ISSA Regulatory Compliance & Legal Framework 3 — Questions and Answers
Question 1: Under HIPAA, which of the following constitutes Protected Health Information (PHI) that a nutritionist must safeguard?
- A general nutrition article published on the practice website
- A client's name combined with their dietary assessment results (Correct answer)
- Anonymized aggregate data used in a research publication
- Generic meal plan templates not linked to any client
Correct answer: A client's name combined with their dietary assessment results
PHI includes any individually identifiable health information, such as a client's name linked to their health or dietary data.
Question 2: Which regulatory term describes the FDA's authority to remove a dietary supplement from the market after it is already being sold?
- Premarket approval
- Mandatory recall authority
- Post-market enforcement action (Correct answer)
- New Dietary Ingredient notification
Correct answer: Post-market enforcement action
Under DSHEA, the FDA uses post-market enforcement authority to remove supplements proven unsafe after they have entered commerce.
Question 3: A nutritionist recommends a specific herbal supplement brand and receives undisclosed commissions from the manufacturer. This practice primarily violates which regulation?
- FDA New Dietary Ingredient (NDI) notification requirements
- FTC guidelines on endorsements and testimonials requiring disclosure of material connections (Correct answer)
- USDA National Organic Program labeling standards
- DSHEA good manufacturing practice (GMP) rules
Correct answer: FTC guidelines on endorsements and testimonials requiring disclosure of material connections
The FTC requires disclosure of any material connection (financial or otherwise) between an endorser and a product's manufacturer.
Question 4: Good Manufacturing Practices (GMPs) for dietary supplements, codified in 21 CFR Part 111, are enforced by which agency?
- FTC
- USDA
- DEA
- FDA (Correct answer)
Correct answer: FDA
The FDA enforces dietary supplement GMPs under 21 CFR Part 111, covering identity, purity, strength, and composition.
Question 5: A client asks a certified nutritionist to recommend supplements to manage their diagnosed hypothyroidism. The most legally appropriate response is to:
- Recommend iodine and selenium supplements at therapeutic doses
- Refer the client to their physician and work collaboratively within scope of practice (Correct answer)
- Provide a detailed supplementation protocol based on published research
- Diagnose the severity and adjust the plan accordingly
Correct answer: Refer the client to their physician and work collaboratively within scope of practice
Managing a diagnosed medical condition like hypothyroidism requires physician oversight; a nutritionist should refer and collaborate rather than treat independently.
Question 6: Which labeling element is NOT required on a dietary supplement's Supplement Facts panel under FDA regulations?
- Serving size
- List of dietary ingredients
- Percent Daily Value when established
- The manufacturer's stock keeping unit (SKU) number (Correct answer)
Correct answer: The manufacturer's stock keeping unit (SKU) number
The Supplement Facts panel requires serving size, dietary ingredients, and %DV when applicable, but internal SKU numbers are not required.
Question 7: A new dietary ingredient (NDI) is defined under DSHEA as an ingredient not marketed in the U.S. in a dietary supplement before which date?
- January 1, 1990
- October 15, 1994 (Correct answer)
- January 1, 2000
- December 31, 1999
Correct answer: October 15, 1994
DSHEA defines an NDI as any dietary ingredient not marketed in the U.S. before October 15, 1994, the date DSHEA was enacted.
ISSA Regulatory Compliance & Legal Framework 3
Under HIPAA, which of the following constitutes Protected Health Information (PHI) that a nutritionist must safeguard?