Earlier this year, a new law known as the FASTER Act took effect, adding sesame as a major food allergen and requiring the ingredient to be labeled as an allergen on packaged foods, including dietary supplements.

In an effort to adhere to the new law, some manufacturers are actually adding sesame to all of their food products and labels rather than properly cleaning their equipment between product runs to avoid allergen cross contamination. This action is taken in an attempt to avoid the costs associated with the processes and systems controls necessary to ensure safe baking practices. Certain products can be extremely difficult to completely eliminate in the processing environment, leading manufacturers to this alternative. To many, this action goes against the spirit of the law.

In response, a group of legislators, spearheaded by U.S. Senator Ron Wyden (D-Ore.) and U.S. representatives Doris Matsui (D-Calif.) and Patrick McHenry (R-N.C.), have urged bakers to stop unnecessarily adding sesame to baked goods and to protect consumers with sesame allergies.

In a letter to the American Bakers Association (ABA), the legislators condemned the actions, claiming adding sesame to baked goods that have not previously contained the ingredient, often without notice, undermines the trust that people with food allergies place in the food industry.

The ABA noted that, given current production operations in hundreds of bakeries coupled with the existing FDA regulatory scheme, including sesame and labeling it as an allergen, is the most realistic and safest way to protect allergic consumers. “We have also encouraged the FDA to use its existing authority under the Food Allergen Labeling & Consumer Protection Act to work toward setting allergen thresholds, which would remove the need to add sesame where only traces below such thresholds might remain after applying rigorous Current Good Manufacturing Processes,” the organization noted in a statement. “Despite rigorous cleaning protocols, sesame is a uniquely challenging allergen to remove from the baking environment, and even the best practices cannot always remove traces of sesame.”

Sesame allergies impact more than 1.5 million Americans, and reactions can be serious and life threatening.

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Over the past 25 years, food allergies have been recognized worldwide as an important public health issue. Specific avoidance diets remain the primary approach to the prevention of reactions among consumers with food allergies. The simple advice, for those who are allergic to peanuts or milk, for example, is just to avoid those foods or any ingredients derived from those foods. For packaged foods, ingredient statements on food labels are the key source of information for allergic consumers wishing to avoid specific foods.

Consumers with food allergies and their caregivers are likely the most diligent label readers in the marketplace, as their health and safety depend upon careful selection of food products. But, in reality, the seemingly simple advice to avoid allergenic ingredients can become quite challenging. Consumers with milk allergies must learn that casein and whey are terms that signify the presence of milk, that gluten and semolina mean wheat, and that tahina means sesame seeds, among many more examples.

General Labeling Regulations

Historically, many countries have stipulated general food labeling laws and regulations that served to protect food-allergic consumers to some degree. These general food labeling laws and regulations required that the ingredients intentionally used in the formulations of the foods should be declared on an ingredient list on the package label; however, these general food labeling provisions did not fully protect food-allergic consumers for a variety of reasons.

First, many exemptions and exceptions existed. Declaration of the sources of some ingredients was not required. Ingredients were often declared by using their common and usual names, which meant using technical terms (e.g., casein) that did not directly reveal the true source. Thus food-allergic consumers found that allergens were often “hidden” in packaged food products. Furthermore, they had to learn to identify technical ingredient terms such as “casein” that indicated the presence of specific allergenic foods. Vague terms such as “hydrolyzed vegetable protein” were allowed in some countries and these did not reveal the source. Some countries had regulations that did not require the labeling of ingredients in complex formulations when the ingredient comprised less than 25% of the finished food; other countries exempted labeling of minor ingredients comprising less than 2% of the formulation.

The History of Food Allergen Labeling Regulations

The plight of food-allergic consumers and their struggles in implementing specific food-avoidance diets were first recognized in the 1990s. Several Nordic countries developed a working paper on food allergens and labeling in 1993 that was submitted to the Codex Alimentarius Commission (CAC), an organization that oversees the Food and Agricultural Organization (FAO) and the World Health Organization (WHO) to develop food standards and guidance that could be recognized and harmonized worldwide. CAC does not promulgate regulations but does provide guidance that individual countries and regulatory jurisdictions may consider and use as they develop regulations.

In response to the Nordic working papers on food allergens, a FAO Technical Consultation was formed in 1995, which led to the development of the first global list of priority allergenic foods (see Table 1). This list was formally adopted by CAC in 1999. The CAC list of priority allergenic foods served as guidance to all countries, but individual countries had the option to adopt this list or to modify the list as they might choose.

Several comments are appropriate regarding the approaches used by the 1995 expert panel to develop this priority list of allergenic foods. In 1995, the level of published information regarding the comparative prevalence of allergies to specific foods was rather limited and primarily consisted of information on pediatric populations of allergic individuals. These data were primarily from referral centers, which see more allergic patients so extrapolation of the prevalence of pediatric allergies to the overall population may have been slightly biased. Data were lacking on adults with food allergies and on the prevalence of specific food allergies in the general population.

Accordingly, the panel relied, in part, on expert judgment to develop the 1999 priority allergen list. The main criterion for inclusion was comparative prevalence, although the differential severity of certain allergenic foods was also recognized. On this basis, milk, eggs, fish, crustacean shellfish, peanuts, soybeans, tree nuts, and cereal grain sources of gluten were considered the priority allergenic foods. The FAO group also considered celiac disease, intolerances, and sensitivity reactions, in addition to food allergies. Thus, gluten was included because of its association with celiac disease, and sulfites were included because of the documented severity of sulfite-induced asthma, even though these illnesses are not true food allergies.

Subsequently, an International Life Sciences Institute (ILSI) Europe Task Force on Food Allergy took a more in-depth look at foods that merited placement on the priority allergenic foods list (Allergy. 1998;53:3-21). The criteria used by this group included clinical evidence of an allergic reaction through double-blind, placebo-controlled food challenge (DBPCFC) and published evidence of severe and/or fatal anaphylactic reactions. Data on prevalence were considered insufficient. This task force determined that the priority list should include milk, eggs, fish, crustacean shellfish, peanuts, soy, tree nuts, wheat, and sesame seeds. Several subsequent groups within ILSI Europe have continued to develop criteria for the selection of allergenic foods of public health significance (Regul Toxicol Pharmacol. 2008;51:42-52; 2011;60:281-289). The criteria have been expanded to include prevalence, severity, and potency.

The adoption by CAC of the priority list of allergenic foods prompted numerous countries to develop their own regulatory lists for the labeling of priority allergenic foods. The eight foods or food groups from that 1999 CAC list were represented on the vast majority of the priority food allergen lists recognized by specific countries; this group of allergenic foods began to be referred to as the “Big 8.”

Several countries, however, decided to include additional foods on their priority allergen lists. As a result, the regulatory framework for the labeling of allergenic foods differs from country to country. The basis for inclusion of additional foods on the priority lists for specific countries has not been clearly delineated but is based, in part, on regional differences in the prevalence, severity, and potency of specific allergenic foods. The role of scientific criteria in these judgments appears to be secondary in many cases. While the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures recognizes the 1999 CAC list, the existence of different priority lists in various parts of the world can lead to trade disputes and consumer confusion.

