Consumer desires for simple, less processed, “natural” food products have led to the current increased popularity of “clean label” foods. Part of this trend includes the use of “free-from” labeling, pertaining to genetically modified components, gluten, allergens, or other attributes.
While generally appealing, free-from allergen claims can be particularly challenging because these foods especially appeal to consumers with food allergies who are at risk of suffering adverse reactions if these label claims are false or misleading. Free-from allergen claims, with the exception of gluten free, have no regulatory basis for, or even industry consensus on, what “allergen free” actually means. The potential for immediate, severe health impacts from incorrect allergen labels raises the bar for decisions about using such claims.
Because free-from allergen claims are not regulated, food companies may voluntarily choose to use such label statements. Sometimes, application of such claims is simple, e.g., canned tomato paste is probably, and always has been, peanut free and gluten free. But, if breaded tomato products are made in a shared facility with the tomato paste, then the decision becomes more complex. Our goal is not to advocate for or against the use of free-from allergen claims but instead to raise awareness of the issues that must be examined as the use of such claims is considered.
Food allergy prevalence estimates vary but could be as high as 10% in the U.S., EU, Canada, Australia, and New Zealand. The prevalence of food allergies is unknown in many other parts of the world but is likely growing worldwide. Food allergy is typically controlled by avoidance, with many countries requiring the labeling of major allergenic foods by law. The lists of major allergenic foods vary among countries, but it is important to note that the allergenic foods that require labeling are not the only foods that may be allergenic. In the U.S., labeling of the “Big 8” allergenic foods is commonly thought to cover 90% of all food allergies in the country. Legislation requires labeling the presence of particular identified foods in a defined fashion but does not give guidance for indicating absence, or free-from-type claims. One exception is gluten free, which does have a regulatory definition. Gluten-free foods have been marketed for decades before the establishment of the regulatory definition, while other terms that have also been used for decades, such as “dairy free,” have no regulatory definition. However, recent dietary trends have precipitated a rise in the use of free-from-type claims for food allergens, including gluten free and dairy free.
Free-From Claims for Food Allergens
A number of free-from claims have gained in popularity in the U.S., EU, and elsewhere. Some claims are more definitive than others. Here, we list examples of some claims that are found in the marketplace, along with a few observations. Although such label claims are not regulated, they must not be false or misleading.
Free-from (specific allergen) (e.g., ‘peanut free’). Given the need, under law and regulation, that certain allergens be labeled, the free-from claim implies additional precautions were taken to ensure the allergen indicated is not present. While the degree of care needed to support a free-from claim is not specified, prudent precautions might include assurance or testing to indicate that no ingredients contain the allergen, an absence of cross-contact risk if the allergen exists in the manufacturing facility, and the lack of agricultural comingling with the allergen.
Allergen free or free from allergens. In the absence of other information, these terms imply the absence of any risk of allergic reaction from any source. In current practice, corporate definitions might be restricted to absence of any major allergen, such as free of the Big 8. As discussed above, many foods not on the Big 8 list of allergens may cause allergic reactions. Thus, a corporate definition of the meaning of allergen free is recommended. Generic allergen-free claims are not allowed in Canada.
Allergen friendly. This label is similar to the allergen-free claim above, but with more nebulous language. In this case, not only is the meaning of the word “allergen” ambiguous, but “friendly” is too. As with the allergen-free designation, it is recommended that allergen-friendly claims be accompanied by a manufacturer’s definition.
Dairy free. This is a frequently used claim and is of note because, in many cases, its use predates the current free-from consumer trend. Dairy-free labeling was originally used to support lifestyle choice or to enable lactose-intolerant consumers to avoid lactose. Currently, many dairy-free choices are not suitable for milk-allergic individuals, due in part to the very low amounts of milk needed to cause allergic reactions in highly sensitive individuals.
Lactose free is a preferred term when the product has no detectable lactose but contains milk proteins (casein or whey). Because lactose-intolerant consumers can tolerate small doses of lactose, the degree of care needed to manufacture lactose-free products is more achievable.
Non-dairy is a related claim and is unique among these examples as its use is covered by regulation in the U.S. Somewhat counter-intuitively, non-dairy ingredients and products must contain derivatives of milk, specifically caseinates, making them unsuitable for milk-allergic consumers.
What Does “Free From” Mean?
