ACBN Regulatory Frameworks & Compliance 3 — Questions and Answers
Question 1: Which labeling requirement mandates that allergens such as peanuts, tree nuts, and soy must be declared on food packages?
- DSHEA
- FALCPA (Correct answer)
- FSMA
- NLEA
Correct answer: FALCPA
The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires clear declaration of the nine major food allergens on packaged food labels.
Question 2: A food manufacturer wants to label a product 'low sodium.' Under FDA regulations, the product must contain no more than how many milligrams of sodium per serving?
- 35 mg
- 140 mg (Correct answer)
- 480 mg
- 600 mg
Correct answer: 140 mg
FDA defines 'low sodium' as 140 mg or less of sodium per reference amount customarily consumed (RACC) per serving.
Question 3: Which regulatory framework established mandatory preventive controls for human food manufacturers in the United States?
- DSHEA 1994
- NLEA 1990
- FSMA 2011 (Correct answer)
- FALCPA 2004
Correct answer: FSMA 2011
The Food Safety Modernization Act (FSMA) of 2011 shifted focus from responding to foodborne illness to preventing it by requiring hazard analysis and preventive controls.
Question 4: A nutrition counselor maintains client session notes on a personal laptop without encryption. Which compliance area does this most directly violate?
- DSHEA supplement regulations
- HIPAA Security Rule technical safeguards (Correct answer)
- FTC advertising standards
- State dietetics scope-of-practice laws
Correct answer: HIPAA Security Rule technical safeguards
The HIPAA Security Rule requires technical safeguards including encryption of electronic PHI on portable devices to protect against unauthorized access.
Question 5: In a state with a 'statutory certification' law for nutritionists, which statement is most accurate?
- Only certified practitioners may practice nutrition counseling in that state
- Anyone may practice nutrition counseling but only certified practitioners may use protected titles (Correct answer)
- Certification is voluntary and confers no title protection
- The state has no authority over nutrition practice
Correct answer: Anyone may practice nutrition counseling but only certified practitioners may use protected titles
Statutory certification protects specific titles (like 'Certified Nutritionist') but does not restrict who may practice nutrition counseling.
Question 6: Which of the following best describes a 'structure/function claim' permitted on dietary supplement labels?
- 'This product treats iron-deficiency anemia'
- 'Calcium builds strong bones' (Correct answer)
- 'Reduces risk of osteoporosis'
- 'Clinically proven to prevent bone fractures'
Correct answer: 'Calcium builds strong bones'
Structure/function claims describe how a nutrient supports normal body structure or function (e.g., 'Calcium builds strong bones') without claiming to treat or prevent disease.
Question 7: A nutritionist is subpoenaed for client records in a lawsuit. What is the most appropriate first step?
- Immediately release all records to comply with the subpoena
- Destroy the records to protect client confidentiality
- Consult legal counsel before releasing any records (Correct answer)
- Notify the client and release records only with their written consent
Correct answer: Consult legal counsel before releasing any records
A subpoena does not automatically override HIPAA protections; legal counsel should be consulted to determine the appropriate legal response before releasing records.
ACBN Regulatory Frameworks & Compliance 3
Which labeling requirement mandates that allergens such as peanuts, tree nuts, and soy must be declared on food packages?