What FALCPA is
FALCPA is Title II of Public Law 108-282. It doesn't stand on its own as a set of label rules. It amended the Federal Food, Drug, and Cosmetic Act, so its requirements now live inside that act, where FDA enforces them.
| Section of FALCPA | What it does |
|---|---|
| Sec. 202 | Congress's findings: why allergen labeling needed fixing |
| Sec. 203 | Defines "major food allergen" (FD&C Act 201(qq)) and adds the labeling rule (403(w)) and a rule for other allergens (403(x)) |
| Sec. 204 | Orders a report on cross-contact and advisory labels like "may contain" |
| Sec. 205 | Directs FDA inspections for cross-contact and correct allergen labeling |
| Sec. 206 | Directs FDA to define "gluten-free" for food labels |
| Sec. 207 to 210 | Allergy data, research, the Food Code and emergency care |
Why Congress passed it
Before FALCPA, a label could be complete and still hide an allergen. Congress's findings name the problems the law was written to solve:
- Eight foods or food groups accounted for 90 percent of food allergies
- There is no cure, so an allergic shopper has to avoid the food
- Ingredients are listed by their common or usual name, which can be unfamiliar. A shopper may not know an ingredient comes from milk or egg
- Spices, flavorings and some colorings can be declared as a class, and incidental additives can be left off the list altogether
- Parents of allergic children often could not pick out the allergen-derived ingredients on real labels
What the law requires on the label
A food that is, or contains an ingredient that bears or contains, a major food allergen is misbranded unless the label names the food source in one of two ways:
| Option | How it works | Example |
|---|---|---|
| (A) Contains statement | The word "Contains" plus the food source, right after or next to the ingredient list, in type no smaller than the list | Contains: milk, wheat |
| (B) In the ingredient list | The food source in parentheses after the ingredient's common or usual name | casein (milk), semolina (wheat) |
- Option B needs no parentheses when the ingredient's own name already says the source, like "wheat flour"
- It also needs none when the source is already named elsewhere in the list, unless it only appears inside an exempt ingredient such as a highly refined oil
- Tree nuts, fish and crustacean shellfish must be named by their specific type or species
- Flavorings, colorings and incidental additives with a major food allergen are covered too, even though the ingredient rules would otherwise let them go unnamed
That second point catches people out: "soybean oil" in the list doesn't declare the soy in soy lecithin, because a highly refined oil is not a major food allergen.
The FASTER Act: sesame becomes the ninth
The Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 added sesame to the legal definition of a major food allergen. Every FDA requirement for major food allergens, labeling and manufacturing alike, now applies to sesame.
Sesame hiding in a spice blend is the case to watch. Spices may be listed simply as "spices", but sesame inside them must be named: "spices (sesame)" in the list, or "Contains sesame".
Which foods FALCPA covers
| Covered | Not covered |
|---|---|
| Packaged foods regulated by FDA, made in the U.S. or imported | Raw agricultural commodities, like fresh produce |
| Dietary supplements | Most meat, poultry, catfish and certain egg products (USDA regulates them) |
| Food that a store, bakery or restaurant packages and labels for sale | Food wrapped or boxed after a customer orders it at the counter |
| Bulk containers shipped between food companies | Alcoholic beverages under TTB labeling rules |
| Single-ingredient foods, like "all-purpose wheat flour" | Highly refined oils |
Exempt ingredients: oils, petitions and notifications
- Highly refined oils made from an allergen, and ingredients made from those oils, are not major food allergens
- The ingredient list still names the oil's source, like "soybean oil", under the general ingredient rules
- Anyone can petition FDA to exempt an ingredient that doesn't cause a risky allergic response. FDA has 180 days; no answer means the petition is denied
- Or file a notification showing the ingredient has no allergenic protein. It can be sold as non-allergenic 90 days later unless FDA objects
What FALCPA does not do
- It sets no threshold. FDA has not established a level below which an allergen can go unlabeled
- It doesn't cover cross-contact. Traces from shared equipment are handled by manufacturing rules, and any "may contain" line is voluntary
- It doesn't let the Contains statement list other allergens. That line is reserved for the nine
- It lets FDA require labeling for other allergens in spices, flavorings, colorings and incidental additives, by regulation
- It blocks states and cities from adding allergen labeling rules of the same type that aren't identical to the federal ones
What happens when a label gets it wrong
A food that breaks the allergen labeling rule is misbranded. FDA can act with recalls, import refusals and seizures, and may send warning letters or put an importer's foods on import alert. In practice, companies usually recall such products voluntarily.
FDA reports that milk is the most common cause of recalls for undeclared allergens. The food types most often involved: bakery products, snack foods, candy, dairy products and dressings. Dark chocolate with undeclared milk is a repeat offender.
Getting it right on your label
- Read the supplier label of every ingredient, including its sub-ingredients and flavorings
- Decide per allergen: name it in the ingredient list, in a Contains statement, or both
- If you use a Contains statement, put every major allergen in it
- Name the specific nut, fish or shellfish
- Check again whenever a supplier or recipe changes
Our label maker flags all 9 major allergens from your recipe, including ones hidden in sub-ingredients like the soy lecithin in chocolate chips, and writes the Contains line with the specific tree nut, fish or shellfish. You can add an allergen by hand if a supplier tells you about one.
Allergen Warning Label Maker →