Fat Burning Standards and Regulations 3 — Questions and Answers
Question 1: Ephedra (ma huang) was banned by the FDA in dietary supplements in 2004 because it posed what risk?
- Liver toxicity
- Unreasonable risk of cardiovascular events and death (Correct answer)
- Kidney failure
- Severe allergic reactions
Correct answer: Unreasonable risk of cardiovascular events and death
The FDA banned ephedra-containing supplements after linking them to heart attacks, strokes, and deaths, invoking its authority under DSHEA to act on unreasonable risk.
Question 2: DMAA (1,3-dimethylamylamine) found in some fat burners has been the subject of FDA enforcement actions because it is classified as:
- A generally recognized as safe (GRAS) substance
- An approved drug ingredient
- An adulterated ingredient not meeting the definition of a dietary ingredient (Correct answer)
- A controlled substance
Correct answer: An adulterated ingredient not meeting the definition of a dietary ingredient
The FDA has stated DMAA does not meet the legal definition of a dietary ingredient and has issued warning letters to companies marketing it in supplements.
Question 3: Under DSHEA, a manufacturer must notify the FDA at least how many days before marketing a dietary supplement containing a New Dietary Ingredient (NDI)?
- 30 days
- 75 days (Correct answer)
- 90 days
- 120 days
Correct answer: 75 days
DSHEA requires a 75-day pre-market notification to the FDA for new dietary ingredients introduced after October 15, 1994.
Question 4: Which of the following statements about Serious Adverse Event Reporting (SAER) for dietary supplements is correct?
- Manufacturers must report serious adverse events to the FDA within 15 business days (Correct answer)
- Only consumers—not manufacturers—must report adverse events
- Adverse event reporting is voluntary for supplement companies
- Manufacturers report to the FTC, not the FDA
Correct answer: Manufacturers must report serious adverse events to the FDA within 15 business days
The Dietary Supplement and Nonprescription Drug Consumer Protection Act (2006) requires manufacturers to submit serious adverse event reports to the FDA within 15 business days.
Question 5: The NSF Certified for Sport® program is primarily valued in fat-burning supplement selection because it ensures:
- The product will improve athletic performance
- No substances banned by major sports organizations are present (Correct answer)
- The supplement is calorie-free
- The product has FDA pre-market approval
Correct answer: No substances banned by major sports organizations are present
NSF Certified for Sport® tests for over 270 substances banned by sports organizations, making it critical for athletes who are subject to drug testing.
Question 6: Under California's Proposition 65, supplement companies selling fat burners in California must warn consumers about ingredients that are known to:
- Exceed the recommended daily value
- Cause cancer or reproductive harm (Correct answer)
- Interact with prescription medications
- Raise blood pressure above normal levels
Correct answer: Cause cancer or reproductive harm
Prop 65 requires businesses to provide warnings before knowingly exposing anyone to chemicals listed as causing cancer or reproductive toxicity.
Question 7: Which labeling element is NOT required on a dietary supplement Facts panel under FDA regulations?
- Serving size
- List of dietary ingredients
- A claim that the product cures obesity (Correct answer)
- Contact information for adverse event reporting
Correct answer: A claim that the product cures obesity
Disease cure claims (e.g., 'cures obesity') are prohibited on supplement labels; only structure/function claims are permitted with proper disclaimer.
Fat Burning Standards and Regulations 3
Ephedra (ma huang) was banned by the FDA in dietary supplements in 2004 because it posed what risk?