Playing It Safe with Allergen Control

Allergens are substances in foods that cause an allergic reaction. Sometimes that reaction is mild- it could be an itchy throat or a rash, but other allergies can be deadly and dangerous, and therefore they must all be clearly listed on your food package label.

The official USA Allergen regulations are addressed in the 2004 Food Allergen Labeling and Consumer Protection Act (FALCPA) You can read more about the regulation on their website here: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm106890.htm. It is important that USA based medible makers follow the U.S. regulations and use them as guidelines to ensure that there is no accidental consumption of allergen compounds.

Under the FALCPA, any food sold in the U.S. under FDA jurisdiction that contains one of the eight major allergens or a protein derived from the allergens must have that allergen clearly identified on the label. The official USA allergens include:

• Milk
• Egg
• Fish
• Crustacean shellfish
• Tree nuts (*including coconut)
• Wheat
• Peanuts
• Soybeans
* Sesame seeds and mustard are considered to be an allergen in Canada but not in the U.S.

Many other ingredients can cause an allergic reaction or sensitivity, but the FDA requires only that the eight allergens above be listed clearly if contained in a food product. It is generally recommended that sesame seeds, mustard and gluten be listed as well. The more information the consumer has, the better decision they can make about consumption.

FALCPA requires that specific tree nuts be identified (almonds, pecans, walnuts), fish species (bass, flounder, cod) and crustacean shellfish (crab, lobster, shrimp). Labels must also identify the food-source names of all major food allergens used in the food. For example, if the product contains lecithin (sourced from soy), flour (made from wheat) or whey (a milk derivative), the label must identify those allergens either in parentheses following their source ingredients—“lecithin (soy), flour (wheat), whey (milk)”—or immediately after or next to the list of ingredients, according to this format: “Contains wheat, milk and soy.”

This requirement is met if the common or usual name of an ingredient that is a major food allergen already identifies that allergen food source name. In other words, you don’t have to label buttermilk as a source of the allergen milk, because it’s already kind of obvious.

Allergen Advisory Statements
Is your product free of an allergen like, say, tree nuts, but made in a facility that also processes tree nuts? If so, your label may be a little more complicated than expected. These days, many food labels include an allergen advisory statement such as “made in facility that also processes (insert name of allergenic ingredient). The FDA advises that because adhering to current good manufacturing practices (cGMPs) is essential for effective reduction of adverse reactions, such precautionary labeling should not be used in lieu of adherence to cGMPs. Think of it this way: An allergen advisory statement isn’t a free pass to mix your nut-free brownies in a hopper that you just used for a caramel pecan cluster run without washing it out first. FDA urges manufacturers to take all steps necessary to eliminate cross contamination and to ensure the absence of the “may contain” identified food.

By following the guidelines and examples set by the FDA, the medibles industry can increase the safety of their products and decrease the chances of someone consuming an allergen. If you are unsure if a particular ingredient you are using has an allergen in it, make sure you request the allergen information from the vendor that sold you that ingredient. They should be able to provide you with all the allergen documentation.

Rachel Zemser

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