In all surveys prognosticating the biggest trends in the food and beverage industry for 2015, allergen-free formulation keeps landing at or near the top. While the category is most often represented by the gluten-free progression, it follows a generation of dairy-free product growth that has seen supermarket space devoted to dairy milk analogues grow by several hundred percent.


It’s all about ingredient substitutions, techniques and cautions. Of the common allergies, the so-named “Big 8” are peanuts, tree nuts, fish, shellfish, eggs, wheat, soy and milk. Dairy and wheat are the hardest to avoid in a processed food industry that has relied so strongly on those two ingredients and their derivatives. They are inexpensive and wholesome sources of carbohydrates and protein that also have the advantage of being highly versatile.   All these factors, plus ease of production and abundance, have made them key components in food and beverage product development.


While lactose intolerance is not a true allergy, it is easily the most prevalent of food sensitivities, affecting whole populations with high incidence. As many as one-third to two- thirds of persons of African, Native American, Jewish, Hispanic and Asian background are estimated to have at least some sensitivity to the milk sugar. And, while true gluten allergy/sensitivity is quite rare, affecting about 1-4% of Americans, the massive growth of that trend proves that developing product lines to account for a particular allergen is as much a result of demand as medical need.


Laying Down the Law on Labeling Food Allergens

By Justin Prochnow 

Food safety continues to be one of the highest priorities of the U.S. Food and Drug Administration (FDA) and, for that reason, the proper labeling of food allergens is a specific area of focus and concern for the FDA when scrutinizing food labels. The Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2006 amended the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. §343(w) and requires that a food containing an ingredient that is or contains protein from a “major food allergen” must declare the presence of the allergen on the label. The FDA considers the failure to properly identify food allergens to be a major potential risk to the safety of consumers.


There are eight major food allergens identified in FALCPA that, at the time FALCPA was passed, accounted for more than 90% of all documented food allergies in the US They include five specific allergens—milk, wheat, soybeans, peanuts and eggs—and three groups of allergens—fish, crustacean shellfish and tree nuts. Pursuant to FALCPA, the specific species of fish, crustacean shellfish or tree nut must be identified when one of those allergens is present in a food.


Identification of food allergens can be carried out in one of two manners: One way is for the food allergen to be identified in the ingredients list, either if it is evident in the common or usual name used in the ingredients list, or in parentheses after the common or usual name, such as “whey (milk).” 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 this case, it must be in a type size that is no smaller than the type-size used for the list of ingredients, i.e., “Contains: milk, eggs, peanuts.”


While some companies opt to include a cautionary warning that products are processed in a facility that also produces products containing one or more major food allergens, such cautionary warnings are not covered by FALCPA and not required by the FDA.


Food products that contain undeclared food allergens are considered misbranded (mislabeled) products and are thus in violation of the Federal Food, Drug, and Cosmetic Act. Companies are usually strongly encouraged to recall products with undeclared food allergens, and the FDA now can likely initiate mandatory recall procedures due to the potential for serious health consequences.


The failure to properly identify food allergens continues to be one of the more frequently cited violations alleged in FDA warning letters. In 2014 alone, the FDA issued and posted at least 12 warning letters that identified the failure to declare one or more major food allergens as one of the alleged labeling violations. Of course, companies also face civil action in the form of a product’s liability case or a false labeling action from consumers who are sensitive to food allergens and consume a product with undeclared food allergens.


Accordingly, the proper labeling of food allergens on food labels is critical for food, beverage and dietary supplement companies. The failure to identify food allergens could subject a company to regulatory and legal consequences that could result in huge impacts on the bottom line for the company.


Justin Prochnow is an attorney and shareholder in the Denver office of the international law firm of Greenberg Traurig LLP.  His practice concentrates on regulatory and legal issues affecting the food and beverage, dietary supplement and cosmetic industries. He can be reached at 303-572-6500 or and is on Twitter at @LawguyJP. This is 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. 

This merging of demand and need also is evident in the residual value of formulating products free of eggs and animal proteins. Those products serve more than the allergic; they also serve the expanding vegan/vegetarian/flexitarian markets, as well as religious dietary needs.


This does not, however, diminish the need for expert execution of product development for allergies to such ingredients as tree nuts, peanuts and soy. Simply put, there are some allergens that, for those afflicted, even a few parts per million can sicken or even kill. Processors getting involved in this arena cannot do so blithely, with an eye on merely hopping a trendy bandwagon.