Global Differences in Lists of Priority Allergenic Foods

Regional differences appear to exist in the prevalence of food allergies around the world. For example, buckwheat allergy is much more common in Southeast Asian countries where soba noodles are frequently consumed but is a rare form of food allergy in North America and most other parts of the world. The identity of the most common allergenic foods differs among countries/regulatory jurisdictions (such as EU and Australia/New Zealand) in part as a result of these regional differences.

In the U.S., the priority list of allergenic foods was established by action of the United States Congress when it passed the Food Allergen Labeling and Consumer Protection Act (FALCPA) in 2004. FALCPA established a list of priority allergenic foods that was quite similar to the 1999 CAC list (see Table 2). The only exception was that FALCPA specifically identified wheat as a cause of food allergies and does not recognize other grain sources of gluten. More recently, the U.S. Congress passed a bill that has prompted the FDA to include sesame seeds on the list of the priority allergenic foods, effective this year.

The first priority list of allergenic foods for the EU was established by EC Directive 2003/89 but has been subsequently expanded by more recent directives (see Table 2). The EU list includes sesame seeds, mustard, celery, molluscan shellfish, and lupine in addition to the Big 8. The European Commission relied upon the expert opinion of the European Food Safety Authority (EFSA) Scientific Panel on Dietetic Products, Nutrition, and Allergies for the addition of molluscan shellfish and lupine to the EU priority allergen list (EFSA J. 2006;327:1-25; 2005;302:1-11).

The decision on lupine appeared to be based upon the recognition that some peanut-allergic individuals will experience allergic reactions to ingested lupine. Several non-EU countries have adopted the EU priority list of allergenic foods (Ukraine, United Kingdom, Iceland, Switzerland, Turkey, and Russia).

In Canada, the original priority allergen list included the Big 8 list with the addition of molluscan shellfish and sesame seeds. More recently, Canada has added mustard to its list. In Australia and New Zealand, the priority list has gone through a couple of iterations but now includes the Big 8 plus sesame seeds, molluscan shellfish, lupine, bee pollen, propolis, and royal jelly (see Table 2).

Japan has a rather unique approach to its priority list, with a short mandatory labeling list and a longer recommended labeling list. The mandatory priority list in Japan comprises wheat, milk, eggs, peanuts, buckwheat, and crustacean shellfish (see Table 2). Crab and shrimp are identified as the only crustacean shellfish of concern. Japan and Korea are the only countries that list buckwheat on their priority allergen lists. Buckwheat is known to cause frequent and occasionally severe allergies in Japan (Adv Food Nutr Res. 2011;62:139-171; Allergy Clin Immunol Int. 2003;15:214-217).

The recommended priority list in Japan is extensive and includes several molluscan shellfish (abalone, squid), several fish (mackerel, salmon, and salmon roe), several fruits (orange, kiwi, peach, apple, banana), one tree nut (walnut), several meats (pork, chicken, beef), soybeans, matsutake mushrooms, yams, and gelatin. The basis for the Japanese priority list was a survey of allergy clinics in Japan in which the causative foods in more than 1,500 cases of food allergy were compared (Allergy Clin Immunol Int. 2003;15:214-217).

The 1999 CAC priority list includes several food groups: tree nuts, fish, and crustacean shellfish. In most countries, fish refers to all species of finfish. The exception is Japan, where only mackerel and salmon are included on the recommended priority list for allergenic foods. Similarly, crustacean shellfish refers to all species of shrimp, crab, and lobster in most countries; in Japan, only crab and shrimp are included on the mandatory priority list for allergen labeling. In several countries including Canada, the labeling regulations refer only to shellfish and not specifically to crustacean shellfish or molluscan shellfish.

Greater differences occur among various countries as to which tree nuts are recognized as part of the group covered by allergen labeling regulations. In Europe, the tree nuts group includes walnuts, pecans, cashews, pistachios, almonds, hazelnuts, Brazil nuts, and macadamia nuts. In Canada, these same eight nuts are listed along with pine nuts; however, the U.S. Congress did not identify specific tree nuts that required mandatory labeling under the provisions of FALCPA. Subsequently, FDA issued a draft guidance document in October 2006 that included a very long list of 19 tree nuts that would need to be specifically included on U.S. food labels. Unfortunately, this list includes several foods that are not tree nuts by botanical definition (coconut and litchi).

Recent FAO/WHO Recommendations

In 2020, on request from the Codex Committee on Food Labeling (CCFL), an ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens was established. In the first of a series of meetings held in late 2020 and early 2021, the consultation developed recommendations relating to the priority list of allergenic foods based on updated information. Considerably more scientific and clinical information was available than had been the case in the previous FAO consultation in 1995. The expert panel based their updated recommendations on the prevalence, potency (threshold dose considerations), and severity of allergic reactions to specific foods.

As a result of these deliberations, a new, revised list of priority allergenic foods was established (see Table 3) that included eight foods or food groups, as before; however, the experts recommended deletion of soybeans from the priority list along with the addition of sesame seeds. This recommendation has been forwarded to the CCFL for consideration and, if approved at that level, will be forwarded to the CAC to create the basis for revised worldwide guidance on allergenic food labeling.

Soybeans were removed from the priority list of allergenic foods based on the low prevalence of soybean allergy, especially among older children and adults, the decline in soybean allergy in infancy, possibly owing to a decreased use of soy-based infant formula, the lower potency of soy protein for elicitation of allergic reactions, and an observed low degree of severity of allergic reactions to soybean reported across all Codex regions. Sesame seed was added to the priority list because of moderate levels (compared with other priority allergenic foods) of prevalence, potency, and severity of allergic reactions. Also, many individual countries had already added sesame seeds to their priority allergenic food lists based on their own assessment of risk factors for sesame seed allergy.

In the recommendation from the expert consultation, the category of tree nuts was restricted to those tree nuts for which evidence of prevalence, potency, and/or severity merited their inclusion. The tree nut list included hazelnut, walnut, pecan, cashew, pistachio, and almond.

The expert consultation also pointed out that regional differences could exist with respect to prevalence, potency, and severity that could merit the inclusion of additional foods on the priority list of allergenic foods in certain countries. Examples might include buckwheat in Japan and Korea and celery tuber in the EU.

Ingredients Derived from Priority Allergenic Foods

The original 1995 list of priority allergenic foods also referred to “products of” those foods. Many food ingredients are derived from the priority allergenic foods that were shown to have medium to high potency and a higher proportion of reported anaphylaxis in more than three Codex regions.

Examples of such ingredients contain large amounts of protein from the allergenic source, while other ingredients contain very low levels of residual protein from the source food. Several countries have exempted certain ingredients from their source labeling provisions. In the U.S., all highly refined oils, including those made from peanuts and soybeans, are exempt. In the EU, highly refined soybean oil is exempt but highly refined peanut oil is not. The EU has also exempted certain other derivatives from source allergen labeling, including wheat starch hydrolysates and fish gelatin for vitamin encapsulation; however, until now, no global consensus has existed to make decisions about source labeling exemptions for certain food ingredients derived from priority allergenic foods.

The ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens took up the topic of assessment of the allergenicity of derivatives from priority allergenic foods at its most recent meeting in November 2022. The recommendations of that consultation are not yet public, but recommendations for a framework by which labeling exemption considerations could be evaluated were made for further consideration by CCFL to create a basis for global scientific consensus on source labeling exemption decisions.

The authors are with the Food Allergy Research and Resource Program in the Department of Food Science and Technology at the University of Nebraska-Lincoln. Reach Dr. Taylor at staylor2@unl.edu and Dr. Baumert at jbaumert2@unl.edu.

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FDA has issued two guidance documents regarding food allergen labeling. One of the documents is a draft guidance that includes requirements from the Food Allergy Safety, Treatment, Education, and Research Act of 2021 (FASTER Act) and the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The agency is seeking comment on

FALCPA amended the Federal Food, Drug, and Cosmetic Act by defining the term “major food allergen” and requiring that foods or ingredients that contain a major food allergen be specifically labeled with the name of the allergen source. This law identified eight foods as major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. The FASTER Act, among other elements, adds sesame to the list of major food allergens and is effective on January 1, 2023. The act makes it the ninth major food allergen recognized in the U.S.

The draft guidance includes:

• New questions and answers about food allergen labeling requirements, such as the labeling of sesame, milk, and eggs; the labeling of major food allergens in the labeling of dietary supplement products; and other technical labeling issues.
• Revised questions and answers to update and clarify information presented in earlier editions of the final guidance, such as the labeling of tree nuts, fish, and crustacean shellfish.
• Images that show examples of labeling requirements.

The agency also issued a final guidance with the same title to preserve the questions and answers from the previous edition that were not changed, except for editorial changes such as renumbering the questions and reorganizing the information in the guidance.

Comments about the draft guidance can be submitted at www.regulations.gov.

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To some degree, food products with “free from” claims, especially those with gluten-free and dairy-free claims, have been on the market for years. In recent years, however, the number and diversity of products with claims relating to allergen-free status has grown much larger. With the passage of an FDA regulation defining gluten-free claims at <20 ppm gluten, the gluten-free market niche has been very active in recent years. Dairy-free products have been available for some time, but the terminology can differ now, with labels that include dairy-free, milk-free, lactose-free, and non-dairy phrasing.

Additional free-from claims have started to appear in the marketplace, including nut-free, peanut-free, egg-free, soy-free, and even allergen-free terminology that goes beyond the required labeling. Compared with gluten-free claims, the number of products available in the market with other free-from claims is smaller and less diverse. Food products with “free” claims definitely appeal to the segment of the market representing consumers with allergies and related illnesses to specific foods. Additionally, some consumers are also known to select products with gluten-free labels based more on their personal lifestyle choice rather than a clinical need for avoidance of gluten. Presumably, the same behavior also occurs when it comes to products with other free-from claims.

While market opportunities exist for food products with free-from claims, potential risks also exist and must be avoided when using these claims. Let’s examine both sides of this issue, with the goal of identifying the safest and most transparent strategy to use for such product claims.

Market Appeal and Challenges

Of course, products with free-from claims appeal to consumers with allergies or intolerances to those specific foods; in fact, they rely solely on ingredients labeling to choose foods safely. Specific food allergies have a prevalence of 1% or less among the U.S. population, however, so the size of the market would be rather small if these products only appealed to consumers who actually had specific food allergies or intolerances. In such situations, marketing of products to the affected and most interested consumers can be quite challenging and may involve specialized approaches, such as online sales and other forms of direct-to-consumer marketing.

Beyond the allergic consumers themselves, however, products with free-from claims can also appeal to consumers who interact with and purchase food for periodic occasions that include food-allergic individuals, such as nuclear and extended family members and organizers of school events and extracurricular activities such as team sports. As companies consider these specialized market niches, the possibility that the specific niche might have broader appeal should be examined on a case-by-case basis.

Dairy-free, milk-free, lactose-free, non-dairy claims: The universe of dairy-free foods has evolved over the decades, but the use of multiple terminologies for these claims can be confusing. Part of the confusion stems from the fact that dairy-free foods can appeal to several categories of consumers: milk-allergic individuals, lactose-intolerant individuals, vegans, and those following certain types of kosher restrictions.

Originally, many dairy-free products were simply intended for lactose-intolerant consumers. Lactose intolerance affects a very large segment of the consuming public because it is a genetically acquired condition that worsens with advancing age and affects many older children and adults, primarily in certain ethnic groups. Affected consumers experience mild intestinal discomfort (flatulence, bloating, cramping, diarrhea) after eating dairy products containing the milk sugar lactose. Lactose-intolerant consumers can often tolerate small doses of lactose in their diets without experiencing symptoms. Some dairy-free products are essentially free of lactose but still contain other milk-derived ingredients, especially milk protein fractions such as caseinates or whey protein concentrates. Some products are specifically labeled “lactose free,” which is the appropriate terminology if the product is free of lactose but contains other milk-derived ingredients.

Lactose-free or dairy-free products containing milk protein would be unsuitable and even hazardous for milk-allergic consumers who must diligently avoid ingestion of any levels of milk protein. Even very small amounts of milk protein are sufficient to provoke adverse reactions in such individuals. The symptoms are variable and can involve the skin (hives, itching, swelling), the intestinal tract (vomiting, diarrhea), and/or the respiratory tract (asthma, rhinitis); very severe anaphylactic reactions and even deaths can occur in some milk-allergic consumers upon inadvertent ingestion of milk proteins. The percentage of consumers with milk allergy is rather small. Up to 2% of infants younger than 3 years of age have a milk allergy, but most of them outgrow that condition to the point where milk allergy is much rarer in adults, although an accurate prevalence estimate is not available for adults.

Few foods in the marketplace are labeled as milk free, but producers are required to include the common name in the ingredients list for products containing caseins and other milk-derived proteins. Dairy-free products are more widely available, but some dairy-free products are not suitable for milk-allergic consumers because these products still contain milk proteins. It could be argued that dairy-free products would ideally contain no detectable lactose or milk proteins so that they are well suited for both types of consumers.

“Non-dairy,” another term encountered in the U.S. marketplace, is usually applied to coffee creamers. Curiously, non-dairy products are required to contain caseinates. Since casein is a major allergenic protein in cow’s milk, non-dairy products pose a serious risk to milk-allergic consumers if these consumers neglect to read the ingredient declaration. The presence of casein is typically identified in the ingredient list, and non-dairy products may even have a “contains milk” statement, but the prominent labeling of the product as non-dairy can cause consumer confusion. Non-dairy coffee creamers may be safe for consumers with lactose intolerance.

The market for dairy-free products has wider appeal beyond those with milk allergy or lactose intolerance. Dairy-free products appeal to vegan consumers and others who do not consume dairy products as a matter of choice. Additionally, some Jewish consumers follow kosher pareve diets, which prohibit the ingestion of milk or meat. Kosher pareve foods cannot contain any milk-derived ingredients and are typically certified by various rabbinical organizations that then allow the application of their symbols on the labels. Kosher pareve foods should be dairy-free but are not always also labeled as dairy-free. It is also important to recognize that as Kosher pareve certification is not focused on food allergen risks and does not use analytical methods for verification of its absence, so it is possible for products labeled as Kosher pareve to contain detectable levels of milk protein, and sometimes at sufficient levels to provoke allergic reactions in milk-allergic consumers.

