Dietary supplement labeling, claims and safety requirements (US) MCQs With Answer
Understanding US regulatory requirements for dietary supplements is essential for M.Pharm students preparing for roles in quality, regulatory affairs, and product development. This set of MCQs focuses on the key laws, labeling elements, permissible and prohibited claims, safety notifications, and manufacturing controls that govern supplements in the United States. Questions emphasize DSHEA provisions, 21 CFR Part 111 cGMPs, Supplement Facts panel requirements, New Dietary Ingredient (NDI) notifications, adverse event reporting, and the roles of FDA and FTC in enforcement. The quiz is designed to deepen your regulatory knowledge and apply it to real-world compliance scenarios.
Q1. Which law primarily defines and regulates dietary supplements in the United States?
- Federal Food, Drug, and Cosmetic Act (FD&C Act) only
- Nutrition Labeling and Education Act (NLEA)
- Dietary Supplement Health and Education Act (DSHEA) of 1994
- Food Safety Modernization Act (FSMA)
Correct Answer: Dietary Supplement Health and Education Act (DSHEA) of 1994
Q2. Which FDA regulation specifically contains current Good Manufacturing Practice requirements for dietary supplements?
- 21 CFR Part 111
- 21 CFR Part 210
- 21 CFR Part 101
- 21 CFR Part 820
Correct Answer: 21 CFR Part 111
Q3. Which item is NOT a required element on a dietary supplement label under US regulations?
- Statement of identity (the term “dietary supplement”)
- Net quantity of contents on the principal display panel
- Nutrition Facts panel identical to conventional foods
- Name and place of business of manufacturer, packer, or distributor
Correct Answer: Nutrition Facts panel identical to conventional foods
Q4. What is the mandatory title for the nutrition display required on dietary supplements?
- Nutrition Facts
- Supplement Facts
- Ingredient Facts
- Dietary Information
Correct Answer: Supplement Facts
Q5. For a proprietary blend on a Supplement Facts panel, which of the following is required?
- Disclosure of exact milligram amounts of each ingredient within the blend
- Listing of individual ingredients in alphabetical order without quantities
- Listing of ingredients in order of predominance and the total weight of the blend
- Omission of any ingredient names to protect trade secrets
Correct Answer: Listing of ingredients in order of predominance and the total weight of the blend
Q6. Which type of claim is expressly prohibited on dietary supplement labeling under US law?
- Structure/function claims with an FDA disclaimer
- Nutrient content claims such as “good source of”
- Health claims authorized by FDA based on petition
- Disease claims stating the product treats or cures a disease
Correct Answer: Disease claims stating the product treats or cures a disease
Q7. What required disclaimer must accompany a structure/function claim on a dietary supplement label?
- “This product is approved by the Food and Drug Administration.”
- “This product has been clinically proven to treat disease.”
- “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
- “Guaranteed by the manufacturer for efficacy.”
Correct Answer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Q8. Under DSHEA, what is the required FDA notification period for a New Dietary Ingredient (NDI) before marketing, unless the manufacturer has evidence of history of safe use?
- 30 days
- 45 days
- 75 days
- No notification is ever required
Correct Answer: 75 days
Q9. Which agency enforces truth-in-advertising for dietary supplement labeling and promotional claims in the US marketplace?
- Environmental Protection Agency (EPA)
- Federal Trade Commission (FTC)
- Occupational Safety and Health Administration (OSHA)
- Centers for Disease Control and Prevention (CDC)
Correct Answer: Federal Trade Commission (FTC)
Q10. Which of the following best describes a “misbranded” dietary supplement?
- A product that exactly meets all label requirements but is packaged in glass
- A product whose labeling is false or misleading in any particular
- A product that contains only vitamins and minerals
- A product with a Supplement Facts panel
Correct Answer: A product whose labeling is false or misleading in any particular
Q11. Under US law, serious adverse events associated with dietary supplements must be reported by manufacturers to FDA within what timeframe?
- 72 hours
- 15 business days
- 6 months
- Immediately by phone only
Correct Answer: 15 business days
Q12. Which of the following would most likely render a dietary supplement “adulterated”?
- Labeling that omits the manufacturer’s address
- Presence of an undeclared pharmaceutical drug at levels that present a health risk
- Use of an ingredient that has an established Daily Value
- Listing active ingredients on the Supplement Facts panel
Correct Answer: Presence of an undeclared pharmaceutical drug at levels that present a health risk
Q13. Which statement about percent Daily Value (%DV) on Supplement Facts panels is true?
- %DV must be declared for all botanical ingredients
- %DV is required only when a Daily Value has been established for that nutrient
- %DV is optional and never used on supplements
- %DV values are set by the FTC
Correct Answer: %DV is required only when a Daily Value has been established for that nutrient
Q14. Which labeling element must appear on the “principal display panel” of a dietary supplement container?
- Full Supplement Facts panel
- Ingredient lot number
- Net quantity of contents
- Complete adverse event log
Correct Answer: Net quantity of contents
Q15. When a manufacturer makes a health claim on a dietary supplement, what must generally support that claim?
- Anecdotal consumer testimonials
- Competent and reliable scientific evidence or an FDA-authorized health claim
- A manufacturer’s internal marketing survey
- Approval from the Federal Reserve
Correct Answer: Competent and reliable scientific evidence or an FDA-authorized health claim
Q16. Which of the following practices is a required part of 21 CFR Part 111 cGMPs for dietary supplement manufacturers?
- Adopting a written quality control unit responsible for approving or rejecting labels, ingredients, packaging, and finished products
- Providing consumer refunds within 24 hours
- Clinical trials for every finished product prior to sale
- Mandatory third-party certification by a specific private organization
Correct Answer: Adopting a written quality control unit responsible for approving or rejecting labels, ingredients, packaging, and finished products
Q17. Are manufacturers required to list major food allergens on dietary supplement labels under the Food Allergen Labeling and Consumer Protection Act (FALCPA)?
- No—FALCPA applies only to conventional foods, not supplements
- Yes—major food allergens must be declared when present in supplements
- Only if the supplement is in tablet form
- Only if marketed to children under 12
Correct Answer: Yes—major food allergens must be declared when present in supplements
Q18. Which enforcement action can FDA use against a dietary supplement company that is in violation?
- Issue warning letters, seize adulterated products, and seek injunctions or criminal prosecution
- Directly fine consumers who purchased the product
- Approve the product retroactively after a fine is paid
- Order immediate revocation of the company’s corporate charter
Correct Answer: Issue warning letters, seize adulterated products, and seek injunctions or criminal prosecution
Q19. Which phrase best describes FDA’s authority to order recalls for dietary supplements?
- FDA has mandatory recall authority for all dietary supplements
- FDA has no role in recalls and cannot request voluntary recalls
- FDA generally requests or negotiates voluntary recalls and can seize products or seek court-ordered remedies if necessary
- Recalls are handled exclusively by the FTC
Correct Answer: FDA generally requests or negotiates voluntary recalls and can seize products or seek court-ordered remedies if necessary
Q20. Which label statement is acceptable for a supplement making a structure/function claim about supporting immune health?
- “Cures influenza and prevents infection in clinical trials”
- “Supports a healthy immune response; This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
- “Guaranteed to treat autoimmune disease”
- “FDA-approved immune support formula”
Correct Answer: “Supports a healthy immune response; This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
