient derived from these grains that has not been processed to remove gluten; and 3) any ingredient derived from these grains that has been processed to remove gluten, if it results in the food containing 20 or more ppm gluten. Foods which, by nature, do not contain any gluten, such as fruits, vegetables and bottled spring water, may make the claim “gluten-free” as well, without having to include any qualifying language. Foods making the claims “without gluten,” “no gluten,” and “free of gluten” must also adhere to these guidelines.
Very few of the other items in the 2007 proposed rule were included in the final rule. For example, the FDA declined to define the terms “low-gluten,” “very-low gluten,” or other tiered labeling claims because the agency determined that there was no scientific basis for these claims. Additionally, the final rule specified no technical requirements for gluten-free labeling statements, including size, conspicuousness, or placement of the statement. The FDA also explicitly declined to establish the use of any universal symbol, logo, or standardized print format to identify a gluten-free food. Impact on Litigation
Litigation and Regulatory Action
In the past, once the FDA has sent a warning letter to a manufacturer to take corrective action concerning product labeling, consumers have filed private suits on the basis of this action. Litigation concerning food labeling claims has been especially prevalent in states with consumer-friendly false advertising laws, such as California and New Jersey.
The new FDA rule likely will help protect manufacturers from many of these consumer lawsuits because they now have a threshold level of gluten that may still legally be allowed in a product. Therefore, even if gluten is found in a product marketed as “gluten-free,” so long as that trace amount is less than 20 ppm, consumers should not be able to bring false advertising claims against the food manufacturer.
Nevertheless, because there is a final rule by the FDA setting the threshold gluten level, manufacturers would be unwise to skirt this rule and label their products as “gluten-free” if indeed they contained more than 20 ppm of gluten. The FDA also discourages making claims on labeling about the gluten content of foods other than the approved terms and would evaluate any and all statements under the sections on misbranding of the Food, Drug, and Cosmetic Act (sections 403(a)(1) and 201(n)).
If manufacturers are in violation of these rules, the FDA may consider the products to be misbranded and take regulatory action against offending companies. In addition, if a food label claims that the product is “gluten-free” but uses the term “wheat” in its ingredient list or has a separate “contains wheat” statement on the label, it will be deemed misbranded unless its labeling “also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a 'gluten-free' claim.”
In terms of monitoring gluten levels, the FDA does not mandate that manufacturers use a specific test or methodology to determine whether their products contain gluten levels of 20 ppm. The FDA concluded that by requiring a specific analytical method in the final rule, manufacturers would be deterred from developing new and advanced testing methodologies. However, the FDA did note that it will employ two enzyme-linked methods to monitor compliance: 1) R-Biopharm: Food and Feed Analysis; and 2) Morinaga Institute of Biological Science: Wheat Protein ELISA Kit (Gliadin).
Moreover, pursuant to the final rule, manufacturers may develop their own analytical tools for determining gluten content and whether gluten levels fall below the 20 ppm threshold. Manufacturers may also use third-party organizations to certify or otherwise verify the gluten content of their foods to confirm that their “gluten-free” products do indeed meet the standard definition of “gluten-free.” Companies wishing to go through the certification process may do so voluntarily; the FDA final rule does not mandate this.
Preemption of State Law
The FDA has also made clear that its new rule preempts any state law defining the limits of gluten to be contained within a product. Section 101.91(d) of the new rule declares that a “State or political subdivision of a State may not establish or continue into effect any law, rule, regulation, or other requirement that is different from the requirements in” 101.91 for the definition and use of the term 'gluten-free,' as well as the terms 'no gluten,' 'free of gluten,' or 'without gluten.'”
Pursuant to the Supremacy Clause of the U.S. Constitution, “state laws that interfere with or are contrary to Federal law are invalid.” Further, if the preemptive action is within the scope of an agency's delegated authority and represents a “reasonable accommodation of conflicting policies that were committed to the agency's care,” preemption is warranted. See
In addressing the preemption issue, the FDA noted the need for “national uniformity” in the meaning of the term “gluten-free.” The agency remarked that if states established multiple definitions of what it means to be “gluten-free,” individuals with celiac disease “would not be able to rely on that term to understand the amount of gluten the food may contain and thereby use the term to identify appropriate dietary selections.”
Standardizing the term “gluten-free” prevents consumer confusion and allows those with celiac disease to make educated purchasing choices. Preemption would also occur with respect to labeling language concerning gluten if a state requirement is “found to obstruct the federal purpose articulated in this rule.
Despite this language, it should be noted that preemption has proven to be a thorny issue in the past for other similar labeling claims. There exist other FDA regulations that allow manufacturers to round down nutrient values to zero, despite the presence of small amounts of the nutrient (e.g., if a serving contains less than 0.5 g of trans fat, the content, when declared, can be expressed as zero). This has prompted several state law suits that argue labeling claims such as “0 g Trans Fat” are inherently misleading to consumers when, in fact, the product contains some trans fat. Similar issues may also arise around “gluten-free” labeling claims, where products do, in fact, contain small traces of gluten (but less than 20 ppm). Although the final rule establishes a federal limit of 20 ppm, there are no absolute assurances that all gluten-related state claims will be preempted by this new federal law.
Also, according to the final rule, preemption may arise if a state or local requirement is found to obstruct the federal purpose of the rule, but state or local requirements are only preempted to the extent that they are different from the rule's requirements. In order to ensure that consumers ' particularly those who suffer from celiac disease ' have confidence to identify and purchase gluten-free products, state requirements could not change the 20 ppm threshold or otherwise establish different requirements related to the use of the terms “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” However, this does not mean that additional state or local labeling requirements or warning statements would be preempted. For example, a state could require a statement about the health effects of gluten consumption on persons with celiac disease or information regarding processing methods.
Additionally, not all state laws regulating gluten are automatically preempted by this final rule. The FDA further explained that the rule preempts state law narrowly and only applies to the terms “gluten-free,” “no gluten,” “free of gluten,” and “without gluten.” State law regulating other claims or warnings concerning gluten would not be affected. For more information, see 21 C.F.R. ' 101.91.
Chris Gunnels is a Senior Associate and Aliyya Haque is an Associate with
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