Egg-free claims: Egg-free products obviously appeal to consumers with egg allergy, although the number of consumers with egg allergy is actually quite small. As with allergies to milk, egg allergy mostly affects young infants and children, with a prevalence of about 2%. Most egg-allergic children outgrow this condition, so egg allergy is not common among older children and adults. The symptoms of egg allergy are similar to those noted for milk, and reactions can be triggered by exposure to very small amounts of egg protein. Egg-free products likely exist in the marketplace because they appeal to vegan consumers and are often available as replacements for products that would otherwise typically contain egg. Examples would include egg-free mayonnaise and egg-free noodles. While the vegan market niche is growing, any egg-free product must be formulated and produced to contain no detectable egg protein so that it is also safe for egg-allergic consumers.

Nut-free and peanut-free claims: The phrase “nut free” on food products can be confusing because it is unclear if this term also means peanut free in all cases. Peanuts are, of course, legumes that are different from the various tree nuts except for their form and texture. “Peanut free” is a labeling term that is much clearer. For consumers, “nut free” should be construed to mean free of the various tree nuts, but not necessarily peanuts. As always, review of the ingredients statement is recommended for clarity Tree nuts as a group are not defined similarly in all countries of the world. A recent expert panel assembled by the Food and Agricultural Organization of the United Nations and the World Health Organization identified walnuts, pecans, cashews, pistachios, hazelnuts, and almonds as the most important tree nuts from an allergy perspective on an international basis. Brazil nuts, macadamia nuts, chestnuts, and pine nuts are identified as tree nuts for labeling purposes in two or more countries, which perhaps reflects regional differences in the allergenicity of tree nuts. The U.S. has an even longer list of tree nuts considered allergens that includes coconut and lychee, even though these examples are not truly nuts by botanical definition.

Peanut- and nut-free products are primarily targeted to peanut- and tree nut-allergic consumers. Peanut allergy affects 1% to 2% of U.S. consumers, while tree nut allergies affect about 0.6%, although some tree nut-allergic individuals can tolerate some of the nuts. About one-third of peanut-allergic individuals are also allergic to tree nuts, so some consumers must avoid both. Allergic reactions to peanuts and tree nuts can on occasion be quite severe and are among the leading causes of deaths due to food anaphylaxis. The doses needed to elicit reactions are very low in some susceptible individuals. Thus, peanut-free and nut-free products should not contain any detectable protein from any of those sources. The market for these specialty free-from products is likely restricted to the allergic segment of the population.

Soy-free claims: Soy-free products appeal to the soy-allergic segment of the population; however, the prevalence of soy allergy is very low, affecting less than 0.1% of the population. At one time, soy allergy was more common among infants due to the popularity of soy-based infant formula, a frequent substitute for milk-based formula for infants who develop cow’s milk allergy; however, the popularity of soy formula for infants has declined and fewer infants are now identified as soy allergic. Like milk and egg allergy, soy allergy is often outgrown, so its prevalence among older children and adults is rather small.

Achieving soy-free status for a food product is challenging due to the ubiquity of soy-based ingredients and the frequency of agricultural comingling of soy with other commodity crops such as wheat, oats, corn, and other legumes. The doses of soy protein needed to provoke allergic reactions are not as low as those needed for peanut, milk, tree nuts, or eggs. The use of the term “soy free” indicates that the products should not contain any detectable soy protein. The suitability of analytical methods for the detection of soy residues is more challenging due to the use of soy-based ingredients, which may contain isolated fractions of the soy proteins, some ingredients with altered structure, chemical modifications, and solubility, and others with varying degrees of hydrolysis. The clinical reactivity of susceptible individuals to these soy-based ingredients is uncertain, leading to the assumption that such ingredients may be hazardous to soy-allergic consumers even if residues cannot be detected.

Allergen-free claims: In the U.S., “allergen free” typically means that the product is free of all of the priority allergenic foods identified in the Food Allergen Labeling & Consumer Protection Act: peanut, tree nuts, milk, eggs, fish, crustacean shellfish, soybeans, and wheat (sesame seeds are soon to be added to this list). Rather obviously, these foods are targeted toward that segment of the consuming public with food allergies. The overall prevalence of food allergies in the U.S. is a matter of some debate but likely falls between 4% and 11% of the U.S. population. Affected individuals can suffer from any or several of a range of symptoms. In some cases, allergic reactions can be triggered by low provoking doses.

The formulation of allergen-free foods can be challenging because it can be hard to find suitable replacement ingredients for some types of food products. Because of the low provoking doses, these foods must not contain any detectable protein from any of these commonly allergenic sources. Most food-allergic consumers would  need to avoid the specific food they’re allergic to, but may not wish to avoid all commonly allergenic foods. Thus, the appeal of allergen-free products is likely far less than the overall prevalence of food allergies in the population; however, the prevalence of consumers with multiple food allergies (three to five foods) is increasing for unknown reasons, which could create a market for such products. Additionally, some of these products may also be vegan depending upon other components of the formulation. While analytical methods with reasonable sensitivity and specificity exist for many of the priority allergenic foods, good methods don’t exist for the detection of all tree nuts or for fish.

Vegan claims: Just as dairy-free and egg-free products can appeal to vegan consumers, vegan product labeling may imply to some consumers that the product is dairy free and egg free. Vegan labeling is often applied primarily as a lifestyle or consumer preference claim, rather than for consumers with medically necessary dietary restrictions, but it would be prudent for food-allergic consumers to interpret these label claims with caution. Food manufacturers should also recognize that vegan-labeled products may appeal to milk- and egg-allergic consumers and evaluate allergen risks accordingly. Other pseudo-free-from claims, such as “school safe” or “classroom safe,” are even more ambiguous and challenging for consumers to interpret.

Regulatory Limitations

Gluten free is the only one of these free-from claims that has a regulatory definition: less than 20 ppm gluten in most countries in the world. The use of other free-from statements on packaged foods is voluntary and is not specifically defined or restricted but must be truthful and not misleading. The use of the word “free” suggests that the food should contain no detectable protein residues, but the availability, specificity, and sensitivity of detection methods to support such claims can vary. The selection of test methods will affect the veracity of these free-from claims.

Recommended Strategy

While “free from” products may appeal to wider audiences of consumers, the food industry must be vigilant about potential risks to that subset of consumers with allergies or intolerances to the specific food(s). For gluten-free claims, the existence of a regulatory definition establishes the manufacturing objective. Gluten-free ingredients must be sourced, and the potential for cross contact from the use of facilities or equipment used for the manufacturing of gluten-containing foods must be carefully managed. A suitable method for the detection of gluten residues must be selected.

No regulatory definition exists for use of these terms other than the free-from claims mentioned herein. As noted, the claim must not be false or misleading. The Food Allergy Research and Resource Program (FARRP) recommends that food manufacturers establish their own definition for a claim and post it in publicly accessible locations such as product websites. The definition should identify and specify the nature of the claim and carefully distinguish among possible variations, e.g., milk free versus dairy free versus lactose free. The definition should identify the allowable levels of allergen residues and the analytical methods used for compliance, e.g., peanut-free products contain less than 5 ppm peanut protein as measured using XX method (specific for peanut protein residues).

