Fat Burning Standards and Regulations 4 — Questions and Answers
Question 1: A structure/function claim on a fat-burning supplement label must include which disclaimer?
- 'Approved by the FDA'
- 'This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.' (Correct answer)
- 'Clinically proven for weight loss'
- 'Safe for all ages'
Correct answer: 'This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.'
FDA regulations require this exact disclaimer on all structure/function claims to differentiate supplements from drugs.
Question 2: Synephrine (bitter orange extract) became prominent in fat-burning supplements largely as a replacement for which banned ingredient?
- Sibutramine
- Ephedra (Correct answer)
- Fenfluramine
- DNP
Correct answer: Ephedra
After the 2004 ephedra ban, synephrine was widely marketed as a structurally similar but legal thermogenic alternative.
Question 3: Which organization maintains the Supplement OWL (Online Wellness Library), a voluntary registry where manufacturers can list their supplement products?
- FDA
- FTC
- Council for Responsible Nutrition (CRN) (Correct answer)
- American Medical Association
Correct answer: Council for Responsible Nutrition (CRN)
The CRN launched the Supplement OWL to improve transparency in the supplement industry by creating a public product registry.
Question 4: The 'Informed Sport' certification is particularly relevant for fat-burning supplements because it:
- Guarantees the product will increase metabolic rate by at least 10%
- Batch tests every production lot for banned substances (Correct answer)
- Certifies that the product is free of caffeine
- Confirms FDA approval of all ingredients
Correct answer: Batch tests every production lot for banned substances
Informed Sport tests every single batch of certified products rather than just periodic audits, providing stronger assurance against contamination with banned substances.
Question 5: Under FDA GMP rules (21 CFR Part 111), which of the following is a required activity for supplement manufacturers?
- Obtaining FDA pre-market approval for each SKU
- Testing finished products to verify identity and purity (Correct answer)
- Submitting clinical trial data before launch
- Registering with the FTC
Correct answer: Testing finished products to verify identity and purity
GMPs require manufacturers to test or examine finished batches of supplements to verify they meet specifications for identity, purity, strength, and composition.
Question 6: 2,4-Dinitrophenol (DNP) is sometimes sold illegally as a fat burner. Its regulatory status in the U.S. is:
- A Schedule III controlled substance
- An FDA-approved weight-loss drug
- An illegal and potentially lethal industrial chemical not permitted in food or supplements (Correct answer)
- A grandfathered ingredient under DSHEA
Correct answer: An illegal and potentially lethal industrial chemical not permitted in food or supplements
DNP is an industrial chemical that causes hyperthermia and has resulted in deaths; the FDA has repeatedly warned that any product containing DNP is illegal and dangerous.
Question 7: Which type of claim is legally permissible on a fat-burning dietary supplement label without FDA pre-approval?
- Disease claim ('treats obesity')
- Health claim ('reduces risk of heart disease')
- Structure/function claim ('supports healthy metabolism') (Correct answer)
- Drug claim ('burns fat as effectively as prescription medication')
Correct answer: Structure/function claim ('supports healthy metabolism')
Structure/function claims describing how a nutrient affects normal body structure or function are permitted without FDA pre-approval, provided the required disclaimer is included.
Fat Burning Standards and Regulations 4
A structure/function claim on a fat-burning supplement label must include which disclaimer?