Regulatory Compliance & Legal Framework Flashcards

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

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.

Which regulatory term describes the FDA's authority to remove a dietary supplement from the market after it is already being sold?

Answer: Post-market enforcement action

Under DSHEA, the FDA uses post-market enforcement authority to remove supplements proven unsafe after they have entered commerce.

A nutritionist recommends a specific herbal supplement brand and receives undisclosed commissions from the manufacturer. This practice primarily violates which regulation?

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.

Good Manufacturing Practices (GMPs) for dietary supplements, codified in 21 CFR Part 111, are enforced by which agency?

Answer: FDA

The FDA enforces dietary supplement GMPs under 21 CFR Part 111, covering identity, purity, strength, and composition.

A client asks a certified nutritionist to recommend supplements to manage their diagnosed hypothyroidism. The most legally appropriate response is to:

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.

Which labeling element is NOT required on a dietary supplement's Supplement Facts panel under FDA regulations?

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.

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?

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.