Health experts estimate more than 100 million people in the US live with some sort of food intolerance or food allergy. This is an alarming figure that has many food brands racing to produce products that are safe for these consumers. However, developing such allergy-friendly foods presents unique challenges.

One of the most important things in creating allergen-free products is understanding the difference between a true allergy and an intolerance. According to the Mayo Clinic, “A true food allergy causes an immune system reaction that affects numerous organs in the body. It can cause a range of symptoms. In some cases, an allergic reaction to a food can be severe or life-threatening.” Intolerances, also known as “non-IgE mediated food hypersensitivity” or “non-allergic food hypersensitivity,” however, are “generally less serious and often limited to digestive problems.”

The Food Allergy Research & Education group (FARE), describing itself as “the leading national organization working on behalf of the 15 million Americans with food allergy,” categorizes the eight foods that are deemed responsible for approximately 90% of all reactions as milk, eggs, peanuts, tree nuts, soy, wheat, fish, and shellfish, noting that “even trace amounts of a food allergen can cause a reaction.” These ingredients must be clearly stated on any processed food to comply with the US Food Allergen Labeling Act (FALCPA).

While all true food allergies can pose a life-threatening reaction, peanuts and tree nuts are the most dangerous, causing the greatest number of food allergy deaths, according to the American Academy of Allergy, Asthma and Immunology. Each year, some 150-200 people die from an adverse reaction to nuts, accounting for 50-62% of those deaths.

Along the entire product manufacturing chain, from purchasing through production and packaging, the manufacturer must maintain the ability to identify and source ingredient alternatives that are free from common allergens, yet still taste as delicious as their traditional counterparts—all while implementing quality-assurance processes and testing to ensure no cross-contamination.

Today’s consumers, particularly in the allergy-free space, also are looking for “cleaner” ingredient panels. Food manufacturers investing in this space also need to be mindful of ingredients that may contain genetically modified organisms (GMOs) and other ingredients that are questionable in consumers’ minds for a wealth of reasons.

Then, there are the “gray area” ingredients such as monosodium glutamate (MSG) and certain chemical food colorants, especially Red Dye #40. While most of the research extant indicates these ingredients do not trigger harmful or discomfiting reactions, there are a handful of studies, the results of which make it premature to make a definitive statement to that effect. Still, consumers are becoming less accepting of these ingredients in their foods and beverages.

Making Without

Using alternatives to ingredient staples traditionally has caused consumer skepticism, and rightfully so. Whether consumers suffer from a specific food allergy or intolerance, or choose to follow a special diet, like gluten-free or paleo, they’ve been vocal about having only bland options that pale in comparison to the majority of supermarket finds. Many under-deliver on texture and flavor while sold at a premium price.

Pioneering the allergen-free category in 2002, Enjoy Life Foods Inc. gives allergy sufferers and those with food and gluten intolerances safe options. The brand’s portfolio features everything from cookies; snack and chocolate bars; baking chocolates and mixes; seed and fruit mixes; and lentil-based chips called Plentils. Aside from not containing the top eight allergens, all products also are certified gluten-free and Non-GMO Project Verified.

“Research shows that free-from shoppers spend an average of $102 per cart load compared to $46 for regular shoppers, a 122% increase in spend per shopping trip,” notes Joel Warady, Enjoy Life CSMO. “As the consumer base continues to expand and prove that individuals are willing to spend more if a product actually tastes good and is safe for them to eat, food manufacturers must focus on finding satisfying ingredient alternatives that exceed expectations about how delicious an allergy-friendly product can be.”

Ingredients First

When ingredients, such as dairy, eggs, nuts, and gluten, are off-limits, it’s necessary to look at ingredients food innovators might not have previously considered. A perfect example: algae-derived protein. Algal protein, as well as oil and starch compounds from algae, had been overlooked for years. Reasons for its slow start ranged from the technical (cost of extraction and processing into a usable ingredient) to the fact that “algae” sounds less than appetizing to many Western consumers. But recent advancements on the supply side are proving algal ingredients are an excellent option for free-from food producers.

Enjoy Life was among the first food brands to use sustainable algal protein as a substitute for dairy, eggs, and soy in its recently launched line of baking mixes.

The company goes to great lengths and rigorous R&D and testing to ensure no undesirable taste profiles can be detected. Its R&D team, Warady notes, is consistently working with new ingredient alternatives (including egg and oil substitutes), to meticulously formulate each product in the pipeline. Until a year ago, the brand used rice protein but quickly shifted to whole algal protein powder, which boasts 65% protein, alongside healthy lipids, insoluble fiber, and micronutrients.

