Food packaging design plays many roles and fulfills many expectations. Additionally, it must contain food safely and provide consumers with certain types of information required by the FDA.
Appropriate product labeling is especially important when it comes to calling out allergens and ingredients that cause illness, such as the gluten that must be avoided by people with celiac disease or gluten sensitivity.
What is and is not covered by the various regulations for allergen labeling and gluten labeling (including what the Gluten-Free Certification Organization (GFCO) recommends) is not always as straightforward as might be expected. Therefore, it is essential to understand what labeling requirements are for food allergens and gluten. Here is how food packaging design protects consumers under the relevant regulatory requirements.
The Food Allergen Labeling and Consumer Protection Act (FALCPA)
Taking effect January 1, 2006, the Food Allergen Labeling and Consumer Protection Act (FALPCA) is the main federal law spelling out how allergens must be represented on packaged foods. The purpose of FALPCA is to assist those affected by food allergies to identify potential allergens in foods quickly and accurately. The following table shows what FALCPA does and does not apply to, and which allergens are and are not covered:
| FALCPA Applies to These Products | FALCPA Does Not Apply to These Products |
| Conventional foods, vitamins, dietary supplements, infant formula and foods, medical foods, retail and food service establishments, vending machine food items, packages labeled for individual sale | Prescription or over-the-counter drugs, personal care items, Kosher labeling, pet foods, pet supplements and supplies, made-to-order restaurant food placed in a container or wrapper, food products regulated by the USDA (including meat, poultry, processed egg products), food products regulated by the Alcohol and Tobacco Tax and Trade Bureau (including spirits, beer, alcoholic drinks, and tobacco products) |
| Allergens Covered by FALCPA | Allergens Not Covered by FALCPA |
| Milk, eggs, peanuts, tree nuts, soy, wheat, fish, crustacean shellfish. Specific nuts, fish, or crustacean shellfish must be called out. | Molluscan shellfish (oysters, scallops, mussels, clams), seeds (like mustard seeds or sesame seeds), whole fruits and vegetables, highly-refined oil derived from major allergens, ingredients made from highly-refined oil. Allergens that may be present due to unintentional cross-contact during processing are not required to be labeled under FALPCA. |
Allergens regulated under FALCPA may be listed in one of three ways. They may be called out in the ingredient list, using the allergen’s common name (“peanuts”), or they may be listed in a sentence beginning with “Contains” followed by the major food allergen name. In cases where an ingredient is a less-common form of an allergen, the ingredient can be followed by the common name of the allergen. For example, an ingredient list may state “albumin (egg).”
Labeling Requirements for Gluten-Free Products
Labeling for gluten is a bit more complex. Sometimes products contain wheat, and wheat must be listed due to FALCPA regulations. At the same time, however, if the fraction of wheat in a product does not contain gluten, the product can declare itself gluten-free. Under FDA regulations, “gluten-free” does not require identification of other gluten sources, like rye or barley when the food ingredient derived from them has another common name. “Malt extract” is an example of this.
Furthermore, “gluten-free” labeling is limited to products that do not contain whole grain glutens, or that contain less than 20 parts per million of these ingredients. This is considered sufficient to ensure product safety. Some products obtain third-party certification (along with a logo) indicating that a product is gluten-free, such as that of the Gluten-Free Certification Organization (GFCO).
Websites, Consumer Help Lines Can Offer Additional Information
Many manufacturers, in addition to including allergen or gluten information on their food packaging designs, supplement this information with information on their websites, or in the information used by agents who operate customer service helplines.
Food packaging design is required to fulfill many functions, some of them having to do with assuring food safety and alerting people with food allergies to ingredients that may be present that are known to be common allergens. Labeling requirements not only fulfill regulatory obligations, but also serve to inform consumers and build trust, so they are a tremendously important element of food packaging design.
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