Youth Market

The fast rise in severe peanut allergies among children put food prophylaxis in the spotlight. More than twice as many children as adults have food allergies, and their reactions can be the most severe. An estimated 8% of children are allergic to some food ingredient, according to Food Allergy Research & Education (FARE), a non-profit organization whose “mission is to find a cure for food allergies, and to keep individuals with food allergies safe and included.” FARE cites a number of worrisome statistics by the Centers for Disease Control (CDC), the most alarming being “the prevalence of food allergies and associated anaphylaxis appears to be on the rise.”


According to FARE, in 2008, the CDC reported an 18% increase in food allergies among children between 1997 and 2007. Also, whereas historically between one fourth and one half of children saw their food allergies resolve after age five or following puberty, FARE notes they “appear to be resolving more slowly than in previous decades, with many children still allergic beyond age five years.” The group also points out that allergies to peanuts, tree nuts, fish or shellfish are “generally lifelong allergies.”


The statistics around childhood food allergies explains why most developers of allergen-free products have had a personal stake in the arena. Typically, those involved at the top have raised one or more of their children with a food allergy or sensitivity.


It’s this level of dedication that has contributed to the high marketability of allergen-free products outside the demographic of the few percent who have the medical need: Most of these foods taste good and are highly nutritious at the same time. And they come from facilities that can rival the clean room of a medical research lab.


“Great nutrition can be very decadent and indulgent,” says Lucy Gibney, MD, chairman and founder of Dr. Lucy’s LLC, a dedicated bakery producing gluten-free and allergy-friendly baked goods. Gibney’s line of cookies grew out of her family’s experience: Her son was diagnosed as an infant with several severe food allergies. This led her to experiment with baking gluten-free and vegan treats.


“I grew up eating the wonderful baked goods my mom made,” says Gibney, “and I wanted the same for my child. Thankfully, I’m a persistent and driven person, because otherwise I would have given up,” she admits. “I was shocked at the technical challenges involved.”


The challenge for Gibney to re-create a baked item that is fundamentally flour and dairy was big. “No wheat, butter, milk or eggs, yet gluten-free baking depends on milk and egg products for the protein to replace gluten,” she explains. “Vegan recipes really need the protein and elasticity provided by wheat flour.”


Recipe for Success

Gibney began by experimenting with various cookie recipes to make more nutritious and interesting versions of classic cookie favorites. She turned to ingredient options like pectin, fruit purée and even tofu as substitutes for gluten protein. All the results were heavy and off-tasting.


Adjusting amounts of the same ingredients made the results worse and the products poor. Gibney realized she was complicating the texture problem—not solving it.

Gibney pressed on with the trial-and-error approach, however, and worked over recipes for weeks.

“I was just attempting to make something good for the family to eat at home,” she says.

The more the failures piled up, the more Gibney became determined to keep trying different ingredients, recipes and methods. One by one she created different flour blends different egg substitutes, different fats—until finally finding the best result for each.


Gibney also focused on the other main ingredients in cookie recipes, such as what egg proteins do for structure, taste and color of a product. If butter couldn’t be used, what would be close to it?


“Butter and eggs are amazing ingredients when it comes to flavor, structure and texture,” acknowledges Gibney. “Working without them can be very complex—blend and balance are the key.”


The butter solution turned out to be easy. Lucy’s uses essentially off-the-shelf Earth Balance brand Buttery Spread. The component ingredients of the spread are sustainable palm fruit oil, expeller-pressed canola oil, olive oil, filtered water, salt, sunflower lecithin, non-dairy lactic acid and annatto extract color. In the effort to provide the best information for food allergy sufferers, the ingredients are listed on Lucy’s packages just as on the Earth Balance labels.


“We sometimes get asked about the oils listed in our ingredient deck,” she says, “but the three oils all are part of the spread that we use.


Before pressing on from that point and developing a unique formulation, Gibney backtracked. She went back to her mother’s old recipes and adapted them using her new discoveries.


“The process required patience, but it was worth it,” she says. “The details matter.”


Because some flours have a strong taste, Gibney says she had to adjust and tinker the amounts of those ingredients to keep the flavor in balance. Perfect taste and texture were at first elusive goals during development of her special flour blend, but Gibney nudged the proportions “by the very smallest percentages” to achieve the desired blend—the right balance of fat, protein and starch, so her cookies would resemble those made with wheat flour.


Rice flour has been a popular alternative to wheat flour for its low cost and easy access. It also has been a pivotal choice for many gluten-free manufacturers for a third reason: It is one of the least allergenic of foods. Yet, because of the grainy texture it can add to certain baked goods, Gibney chose not to use it.

