Interest in nutraceuticals continues to increase, due to individuals viewing them as having health benefits and/or preventing disease. Nutraceuticals are broadly defined as dietary supplements, functional foods, and medicinal herbs, and are consumed across demographics as part of wellness strategies. With rising consumer demand, companies are now focusing more on nutraceutical product development and health-conscious product development to meet diverse needs.
Global Regulatory Framework for Nutraceuticals: Compliance, Safety, and Claims
Interest in nutraceuticals continues to increase, due to individuals viewing them as having health benefits and/or preventing disease. Nutraceuticals are broadly defined as dietary supplements, functional foods, and medicinal herbs, and are consumed across demographics as part of wellness strategies. With rising consumer demand, companies are now focusing more on nutraceutical product development and health-conscious product development to meet diverse needs.
Nutraceuticals are subject to different regulations worldwide. In this article, we briefly discuss the global regulatory framework, types of nutraceuticals, safety requirements, labeling, and health claims, helping stakeholders understand compliance in the international marketplace.
Key Categories of Nutraceuticals
Nutraceuticals can be categorized based on their origins, chemical structure, or ends use. These categories guide nutraceutical product design and marketing strategies for both manufacturers and consumers. [1]
Dietary supplements:
- These products may contain vitamins, minerals, amino acids or other bioactive constituents.
- Usually in caps, pills, powders or liquid forms. [2]
- Examples that many consumers recognize may include ginseng, coenzyme Q10 and calcium supplements.
Functional foods:
- Foods that deliver benefits beyond essential nutrients, often enhanced through nutraceutical product innovation and formulation.
- Functional foods include claims such as fortified with omega-3, and probitic yogurts, and foods fortified with fiber.[3]
- Functional foods have been demonstrated to assist in the prevention of chronic disease such as heart disease and diabetes.
Folk or Medicinal Herbs:
- Plant-based substances that contain curative properties are known as medicinal herbs (e.g., turmeric, ginseng, echinacea).
- Used for centuries and remain integral to functional foods and dietary supplements. [4]
Regulations and the Safety of Nutraceuticals
The safety and the obligation to comply with regulations are fundamental to us ensuring and verifying that the nutraceutical products we consume do not impose risks. Various regulations bodies throughout the world have frameworks that aid producers of nutraceutical products and their consumers to offer guidance on those products.
- Safety Testing and Authorization.
- Safety testing programs must come before the marketing of nutraceutical products to evaluate safety, determine efficacy, administrative safety, and to identify potential hazards. Safety testing programs include:
- Toxicology Studies: Evaluates potentially poisoned effects that may occur after the consumption of prescribed doses.
- Clinical Trials: Studies conducted on humans to evaluate product safety and efficacy.
- Allergen Testing: Examines whether the product(s) contains allergens to those sensitive persons.[5]
- Labeling Requirements.
Nutraceutical products must comply with specific labeling requirements to ensure consumers have clear information that is transparent. A nutraceutical product must show disclosure of:
- Product Name and Description: Is easily identified as a not only a product but a functional product.
- Active Ingredients and quantity: Provide information about the bioactive ingredients and amounts.
- Health Claims: Only display scientifically proven health claims on the label.
- Allergen Warnings: Indicate if allergens or dangerous materials are present.[6]
- Claims and Marketing
Marketing must avoid misleading consumers. Agencies like FDA, EFSA, and FSSAI require scientific validation before claims are approved. This ensures that nutraceutical product development aligns with consumer protection.
Manufacturers must ensure that:
- Health claims are validated by scientific evidence.
- Structure/function claims are accurate and supported by credible studies.
- Disease prevention claims must be aligned with regulatory approval (e.g., FDA approval for disease-related claims). [7]
Types of Claims Made in Different Regions
Nutraceutical claims vary across regions, and manufacturers must be familiar with the specific regulations in each country. Below are the types of claims allowed by regulatory authorities in major regions:
- United States – FDA
Regulatory Authority:
- FDA (Food and Drug Administration) under the Dietary Supplement Health and Education Act (DSHEA), 1994.
Definition:
- Nutraceuticals are considered dietary supplements, which include vitamins, minerals, amino acids, herbs, and other bioactive substances that supplement the diet.
Registration & Licensing:
- Product Notification: Required for New Dietary Ingredients (NDI).
- GMP Compliance: Manufacturers must comply with 21 CFR Part 111 for good manufacturing practices.
- Adverse Event Reporting: Serious adverse events must be reported within 15 days.
- Labeling: Must include product name, ingredients, dosage, and any required warnings. [8]
Types of Claims Allowed:
- Structure/Function Claims: Claims allowed with scientific evidence; must include an FDA disclaimer (e.g., “Calcium builds strong bones”).
- Nutrient Content Claims: Claims about the level of a nutrient in the product (e.g., “High in Vitamin C”), approved if they meet regulatory criteria.
- Disease Prevention/Treatment Claims: Not allowed without drug approval. Nutraceuticals cannot make claims related to disease prevention or treatment unless FDA-approved as a drug.