With the other free-from claims, food manufacturers need to source ingredients that are reliably and consistently free of detectable residues of the relevant allergenic food(s). As mentioned earlier, sourcing can be quite difficult for ingredients that are sourced from agricultural commodities subject to comingling, particularly with respect to soy and wheat (gluten) residues. FARRP recommends analysis of individual lots of ingredients for use in products with free-from claims and the retention of samples of all such ingredients to use in investigating any potential problems.

The selection of suitable analytical methods to support free-from claims can be challenging. Enzyme-linked immunosorbent assays (ELISAs) specific for proteins from the allergenic source are the most frequently used. For support of free-from claims specifically, FARRP recommends the use of the quantitative, well-based ELISA methods as opposed to lateral flow devices (LFDs). If a company does utilize LFDs for qualification of ingredients or analysis of finished products, it is highly recommended that an evaluation of the LFD in the ingredient or food matrix is conducted to ensure that the matrix does not affect the sensitivity and reliability of the LFD.

For some allergenic foods such as peanut and gluten, several excellent ELISA methods are commercially available; however, the availability of robust ELISA methods requires more care as methods may not have equivalent sensitivity, utility in specific matrixes, or reliability in detecting processed versions of the proteins from the allergenic source.

Food products free of specific allergens or groups of allergens can have market appeal beyond the segment of consumers with food allergies and intolerances. Market opportunities may exist but would not be expected to generate the magnitude of the gluten-free market unless they also become market trends generating their own inertia. The size and profitability of these “free” markets is uncertain, however. The degree of difficulty involved in making products for such markets is variable, and great care must be taken to protect those consumers who are truly sensitive to small amounts of these allergenic foods, because they will be among the consumers attracted to such products.

The authors are with the Food Allergy Research and Resource Program in the Department of Food Science and Technology at the University of Nebraska-Lincoln. Reach Dr. Taylor at staylor2@unl.edu, Dr. Downs at mdowns2@unl.edu, and Dr. Baumert at jbaumert2@unl.edu.

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As of August 2021, finalized rules are in effect for gluten-free claims on fermented and hydrolyzed foods regulated by FDA. If a fermented or hydrolyzed food (or a food containing fermented or hydrolyzed ingredients) bears a gluten-free label, the manufacturer must maintain records demonstrating that the food or ingredient met the FDA definition of gluten free prior to fermentation or hydrolysis and that gluten cross-contact was controlled after fermentation or hydrolysis. While this regulation seems straightforward on paper, challenges remain for food manufacturers trying to interpret the rule for their products. This article reviews the development of the current gluten-free regulations and the impact of the recently finalized rule for fermented and hydrolyzed foods. 

Gluten and Celiac Disease

Celiac disease, also known as gluten-sensitive enteropathy, a lifelong condition affecting an estimated 1% of the U.S. population, is characterized by a chronic immune-mediated inflammatory response to the gluten proteins found in certain cereal grains, including wheat, rye, barley, and sometimes oats. The inflammatory process in celiac disease primarily impacts the intestinal tract, creating a chronic malabsorption syndrome unless treated. The symptoms of celiac disease, which are reflective of an inability to absorb nutrients including weight loss, anemia (iron deficiency), bone loss (calcium deficiency), and growth retardation in children, along with nausea, abdominal cramping, and diarrhea.

Gluten is a complex mixture of different individual proteins and includes two major fractions—prolamins (also referred to as gliadins) and glutelins. Individuals affected by celiac disease must strictly avoid gluten-containing foods to prevent serious adverse health outcomes, making establishment of regulatory criteria for the use of gluten-free claims critical to their ability to make safe food choices.

For many years, food manufacturers catering to celiac consumers had been labeling products as gluten free, but there was no established regulatory definition in the U.S. prior to 2013. The development of the current regulatory structure started with the Food Allergen Labeling and Consumer Protection Act of 2004, which required the Secretary of Health and Human Services to issue regulations to define and permit use of the term “gluten-free” for food labels. The final rule for gluten-free labeling of foods under FDA jurisdiction was published in August 2013, with a compliance date of August 5, 2014.

Gluten-Free Regulatory Definition

The gluten-free labeling regulation finalized by FDA and incorporated as 21 CFR 101.91 defines gluten-containing grains as wheat (any species belonging to the genus Triticum), rye (any species belonging to the genus Secale), barley (any species belonging to the genus Hordeum), or any of their crossbred hybrids (e.g., triticale). As illustrated in Table 1, this definition can encompass many different individual species, particularly when it comes to wheat. The rule also defines gluten as “the proteins that naturally occur in gluten-containing grains that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins).”

Table 1: Examples of gluten-containing grains.

     With respect to the definition of gluten-free, the rule stipulates that a product bearing a gluten-free label may not contain any of the following:

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 ppm or more gluten in the food.

Foods that inherently do not contain gluten may be labeled as gluten free if the presence of any unavoidable gluten is less than 20 ppm gluten.

Failure to meet these requirements for a product labeled as gluten free would result in a misbranded product. In addition, the terms “no gluten,” “free of gluten,” and “without gluten” must meet the same requirements as products labeled “gluten free.”

When compliance with the gluten-free rule is based on analysis, FDA indicated it would use a “scientifically valid method that can reliably detect and quantify the presence of 20 ppm gluten in a variety of food matrices, including both raw and cooked or baked products.” The reliance on analytical methods for evaluating compliance with the regulation plays a key role in the agency’s perspectives on fermented and hydrolyzed foods.

Methods for Gluten Quantification

Several methods have been developed for the detection and quantification of gluten in food matrices, including a few that have been validated as AOAC Official Methods of Analysis. These methods are generally sandwich enzyme-linked immunosorbent assays (ELISAs) that employ different types of gluten-specific antibodies. Sandwich ELISAs can provide sensitive, reproducible, and accurate quantification of intact gluten, but they require multiple intact binding sites to be present on the target protein molecule (see Figure 1). When gluten proteins undergo partial hydrolysis during fermentation, one or more of the required binding sites may be disrupted, affecting detection.

Figure 1: Sandwich ELISAs and partially hydrolyzed proteins.

Competitive ELISA methods, on the other hand, only require one binding site for protein detection. While competitive ELISAs are more appropriate for detection of partially hydrolyzed gluten proteins, accurate quantification remains a challenge. Different fermentation processes and conditions may result in different levels of hydrolysis and different cleavage sites yielding multiple peptides of varying length and immunogenicity. These differences in hydrolysis make it difficult to develop a single ELISA calibrant that will be applicable for accurate quantification of gluten in a diverse range of fermented and hydrolyzed products.

In the preamble to the final rule for gluten-free labeling, FDA indicated that they were unaware of any currently available methods that could reliably detect and quantify the presence of 20 ppm intact gluten in fermented or hydrolyzed foods. They therefore indicated their intent to issue a separate rule for how they would verify the compliance of fermented and hydrolyzed foods.

