Food Allergy Safety Allergen Labeling & Ingredient Disclosure 1 — Questions and Answers
Question 1: How many major food allergens are currently recognized by the FDA under US federal law?
- 7
- 8
- 9 (Correct answer)
- 11
Correct answer: 9
The FDA recognizes 9 major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame (added in 2023).
Question 2: Which law originally established mandatory allergen labeling requirements for packaged foods sold in the United States?
- The Food Safety Modernization Act (FSMA)
- The Food Allergen Labeling and Consumer Protection Act (FALCPA) (Correct answer)
- The Federal Food, Drug, and Cosmetic Act (FD&C Act)
- The Nutrition Labeling and Education Act (NLEA)
Correct answer: The Food Allergen Labeling and Consumer Protection Act (FALCPA)
FALCPA, enacted in 2004, established the requirement that the eight major food allergens (at the time) be declared on packaged food labels.
Question 3: Which of the following is the most recently added major food allergen recognized by the FDA?
- Wheat
- Tree nuts
- Shellfish
- Sesame (Correct answer)
Correct answer: Sesame
Sesame was designated as the 9th major food allergen under the FASTER Act, signed in 2021, with labeling compliance required starting January 1, 2023.
Question 4: Under FALCPA, a 'Contains' statement on a food label must include which of the following?
- Only allergens present in amounts above 10 mg per serving
- All major allergens present in the food, including those from flavorings and colorings (Correct answer)
- Only allergens added directly as primary ingredients
- Allergens that may have been introduced through cross-contact during manufacturing
Correct answer: All major allergens present in the food, including those from flavorings and colorings
A 'Contains' statement must list all major food allergens present in the product, including those derived from flavorings, colorings, and incidental additives.
Question 5: When 'spices' are listed on a food label and one of those spices is derived from a major allergen, what must the manufacturer do?
- List 'spices' without further specification, as spices are fully exempt
- Declare the allergen source even when using the collective term 'spices' (Correct answer)
- Only disclose if the spice accounts for more than 5% of the product
- Add a separate advisory statement on the front of the package
Correct answer: Declare the allergen source even when using the collective term 'spices'
Even when ingredients are listed using collective terms like 'spices,' if a major allergen is present, its source must be disclosed per FALCPA requirements.
Question 6: Which of the following is an example of a 'hidden allergen' that could mislead consumers reading a food label?
- 'Peanuts' listed plainly in the ingredient list
- 'Casein' listed without indicating it is derived from milk (Correct answer)
- 'Contains: Milk' printed after the ingredient list
- 'Egg' printed in bold type within the ingredient list
Correct answer: 'Casein' listed without indicating it is derived from milk
Casein is a milk protein that may not be recognized as a milk derivative by consumers, making it a classic example of a hidden allergen when not properly disclosed.
Question 7: Precautionary allergen labeling (PAL) statements such as 'May contain traces of peanuts' are best described as:
- Required by FDA on all products made in shared facilities
- Voluntary statements not specifically regulated by FDA (Correct answer)
- Required only when cross-contact has been confirmed through laboratory testing
- Prohibited by FDA because they are considered misleading
Correct answer: Voluntary statements not specifically regulated by FDA
PAL or advisory statements are voluntary and not specifically mandated or regulated by FDA, though they are intended to inform consumers of cross-contact risk.
Food Allergy Safety Allergen Labeling & Ingredient Disclosure 1
How many major food allergens are currently recognized by the FDA under US federal law?