Nutraceuticals: trends, scope and regulatory aspects (FSSAI) MCQs With Answer

Nutraceuticals: trends, scope and regulatory aspects (FSSAI) MCQs With Answer

Introduction: This quiz-focused blog is designed for M.Pharm students studying Advanced Pharmacognosy I (MPG 102T) to deepen understanding of nutraceutical science, current market trends, and Indian regulatory frameworks under FSSAI. It covers core concepts such as definitions and classification, safety and efficacy evidence, analytical and stability considerations, formulation strategies to improve bioavailability, quality-control challenges with botanicals, and critical regulatory requirements including novel food approvals, permissible claims and labeling. Each multiple-choice question emphasizes applied knowledge relevant to research, product development and regulatory compliance to prepare students for academic exams and real-world pharmaceutical and nutraceutical practice.

Q1. Which of the following best defines a ‘nutraceutical’ in the context of food and health sciences?

• A synthetic drug derived from vitamins that treats diseases
• A food or part of a food that provides medical or health benefits, including the prevention and treatment of disease
• A cosmetic ingredient used to enhance skin appearance
• A bulk commodity used only for caloric intake

Correct Answer: A food or part of a food that provides medical or health benefits, including the prevention and treatment of disease

Q2. Which regulation specifically addresses nutraceuticals, health supplements and novel foods under Indian law?

• Drugs and Cosmetics Act, 1940
• Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016
• Indian Pharmacopoeia Commission Guidelines, 2010
• Plant Protection Code, 2012

Correct Answer: Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Uses, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016

Q3. Under FSSAI classification, which of the following is NOT a recognized category related to nutraceuticals?

• Health supplements
• Functional foods
• Foods for Special Medical Purpose (FSMP)
• Prescription-only small molecule therapeutics

Correct Answer: Prescription-only small molecule therapeutics

Q4. Regarding novel foods under FSSAI, which statement is correct?

• Novel foods can be marketed without any dossier or safety review if used traditionally abroad
• Novel foods must undergo a prior safety assessment and approval process before commercialization
• Novel foods are always treated as pharmaceutical drugs and require clinical trial approval from CDSCO
• Novel foods are exempt from labeling requirements

Correct Answer: Novel foods must undergo a prior safety assessment and approval process before commercialization

Q5. For substantiating health claims on nutraceutical products in India, which type of evidence is prioritized by regulators?

• Anecdotal user testimonials on social media
• In vitro cell-line studies only
• Robust human clinical evidence, preferably randomized controlled trials and systematic reviews
• Traditional knowledge without any scientific validation

Correct Answer: Robust human clinical evidence, preferably randomized controlled trials and systematic reviews

Q6. Which type of health claim is generally permissible for nutraceuticals under FSSAI guidance while disease cure claims are restricted?

• Therapeutic claims stating cure of tuberculosis
• Structure/function claims that describe how a nutrient supports normal body functions
• Claims that guarantee 100% prevention of chronic diseases
• Claims that imply the product is a substitute for prescription medication

Correct Answer: Structure/function claims that describe how a nutrient supports normal body functions

Q7. Which labelling element is mandatory for nutraceutical products under food safety regulations?

• Guaranteed therapeutic effect statement for specific diseases
• Batch or lot number and manufacturing/expiry dates
• Manufacturer’s secret herbal ratio without disclosure
• Prescription requirement statement

Correct Answer: Batch or lot number and manufacturing/expiry dates

Q8. For standardization of an herbal nutraceutical containing multiple botanicals, which analytical strategy is most appropriate?

• Quantitative determination of characteristic marker compounds using validated HPLC/UPLC methods
• Visual color inspection only
• Relying solely on traditional textual claims without assays
• Measuring only ash value and ignoring active constituents

Correct Answer: Quantitative determination of characteristic marker compounds using validated HPLC/UPLC methods

Q9. Which accelerated stability testing condition is commonly used to estimate shelf-life parameters for nutraceutical formulations?

• 0°C for 1 month
• 40°C ± 2°C and 75% ± 5% relative humidity
• 25°C with uncontrolled humidity only
• 100°C in dry conditions

Correct Answer: 40°C ± 2°C and 75% ± 5% relative humidity

Q10. What does the acronym GRAS stand for in the context of food safety and nutraceutical ingredients?