Gluten-Free Labeling of Fermented or Hydrolyzed Foods

In the final rule, FDA outlined compliance requirements for situations in which a scientifically valid method is not available to quantify gluten because the food is fermented or hydrolyzed or contains ingredients that are fermented or hydrolyzed. For fermented and hydrolyzed foods, manufacturers must make and keep records adequately demonstrating that all three of the following are met:

1. The food meets the definition of gluten free prior to fermentation or hydrolysis;
2. The potential for gluten cross-contact occurring after fermentation or hydrolysis has been adequately evaluated; and
3. If risks of gluten cross-contact are identified, the manufacturer has implemented sufficient controls to prevent cross-contact during production.

For foods that contain fermented or hydrolyzed ingredients, manufacturers must maintain records demonstrating that the ingredients meet the requirements for gluten-free fermented or hydrolyzed foods.

The particular types of documentation necessary for demonstrating that a food meets the definition of gluten free prior to fermentation should be assessed by the manufacturer. While the rule does not mandate analysis or specific documents, the preamble to the proposed rule does indicate that ingredients are likely to be at different levels of risk for gluten cross-contact and therefore may require different forms of documentation. For example, ingredients derived from commodities such as legumes, grains, or seeds that are susceptible to cross-contact with gluten-containing grains may require different types of documentation than foods that are inherently gluten free and have a low-risk of gluten cross-contact (e.g., fluid milk). In general, examples of documentation include certificates of analysis, analytical test results, and verification of supplier cross-contact management.

The final rule for fermented and hydrolyzed foods also contains separate information about gluten-free claims on distilled foods, such as distilled vinegars. Unlike fermentation, which FDA does not consider to be a process that can be validated as removing gluten, distillation is a process that physically separates gluten proteins and peptides from other components based on clearly defined properties. When conducted following good manufacturing practices, distillation will separate volatile compounds (e.g., alcohols) from nonvolatile compounds, including any proteins and protein fragments. As a result, for distilled foods, FDA will use methods capable of detecting the presence of proteins and protein fragments in foods to evaluate compliance with the gluten-free requirements.

Enzymes

In response to comments to the proposed rule, the final rule preamble specifically indicates that FDA declines to exempt enzymes from the requirements that apply to fermented and hydrolyzed foods. When enzymes are produced in a system with gluten-containing nutrient media, FDA expressed concerns about how much carryover of gluten into the finished enzyme product would occur. Given that microbial fermentation processes used to produce the enzymes may also partially hydrolyze any gluten protein present, FDA points to the analytical challenges involved in verifying the subsequent removal of gluten residues from the enzyme product that will result in a final gluten concentration below 20 ppm intact gluten.

Soy Sauce

Soy sauce is a commonly used fermented or hydrolyzed food ingredient that may be derived from gluten-containing grains. Traditional soy sauce is commonly produced from a fungal fermentation of soybeans and wheat. As these types of soy sauce do not meet the gluten-free definition prior to fermentation, they are not allowed to be labeled as gluten free. Certain styles of traditionally fermented soy sauce, including some types of tamari, do not include any wheat in the formulation. If the ingredients used to make tamari meet the gluten-free definition prior to fermentation, then the resulting product could be labeled as gluten free. Lastly, some types of soy sauce do not rely on fermentation but rather use a combination of acid-hydrolyzed soybeans and other ingredients to formulate the product. If all the ingredients meet the gluten-free definition prior to hydrolysis and production, the soy sauce may be labeled as gluten free.

Malt, Malt Extract, and Malt Syrup

Malt is defined in 21 CFR 184.1445 as the “product of barley (Hordeum vulgare L.) germinated under controlled conditions.” Malt extract and malt syrup are terms both referring to viscous concentrated water extracts obtained from barley malt. FDA has indicated that because malt, malt extract, and malt syrup are derived from a gluten-containing grain and have not been processed to remove gluten, they may not be used as ingredients in foods labeled as gluten free.

Gluten-Free Beer, Wine, and Spirits

In the U.S., beer (malt beverages), wine, and spirits primarily fall under the regulatory authority of the Alcohol and Tobacco Tax and Trade Bureau (TTB). Beers not meeting the definition of a malt beverage, however, are regulated by FDA. Beers regulated by FDA would include those that are not made from both malted barley and hops—for example, beers using substitutes for malted barley such as sorghum, millet, or rice. Often, these beers have been formulated with gluten-free claims in mind, as they are not made from gluten-containing grains. Despite differences in regulatory jurisdiction, FDA and TTB both recognize the same definition of gluten free for fermented and hydrolyzed beverages. For beer or wine to be labeled as gluten free, the ingredients or mash used to make the beer must meet the definition of gluten free prior to fermentation, and controls must be in place to prevent gluten cross-contact after fermentation.

The TTB does, however, allow alternative statements on products fermented from gluten-containing grains (TTB Ruling 2020-2). In certain instances, manufacturers can include the claim that the products are “[Processed or Treated or Crafted] to remove gluten.” If this claim is used, there are additional requirements that must be met:

1. The label must also include the following statement: “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”;
2. The manufacturer must submit a detailed description of the method used to remove gluten and must be prepared to substantiate claims about gluten reduction upon request;
3. Gluten cross-contact must be controlled after treatment to reduce gluten;
   and
4. No labeling statements are allowed with respect to specific gluten concentrations.

TTB requires pre-authorization of all product labels, and allowable label claims meeting these criteria would be evaluated during that process. For FDA-regulated beers, the final rule indicates that beers not meeting the definition of gluten free are not precluded from using the types of alternative statements recognized by TTB, but the claims must be truthful and not misleading. That being said, FDA does not consider fermentation or hydrolysis itself a process that can be verified as reducing the gluten content of beers made from
gluten-containing grains.

TTB has also indicated that distilled spirits would be allowed to bear a gluten-free claim, and these products would need to comply with the same requirements as distilled products regulated by FDA. Specifically, manufacturers of distilled spirits made from gluten-containing grains must follow good manufacturing practices to prevent introduction of any gluten-containing material into the distillate and must implement controls to prevent gluten cross-contact after distillation. Manufacturers must also be prepared to provide verification of the absence of protein from the distillate and the absence of gluten from any ingredients added after distillation.

Impacts and Future Directions

Given the wide range and diversity of fermented foods and ingredients, the final rule has the potential to impact many products that had previously been labeled as gluten free. Even if the product is inherently gluten free, manufacturers must develop and maintain the required documentation for compliance with the rule.

While FDA has left the door open to enforcing compliance through use of novel gluten quantification methods developed in the future, there are many challenges associated with such an undertaking. Development and validation of a single method capable of quantifying intact gluten equivalents across the wide diversity of relevant fermented and hydrolyzed foods would require substantial time, effort, and resources.

The authors are with the Food Allergy Research and Resource Program in the Department of Food Science and Technology at the University of Nebraska-Lincoln. Reach Dr. Downs at mdowns2@unl.edu and Dr. Taylor at staylor2@unl.edu.

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Online food retailers do not regularly present nutrition information on their websites, and laws requiring them to do so are lagging behind the rules and regulations that brick-and-mortar retailers must follow, according to a new study conducted by the New York University School of Global Public Health and the Friedman School of Nutrition Science and Policy at Tufts University.

