Food allergen safety: a US perspective

FDA is increasing its efforts to enforce FSMA. “Cross-contact” must be controlled in items exported to the US. Rapid methods play a key role in the Allergen Control Plans of manufacturers. New regulations for private third-party food laboratory accreditation are expected soon.

The authors of the recently published “Prevalence and Severity of Food Allergies among U.S. Adults,” estimate 10.8% of US adults have at least one current food allergy. That’s more than 26 million people age 18 or older. The majority of food allergies are caused by one or more allergenic proteins, which elicit an allergic response mediated by IgE. Food intolerance such as Celiac disease and lactose intolerance are distinct from food allergies as they are mediated through IgA and IgG, negating the risk of anaphylactic shock. It has been reported by CDC that approximately 175 people die from anaphylactic shock in the US per year, and in most cases, it’s linked to a food allergy. Non-Celiac gluten intolerance (gluten sensitivity) affects a higher percentage of US population, prompting an upsurge in gluten-free diets, and consequently a greater demand for gluten control programs. This, in turn, has helped spawn a growing market for “Free From” Foods. Undeclared allergens, and their derived ingredients can enter the food supply inadvertently by errors made by processing mistakes, incorrect labeling, improper storage, formulation misunderstandings between suppliers, co-packer and food manufacturers. Sometimes a change of suppliers for the same ingredients, additives or processing aids can introduce an unexpected allergen. Errors may occur after improper utilization of re-work product, improper or inadequate cleaning after a production run with a known allergen and by cross-contact with common utensils and equipment. An emerging concern is that food allergens may also enter the food supply chain through food fraud. Undeclared allergens continues to be responsible for the highest percentage of reported food recalls. In the 4th quarter of 2018, 46% of the food recalls under FDA’s jurisdiction were due to undeclared food allergens and the trend is continuing through September of 2019.  
US regulations The US food industry (including the dietary supplement sector) must comply with the Food Allergen Labeling and Consumer Protection Act (FALCPA), which took effect on January 1, 2006. It requires food manufacturers to use common names to identify eight major allergens (Big 8) as “Peanut, Tree Nut, Milk, Egg, Soy, Fish, Shellfish and/or Wheat”. The Federal Food, Drug, and Cosmetic Act gives the FDA the authority to issue regulations requiring the disclosure of food ingredients, spices, flavorings, colorings and incidental additives that contain allergens other than the eight major food allergens. Highly refined oils are exempt from allergen labeling requirements if the manufacturer can demonstrate that processing removes all traces of the allergen protein. Harmonization challenges for imported and exported foods abound as regulatory agencies around the world target different allergens for labeling compliance. FDA announced in late 2018 that it was investigating the prevalence and severity of sesame allergies in the US to inform possible regulatory action that would require sesame to be labeled as an allergen on packaged foods. FDA uses a level of “detectable” as its threshold of acceptability for the presence of an allergen in a food, while

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