ISSA Regulatory Compliance & Legal Framework 2 — Questions and Answers
Question 1: Under FTC regulations, what is required for a nutritionist to use the term 'clinically proven' in marketing materials for a dietary supplement?
- Anecdotal client testimonials supporting the claim
- Competent and reliable scientific evidence substantiating the claim (Correct answer)
- Approval from a single licensed physician
- A manufacturer's certificate of analysis
Correct 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.
Question 2: Which federal agency has primary authority to take enforcement action against a dietary supplement company making false disease claims on its label?
- Federal Trade Commission (FTC)
- U.S. Department of Agriculture (USDA)
- Food and Drug Administration (FDA) (Correct answer)
- Consumer Product Safety Commission (CPSC)
Correct answer: Food and Drug Administration (FDA)
The FDA regulates dietary supplement labeling, including disease claims, under DSHEA and the FD&C Act.
Question 3: 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?
- Violation of DSHEA supplement advertising rules
- Unauthorized practice of medicine or dietetics (Correct answer)
- Breach of HIPAA patient privacy standards
- Violation of FTC endorsement guidelines
Correct 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.
Question 4: DSHEA places the burden of proving a dietary supplement is unsafe BEFORE it reaches the market on which party?
- The supplement manufacturer
- The FDA (Correct answer)
- The FTC
- Independent third-party testing labs
Correct answer: The FDA
Under DSHEA, the FDA must prove a supplement is unsafe rather than the manufacturer proving it is safe before marketing.
Question 5: 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?
- Estimated Average Requirement (EAR)
- Recommended Dietary Allowance (RDA)
- Tolerable Upper Intake Level (UL) (Correct answer)
- Adequate Intake (AI)
Correct 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.
Question 6: 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?
- FDA labeling regulations under DSHEA
- FTC testimonial and endorsement guidelines
- Client confidentiality and informed consent standards (Correct answer)
- USDA dietary guidelines compliance
Correct answer: Client confidentiality and informed consent standards
Sharing identifiable client information or images without written consent breaches confidentiality and informed consent ethical obligations.
Question 7: Which statement correctly describes a 'structure/function claim' allowed on dietary supplement labels under DSHEA?
- 'This product cures Type 2 diabetes'
- 'This product reduces the risk of heart disease'
- 'Calcium supports bone health' (Correct answer)
- 'This supplement treats iron-deficiency anemia'
Correct 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.
ISSA Regulatory Compliance & Legal Framework 2
Under FTC regulations, what is required for a nutritionist to use the term 'clinically proven' in marketing materials for a dietary supplement?