“The frequent evolution of allergy-friendly and gluten-free formulations has challenged us to find new ingredients that many other brands typically don’t risk experimenting with,” agrees Paul Maki, R&D manager for Enjoy Life. “Being free from the top eight allergens, for instance, creates a limited source of protein; our team likes to get creative to find ways to supplement that.”

The Enjoy Life R&D team opts for other alternatives, such as a combination of baking powder, flax, and applesauce to replace egg; as well as the use of unrefined, natural fruit juices and honey, or pure brown cane sugar, to replace traditional sweeteners.  It uses non-hydrogenated, trans fat-free safflower oil to substitute for trans fats, in addition to sunflower seeds and lentils for maximum nutrition.

Additionally, Enjoy Life uses flour from the gluten-free Ethiopian supergrain teff, and nutrient-rich quinoa, millet, and buckwheat. All are employed as grain alternative flours that contain soy and rice flour—substances the company originally used from 2002-2004.

Recent SPINS data show food products containing ancient grains such as teff increased nearly 17% in 2016 over the previous year, translating to a nearly $200 million increase. This growth proves that consumer shifts toward the next big ingredient create evolving trends—and brands might take great measures to meet them.

Shared Responsibility

When confronting manufacturing of products for those persons with food allergies, cross-contamination can mean a trip to the emergency room or even worse for the inadvertent consumer. That shouldn’t be an option for food manufacturers or suppliers operating in the space, and as the category grows, it’s important for all parties involved to abide by the strictest standards.

Ben Larkin, quality-assurance manager for Enjoy Life, adds that the company has its own rigorous set of independent, in-house tests for gluten, casein, peanut, and soy protein for all ingredients. “We retest every ingredient received from our suppliers to ensure safety and quality control,” he avers. “We also clean our equipment thoroughly before and after all product and flavor changes—a process that occurs daily in our new state-of-the-art, allergy-friendly, and dedicated nut-, gluten- and dairy-free production facility.”

Now under Mondelez International Inc., which acquired the brand last year, Enjoy Life retains its operational autonomy and unparalleled industry knowledge, while tapping into the Mondelez’s manufacturing and food science resources. The relationship allows Enjoy Life to source and experiment with original, edge-of-trend flavors and textures, while upholding the highest quality ingredient and nutrition standards.

Enjoy Life’s position on allergy safety and keeping unfavorable ingredients away is deeply ingrained into all of levels of its operations and staff. It is shared by a tight and trusted group of ingredient suppliers that are required to complete non-contamination certificates for every item purchased.

Nutritional Balancing Act

While there are many unique new ingredients becoming available to free-from food manufacturers, it’s  critical to remember the impact of nutrition and to create a well-rounded product that is not only allergen- friendly but still offers nutritional value.

Drink Eat Well LLC’s Hilary’s brand of convenient and culinary-created frozen veggie burgers, snack bites, and shelf-stable dressings are free from common allergens and employ vibrant packaging design to clearly displays product attributes. Using only Non-GMO Project Verified, gluten-free, and USDA-certified ingredients, packaging exhibits a verification seal as well as its free-from claims.

Hilary’s formulates with ingredient alternatives selected to not only appeal to the allergen aware consumer but provide optimum nutrition, as well.

“At Hilary’s, we try not to think of our ingredients as substitutes and instead focus on choosing whole food ingredients that are familiar and inherently free from the ‘big eight’ food allergens,” says Hilary Kass, head of Research & Product Development for the line.

In 2005, the company’s founder, Hilary Brown, set out to create a veggie burger without relying on gluten, soy, or corn—all common ingredients in vegetarian burgers up until then. She then worked on the remaining five main food allergens. To achieve effective binding without eggs, she formulated a combination of psyllium husk powder and arrowroot, both simple ingredients with good nutritional qualities.

As shoppers continue to seek more nutrition from their food, often through fewer ingredients and the same flavor expectations, CPG food and snack brands in the free-from category are relying on a combination of the tireless efforts across the board.

“Our R&D team has a long history in the natural, whole foods world,” says Kass. “This has made it easier for us to offer the allergen-free, whole food options consumers are looking for, even in the processed food world.”

