If the food product you produce is regulated by the FDA, your business falls under the requirements outlined under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). This labeling applies to all retail and foodservice establishments that package, label, and offer products for human consumption. This applies to food products that are labeled on or after January 1, 2006. Unsure of how FALCPA affects your food service business? This Question-and-Answer section covers the essentials of food allergen labeling laws.
Food Allergen Q&ADoes FALCPA apply to my foodservice business?
If you are a retail and foodservice establishment that packages, labels, and offers products for human consumption, then FALCPA labeling apples to your business. The FDA has control over packaged foods, conventional foods, vitamins and dietary supplements, infant formula and infant foods, and medical foods (such as ingestible product produced for feeding tubes). Additionally, this includes items in vending machines and all packages labeled "for individual sale."What products are exempt from FALCPA?
As a general rule of thumb, meat, poultry, and alcoholic beverages are not subject to FALCPA labeling requirements. To get more specific, the following are exempt:
- Fresh fruits and vegetables in their natural state
- Highly refined oil derived from one of the “Big Eight” allergen foods (milk, fish, soybeans, tree nuts, peanuts, eggs, shellfish, and wheat)
- Any food product regulated by the USDA (this includes meat, poultry, and certain egg products)
- Any food product regulated by the Alcohol, Tobacco Tax and Trade Bureau (this includes alcoholic drinks, spirits, beer, and tobacco products)
- Any restaurant foods that are placed in a wrapper or container in response to a person's order for that food (for example, street vendors, festival foods, fast food restaurants)
How about imported Products?
FALCPA applies to all packaged foods (except meat, poultry, and certain egg products) sold in the United States, no matter if they are manufactured in the USA or manufactured abroad and imported into the USA.What about flavors, colors, and food additives? Are they subject to FALCPA?
Any flavoring, spice, coloring, or processing aid that is or contains one of the eight major food allergens must list the allergen in plain English on the label. These "processing ingredients" are used in the making of the food product, but may not be present as a major ingredient. For example, a product used to keep food from sticking to a baking pan. This includes allergens such as soy, lecithin, or wheat starch.Is there a penalty if I don't comply?
Yes. A company will be subject to civil and criminal penalty provisions of the Federal Food, Drug, and Cosmetic Act if your company's package food products do not comply with FALCPA labeling requirements. Food products with undeclared allergens will be subject to recall.Can I ask the FDA to have a food product exempted from FALCPA labeling?
Yes, anyone can petition Secretary of Health and Human Services to request an exemption. Scientific evidenced must be submitted to prove that such a food ingredient with a particular production method does not cause an allergic response. Petition at their Guidance and Regulation page.How to list major food allergens:
FALCPA requirements are met if the common or usual name of an ingredient (e.g., buttermilk) that is a major food allergen already identifies that allergen's food source name (i.e., milk). Otherwise, the allergen's food source name must be declared at least once on the food label in one of two ways:
1. In parentheses following the name of the ingredient. Example: "Lecithin (soy)," "flour (wheat)," "whey (milk)"
2. Immediately after or next to the list of ingredients in a "contains" statement. Example: "Contains Wheat, Milk, and Soy."