Regulatory Guide to Nutraceuticals in India: FSSAI vs CDSCO

In 2022, a startup launched a plant-based supplement claiming to treat hormonal imbalances. Within months, it was pulled off shelves by FSSAI for misleading claims. The founders were shocked. “We thought it was just a wellness product,” they argued.

The world of nutraceuticals regulation in India is constantly evolving, where supplements often exist in the uncertain space between food and medicine. With the increasing demand for products that promote health and well-being—especially after COVID-19—the need for a strong regulatory framework governing nutraceuticals in India becomes even more important. This framework is vital to ensure both consumer safety and product credibility.

For any Food Business Operator looking to navigate this complex landscape, understanding FSSAI guidelines on nutraceuticals is crucial. The significance of FSSAI and CDSCO in assessing nutraceutical products in India cannot be emphasized enough, as they establish clear standards for licensing and regulate health claims on nutraceutical labels.

One important legislation to be aware of is the Functional Food and Novel Food Regulations, 2016. These regulations outline purity criteria and restrictions on nutritional claims for nutraceutical products. They play a key role in preventing prohibited substances from being included in nutraceuticals and ensuring that products meet established safety standards.

As we delve into how India regulates nutraceuticals, we'll also explore the scientific evidence behind the health benefits of various nutrients classified as nutraceuticals, such as those related to Methylene tetrahydrofolate reductase (MTHFR) gene support.

The Regulatory Bodies: Who Governs What?

FSSAI (Food Safety and Standards Authority of India)

• Governs nutraceuticals under the Food Safety and Standards Act, 2006
• Defines categories: health supplements, nutraceuticals, functional foods, foods for special dietary use (FSDU), and foods for special medical purposes (FSMP)
• Key regulation: FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use) Regulations, 2022

FSSAI ensures that products:

• Contain approved ingredients
• Follow dosage limits
• Avoid therapeutic claims (e.g., "cures," "treats")
• Include accurate labeling and safety info

CDSCO (Central Drugs Standard Control Organization)

• India's national drug regulator
• Governs pharmaceuticals under the Drugs and Cosmetics Act, 1940
• Currently does not regulate most nutraceuticals, unless they resemble or cross into the territory of drugs

But that may change. High-potency or therapeutic-looking products may soon fall under CDSCO’s purview.

As you navigate the landscape of nutraceuticals in India, it's essential to understand FSSAI's role in nutraceutical regulation and stay informed about food safety standards amendments 2021. Additionally, consider the scientific data requirements outlined in Part B Schedule VI of the Functional Food and Novel Food) first amendment Regulations. If you're interested in the types of nutraceutical classification types or specific guidelines like FSSAI nutraceutical guidelines, ensure you check rules regarding organic or genetically modified ingredients usage in Indian nutraceuticals.

Keep in mind that certain ingredients with health implications, such as Selenium for conditions like Diabetes Mellitus, must adhere to strict regulations set forth by these governing bodies.

What Defines a Nutraceutical in India?

The definition of nutraceuticals in India is primarily guided by the FSSAI classification of nutraceuticals, which categorizes these products as:

• Food-based products
• Intended to supplement the diet
• Not to treat or prevent diseases

Nutraceuticals can include a variety of components such as vitamins and minerals in nutraceuticals, botanicals and amino acids, and other bioactive substances. It’s important to note that if a product includes high doses or makes medical claims, it risks being classified as a drug—thus triggering CDSCO regulations for supplements.

Additionally, products that fall under specific categories like Food for Special Medical Purpose must adhere to the guidelines set forth in the Food Safety and Standards (Packaging and Labelling) Regulations, 2021. When considering dietary supplements in India, one should also be aware of nutritional labeling mandates Indian regulations that ensure proper information is provided to consumers.

As you explore approval procedures for novel foods or special dietary use products in India, consider the various types and classifications of nutraceuticals available. This includes understanding the role of prebiotics, dietary fibre, and the benefits of antioxidants in nutraceuticals.