“Because people’s nutrition perceptions and needs are unique, Hilary’s does not make claims about following specific dietary practices,” continues Kass. “Rather, we offer simple whole foods, with real ingredients that are minimally processed and free-from common allergens.  We believe this is naturally beneficial to all people.”

Efforts including meticulous R&D teams, visionary marketing leaders, creative chefs, and innovative product developers to bring forth new ingredients, recipes and products with the most  natural, cleanest labels possible. The brand also explores exotic, spicy, and earthy flavor profiles, with varieties ranging from Spicy Thai Burger to Mediterranean Bites and Root Veggie Burgers.

Standard Production

Hilary’s follows all FDA standards for CGMP, including an allergen-control plan based on the “Components of an Effective Allergen Control Plan” program of the Food Allergy Research and Resource Program of the University of Nebraska, Lincoln. This plan requires each ingredient supplier to provide, within the plan, all sanitation and cleaning procedures and to commit to notifying the manufacturer of any changes to the allergen status of the ingredients they supply. “All the suppliers we choose readily follow these practices,” Kass emphasizes.

In addition to being USDA-certified and Non-GMO Project-verified, all of Hilary’s products also are certified-organic. (Organic certification also has never allowed the use of GMOs.) Both of these certifications have stringent monitoring practices. “We must receive current organic certificates on each ingredient, which ensures that the product was not grown or produced with certain synthetic pesticides or herbicides,” says Kass.

Non-GMO Project verification requires a standard ingredient form be completed and requires ingredient suppliers to answer if the ingredient contains any additives (i.e., preservatives, carriers, anti-caking agents, etc.) or processing aids (enzymes, solvents, extractants, microorganisms, etc.) in its manufacturing process.

The Project also requires listing of all ingredient raw materials, additives (e.g., preservatives, carriers, pH adjusters, etc.), incidental additives, processing aids, and fermentation media/substrates (such as microbial ingredients) used in the manufacturing process. Examples include anti-caking agents in salts and standardizing agents in powders; solvents in extracts; all processing aids, preservatives, and carriers; and antioxidants in oils.

“Because our products are made from whole foods that are minimally processed, we can dive right into the kitchen playing with the unlimited options of cooked whole grains, organic vegetables, whole beans, and herbs and spices,” adds Kass. “Knowing there are ingredients we will never use—like gluten, dairy, soy, corn, eggs, and nuts—gives us an opportunity to reach farther into the whole foods spectrum to use lesser known items, like psyllium husk powder, millet, leafy greens, beets, and adzuki beans. Then we look hard at what type of processing is involved. Our team is passionate about eating a very clean diet on a personal level, so we simply carry these values into the foods we produce for our customers.”

Freeze Fame

Elevation Brands LLC’s Ian’s Natural Foods has a long history of remaking the frozen food aisle with its comprehensive line of gluten- and allergen-free (and non-GMO) products. With everything from chicken nuggets and pizza to snacks and breakfast items, they contain no GMOs, egg, soy, wheat, gluten, dairy, casein, peanuts, tree nuts, or common allergens.

“The foundation of Ian’s brand was the love of a father for his son Ian, who inspired him to create a clean product line of gluten-free foods with no artificial colors, ingredients, or preservatives,” says Chuck Marble, CEO at Ian’s. “We have refined this mission to include developing for persons with food allergens as well, making us one of the pioneer brands in the free-from, natural industry.”

Some hallmarks of the Ian’s brand include not using ingredients such as HFCS or hydrogenated oils, and not using baking powder in batter systems to avoid sodium acid pyrophosphate. Examples of clean ingredients Ian’s will use include white meat, antibiotic-free Global Animal Partnership (GAP)-rated chicken; turkey dogs without added nitrites or nitrates; and fish that is whole muscle, wild-caught, Marine Stewardship Council-certified Pollock. These promote the sustainable message Ian’s also embraces.

“We work diligently with our suppliers to stay current with clean food ingredients, producing a great tasting product that is allergy-friendly,” explains Marble. “Food safety comes first, as we adhere to a very strict supplier approval process that ensures we set the food safety and quality bar high when selecting our suppliers and their ingredients. More important is the partnership and testing of ingredient suppliers for food allergens. With food allergen recalls growing at an alarming rate, this is a critical component of our promise to consumers.”

As a pioneer in the field, Ian’s recognized that flavor must trump all other considerations in making such seemingly restrictive products as allergen-free foods. Ian’s administration developed its “Nutritional Charter” was developed internally to provide guidelines for the R&D team and plays a significant role in the sourcing and ingredient selection process.

