Regulatory Frameworks & Compliance Flashcards
7 cards from real ACBN practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Frameworks & Compliance flashcards as text
Which federal agency is primarily responsible for regulating dietary supplements under DSHEA?
Answer: FDA
The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Under DSHEA, who bears the burden of proof that a dietary supplement is unsafe?
Answer: The FDA
Unlike drugs, DSHEA places the burden of proof on the FDA to demonstrate that a supplement is unsafe before restricting it.
A nutritionist in a state without licensure laws wants to use the title 'Registered Dietitian.' What is the most appropriate action?
Answer: Obtain CDR credentialing before using the title
The 'Registered Dietitian' credential is issued by the Commission on Dietetic Registration (CDR) and cannot be used without meeting CDR requirements regardless of state law.
Which of the following claims is NOT permitted on a dietary supplement label without FDA pre-approval?
Answer: Disease claim
Disease claims (stating a supplement treats or cures a disease) require FDA pre-approval and are generally not permitted on supplement labels.
What does the FTC primarily regulate in the context of nutrition professionals?
Answer: Advertising and marketing claims
The Federal Trade Commission (FTC) regulates advertising and marketing claims, including those made by nutrition professionals promoting products or services.
A client asks a nutritionist to recommend a specific supplement the nutritionist personally sells. Which ethical principle is most at risk?
Answer: Conflict of interest disclosure
When a practitioner profits from recommending products to clients, failure to disclose creates a conflict of interest that violates professional ethics codes.
Under HIPAA, which of the following would be considered a permissible disclosure of a client's PHI without authorization?
Answer: Disclosing to a treating physician involved in the client's care
HIPAA permits disclosure of PHI to other treating healthcare providers involved in the patient's care as a treatment purpose exception.