FSSAI vs CDSCO - Key Differences

This outlines the key differences between FSSAI and CDSCO, essential for understanding the regulatory framework governing nutraceuticals in India. While the FSSAI operates under the Food Safety and Standards Act, 2006, CDSCO is governed by the Drugs and Cosmetics Act, 1940.

When considering product type classification, it's important to note that FSSAI regulates food supplements, whereas CDSCO oversees medicines, biologics, and active pharmaceutical ingredients (APIs). Additionally, the approval requirements for nutraceuticals and drugs differ significantly; FSSAI allows self-regulation with no pre-market approval, while CDSCO mandates clinical trials and thorough registration processes.

The claims allowed on labels also vary between these two authorities. FSSAI permits structure/function claims that suggest support for health functions, while CDSCO restricts labels to therapeutic claims that assert treatment or preventive properties.

Facility standards play a crucial role as well: manufacturers must adhere to food-grade GMP regulations set by FSSAI for supplements but comply with stricter pharma-grade GMP under CDSCO when producing medicinal products.

Finally, labeling requirements differ greatly—FSSAI requires clear nutrient information and disclaimers on supplement labels, whereas CDSCO stipulates comprehensive details including prescription information and potential side effects.

For those interested in organic ingredients use in nutraceuticals India or seeking information on amendments and updates to Indian nutraceutical regulations, understanding these FSSAI vs CDSCO key differences is vital. Furthermore, consider the role of probiotics and flavonoids in health when evaluating products under these regulatory frameworks.

Recent Developments in India

• In 2024, a government task force recommended that high-potency or borderline products, such as hormone support supplements and joint health blends, be reviewed under CDSCO guidelines for high-potency products. This review is part of the broader context of recent developments in Indian nutraceutical regulation.
• e-Commerce scrutiny of nutraceuticals has intensified, with online platforms like Amazon and Flipkart facing pressure to remove unapproved Nutra products. This scrutiny aligns with the legal framework established by the FSS Act, 2006, particularly Section 22 FSS Act, which governs health supplements regulation in India.
• There has been a significant rise in legal notices for misleading claims and non-compliance with ingredient limits compliance. These notices often address violations related to permitted health claims on nutraceutical product labels under Indian law and ensure adherence to standards set for categories covered under Indian nutraceutical regulations.
• Additionally, awareness regarding genetically modified ingredients restrictions in India has increased among consumers and regulators alike, further shaping the landscape of nutraceutical marketing and production.

What Indian Brands Must Keep in Mind

• Follow FSSAI's approved list of ingredients and their dosage limits
• Avoid medical claims (words like "treats," "heals," or "cures") to comply with nutraceuticals compliance requirements
• Conduct stability and shelf-life studies
• Use third-party labs for batch testing
• Maintain documentation for traceability

Many export-focused Indian nutraceutical brands are voluntarily aligning with US-FDA, EFSA, or TGA norms to ensure global market access. This alignment includes adhering to compliance requirements for Indian nutraceutical brands and understanding food business operator obligations nutraceuticals India.

Additionally, brands should be aware of specific regulations related to Food for Special Dietary Use and consider the implications of using ingredients like Omega-3 fatty acids and Anthocyanins. As the market evolves, some companies are also exploring nutraceuticals for COVID-19 management while ensuring that their marketing practices align with Nutra claims regulation.

For those looking to expand their knowledge, resources such as Learn compliance requirements for manufacturing/importing nutraceutical products in India and Learn about scientific data submission requirements for ingredient combinations in Indian regulations can be invaluable.

When Does CDSCO Get Involved in Nutraceuticals?

