ISSA Regulatory Compliance & Legal Framework 3

Question 1

Under HIPAA, which of the following constitutes Protected Health Information (PHI) that a nutritionist must safeguard?

Accepted Answer

A client's name combined with their dietary assessment results

Answer

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?

Accepted Answer

Post-market enforcement action

Answer

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?

Accepted Answer

FTC guidelines on endorsements and testimonials requiring disclosure of material connections

Answer

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?

Accepted Answer

FDA

Answer

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:

Accepted Answer

Refer the client to their physician and work collaboratively within scope of practice

Answer

Managing a diagnosed medical condition like hypothyroidism requires physician oversight; a nutritionist should refer and collaborate rather than treat independently.

(ISSA) International Sports Sciences Association Certified Nutritionist Practice Test

(ISSA) International Sports Sciences Association Certified Nutritionist Practice Test

ISSA Regulatory Compliance & Legal Framework 3