In the absence of regulatory definition, “free from” is most commonly taken to mean the absence of detectable residues. Regardless of whether an allergen-free claim is specific to one allergen or is more general, such a claim must be true within any definitions set by the manufacturer. Due to the positive nature of the claim, and the marketing of such products to a sensitive population, additional product testing for allergens is often included as a part of quality criteria. For multiple or general allergen-free claims, this may involve multiple tests for each product. In some cases (most notably for some tree nuts specified as allergens by FDA in the U.S.), commercial detection methods may not exist. It should also be noted that the sensitivity, specificity, and utility of analytical methods can vary greatly when used in different food matrices. Where methods are unavailable, or perform poorly, particular care must be taken to ensure that the possibility of contamination of the food with these allergens is negligible.
Novel Foods and Allergen-Free Claims
Novel foods, made with non-traditional ingredients and often targeting clean label consumer groups, are a tempting target for allergen-free claims. The novel foods in question may also be inherently suited to such claims by virtue of containing ingredients that are meant to replace known food ingredients (e.g., plant-based milks). Although such foods may not contain major known food allergens, most if not all have the capacity to cause allergic reactions in some individuals. Our previous article, discusses the potential allergenicity of novel foods. Some novel foods may cause reactions in individuals sensitized to food allergens that the novel foods do not actually contain (cross-reactivity). The ability of insect-derived foods to elicit reactions in those sensitized to shellfish is relatively well known. Less well known, and still requiring further study, is the ability of some legumes (such as pea) to cause reactions in some peanut or soy-allergic subjects. Would a “free from shellfish” claim be suitable for a product containing insect protein? While there is scant guidance in regulation as to the treatment of cross-reactive foods, knowledge of the potential for cross-reactivity should be sought.
Additional Information for the Consumer
As we can see, allergen-free claims come with a set of issues arising largely from a lack of regulatory standards. Defining what is meant by claims and how they are verified and communicated to the consumer is key. This additional information cannot, in most cases, be adequately conveyed on product packaging. Many manufacturers making allergen-free claims therefore use their websites to provide additional detail. In this instance, an issue arises in a situation where consumers may see a claim on packaging but may not refer to the website for additional detail that may be important to informing their product choice. Systems such as smart labeling technology, where information from a smartphone-scanned code on a label immediately produces relevant information and definitions, may help to address the disconnect between packaging and additional information. However, there is an obvious need for food companies to ensure the accuracy of their product information in an environment that allows or demands modification of recipes.
General Guidance for Allergen-Free Labeling
Much as was the case with gluten-free labeling prior to the adoption of regulation in the U.S., food manufacturers currently rely on international guidance, scientific evidence, and common sense to dictate their policies on allergen free-from labeling. In the case of the gluten-free label, manufacturers were guided by the international Codex Alimentarius Commission. This is not currently the case with allergen-free claims; however, we can summarize some best-practice guidance, drawing largely from non-U.S. regulatory bodies:
- Free-from allergen label claims are voluntary but must always be truthful and not misleading.
- Always remember that any free-from allergen claim is a deliberate and positive statement, made—in part—to a particular set of consumers who may suffer severe health consequences or even death should they consume their particular allergenic food.
- Required allergen labeling lists, regardless of locale, are in fact not exhaustive lists of all allergenic foods. A food that is “Big-8 free” may contain other allergenic foods and may cause allergic reactions in some consumers.
- Free-from claims lack regulatory definitions, though guidance is available in Canada and the EU. Given the lack of regulatory definition, we would recommend that food manufacturers clearly state what they mean by allergen-free or similar claims in such a way as to reach and to be understandable to their consumers.
- Consider known or likely cross-reactivities when considering free-from claims.
- A free-from statement or similar in conjunction with precautionary labeling, e.g., “free from allergens; may contain peanut” is often confusing to the consumer and may be misleading. A free-from statement should be regarded as a stronger claim than the absence of allergen labeling, and, this being the case, it is difficult to justify the use of a positive claim where precautionary labeling is warranted.
A Need for Clarity
Established regulations around gluten-free claims have increased consumer confidence regarding labeling and have expanded the range of products available to celiac sufferers by removing barriers to food manufacturers. Perhaps properly considered regulation around allergen-free labeling would have a similar effect. A key component of such regulation would have to be, as is the case for gluten, an upper limit for the amount of a food allergen that could be present and still be safe for food allergic consumers. Regulation on free-from labeling does not appear to be high on FDA’s priority list. In the meantime, food manufacturers must exercise particular care when considering usage of such labels.
Dr. Johnson is an assistant professor of food science and technology at the University of Nebraska-Lincoln. Reach him at firstname.lastname@example.org. Dr. Goodman is a research professor of food science and technology at the University of Nebraska-Lincoln. Reach him at email@example.com.