A product may attract CDSCO regulation under nutraceuticals regulation India if it:

• Has high-potency ingredients beyond FSSAI limits, such as high-potency ingredients limits like Vitamin D3 > 1000 IU
• Uses pharma-grade excipients or delivery systems, adhering to pharma-grade excipients regulation (e.g., transdermal patches)
• Is sold through doctors or branded like a drug
• Makes explicit therapeutic claims on labels

In such cases, the product may require:

• Clinical trials for nutraceuticals
• Drug license requirements (Form 25 or 28)
• Labeling revisions that comply with functional foods regulation India and clarify permitted ingredients and additives in Indian health supplement products

Future Outlook: Toward Harmonized Regulation of Nutraceuticals and Drugs

India’s Nutra space is poised for reform, with a clear future outlook on Indian nutraceutical regulation. We can expect:

• Stricter borderlines between food and drug categories, leading to the establishment of hybrid categories like "nutraceutical-drugs"
• Pre-market registration for high-risk formulations to ensure safety and efficacy
• Unified digital portals for FSSAI/CDSCO coordination, streamlining the regulatory process
• Increased emphasis on Functional Food and Novel Food classifications under the Food Safety and Standards Act 2006

This shift may raise entry barriers but will also build consumer trust and enable medical adoption. As regulations evolve, key aspects such as Schedule III nutrient limits and the FSS (Approval of non-specified food and food ingredients) Regulations will play crucial roles in shaping the industry.

Additionally, understanding labeling and advertising restrictions under Indian FSSAI rules for nutraceuticals will be essential for compliance. As we navigate this new landscape, considerations around permitted food additives in nutraceuticals India and overage allowance in nutraceutical formulation India will become increasingly important.

Stay informed about emerging trends like the incorporation of antioxidants such as glutathione, various dietary fibre types and benefits, and the growing demand for probiotics in the evolving market.

Conclusion: A Sector Growing Up Fast

The Indian nutraceutical industry is expected to grow over $18 billion by 2030. However, this rapid growth highlights the need for responsible regulation in the field.

The roles of FSSAI and CDSCO in regulating nutraceuticals are crucial as they create a system that ensures safety and effectiveness. While FSSAI has established a strong foundation, CDSCO is stepping in to address specific cases, especially in the approval process for new foods in India. This dual-regulation system in India presents both opportunities and responsibilities for brands and consumers.

Whether you’re creating a probiotic capsule or launching a liver detox blend that includes essential ingredients like Vitamin C and spices, one thing is clear: regulation is no longer an afterthought. It’s now an essential part of your brand promise. As you navigate nutrient limits in health supplements in India, make sure to consider the Recommended Dietary Allowances set by the Indian Council of Medical Research (ICMR) and guidelines from the Codex Alimentarius Commission.

Also, keep in mind factors such as excess nutrients and the impact of micronutrients on chronic diseases when designing your products. In this changing landscape, understanding how polyunsaturated fatty acids used in nutraceuticals affect consumer health will be crucial for success.

FAQs (Frequently Asked Questions)

Q1. Who regulates nutraceuticals in India?

FSSAI regulates most nutraceuticals. However, CDSCO may intervene if the product resembles a drug in potency or claims, particularly under the regulatory process for nutraceutical approval in India.

Q2. What is the main difference between FSSAI and CDSCO?

The difference between FSSAI and CDSCO lies in their scopes: FSSAI governs food and supplement safety, including labeling requirements for nutraceuticals India, while CDSCO regulates pharmaceutical drugs and requires clinical trials.

Q3. What is the regulatory framework governing nutraceuticals in India?

In India, nutraceuticals are primarily governed by the Food Safety and Standards Authority of India (FSSAI) under the Food Safety and Standards Act, 2006. However, products making high-potency or explicit medical claims may be regulated as drugs by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act, 1940.

Q4. What are the key differences between FSSAI and CDSCO regulations regarding nutraceuticals?

Key differences include their governing laws—FSSAI operates under the Food Safety and Standards Act while CDSCO functions under the Drugs and Cosmetics Act. They differ in product types regulated, approval requirements, permissible claims, manufacturing facility standards, and labeling norms. FSSAI focuses on food-based supplements without medicinal claims; CDSCO oversees pharmaceutical-grade products with therapeutic claims.

Q5. What recent developments are impacting the Indian nutraceutical industry?

Recent developments include government task force recommendations to review high-potency nutraceuticals under CDSCO guidelines, increased pressure on e-commerce platforms to remove unapproved products, and a rise in legal notices for misleading claims or non-compliance with ingredient limits. These changes signal stricter enforcement and clearer regulatory boundaries.