Regulatory Compliance & Legal Framework Flashcards

Under FTC regulations, what is required for a nutritionist to use the term 'clinically proven' in marketing materials for a dietary supplement?

Answer: Competent and reliable scientific evidence substantiating the claim

The FTC requires that health claims be backed by competent and reliable scientific evidence, typically randomized controlled trials.

Which federal agency has primary authority to take enforcement action against a dietary supplement company making false disease claims on its label?

Answer: Food and Drug Administration (FDA)

The FDA regulates dietary supplement labeling, including disease claims, under DSHEA and the FD&C Act.

A nutrition coach who is not a licensed dietitian provides a written meal plan diagnosing a client's 'iron-deficiency anemia.' Which legal issue does this most directly raise?

Answer: Unauthorized practice of medicine or dietetics

Diagnosing a medical condition and prescribing a therapeutic diet falls within the scope of licensed dietitians or physicians, not uncredentialed coaches.

DSHEA places the burden of proving a dietary supplement is unsafe BEFORE it reaches the market on which party?

Answer: The FDA

Under DSHEA, the FDA must prove a supplement is unsafe rather than the manufacturer proving it is safe before marketing.

What is the maximum daily intake level of a nutrient above which adverse health effects are likely to occur, as established by the Institute of Medicine?

Answer: Tolerable Upper Intake Level (UL)

The Tolerable Upper Intake Level (UL) is the highest daily intake unlikely to cause adverse effects in most individuals.

A sports nutritionist publishes a client's before-and-after photos and dietary records on social media without written consent. This most likely violates which principle?

Answer: Client confidentiality and informed consent standards

Sharing identifiable client information or images without written consent breaches confidentiality and informed consent ethical obligations.

Which statement correctly describes a 'structure/function claim' allowed on dietary supplement labels under DSHEA?

Answer: 'Calcium supports bone health'

Structure/function claims describe how a nutrient affects normal body structure or function (e.g., 'supports bone health') without claiming to treat or cure a disease.