ACBN Regulatory Frameworks & Compliance 2 — Questions and Answers
Question 1: Which federal agency is primarily responsible for regulating dietary supplements under DSHEA?
- USDA
- FDA (Correct answer)
- FTC
- CDC
Correct answer: FDA
The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act (DSHEA) of 1994.
Question 2: Under DSHEA, who bears the burden of proof that a dietary supplement is unsafe?
- The manufacturer
- The retailer
- The FDA (Correct answer)
- The consumer
Correct answer: The FDA
Unlike drugs, DSHEA places the burden of proof on the FDA to demonstrate that a supplement is unsafe before restricting it.
Question 3: A nutritionist in a state without licensure laws wants to use the title 'Registered Dietitian.' What is the most appropriate action?
- Use the title freely since no state law prohibits it
- Obtain CDR credentialing before using the title (Correct answer)
- Petition the state legislature to add the title
- Use 'Certified Nutritionist' instead without credentials
Correct 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.
Question 4: Which of the following claims is NOT permitted on a dietary supplement label without FDA pre-approval?
- Structure/function claim
- Nutrient content claim
- Disease claim (Correct answer)
- Health claim approved via qualified process
Correct 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.
Question 5: What does the FTC primarily regulate in the context of nutrition professionals?
- Scope of practice for dietitians
- Advertising and marketing claims (Correct answer)
- Food labeling standards
- Supplement manufacturing practices
Correct 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.
Question 6: A client asks a nutritionist to recommend a specific supplement the nutritionist personally sells. Which ethical principle is most at risk?
- Beneficence
- Justice
- Conflict of interest disclosure (Correct answer)
- Autonomy
Correct 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.
Question 7: Under HIPAA, which of the following would be considered a permissible disclosure of a client's PHI without authorization?
- Sharing records with a client's employer upon employer request
- Releasing records to a marketing firm for research
- Disclosing to a treating physician involved in the client's care (Correct answer)
- Posting de-identified outcomes data with client names
Correct 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.
ACBN Regulatory Frameworks & Compliance 2
Which federal agency is primarily responsible for regulating dietary supplements under DSHEA?