Lead author Jennifer L. Pomeranz, MPH, assistant professor in the department of public health policy and management at New York University, fell upon the genesis of the paper by accident, and says that she was looking for food labels of products for a different study, and searched online retailers to find them. “I noticed that the labels I found were inconsistent across retailers and sometimes were mock-ups of the products rather than the real food packaging you’d find in the store,” she tells Food Quality & Safety.

The study examined whether 10 popular products across nine national online food retailers disclosed the information panel, which includes the nutrition facts label, ingredient list, common allergens, and the percentage of juice for fruit drinks. The investigators discovered that the required information was present, visible, and legible for only 36% of the products. What’s more, potential allergens were only disclosed on 11% of the items. Failure to disclose this information may present safety concerns for consumers who depend on the labeling, as in the case of allergens, sodium, or sugar, the researchers noted.

“Although, arguably, the FDA’s regulations for food labeling already apply to online food retailers, the FDA has not issued a clear statement confirming this to be the case,” Pomeranz says.

The team also conducted legal research using LexisNexis to analyze federal regulatory agencies’ authority. The researchers believe online food retailers should voluntarily disclose the full information panel conspicuously and legibly. “The FDA could issue guidance documents explaining that their labeling requirements apply in the online food retail environment,” Pomeranz says. “Congress could pass a law requiring the same. The USDA could also issue regulations requiring that online SNAP [Supplemental Nutrition Assistance Program] retailers disclose the full information panel conspicuously and legibly. We hope our study will bring to light the issues consumers face when shopping online and urge the federal agencies to act to protect consumers and ensure an efficient and transparent marketplace.”

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On Friday, April 23, 2021, President Biden signed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 into law. The law contains two main components. First, sesame is added as a major food allergen, marking the first official change to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) since its passage. Second, the FASTER act requires reports on selected food allergy topics to be delivered to Congress, including those on how to establish and implement criteria for future updates to the list of major food allergens.

Sesame seeds (Sesamum indicum) are an oilseed crop, with yellow, white, red, brown, and black varieties grown for various food ingredients. Sesame seeds are approximately 50% fat, 23% carbohydrate, 18% protein, 4% ash, and 5% water. In 2019, the estimated global production of sesame was 6.5 million metric tons; the top producing countries were Sudan, Myanmar, India, Tanzania, Nigeria, and China. Sesame-derived food ingredients can include whole seeds, oils, flours, and pastes (commonly referred to as tahini).

Sesame is also known to cause food allergies and can be responsible for serious and life-threatening allergic reactions in sensitive individuals. The prevalence of sesame allergy varies around the world, with relatively higher prevalence observed in the Middle East, Israel, and Australia and lower prevalence observed in North America and Europe. Recent estimates in the U.S. indicate a convincing self-reported sesame allergy prevalence of approximately 0.2% in both adults and children. In comparison with the prevalence of other food allergies reported in the same studies, allergy to sesame is less prevalent than reported allergies to current major allergens (peanuts, tree nuts, wheat, soy, milk, crustacean shellfish, egg, fish) and molluscan shellfish. The allergenic potency of sesame is broadly similar to other seeds and nuts. The VITAL 3.0 reference dose (the ED01, or the dose expected to elicit reactions in the 1% most sensitive sesame-allergic individuals) is 0.1 mg total sesame protein. For comparative purposes, the sesame ED01 is the same as hazelnut, but higher than cashew and walnut and lower than peanut. The proteins in sesame seeds that have been identified as allergenic are predominantly seed storage proteins, as is also the case with tree nuts and peanuts.

In several regulatory jurisdictions around the world, including Canada, the EU, and Australia and New Zealand, sesame has been a priority food allergen for many years, with corresponding labeling requirements. In the U.S., sesame was not originally considered a major allergen in the context of FALCPA, but labeling of sesame or sesame ingredients was still required for many products in which such ingredients were used. For example, whole sesame seeds used as an ingredient were required to be labeled as such. However, sesame paste might have been declared as tahini, thus requiring sesame-allergic consumers to know that tahini was made from sesame. Additionally, when other forms of sesame (i.e., not whole seeds) were used, there were selected instances where those ingredients could be labeled as “spice” or “flavor.” The FASTER Act sought to remedy some of the potential confusion and improve labeling clarity by requiring sesame-derived ingredients to be subject to the same labeling regulations as other major food allergens.

The Amendment and Implications for FSMA

The FASTER Act amends Section 201(qq) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (qq)) to read:
(qq) The term “major food allergen” means any of the following:

(1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame.

The amendment to include sesame as a major food allergen is effective as of January 1, 2023. With this change, sesame and sesame-derived ingredients will need to follow all FALCPA labeling requirements. Specifically, all sesame and sesame-derived ingredients must be declared as sesame either in the ingredients list or in a “Contains” statement. If a “Contains” statement is used, all major allergen ingredients must be included. As noted above, one common sesame-derived ingredient used in foods is sesame oil. While FALCPA does exempt highly refined oils derived from allergenic foods from labeling, much of the sesame oil used in food production is not highly refined and is therefore not exempt from labeling. FALCPA does not provide a specific definition of highly refined oils, but industry best practice would indicate that processing should include refining, bleaching, and deodorizing. Sesame-derived ingredients must also be declared by their common or usual name; tahini may still be used on the ingredient list, but sesame must appear either parenthetically or in a “Contains” statement.

In addition to direct changes in FALCPA requirements, the inclusion of sesame in the definition of major food allergens also has implications for the Food Safety Modernization Act (FSMA). The FSMA Final Rule for Preventive Controls for Human Food includes the following definition: “Food allergen means a major food allergen as defined in section 201(qq) of the Federal Food, Drug, and Cosmetic Act.” With the FASTER Act amendment, sesame will also be considered a major food allergen in the context of FSMA. As such, manufacturers will need to include sesame in food safety plan hazard assessments and will need to have preventive controls in place for the ingredient, if undeclared sesame is identified as a potential hazard.

Allergen Management

Given that sesame has been considered a priority allergen in other regulatory jurisdictions for many years, there are tools and resources available to aid in sesame allergen management. Commercial detection methods for sesame are available in multiple formats, from several different kit manufacturers. Enzyme-linked immunosorbent assay (ELISA) methods are available for the detection and quantification of sesame in ingredients, processed food products, and environmental samples. The sesame ELISA methods, like other allergen ELISAs, are generally most appropriate for use in centralized or third-party laboratories due to the equipment and expertise required. Rapid methods, including lateral flow devices (LFDs), are also available for sesame. LFDs are easy to use, require minimal equipment, and are good options for detecting allergen-specific residues from equipment swabs and rinse waters when conducting allergen change-over validation studies. For selected situations where confirmatory analysis may be required, commercial PCR methods are also available for sesame detection.