Cost:
No pre-market fee for most supplements, but fees apply for New Dietary Ingredient (NDI) notifications. [9]
- European Union – EFSA
Regulatory Authority:
- EFSA (European Food Safety Authority) and member state authorities.
Definition:
- Nutraceuticals are considered food supplements, which are concentrated sources of nutrients or bioactive substances intended to supplement the normal diet.
Registration & Licensing:
- Product registration follows Directive 2002/46/EC for food supplements.
- Safety, labeling, and claims evaluation are managed by EFSA.
Types of Claims Allowed:
- Nutrient Content Claims: Defined for vitamins and minerals (e.g., “Rich in vitamin C”).
- Function Claims: Claims about the effects of nutrients or bioactive substances on the body (e.g., “Omega-3 fatty acids contribute to normal heart function”).
- Reduction of Disease Risk Claims: Permitted only if approved by EFSA (e.g., “Calcium helps prevent osteoporosis”). These claims must be supported by scientific evidence. [10]
Cost:
- Varies by country, generally part of filing fees for product registration.
- India – FSSAI
Regulatory Authority:
- Food Safety and Standards Authority of India (FSSAI).
Definition:
- Nutraceuticals are considered Foods for Special Dietary Uses (FSDU) that provide health benefits beyond basic nutrition.
Registration & Licensing:
- Product Licensing: Approval is required before marketing.
- Ingredient Safety Evaluation: All ingredients must meet safety standards.
- Site Licensing: Manufacturing facilities must be licensed by FSSAI.
- GMP Compliance: Adherence to Good Manufacturing Practices is mandatory.
- Adverse Reaction Reporting: Manufacturers must report adverse reactions.
- Labeling: Labels must comply with FSSAI guidelines for nutraceuticals.
Types of Claims Allowed:
- General Health Claims: Claims related to overall wellness (e.g., “Supports general well-being”).
- Specific Health Claims: Must be substantiated by scientific evidence (e.g., “Helps reduce cholesterol,” “Supports immune system”). These claims are subject to FSSAI approval. [9]
Cost:
- Approx. ₹100 per product for registration.
- Australia – TGA
Regulatory Authority:
- Therapeutic Goods Administration (TGA).
Definition:
- Nutraceuticals are classified as complementary medicines under the TGA regulations.
Registration & Licensing:
- Must be listed in the Australian Register of Therapeutic Goods (ARTG).
- Evidence for safety, quality, and efficacy is required.
- Labeling and dosage information must comply with TGA guidelines.
- GMP Compliance is mandatory.
Types of Claims Allowed:
- Health Claims: Functional benefits of the product (e.g., “Supports digestive health”).
- Structure/Function Claims: Claims that describe the effect of the product on body structure or function (e.g., “Supports joint health”).
- Disease Prevention/Treatment Claims: Not allowed without therapeutic registration and approval from TGA.
Cost:
- Approx. AUD 720 per product for registration.
- Canada – Health Canada
Regulatory Authority:
- Natural Health Product Directorate (NHPD).
Definition:
- Nutraceuticals are classified as Natural Health Products (NHPs), which provide health or therapeutic benefits.
Registration & Licensing:
- A product license is required before marketing.
- Labeling must include ingredients, health claims, warnings, and dosage information.
- Site Licensing and GMP compliance are required.
Types of Claims Allowed:
- Structure/Function Claims: Claims about the effect of a product on body functions (e.g., “Probiotics support healthy gut function”).
- Nutrient Function Claims: Claims about the role of a nutrient in normal body function (e.g., “Vitamin C helps in the maintenance of healthy skin”).
- Disease Risk Reduction Claims: Approved by NHPD only (e.g., “Omega-3 fatty acids may reduce the risk of cardiovascular disease”).
Cost:
- Currently, there are no pre-market fees, but administrative fees may apply. [11]
- Japan – FOSHU
Regulatory Authority:
- Ministry of Health, Labour and Welfare (MHLW).
Definition:
- Nutraceuticals in Japan are classified as Foods for Specified Health Uses (FOSHU). These are foods with scientifically validated health benefits.
Registration & Licensing:
- Products must undergo safety and efficacy testing before being approved as FOSHU.
- Health Claims require approval from the Ministry of Health, Labour and Welfare.
- Labeling must include approved health claims and dosage information.
Types of Claims Allowed:
- Specific Health Claims: These claims pertain to recognized physiological effects and must be supported by clinical trials (e.g., “Reduces cholesterol levels”).
- Functional Claims: Claims that describe the effect of a product on body functions (e.g., “Supports immune function”).
- Disease Risk Reduction Claims: Requires ministry approval and clinical evidence (e.g., “Helps reduce the risk of hypertension”).
