ACBN Regulatory Frameworks & Compliance 4 — Questions and Answers
Question 1: The Nutrition Labeling and Education Act (NLEA) of 1990 primarily required which of the following?
- Mandatory third-party testing of supplements
- Standardized nutrition facts panels on most packaged foods (Correct answer)
- Allergen declaration on all food products
- Pre-market approval for new dietary ingredients
Correct answer: Standardized nutrition facts panels on most packaged foods
NLEA made Nutrition Facts panels mandatory on most packaged foods and standardized serving sizes and nutrient declarations.
Question 2: Which entity is responsible for setting the Dietary Reference Intakes (DRIs) used as the scientific basis for U.S. nutrition policy?
- FDA
- USDA
- National Academies of Sciences, Engineering, and Medicine (Correct answer)
- Academy of Nutrition and Dietetics
Correct answer: National Academies of Sciences, Engineering, and Medicine
The National Academies of Sciences, Engineering, and Medicine establish the DRIs through expert committee review of current nutritional science.
Question 3: A private-practice nutritionist uses a client testimonial in advertising without the client's written authorization. This most directly violates which regulation?
- HIPAA Privacy Rule and FTC endorsement guidelines (Correct answer)
- DSHEA labeling requirements
- FSMA preventive controls rule
- NLEA nutrient content claim standards
Correct answer: HIPAA Privacy Rule and FTC endorsement guidelines
Using a client's identifiable testimony without authorization violates HIPAA's privacy protections and FTC's guidelines on endorsements and testimonials in advertising.
Question 4: Under current FDA regulations, a 'new dietary ingredient' (NDI) introduced after October 15, 1994, requires the manufacturer to:
- Obtain FDA approval before marketing
- Submit a pre-market notification to FDA at least 75 days before marketing (Correct answer)
- Register with the USDA and pass third-party testing
- Obtain a Generally Recognized As Safe (GRAS) designation
Correct answer: Submit a pre-market notification to FDA at least 75 days before marketing
Manufacturers must submit an NDI notification to the FDA at least 75 days prior to marketing a supplement containing an ingredient not in the food supply before October 15, 1994.
Question 5: Which of the following activities would most likely constitute 'practicing medicine' and exceed a nutritionist's scope of practice?
- Recommending a heart-healthy diet to a client with elevated cholesterol
- Diagnosing celiac disease based on a client's reported symptoms (Correct answer)
- Providing general guidance on increasing fiber intake
- Teaching a cooking class on low-glycemic meal preparation
Correct answer: Diagnosing celiac disease based on a client's reported symptoms
Diagnosing a medical condition such as celiac disease is within the scope of licensed medical practitioners and exceeds the scope of nutritionists.
Question 6: In the context of Good Manufacturing Practices (GMPs) for dietary supplements, which of the following is a core manufacturer responsibility?
- Submitting all products for FDA pre-market testing
- Ensuring product identity, purity, strength, and composition (Correct answer)
- Obtaining USDA organic certification for all raw materials
- Filing quarterly adverse event reports for all products
Correct answer: Ensuring product identity, purity, strength, and composition
21 CFR Part 111 GMP regulations require manufacturers to verify identity, purity, strength, and composition of dietary supplement products throughout manufacturing.
Question 7: A nutritionist working in a clinical setting must complete a Breach Risk Assessment following a HIPAA incident. What is the key purpose of this assessment?
- To determine whether notification to affected individuals and HHS is required (Correct answer)
- To calculate the financial penalty owed to HHS OCR
- To document the breach in the client's medical record
- To notify state licensure boards of the incident
Correct answer: To determine whether notification to affected individuals and HHS is required
The Breach Risk Assessment evaluates four factors to determine if PHI was actually compromised and whether breach notification obligations are triggered under HIPAA.
ACBN Regulatory Frameworks & Compliance 4
The Nutrition Labeling and Education Act (NLEA) of 1990 primarily required which of the following?