The Challenges of Allergen-Free Claims on Labels

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.