“We source whole-grain ingredients when appropriate, such as brown rice, to fill the gap in a gluten-free market dominated by refined, nutrient-poor grains,” adds Marble. “Our primary oil of choice is non-GMO, expeller-pressed canola oil, as it is high in monounsaturated, heart-healthy fats.”

Marble describes the Ian’s development process as first determining what products its consumers frequently ask the company to develop or reformulate. Such requests often will be due to those consumers’ special dietary needs. “We also look at trends and favorite food groups and reformulate by removing allergens for those with food allergies, or who have eliminated gluten from their diets, or who looking for healthy lifestyle changes,” he says.

“The use of technology, techniques, and better ingredients that deliver phenomenal nutritional benefits will forever be evolving, especially as younger generations keep shaping the way in which developers and manufacturers approach innovation,” says Warady.

He predicts the allergen-friendly category will become increasingly ubiquitous across shelf-space and use that momentum to become ever more mainstream for the growing food allergy, celiac, and food intolerance sufferers. After all, the category now comprises some one-third of Americans and their families. That’s hardly a niche market and one that cannot be ignored.   

Food Allergy Myths and Facts

Myth: Food allergies are not real.
Fact: Food allergies are real and involve the body’s immune system. With a true food allergy, the immune system misinterprets compounds in the ingredient—typically proteins—as harmful invaders and releases histamines and other chemicals to protect the body from harm. Symptoms can include hives, vomiting, diarrhea, and respiratory distress. In severe cases, potentially fatal anaphylactic shock can ensue.

Myth: Food allergies are one of the most common health conditions in the US.
Fact: While allergies, not specifically food allergies, are one of the most common health conditions, affecting one in five Americans, true food allergies only affect about 0.5-2.0% of the population.

Myth: Food additives and artificial flavors cause the majority of food allergic reactions.
Fact: Contrary to common belief, natural foods account for the majority of allergic reactions. The foods that cause 90% of allergic reactions are: peanuts, milk, eggs, wheat, soy, tree nuts, fish, and crustacean shellfish.

Myth: Each allergic reaction to food becomes increasingly worse.
Fact: The severity of a reaction is based on a number of factors, including the amount of food ingested. A food-allergic individual can experience a mild or severe reaction.

Myth: For peanut allergic individuals, airborne exposure–like smelling peanuts–can cause an anaphylactic reaction.
Fact: According to a study by Sampson, Sicherer, and colleagues, airborne exposure does not affect the body systemically (i.e., with an anaphylactic reaction). In order for an individual with a peanut allergy to have a life-threatening allergic reaction, the protein must be ingested. The aroma of peanuts comes from different compounds that cannot cause an allergic reaction. Still, smelling the aroma of peanuts is not the same as inhaling/ingesting peanut particles, which could potentially contain the allergenic protein.

Myth: Peanut oil should be avoided by those with peanut allergies.
Fact: Highly refined peanut oil can be used by people with peanut allergy, because the allergenic proteins have been destroyed. But caution should be taken with natural, cold-pressed, or flavored oils—these can contain enough of the allergenic compounds in the original ingredient to trigger a reaction.

Myth: Parents should delay the introduction of potential allergens and allergen-containing foods to prevent allergies in their children.
Fact: In 2008, the American Academy of Pediatrics stated that there is no convincing evidence that delaying the introduction of potential allergens (such as eggs, fish, or peanut-containing foods) to children prevents allergies. Milk, eggs, peanuts, tree nuts, and seafood are considered safe to introduce to children at the same time as all other solid foods—according to the Guidelines for the Diagnosis and Management of Food Allergy in the US, not beyond four to six months of age.

Sources: Adapted from materials by the University of Nebraska–Lincoln Institute of Agriculture and Natural Resources Food Allergy Research and Resource Program, the National Peanut Board, International Food Information Council (IFIC), and other sources.

Two More for the Road

According to the International Food Information Council (IFIC), the FDA includes on its list of recall substances all eight of the major allergens. If these substances are present in a food, but not listed on the label, the product must be recalled. IFIC also notes that the FDA requires that substances that cause non-allergic-based reactions, such as the additives sulfites and tartrazine (FD&C Yellow #5), also be included on this list since “some individuals have unique sensitivities to these food components, which are not allergenic or allergy-causing in nature, but may cause comparably severe reactions.”

