RAC Product Labeling and Advertising 2 — Questions and Answers
Question 1: Under 21 CFR Part 101, which statement about the Nutrition Facts panel serving size is correct?
- Serving size must reflect the amount typically consumed in one sitting based on Reference Amounts Customarily Consumed (RACC) (Correct answer)
- Serving size is set by the manufacturer based on marketing preferences
- Serving size must always equal the entire package contents
- Serving size is determined solely by caloric content of the food
Correct answer: Serving size must reflect the amount typically consumed in one sitting based on Reference Amounts Customarily Consumed (RACC)
FDA requires serving sizes to reflect RACC values so consumers can make realistic comparisons between similar products.
Question 2: A medical device manufacturer wants to promote an off-label use of their FDA-cleared device to physicians. Under current FDA policy, which activity is generally permissible?
- Distributing peer-reviewed journal articles about off-label use upon unsolicited physician request (Correct answer)
- Including off-label indications in the device labeling approved by FDA
- Running direct-to-consumer TV ads promoting the off-label use
- Training sales reps to proactively detail off-label uses to physicians
Correct answer: Distributing peer-reviewed journal articles about off-label use upon unsolicited physician request
FDA's 2023 guidance allows firms to respond to unsolicited requests for off-label information by providing unbiased scientific information such as reprints.
Question 3: Which FTC standard applies when an advertiser claims a product produces a specific quantified outcome (e.g., 'Lose 10 lbs in 2 weeks')?
- Competent and reliable scientific evidence that the specific result is typical for users (Correct answer)
- A single published case study demonstrating the claimed result
- Expert opinion from a company-employed nutritionist
- Consumer testimonials showing the claimed result for at least three individuals
Correct answer: Competent and reliable scientific evidence that the specific result is typical for users
FTC requires substantiation through competent and reliable scientific evidence, and specific performance claims imply typical results unless clearly disclaimed.
Question 4: Under FDA regulations, what distinguishes 'labeling' from 'label' for a drug product?
- Labeling encompasses all written, printed, or graphic matter accompanying the article, while the label is only the immediate container (Correct answer)
- Labeling refers only to the package insert, while the label is the outer carton
- Labeling and label are legally synonymous terms under 21 USC 321
- Labeling applies only to OTC products, while label applies to prescription drugs
Correct answer: Labeling encompasses all written, printed, or graphic matter accompanying the article, while the label is only the immediate container
Under 21 USC 321(m), 'labeling' is broader than 'label' and includes all written material accompanying the product, including brochures and websites.
Question 5: A dietary supplement label claims 'Supports healthy cholesterol levels already within normal range.' How is this claim classified under DSHEA?
- Structure/function claim requiring a disclaimer that FDA has not evaluated the statement (Correct answer)
- Disease claim that requires an approved New Drug Application
- Nutrient content claim subject to 21 CFR Part 101 definitions
- Qualified health claim requiring FDA pre-authorization
Correct answer: Structure/function claim requiring a disclaimer that FDA has not evaluated the statement
Qualifying a benefit claim by stating 'already within normal range' typically converts a potential disease claim to a permissible structure/function claim under DSHEA.
Question 6: Under EU Regulation 1169/2011 on food information to consumers, what is the minimum font size requirement for mandatory information on pre-packaged food?
- 1.2 mm x-height, or 0.9 mm for packages with largest surface area less than 80 cm² (Correct answer)
- 8 point font for all mandatory information regardless of package size
- 10 point font on packages larger than 500g, 6 point on smaller packages
- Font size is left to member state discretion with no EU minimum
Correct answer: 1.2 mm x-height, or 0.9 mm for packages with largest surface area less than 80 cm²
EU Regulation 1169/2011 Article 13 mandates a minimum x-height of 1.2 mm, reduced to 0.9 mm for very small packages.
Question 7: When a pharmaceutical company updates its FDA-approved labeling to add a new safety warning under the CBE-0 process, which statement is accurate?
- The company may implement the change immediately and submit the supplement simultaneously (Correct answer)
- The change requires prior FDA approval before implementation
- The company must wait 30 days after FDA receipt before implementing the change
- CBE-0 is only available for labeling changes to OTC monograph products
Correct answer: The company may implement the change immediately and submit the supplement simultaneously
CBE-0 (Changes Being Effected immediately) allows manufacturers to implement certain safety-related labeling changes without waiting for FDA approval.
RAC Product Labeling and Advertising 2
Under 21 CFR Part 101, which statement about the Nutrition Facts panel serving size is correct?