Gibney settled on a proprietary blend of six flours: gluten-free oat, chickpea, potato starch, tapioca, sorghum and fava bean flour. Most of Lucy’s recipes use oat flakes from a dedicated miller, in order to ensure no cross-contamination with gluten occurs. These add taste, fiber, nutrients and texture. Its blend matches the texture of wheat flour, which Gibney wanted for consumers. As a result, the company’s product price tends to on the higher end, yet customers know the quality is there.


Lucy’s cookies also use xanthan gum to contribute the elasticity usually provided by wheat gluten. And, for sweetness, Gibney opted for a high-quality, organic cane sugar.


“Again, blend and balance are essential where ingredients are concerned, since it’s about functionality as well as flavor,” she reiterates.


While cost and availability are always a challenge, the results, she says, are well worth it and the best for Lucy’s Cookies customers.


Technique Matters

Not surprisingly, the nutrition profile of Lucy’s cookies compares favorably to mainstream bakery cookies. This is especially important for people following a gluten-free diet, since many can be lacking in desired nutrients, such as protein.


“Picking the right alternative ingredients is one of the ways to manage that nutritional risk,” Gibney points out.


Once the ingredient panel has been determined for a gluten-free cookie or similar item, the baking process generally is like that for a standard one, notes Gibney. But there are some prep techniques that can be included to maintain or improve quality, texture and mouthfeel of the final product.


“Using a large and powerful mixer helps make a perfect and airy batter,” she says. “The mixing is more thorough. Also, Lucy’s employed high-end bakery convection ovens to provide the most even baking possible, as well as the correct amount of crispiness.”


Gibney explains that crispiness is important from an organoleptic standpoint—most Americans prefer crispy cookies—but also because crispy cookies enjoy much better shelf-stable attributes. To keep a soft and chewy cookie shelf-stable, various conditioners and even artificial ingredients might be necessary.

In the reverse of a baked item, some allergen-free treats benefit from steering toward the most simple ingredient line-up. Pascha Co. chocolatiers describes itself as “a company on a mission to make the purest, safest chocolate without any allergenic ingredients.” CEO Simon Lester founded the company because he wanted to “share allergen-free chocolate with his family.”


In addition to using pure, minimalist recipes, the company facility is “clear of major allergy triggers,” including peanuts, nuts, dairy, soy, eggs, wheat and sesame. The company also avoids rice. Moreover, all products are certified-
organic, fair trade, kosher, vegan and non-GMO verified.


Adding community concerns to the mix, Lester’s company also is part of the “One Percent for the Planet” movement, an organization of volunteer companies whose members donate at least 1% of sales to nonprofit partners thoroughly vetted for participation in its network.


Multiple Category Challenges

Allergen-free formulating becomes extra complicated when a company provides multiple categories of product.


“At Peas of Mind, we take pride in reinventing the classic foods kids love,” says Jill Litwin, founder and CEO of Peas of Mind LLC, makers of healthful, allergen-free foods for toddlers.

“We transform pizza, fries and other kid favorites from ‘junk’ food into healthful foods that target the unique needs of growing toddlers. One of our key goals in creating a product is to infuse each one with a full serving of veggies.”


Last year, Litwin decided the time had come to take on the much-loved—and often dreaded by parents—chicken nugget. “In order to take this finger-food favorite into the health food realm, we needed to figure out how to give our nugget a Peas of Mind twist,” she explains. Litwin’s goal was to offer a natural, allergen-free version that was different from the competition by making it vegan/vegetarian, veggie-infused and gluten-free.


“Prior to creating the new nugget product, we knew that our formula and process was not going to look anything like the standard production process for a chicken nugget,” continues Litwin. “Instead, we needed our version to be comprised of allergen-free ingredients and include servings of vegetables, necessitating turning the usual nugget formulation process on its head.”


 The first step for Peas of Mind was doing the homework: Months of market research taught Litwin that first and foremost, it’s the crunchy exterior that makes a chicken nugget an American classic.

“But we had to achieve that texture without the traditional breading process of egg, flour and flash-frying,” she elaborates. “Each of those steps and ingredients contain or promote allergens and can be weak in nutrients.”


Next for the company was the experimentation stage—also known as trial and error. After multiple formula iterations, Litwin discovered the best ingredient to attain a sufficiently superior, crispy coating was a cornmeal mixture.


“The cornmeal blend we developed is not only gluten-free but gives our product that satisfying, craved crunch necessary for a kid-approved nugget to mimic the traditional chicken version,” she says.

Once the formula was determined and set, Litwin and her team met with John McIsaac, vice president of business development, Reiser & Co. Inc. “He introduced us to a piece of equipment that enabled us to make a baked nugget that wasn’t breaded and that also ensured no cross-contamination with other products. McIsaac was also able to help us learn more about how equipment providers help manufacturers meet specific allergen concerns for each stage of the production process. As an aside, he informed us that Reiser has experienced a significant increase in clients concerned about allergies and cross-contamination.”


