Packaging and Label Design FDA and US Regulatory Compliance

Question 1

Under FDA regulations, what must appear on the principal display panel of a food product?

Accepted Answer

Statement of identity and net quantity of contents

Answer

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?

Accepted Answer

Federal Food, Drug, and Cosmetic Act (FD&C Act)

Answer

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?

Accepted Answer

8 pt

Answer

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?

Accepted Answer

FALCPA (Food Allergen Labeling and Consumer Protection Act)

Answer

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)?

Accepted Answer

Milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soybeans, sesame

Answer

The FASTER Act added sesame as the ninth major allergen, effective January 1, 2023, joining the original eight established by FALCPA.

Packaging and Label Design Practice Test