Food Allergen Control and Labelling Training (US FDA) Training

About this course

Why allergen control matters

For a person with a food allergy, the label is often the only protection they have. FDA reports that, from September 2009 to September 2014, about one third of the foods reported to its Reportable Food Registry as serious health risks involved undeclared allergens. Milk is the most common cause of these recalls, and bakery products and snack foods are among the food types most often involved. In November 2025, FDA sent a warning letter to a New Jersey bakery whose rolls and brioche were packed with no allergen labelling and whose food safety plan had no controls for undeclared allergens. One label error can mean a recall, refusal at the US border and a lost customer. FDA's guidance lists the actions it can take against misbranded food: recalls, import refusal, seizure, warning letters and import alerts.

What makes this course different

The course teaches the US rules only, and it teaches them at the level a label team needs. It follows FDA's final guidance of January 2025, Edition 5, point by point: the nine major food allergens including sesame from January 2023, naming the food source, tree nuts by type, milk and eggs from other animals, allergens hidden in spices, flavourings and processing aids, and the Contains statement. It then links the label to the plant, through Part 117 allergen controls for cross-contact and labelling. It is clear on two points many teams get wrong: FDA has set no threshold for any allergen, and an advisory statement never replaces good manufacturing practice or allergen controls. It also covers claims that an allergen is absent, which FDA expects to mean no allergen at all, including from cross-contact, and the label controls that keep the right label on the right pack.

Who should take it

The course suits food safety, quality and regulatory staff who approve labels, production and packing supervisors who run changeovers and label checks, artwork and packaging teams, and exporters selling to the US, where the same law applies to imported food. It is equally useful for purchasing and supplier quality staff, because an allergen hidden in a bought-in spice mix or flavouring must still be declared on the finished label, and the supplier's specification is often the only place it shows. A built snack and bakery maker in Mumbai, handling six of the nine major allergens on two shared lines, runs through every module, so each rule is shown on real products, lines and labels. The ten modules take about two hours of video, with three practice questions after each one, and can be watched in any order.

What you can do afterwards

After the course, learners can check a label against section 403(w), declare each major allergen correctly in the ingredient list or a Contains statement, find allergens hidden in bought-in ingredients, set cross-contact and label controls with monitoring and records, decide when an advisory statement can be truthful, and respond to an undeclared allergen, from a correction to a recall and a report to FDA within 24 hours where the law requires it. The scenario-based final exam leads to the Sterling Academy Certificate of Completion, a training certificate that is not approved by FDA.