Food allergies can range from the mildly irritating – think itching or swelling – to potentially life threatening, brought on by an anaphylactic attack. Anaphylaxis can occur in moments, typically within 20–120 minutes, and will involve more than one organ system, for example, the skin, respiratory tract and/or gastrointestinal tract. It will also likely require the use of an adrenaline injector, such as an EpiPen, to deliver a single pre-measured dose of adrenaline for quick relief.

Critics have long charged, however, that not enough is being done to prevent the mislabelling of products as well as bad actors employing poor practices. This is what agencies such as the Food and Drug Administration (FDA) in the US and the Food Standards Agency (FSA) in the UK have historically been tasked with policing.

Anaphylaxis, for example, is a growing problem. In 2021, the British Medical Journal reported that while the death rate has fallen – likely due to improvements in the recognition and management of symptoms – hospital admissions for food-induced anaphylaxis have tripled over the 20-year period from 1998–2018. The research from Imperial College London’s National Heart and Lung Institute measured time trends, age and sex distributions for admissions due to food and non-food anaphylaxis triggers and then compared with reported fatalities. It showed 101,000-plus people were admitted to hospital for anaphylaxis, and of these 30,700 (30%) were coded as due to a food trigger.

While the obvious question is why this should be the case, the actual answer is not clear cut. The US-based Food Allergy and Anaphylaxis Team (FAACT) argues that increasing susceptibility is likely multifactorial in nature, not being explainable by genetics alone and likely the result of our modern, industrialised environment.

Determining the causes of allergies is one thing, protecting people through product labelling is entirely another. In the US, the FDA is tasked with enforcement. As Donald Prater, acting director of the Center for Food Safety and Applied Nutrition (CFSAN) at the FDA, puts it: “The FDA enforces regulations requiring companies to list all ingredients on packaged foods and beverages, which is important for those with food allergies and hypersensitivities who need to avoid specific types of foods. Additionally, for foods designated major food allergens, there are more specific labelling requirements.”

Unsurprisingly, the labelling landscape is an ever changing one; a case in point being the recent implementation of the FASTER Act in the US. Originally, there were eight designated major food allergens: milk, eggs, soy, peanuts, wheat, tree nuts, crustacean shellfish and fish. However, on 23 April 2021, the Food Allergy Safety, Treatment, Education and Research (FASTER) Act was signed into law, declaring sesame as the ninth major food allergen.

“All requirements applicable to the other eight major food allergens, including allergen labelling to identify the food source of all major food allergens used to make the food and manufacturing requirements, apply to sesame as of 1 January 2023,” says Prater.

Product recall

Guidance for the food industry, consumers and other stakeholders on the best ways to manage allergen hazards in food similarly comes under the remit of the FDA. The body conducts inspections and sampling to check that major food allergens are properly labelled on products and determines whether food facilities implement adequate controls to prevent allergen cross-contact – the inadvertent introduction of a major food allergen into a product – and labelling controls to prevent undeclared allergens during manufacturing and packaging.

When problems are found, the FDA works with firms to recall products and provide public notifications to immediately alert consumers. In addition, it has the authority “to seize and remove violative products from the marketplace or refuse entry of imported products,” notes Prater.

“In the US, the retail food regulations are primarily governed by the state, local, tribal and territorial regulatory agencies,” says Prater. The FDA also offers a model food code for adoption by these regulatory agencies, however as Prater notes, this code is neither federal law nor federal regulation. Worth noting, too, is that in addition to the packaged food labelling requirements, the most recent and updated model food code offers a provision regarding consumer notification of major food allergens at retail level. In short, paragraph 3-602.12(C) states that the permit holder “shall notify consumers by written notification of the presence of major food allergens as an ingredient in unpackaged food items that are served or sold to the consumer”. This written notification can be provided in many forms such as physical or electronic means, including brochures, deli case or menu notifications, label statements, table tents or placards.

Labelling rules

Meanwhile in the UK, it is the FSA which is tasked with allergen labelling and providing guidance to consumers with food allergies, food intolerances or coeliac disease – better known collectively as food hypersensitivities (FHS). This includes working with consumers and the food industry to ensure consumers with food hypersensitivities can make safe and informed choices. The government agency, founded in April 2000, currently estimates that approximately 5–8% of children and 1–2% of adults in the UK have some form of food allergy.

“Our priority is helping those with food hypersensitivities to make safe food choices,” says Dr James Cooper, deputy director of food policy at the FSA. “That’s why we’ve recently updated our food allergen and labelling technical guidance, which helps businesses to label food accurately to keep consumers safe.”

As Cooper explains, the FSA’s labelling rules are there to ensure those with food hypersensitivities have easy access to the information they need to make an informed choice on the foods they eat.

“Food businesses selling pre-packed food are required by law to identify the presence of any of the 14 mandatory allergens on the label,” he says. These allergens are: celery, cereals containing gluten (such as wheat, barley and oats), crustaceans (such as prawns, crabs and lobsters), eggs, fish, lupin, milk, molluscs (such as mussels and oysters), mustard, peanuts, sesame, soybeans, sulphur dioxide and sulphites and tree nuts (such as almonds, hazelnuts, walnuts, Brazil nuts, cashews, pecans, pistachios and macadamia nuts). “[These] 14 allergens, as defined in legislation, are those that are recognised as the most common ingredients or processing aids of public health concern across Europe,” Cooper adds.

Free-from confusion

As the agency advises, a ‘free-from’ allergen claim should only be used as food safety information because it is a guarantee that a specified allergen is absent. To use it, food businesses have to implement strict controls to eliminate any risk of cross-contamination.

Matters become slightly more complicated when it comes to labelling vegan products. “Veganism is a lifestyle or choice that people make,” says Cooper, “so labels that claim foods are vegan are not [considered as] food safety labelling.” While the FDA does not have specific regulatory definitions for ‘vegan’ or ‘plant-based’, the agency would not expect something labelled as such to contain egg or milk ingredients in their formulations. “[Products labelled as vegan] are different to foods labelled as ‘free-from’, which is a guarantee that the specified food will be absent from the product,” says Cooper.

However, if a vegan product has a risk of crosscontamination with either crustaceans, molluscs, fish, milk or egg – all regulated allergens and animal products – it should communicate this risk with a precautionary allergen label such as ‘may contain’ alongside its vegan claim. “We continue to encourage people who have allergies and intolerances to check the label of food products at all times even if labelled as vegan, to make sure the food is safe for them to eat,” advises Cooper.

Irrespective of which side of the Atlantic one is on, food labelling, by definition, has to be responsive to developments in science. And while there are still significant gaps in terms of identifying the basic causes of allergies in the first place, such gaps are slowly being filled in, with vulnerable consumers set to benefit. For some it could be a matter of life or death, literally.