Packaging and Label Design FDA and US Regulatory Compliance 1 — Questions and Answers
Question 1: Under FDA regulations, what must appear on the principal display panel of a food product?
- Statement of identity and net quantity of contents (Correct answer)
- Nutrition Facts panel
- Ingredient list
- Manufacturer address
Correct answer: Statement of identity and net quantity of contents
FDA 21 CFR 101.3 and 101.105 require the statement of identity (product name) and net quantity of contents on the PDP.
Question 2: Which US law governs the labeling of most packaged food products?
- Federal Food, Drug, and Cosmetic Act (FD&C Act) (Correct answer)
- Fair Packaging and Labeling Act only
- USDA Agricultural Marketing Act
- Consumer Product Safety Act
Correct answer: Federal Food, Drug, and Cosmetic Act (FD&C Act)
The FD&C Act, enforced by the FDA, is the primary law governing food labeling requirements in the United States.
Question 3: What is the minimum type size required by FDA for the Nutrition Facts label on most standard-sized food packages?
- 8 pt (Correct answer)
- 6 pt
- 10 pt
- 12 pt
Correct answer: 8 pt
FDA regulations require that most type in the Nutrition Facts panel be at least 8 pt to ensure consumer legibility.
Question 4: Which allergen labeling law requires major allergens to be declared on US food labels?
- FALCPA (Food Allergen Labeling and Consumer Protection Act) (Correct answer)
- FSMA
- GRAS regulations
- FD&C Act Section 402
Correct answer: FALCPA (Food Allergen Labeling and Consumer Protection Act)
FALCPA, enacted in 2004, requires that the eight major food allergens be clearly declared on packaged food labels sold in the US.
Question 5: What are the nine major food allergens now required to be declared on US labels under FASTER Act (2023)?
- Milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, sesame (Correct answer)
- Milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, corn
- Milk, eggs, peanuts, tree nuts, wheat, gluten, soy, shellfish, mustard
- Milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, sulfites
Correct answer: Milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, sesame
The FASTER Act added sesame as the ninth major allergen, effective January 1, 2023, joining the original eight established by FALCPA.
Question 6: What information is required on the 'information panel' of a US food label per FDA regulations?
- Nutrition Facts, ingredient list, allergen declaration, and manufacturer information (Correct answer)
- Only the ingredient list
- Only the Nutrition Facts panel
- The UPC barcode and lot number
Correct answer: Nutrition Facts, ingredient list, allergen declaration, and manufacturer information
FDA regulations require the information panel to carry Nutrition Facts, ingredients, allergen statements, and name/address of manufacturer, packer, or distributor.
Packaging and Label Design FDA and US Regulatory Compliance 1
Under FDA regulations, what must appear on the principal display panel of a food product?