• Gradual Release and Safety
• Generally Recognized as Safe
• Global Registry of Approved Substances
• Guaranteed Regulatory Approved Substance

Correct Answer: Generally Recognized as Safe

Q11. Which of the following would NOT typically be classified as a nutraceutical?

• Omega-3 fatty acid concentrate marketed for cardiovascular health
• Probiotic formulation with specified CFU for gut health
• Table sugar sold for caloric sweetening with no health claim
• Standardized turmeric extract for anti-inflammatory support

Correct Answer: Table sugar sold for caloric sweetening with no health claim

Q12. Which formulation approach is commonly used to improve oral bioavailability of poorly water-soluble nutraceutical actives?

• Lyophilization without any carrier
• Self-emulsifying drug delivery systems (SEDDS) or lipid-based formulations
• Simply increasing tablet size without excipients
• Dry mixing with inert silica only

Correct Answer: Self-emulsifying drug delivery systems (SEDDS) or lipid-based formulations

Q13. In quality control of botanical nutraceuticals, which contaminant class is of greatest regulatory concern due to chronic toxicity risks?

• Residual moisture below 1% only
• Heavy metals such as lead, arsenic and mercury
• Benign plant pigments
• Saccharides naturally present in herbs

Correct Answer: Heavy metals such as lead, arsenic and mercury

Q14. To legally manufacture nutraceuticals in India, a producer must obtain which of the following?

• Marketing authorization from the Drug Controller General of India for all products
• Appropriate FSSAI registration or license (state/central) depending on scale and turnover
• No registration is required for food products
• Only international certifications such as HALAL or ISO are sufficient

Correct Answer: Appropriate FSSAI registration or license (state/central) depending on scale and turnover

Q15. For probiotic nutraceuticals, which specification is critical to declare and ensure on the label until end of shelf-life?

• Taxonomic strain identification and colony forming units (CFU) at end of shelf-life
• General mention of ‘live bacteria’ without counts
• Only the genus name without species or strain
• Manufacturing pH only

Correct Answer: Taxonomic strain identification and colony forming units (CFU) at end of shelf-life

Q16. Which widely known botanical–drug interaction mechanism is exemplified by St. John’s Wort?

• Inhibition of intestinal P-glycoprotein only, increasing drug exposure dramatically
• Induction of CYP3A4 leading to reduced plasma concentrations of co-administered drugs
• Direct antagonism at opioid receptors
• Permanent irreversible binding to insulin molecules

Correct Answer: Induction of CYP3A4 leading to reduced plasma concentrations of co-administered drugs

Q17. When evaluating a novel botanical ingredient for nutraceutical use, regulatory reviewers most commonly request which types of data?

• Only historical culinary recipes
• Comprehensive safety data including toxicology, ADME, and history of safe use documentation
• Proof that the plant tastes pleasant
• Patent number only

Correct Answer: Comprehensive safety data including toxicology, ADME, and history of safe use documentation

Q18. Which US agency maintains the GRAS notification process and generally recognized as safe evaluations relevant to food ingredients?

• Centers for Disease Control and Prevention (CDC)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• Federal Trade Commission (FTC)

Correct Answer: Food and Drug Administration (FDA)

Q19. For highest-level clinical substantiation of a specific health claim for a nutraceutical, which study design is considered the gold standard?

• Single-arm open-label observational study
• Randomized, double-blind, placebo-controlled clinical trial
• Case reports and expert opinion
• In vitro mechanistic assays only

Correct Answer: Randomized, double-blind, placebo-controlled clinical trial

Q20. Where are permissible ingredients, maximum limits and standards for nutraceuticals typically enumerated in Indian regulatory documentation?

• Schedules and annexures of the FSSAI regulations specific to nutraceuticals and functional foods
• Only in press releases with no binding force
• In proprietary manufacturer SOPs kept confidential
• Under the Indian Penal Code

Correct Answer: Schedules and annexures of the FSSAI regulations specific to nutraceuticals and functional foods

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