Superfoods Regulatory Frameworks & Compliance 2 — Questions and Answers
Question 1: Which FDA regulation requires that structure/function claims on superfood supplements include a disclaimer?
- 21 CFR Part 101
- 21 CFR Part 111
- DSHEA Section 6 (Correct answer)
- FTC Act Section 5
Correct answer: DSHEA Section 6
DSHEA Section 6 requires structure/function claims to be accompanied by a specific disclaimer stating the claim has not been evaluated by the FDA.
Question 2: What is the maximum permitted level of lead in a dietary supplement serving under California's Proposition 65?
- 0.5 mcg/day (Correct answer)
- 10 mcg/day
- 0.5 mg/day
- 5 mcg/day
Correct answer: 0.5 mcg/day
California Proposition 65 sets a safe harbor level of 0.5 micrograms of lead per day for dietary supplements.
Question 3: Under DSHEA, who bears the primary burden of proving a dietary supplement is unsafe?
- The manufacturer
- The FDA (Correct answer)
- The FTC
- Third-party certifiers
Correct answer: The FDA
DSHEA shifted the burden of proof to the FDA, which must demonstrate that a supplement is unsafe before it can be removed from the market.
Question 4: A company markets a superfood blend claiming it 'supports heart health.' Which agency primarily oversees the truthfulness of this advertising claim?
- FDA
- USDA
- FTC (Correct answer)
- NIH
Correct answer: FTC
The Federal Trade Commission (FTC) has primary jurisdiction over advertising claims, including those for dietary supplements and superfoods.
Question 5: Which certification mark indicates that a supplement product has been tested for banned substances and verified for label accuracy?
- USDA Organic
- NSF Certified for Sport (Correct answer)
- Non-GMO Project Verified
- Fair Trade USA
Correct answer: NSF Certified for Sport
NSF Certified for Sport verifies that products are free of banned substances and that label claims accurately match contents.
Question 6: Under 21 CFR Part 111, which of the following is required in a dietary supplement's Current Good Manufacturing Practice?
- Pre-market FDA approval
- Master manufacturing records (Correct answer)
- Biennial third-party audits
- Clinical trial data submission
Correct answer: Master manufacturing records
21 CFR Part 111 requires manufacturers to maintain master manufacturing records that document the production of each batch of supplement.
Question 7: Which health claim type requires the highest level of scientific evidence before it can appear on a superfood product label?
- Qualified health claim
- Structure/function claim
- Authorized health claim (Correct answer)
- Nutrient content claim
Correct answer: Authorized health claim
Authorized health claims require significant scientific agreement, the highest evidentiary standard, and must be pre-approved by the FDA.
Superfoods Regulatory Frameworks & Compliance 2
Which FDA regulation requires that structure/function claims on superfood supplements include a disclaimer?