Sulfiting agents are commonly used to preserve the color of foods, such as in dried fruits and vegetables, and to inhibit the growth of micro-organisms in fermented foods, such as wine. Sulfites can also be found in beer, some fruit drinks, shrimp, and some prepared foods. Although sulfites are safe for the majority of people, for some, they have been found to cause a reaction. For this reason, the FDA requires that when sulfites are added to foods in greater than 10ppm, they must be indicated on the label as added sulfites. Some products are known to naturally contain sulfites, such as cider and some other fermented beverages. In some cases, these, too, must be labeled as “containing sulfites.”

Food Allergen Labeling 101

by Justin Prochnow

Failure to properly declare major food allergens is one of the most commonly cited labeling violations in Food and Drug Administration (FDA) warning letters. Companies that discover a product has been improperly labeled by the omission of a major food allergen often come to the decision that a voluntary recall is necessary to ensure consumer safety and to avoid action from regulators and class action lawyers.

With that in mind, it is always helpful to get a quick refresher on the key points of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and the requirements for the proper labeling of food allergens.

In a nutshell, FALCPA identifies five foods and three food groups, as food allergens. The five foods are milk, eggs, peanuts, wheat, and soybeans, and the three foods groups are fish, crustacean shellfish, and tree nuts. These eight major food allergens identified in FALCPA accounted for over 90% of all documented food allergies in the US.

FALCPA requires food manufacturers to label food products that contain an ingredient from a major food allergen in one of two ways: The first option is to include the name of the food source in parentheses following the common or usual name of the food containing the major food allergen, if it does not appear elsewhere in the ingredients statement. For example, the label could display “whey (milk)” to comply with the requirement to declare the major food allergen. (However, if milk was the ingredient listed or milk is listed as an ingredient elsewhere in the ingredient statement, it would not be necessary to also declare “milk” in parentheses after “whey”).

The second option is to place the word “Contains” followed by the name of the food source from which the major food allergen is derived, immediately after or adjacent to the list of ingredients, in type size that is at least the same size as the type size used in the list of ingredients. For example, “Contains wheat, milk, and soy.” An important aspect is that if a company elects to use the “Contains” statement format, all food allergens must be declared in the statement, even if some of them are clearly declared in the ingredients list. This is to prevent situations in which someone reads the “Contains” statement, sees one particular allergen stated, and that consumer assumes there are no other allergens in the product.

If the food source is one the allergens from one of the three groups, you must declare the specific type of the food from the respective group, such as tree nuts (e.g. almonds, pecans, walnuts), fish (e.g., salmon, cod) or crustacean shellfish (e.g., crab, lobster). Numerous warning letters have been issued in which the FDA has asserted allergen declarations like “contains fish” or “contains tree nuts” are improper.

The failure to comply with another labeling requirement can also often lead to a failure to properly declare a food allergen. If an ingredient is itself made of multiple ingredients, the subcomponent ingredients must also be declared, either in parentheses after the common or usual name or as separate ingredients in the ingredients list. If a company fails to identify subcomponents and one of those subcomponents is a major food allergen, the company has now committed two labeling violations.

Many companies choose to provide an advisory statement that a product may contain certain of the major food allergens because it is manufactured in the same facilities in which products with one or more of the major food allergens also are manufactured. There is no regulatory requirement to provide such an advisory; companies sometimes do so in an effort to stave off any potential safety issues that might result from someone with severe allergies to one of the major food allergens. However, if such a statement is made, it must be truthful and it can’t be used in lieu of compliance with Good Manufacturing Practices.

The failure to properly label food allergens is a violation of the Federal Food, Drug and Cosmetic Act and can cause a product to be deemed misbranded. More importantly, the failure to declare food allergens can result in serious adverse events for persons allergic to one of the eight major food allergens. For these reasons, knowing the law and ensuring compliance is equally important for the safety of consumers and the livelihood of industry companies.

Justin J. Prochnow is an attorney and Shareholder in the Denver office of the international law firm of Greenberg Traurig LLP. His practice concentrates on legal issues affecting the food & beverage, dietary supplement and cosmetic industries. He can be reached at (303) 572-6562 or prochnowjj@gtlaw.com and he can be followed on Twitter at @LawguyJP.

This article is issued for informational purposes only and is not intended to be construed or used as general legal advice. The opinions expressed are those of the author exclusively.