Cost:
- The cost varies by product; registration fees apply. [12]
Global Nutraceutical market overview: key parameters and regional comparison
Table 1: Global Regulatory Comparison for Nutraceuticals
Country | Definition | Regulations for Licensing & Registration | Regulation Year | Regulatory Authority | Requirements for Registration | Fee | Claim Approval Authority | Health Claims |
USA | Regulated as Dietary Supplements under DSHEA. | DSHEA, 1994; FDA oversees labeling & safety. | 1994 | FDA | – Safety check- Self-regulation- Labeling- Post-market surveillance. | ~$720 (annual) | USFDA (FDA, CFSAN) | – Nutrient content- Structure/function- Disease risk reduction (with evidence). |
Europe (EU) | Treated as Food Supplements, health claims regulated. | EC No 1924/2006; EFSA evaluates claims. | 2002 | EFSA + Member States | – Product evaluation- Safety & efficacy- Labeling requirements. | €1,000–€20,000 (varies by state) | EFSA + EU Commission | – Nutrition- General health- Disease risk reduction (with approval). |
India | Foods providing health benefits beyond basic nutrition. | FSSAI regulations, 2016. | 2008 (updated 2016) | FSSAI | – Pre-market approval- Ingredient limits- Product evaluation. | ₹1000 (license application) | FSSAI | – General health- Specific claims (with evidence & approval). |
Japan | Foods for Specified Health Uses (FOSHU). | FOSHU regulations under MHLW. | 1991 (formalized 2001) | MHLW | – Clinical evidence- Product evaluation- Labeling compliance. | ¥100,000–¥2,000,000 (depends on claim) | MHLW | – General health- FOSHU-approved claims- Disease risk reduction (with clinical evidence). |
Australia | Complementary Medicines. | TGA regulations. | 1989 | TGA | – Licensing- GMP certification- Safety & efficacy evidence. | AUD $720 (listed medicines) | TGA | – General health- Higher-level claims (with clinical trial evidence). |
Canada | Natural Health Products (NHPs). | NHPR, 2004. | 2004 | Health Canada (NNHPD) | – Product & site licensing- Safety & efficacy- Labeling compliance. | No pre-market fee; site license fees apply | Health Canada (NNHPD) | – General health- Specific claims (with clinical evidence). |
Challenges in the Global Nutraceutical Market
Although regulatory frameworks exist, manufacturers still experience regulatory issues in the nutraceutical market. The following regulatory issues exist:
- Regulatory Inconsistency: Regulations differ from country to country. Definitions, safety standards and regulations governing health claims vary country to country impeding manufacturers from selling their products across markets.
- No Standardization: There is no universally accepted definition for nutraceutical. Thus, some products may be in a grey area confusing both consumers and manufacturers alike.
- Scientific Validation: It is difficult to be able to provide scientific evidence to substantiate health claims. [13]
These challenges also impact nutraceutical product design and innovation strategies, requiring rigorous compliance across regions.
Case Study: Global Regulatory Compliance for Gut-Health Probiotic Yogurt
Food Research Lab developed Gut-Health Probiotic Yogurt, a functional food with clinically proven probiotics for digestive health. To market it globally, FRL navigated key regional regulations:
- USA (FDA)
- Marketed as a dietary supplement under DSHEA (1994).
- Labeling met FDA rules, with structure/function claims like “Supports digestive health” backed by clinical data.
- Europe (EFSA)
- Evaluated under Regulation (EC) No 1924/2006.
- Scientific dossier with trial data supported claims like “Supports normal intestinal function”, earning approval.
- India (FSSAI)
- Classified as FSDU (Food for Special Dietary Uses).
- Pre-market approval ensured compliance for claims like “Supports gut health.”
- Japan (FOSHU)
- Approval sought via Ministry of Health, Labour and Welfare (MHLW).
- Clinical trials validated claims like “Reduces risk of digestive disturbances,” leading to FOSHU certification.
Challenges and Outcomes
FRL faced challenges in differing regulations, clinical trials, and claim validation. Compliance with global standards enabled safe, successful launches across markets, gaining both consumer trust and regulatory approval.
How FRL Supports Manufacturers
The Food Research Lab is positioned to assist nutraceutical manufacturers with regulatory compliance in several ways:
- Regulatory Consulting: Comprehensive advice regarding International Regulations in the nutraceutical industry, including from the FSSAI, FDA, EFSA, and others
- Testing Products: Assessing products for safety, efficacy (if available), and compliance with labelling regulations
- Scientific research: Designing and conducting clinical trials and other studies to demonstrate health claims for products
- Sourcing ingredients: Helping manufacturers locate reliable, safe and regulated supply chains for product ingredients
Conclusion
The nutraceutical industry continues to expand as consumers increasingly demand products that enhance health and well-being. By adhering to frameworks from authorities such as FDA, EFSA, FSSAI, and TGA, manufacturers can ensure safety, efficacy, and compliance.
However, inconsistencies in regulations, scientific validation, and marketing remain major challenges. Companies that embrace health-conscious product development, robust clinical validation, and transparent labeling will gain trust globally.
By leveraging the expertise of Food Research Lab, manufacturers can strengthen compliance, accelerate nutraceutical product development, and deliver effective functional foods and dietary supplements that meet consumer expectations.
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