Starting Aug. 5, the Food and Drug Administration is requiring that FDA-regulated food labeled gluten-free must comply with the agency’s definition and requirements. Here are some frequently asked questions about the FDA’s gluten-free labeling rule. For additional information, see the FDA’s website. This information is not intended to constitute legal advice; seek the advice of an attorney as needed.
Q: Why did the FDA issue a gluten-free labeling rule?
A: The rule is designed to provide guidance to consumers—especially those with celiac disease—looking for items that meet the defined standard for gluten content. Celiac disease is an autoimmune disease triggered by the consumption of gluten.
Q: Are restaurants required to comply with the FDA’s new rule on gluten-free labeling?
A: “Some foods sold in restaurants, including foods packaged and labeled by the restaurant, are subject to the requirements in the final rule,” according to an FDA official. “Restaurant foods such as menu or menu-board items will not generally be subject to the federal rule. However, we encourage the restaurant industry to move quickly to ensure that when restaurants choose to provide gluten-free options they take steps to ensure that the use of ‘gluten-free’ labeling is consistent with the federal definition.”
The FDA's Aug. 5, 2014, Constituent Update notes that: “FDA recognizes that people with celiac disease are also interested in being able to identify gluten free foods served in restaurants and other retail establishments that serve prepared foods to customers. The gluten-free final rule applies to packaged foods, which may be sold in some retail and food-service establishments … Given the public health significance of “gluten-free” labeling, FDA says that restaurants and other establishments making a gluten-free claim on their menus should be consistent with FDA’s definition. State and local governments play an important role in oversight of these establishments. We look forward to working with the states, the restaurant industry and other stakeholders to support education and outreach on the appropriate use of the term gluten-free.”
Q: Does the rule require that all gluten-free foods be labeled as such?
A: No. Labeling foods as gluten-free is voluntary. According to the FDA, “firms are not required to label their foods ‘gluten-free,’ but if firms whose foods are regulated by FDA voluntarily choose to make this labeling claim, those products must conform to our definition for a ‘gluten-free’ food.” The FDA defined gluten-free in an FDA final rule published in the Federal Register Aug. 5, 2013.
Q: What is the FDA’s regulatory definition of gluten free?
A: A gluten-free food must not contain an ingredient that is:
a gluten-containing grain (e.g., spelt, wheat, rye, barley);
derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or
derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.
Also, any unavoidable presence of gluten in the food must be less than 20 ppm.
Q: When are businesses required to start complying with the FDA’s rule on gluten-free labeling?
A: Starting Aug. 5, 2014, all FDA-regulated foods labeled “gluten-free” must comply with all requirements set forth by the final rule. After this date, any food product labeled “gluten-free” that does not meet the criteria established in the final rule—including a food that contains 20 ppm or more gluten—would be deemed misbranded and would be subject to regulatory enforcement.
Q: Can an item be labeled gluten-free if it is made with a small amount of a gluten-containing ingredient resulting in a finished product that contains less than 20 ppm of gluten?
A: The FDA website states that: “A food labeled gluten-free cannot be intentionally made with any amount of a gluten-containing grain (wheat, rye, barley or their crossbred hybrids like triticale) or an ingredient derived from such grain that was not processed to remove gluten. The goal of manufacturing any food labeled gluten-free should be for the food to not contain any gluten or to contain the lowest amount possible that is less than 20 ppm gluten.”
Q: What does 20 ppm of gluten look like?
A: Mathematically, it equates to 20 milligrams of gluten per kilogram (or 2.2 pounds) of food. Visually, that represents 1/200th of a teaspoon of flour, one single wheat seed co-mingled with 5,000 sorghum seeds, or one drop of food coloring in a gallon of water, says Beckee Moreland, director of the Gluten-Free Resource Education and Awareness Training (GREAT) Kitchens program. Operated by the National Foundation for Celiac Awareness, the GREAT Kitchens program trains restaurants on gluten-free protocols.
Q: Can a restaurant that cooks with gluten-containing ingredients—and perhaps even has airborne flour—still achieve the 20 ppm benchmark for specific menu items?
A: “It might not be easy, but it’s possible,” says Moreland. “You have to be committed to the process that includes assessing your risk, making modifications and training your staff.”
Betsy Craig, CEO of MenuTrinfo, which provides gluten-free training and gluten-free certification to restaurants, notes: “With the right products and the right procedures in place, 20 ppm is very achievable in any environment.”
Q: How do I ensure that gluten levels are within the FDA’s 20 ppm threshold?
A: “The FDA set a benchmark to be gluten-free, but it doesn’t require a specific method to determine you’ve reached that benchmark,” says attorney Steven B. Steinborn, a partner with Hogan Lovells law firm in Washington, D.C. Steinborn specializes in legal concerns related to food labeling, advertising and food safety. Quality assurance options include such steps as
conducting in-house gluten testing of starting ingredients or finished foods
employing a third-party laboratory to conduct in-house gluten testing
requesting certificates of gluten analysis from ingredient suppliers
participating in a third-party gluten-free certification program.
Q: What other terms are considered synonymous with “gluten-free” and are regulated by the FDA?
A: The FDA states: “A food that bears the claim ‘no gluten,’ ‘free of gluten’ or ‘without gluten’ in its labeling and fails to meet the requirements for a ‘gluten-free’ claim will be deemed to be misbranded.”
Q: Are other claims about gluten levels—such as “low gluten” or “very low gluten”—allowed?
A: The FDA rule does not define terms such as “low gluten” or “very low gluten.” The FDA will evaluate these claims on a case-by-case basis to determine if the claim is truthful and not misleading. In its formal guidance on the rule, the FDA discourages the use of claims other than “gluten-free.”
“The general rule of thumb is that you should not make a claim that will make consumers think something is gluten-free when it’s not,” says food-and-drug attorney Steinborn. “You don’t want to create a disconnect with your customers, and you don’t want to create a regulatory issue with regulators. You are responsible for all reasonable interpretations of a claim.” Seek legal counsel over specific wordings as needed.
Q: Are statements like “made with no gluten-containing ingredients” or “not made with gluten-containing ingredients” permitted without making a specific gluten-free claim?
A: FDA rules and regulations do not prohibit these statements, provided they are truthful and not misleading. Unless the food also bears a gluten-free claim, consumers should not assume that a food carrying these statements meets all the FDA requirements for a gluten-free food.
Q: Are there specific recordkeeping requirements for foods to be labeled gluten-free?
A: No. The final rule does not impose any specific new recordkeeping requirements. Nevertheless, attorney Steinborn recommends that restaurants closely document the process. “You want to be able to show how you reached your conclusion that an item is gluten-free,” he says. “If there’s a problem, you should be able to say, ‘Here are the ingredients. Here are the vendors along with certificates verifying that the items are gluten free. Here are our written procedures for preventing cross-contact, and here are the results of any in-house testing or third-party testing.’”