One of the reasons Litwin acknowledges that she chose Reiser & Co. was because McIsaac pointed out that the root of the Reiser brand was in the meat industry, where prevention of any contamination is utterly paramount, and contaminations and allergens typically arise from improperly cleaned machines.

In addition to using all stainless-steel surfaces, the key to proper cleaning, as McIsaac explained, is accessibility. Reiser’s machines are “designed to be simple to take apart so that a thorough sanitization is uncomplicated.”


As with any responsible manufacturer of allergen-free product, Peas of Mind takes extra care to limit any possibilities of cross-contamination between its products and other shared equipment in the plant.

“Each of our allergen-free products is run on a dedicated line,” declares Litwin.


She continues, “We take extra precautions by using parchment paper as a barrier between our product and any shared surfaces or equipment. All of our surfaces and equipment are disinfected after just one use. We also have our products tested for allergens by sending randomly selected samples to an independent lab that specializes in allergy testing. We practice complete transparency and are available to discuss our process with any concerned consumer, which we find gives our consumers—dare I say it?—Peas of Mind about their purchase.”


Mass Appeal

Ramping up from a single-category offering to multiple channels can compound allergen-free formulation challenges exponentially. Companies seeking to expand horizontally need to take extra precautions at every stage, from ingredient procurement and storage to facility management to product-line integration.

Gary Godin, CFO of Elevation Brands, LLC, parent company of Ian’s Natural Foods, describes “trust” as the primary ingredient in foods designed to cater to specific allergy and intolerance needs. The company makes a comprehensive variety of allergy-friendly/gluten-free meal solutions and products, covering breakfast, lunch and dinner, as well as snack and dessert channels.


“Making safe food for families with multiple food allergies takes great care,” says Godin. “To ensure the trust consumers bestow is never broken, Ian’s is highly diligent about how it procures and stores ingredients for its foods.”


Godin describes how the company developed tightly written product and ingredient specifications that must be adhered to by suppliers, and provides training to its entire team on a regular basis to ensure understanding of the seriousness of food-handling safety.


“Ian’s is relentless in following the most stringent food safety, sanitation and testing protocols in its dedicated peanut- and tree nut-free, SQF-2, USDA manufacturing facility,” Godin states. “Ian’s cleans, sanitizes and tests its processing equipment after each shift to ensure no traces of food allergens are present.”


Ian’s developed a standard operating practice that even calls for the cleaning and testing process to be repeated after products containing particular food allergens are run on the equipment. Moreover, before any batch of Ian’s products are shipped for sale, they are tested and verified by an independent, third-party laboratory for safety.


“We test to the lowest limits of detection for food allergens, and our standards for acceptability are more stringent than FDA statutes for making food-allergy claims,” says Godin, “so we are confident our food is safe for families with allergies.”


“For people whose health depends on a company’s quality program, every food-safety effort matters,” echoes Gibney. “This can become part of brand equity.”


To support its gluten-free, vegan- and allergy- friendly claims, Lucy’s carefully selects ingredients that come from the safest growing and processing environments, knowing that it’s essential for ingredients not to have even the slightest risk of cross-contact with allergens.


“The Lucy’s production plant is a dedicated bakery, where neither gluten nor the allergens are allowed, thus greatly reducing risk,” she says. “The company also periodically tests finished cookies to verify its processes.”


Putting her expertise as a practicing physician to the task, Gibney established a testing lab in Lucy’s production facility. Lucy’s tests each new lot of ingredients.


“For example, if baking powder comes from a supplier that also processes something with milk powder, then every new lot of baking powder should be tested for milk contamination,” she explains.

Lucy’s prides itself on food safety. Lucy’s set out to do something special in food-allergy safety and make a difference. “Each year, during our regular food safety audits, I enjoy the interest and praise that comes from our inspectors,” says Gibney. “Our programs are the strongest out there and our passion for doing it right is never failing. It’s what we’re all about, and that commitment and passion is evident in our staff. Our people like being part of something special.”


This approach proves to be one of the overriding commonalities among manufacturers of allergen-free products.


“Many of our employees ‘walk the walk as well as talk the talk,’” Gibney professes. “A number of them have food allergy-related diseases, allergies or intolerances, or an immediate family member does. They range from highly dangerous peanut and tree nut allergies to celiac disease and dairy and gluten intolerance. This brings a high level of credibility to who we are and what we do, because we rely on our products firsthand to provide solutions in our lives.”