Packaging and Label Design FDA and US Regulatory Compliance 2 — Questions and Answers
Question 1: What does 'net quantity of contents' on a US food label refer to?
- The amount of food in the package, excluding the container weight (Correct answer)
- The total weight including packaging
- The number of servings in the package
- The volume at room temperature only
Correct answer: The amount of food in the package, excluding the container weight
Net quantity declares only the product itself, not the package weight, using weight, volume, or count as appropriate.
Question 2: Which FTC regulation governs environmental marketing claims like 'recyclable' or 'biodegradable' on packaging?
- FTC Green Guides (16 CFR Part 260) (Correct answer)
- FDA 21 CFR 101
- EPA Resource Conservation Act
- USDA NOP regulations
Correct answer: FTC Green Guides (16 CFR Part 260)
The FTC Green Guides provide guidance on how to make truthful, non-deceptive environmental marketing claims on product packaging and advertising.
Question 3: Under FDA food labeling rules, ingredients must be listed in what order?
- Descending order by weight (Correct answer)
- Alphabetical order
- Order of addition during manufacturing
- Descending order by volume
Correct answer: Descending order by weight
FDA 21 CFR 101.4 requires ingredients to be declared in descending order of predominance by weight.
Question 4: What is a 'structure/function claim' on a dietary supplement label?
- A claim describing the role of a nutrient or ingredient in the body's normal function (Correct answer)
- A claim that the product treats or cures a disease
- A statement about the product's physical structure
- A mandatory FDA-required disclosure
Correct answer: A claim describing the role of a nutrient or ingredient in the body's normal function
Structure/function claims describe how a nutrient or ingredient affects normal body function (e.g., 'Calcium builds strong bones') but cannot imply disease treatment.
Question 5: What label statement must accompany a structure/function claim on a dietary supplement?
- This statement has not been evaluated by the Food and Drug Administration. (Correct answer)
- FDA Approved
- Clinically Tested
- Consult your physician before use
Correct answer: This statement has not been evaluated by the Food and Drug Administration.
FDA regulations require this disclaimer to appear prominently on any dietary supplement label making a structure/function claim.
Question 6: Which regulation requires country of origin labeling (COOL) for fresh beef in the US?
- USDA Agricultural Marketing Act / 2002 Farm Bill (Correct answer)
- FDA FD&C Act
- FTC regulations
- EPA packaging rules
Correct answer: USDA Agricultural Marketing Act / 2002 Farm Bill
Mandatory COOL for beef, pork, lamb, chicken, fish, shellfish, and perishable commodities is governed by USDA under the Agricultural Marketing Act.
Packaging and Label Design FDA and US Regulatory Compliance 2
What does 'net quantity of contents' on a US food label refer to?