When developing an allergen management plan or analysis strategy for sesame, one of the most important considerations is the form of the sesame ingredient. Sesame seeds, sesame paste, sesame flour, and sesame oil present very different challenges for allergen control and detection. With sesame seeds, it is important to recognize the particulate nature of potential cross-contact. In developing allergen change-over procedures, visual inspection for sesame seeds remaining on equipment is likely more crucial than analysis of equipment swabs. If ingredients or finished products are analyzed for cross-contact with sesame seeds, additional rigorous homogenization techniques (e.g., grinding under liquid nitrogen) are often required to break the seed coat and achieve sufficient sesame protein extraction for analysis. In the case of sesame paste, the oily, sticky nature of resulting food soils can be a challenge for allergen cleaning protocols. Soil removal strategies for similar ingredients (e.g., peanut butter and tree nut butters) have been successfully developed, however, and may be applicable to the cleaning of sesame paste. Sesame oil that has not been highly refined is likely to contain sesame protein; however, the protein may not be at concentrations high enough to be detectable in equipment swabs during allergen change-over validations. A swab of dirty equipment, after production of the product containing sesame oil and prior to cleaning, can serve as a positive control to verify the detection of sesame protein residues.

Impact on Food Safety Plans

While sesame has long been known to cause food allergies, the requirements to manage sesame as a major food allergen as a result of the FASTER Act will likely require multiple layers of changes on the part of some food manufacturers. Both allergen labeling controls and allergen cross-contact controls will be required for operations that handle sesame seeds or other sesame-derived ingredients. Despite the changes that may be required for food safety plans, the principles used for other food allergen controls are also relevant for sesame. Food manufacturers should be able to use existing best practices, tools, and resources to comply with the new application of food allergen regulations to sesame going forward.

Dr. Downs is an assistant professor in the department of food science and technology at the University of Nebraska, Lincoln. Reach her at mdowns2@unl.edu. Dr. Taylor is professor emeritus of food science and technology and co-founder and co-director of the Food Allergy Research and Resource Program (FARRP) at the University of Nebraska-Lincoln. Reach him at staylor2@unl.edu.

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Careful management of allergens and organics is increasingly important in the food and beverage industry. Manufacturers must closely manage and track both during the production process to avoid cross contamination, properly label goods, and meet the expectations of customers, consumers, and regulators.

Considering the growing consumer demand for organic and allergen-free products, the payoff for investing time and resources into proper plant management is worth it. People are paying more attention—and a higher dollar amount—in looking for specific products that meet their dietary and lifestyle preferences. If you can reliably produce products that meet those preferences, you can capture their business, build customer loyalty, and remain competitive in your market.

Today, properly managing allergens and organics doesn’t have to be a complex, multi-system process. An enterprise resource planning (ERP) system with industry-specific features can centralize key aspects of food and beverage manufacturing, saving manufacturers time, reducing risks, and helping them make consistent, quality products with every batch. An ERP system is software that manufacturers can use to manage day-to-day business activities, such as procurement, project management, risk management and compliance, and supply chain operations.

What Complicates Managing Allergens and Organics?

Many manufacturers use disparate systems to manage data and scheduling around allergens and organics, which can lead to inefficiencies and errors and adds time to the process. This process can be complex because you’re relying on multiple systems to coordinate cleaning and sanitation and prevent cross contamination.

If you’re using disparate systems and experiencing these issues, you could face significant consequences if you continue. Your stakeholders are putting your processes under a closer microscope, and they expect you to have full control of them and maintain traceability for your products and ingredients.

What Are the Risks When you Poorly Manage Allergens and Organics?

If you don’t manage these elements correctly and efficiently, there’s more at stake than simply missing out on increasing demand in certain markets. You can also face:

• Penalties for not meeting regulations;
• Poor traceability in the event of a recall;
• Real risks to consumer health, in the case of allergens;
• Lower-quality outcomes for products;
• Loss of customers due to dissatisfaction; and
• Reputational damage due to bad press.

How Can You Ensure Optimal Management?

The most efficient, reliable way to manage allergens and organics is to implement an ERP system tailored to the food and beverage industry. Such an ERP will have features that enable you to:

• Categorize and track ingredients at every point in the supply chain, retaining essential information for management, labeling, and distribution; this will help you simplify and optimize everything from recipe management to batch production management and labeling, so you can avoid risks and maintain high customer and consumer satisfaction.
• Manage ingredient data and allergen information in your ERP to optimize scheduling and production, integrating sanitation processes to avoid cross contamination. You can create classifications and rules around items, noting that they contain allergens or are organic, to prevent errors (such as mixing non-organic and organic ingredients) and to ensure proper labeling.
• Support organic versus non-organic classifications with a warehousing functionality, allowing you to apply specific attributes and rules for segregating materials and storage and inventory processes that prevent mixing and cross-contamination.
• Access full audit trails, with everything in one system, documented and tracked, so that you’re prepared for inspections and audits; customers and regulatory committees may want to conduct inspections and review documentation around maintenance and allergens and organics protocols.

This approach centralizes information and processes into one location. Everything is integrated into a single system and can be used with mobile technologies, helping companies consolidate their multi-system operations for better management and traceability.

Hilton is director of business solutions at Columbus US, a Minneapolis-based organization that specializes in cloud management tools for the food and beverge industry. Reach him at donh@columbusglobal.com.

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When it comes to marketing strategies, what sets brands apart is how they leverage being social on social media. This May, a number of small- to large-sized businesses harnessed the power of social media to humanize connections, amplify important messages, and spark the drive for change for celiac disease.

Celiac disease, a chronic digestive and immune disorder, is triggered by the consumption of gluten and adversely impacts the small intestine. According to the National Institutes of Health, celiac disease affects more than three million Americans, which is roughly 1% of the total population. In many cases, the disease skips the radar and is left undiagnosed.

Given the rapid use of virtual work–life spaces, organizations and individuals alike voiced their stories about the illness through social media. ABC News highlighted some of the stories shared by children across the nation.

How can food businesses can use social media to engage with customers and expand public awareness of the disease?

Engage Users

Engagement is more than just likes, emojis, and reshares. User engagement encompasses responding to questions promptly, asking questions that spark visitor curiosity, and highlighting useful resources. Invite your users to share their stories. The end goal is to make the process as simple and relatable as possible.

Implement Design Thinking

While our initial impulse is to hit the drawing board and design content that we are most passionate about, it’s important to implement design thinking methodologies. In simple terms, design thinking requires developers to build their products and services as if they are the end user, or the customer. It is a process through which a product is developed and constantly modified, based on input provided by the customers or clients. For example, UberEats has implemented The Walkabout Program, which allows designers to immerse themselves in a city’s transportation system, restaurants, and their locations, as well as give them access to dining trends exhibited by the public. This is an example of design thinking in action.

Data Analytics

A lot can be learned by simply sifting through the data generated by each social media post. Important data points such as click-rates, post skips, post reactions, and post shares let you know how well you’ve captured the interest of your users. In its recent press release, TikTok explained how the algorithm behind “For You” posts work. Understanding at least at the basic level how algorithms for each platform work will help you better develop your user engagement.

Make Important Announcements

Restaurants are seeing the benefits of announcing important changes and updates to their menus via social media platforms. The Celiac Disease Foundation encourages businesses to spread awareness of the disease 365 days of the year. They have provided a great resource to develop social media posts on Facebook, Twitter, and Instagram.

What are some social media strategies that you have used to engage your customers? Share your ideas in the comments below!

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