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 labeling requirement mandates that allergens such as peanuts, tree nuts, and soy must be declared on food packages?
Answer: FALCPA
The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires clear declaration of the nine major food allergens on packaged food labels.
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?
Answer: 140 mg
FDA defines 'low sodium' as 140 mg or less of sodium per reference amount customarily consumed (RACC) per serving.
Which regulatory framework established mandatory preventive controls for human food manufacturers in the United States?
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.
A nutrition counselor maintains client session notes on a personal laptop without encryption. Which compliance area does this most directly violate?
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.
In a state with a 'statutory certification' law for nutritionists, which statement is most accurate?
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.
Which of the following best describes a 'structure/function claim' permitted on dietary supplement labels?
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.
A nutritionist is subpoenaed for client records in a lawsuit. What is the most appropriate first step?
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.