By S&S Co. Advocates & Solicitors · Published 30 September 2026 · Informational content, not legal advice: see our disclaimer
A Distinct Regulatory Category
Health supplements, nutraceuticals, foods for special dietary use, foods for special medical purpose, functional foods and novel foods are not regulated as ordinary packaged food under FSSAI's general labelling and standards framework. Instead, they fall under a dedicated regulation, the Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Food) Regulations, 2016, which sets out composition, labelling and claims rules specific to this category. A manufacturer entering this space needs to recognise early that the general food labelling rules it may already be familiar with do not fully capture what this category requires.
The Boundary With 'Drug' Claims
The single most consequential rule in this regulation is the bar on disease-related claims. A product marketed as a health supplement or nutraceutical cannot claim to cure, mitigate, treat or prevent any disease. Making such a claim does not merely risk an FSSAI labelling violation: it risks the product being characterised as a "drug" under the Drugs and Cosmetics Act instead, which carries its own, considerably more onerous licensing, manufacturing and claims-substantiation regime. Marketing teams drafting packaging copy and advertising for products in this category need to work from a vocabulary that describes structure, function or nutritional support, rather than disease outcomes.
Mandatory Labelling Elements
Beyond the standard food labelling requirements that apply to packaged food generally, products in this category must additionally disclose the recommended dosage and any relevant safety warnings specific to the ingredient or formulation, and must carry a mandatory statement that the product is not a substitute for a balanced diet. These elements exist because a health supplement is, by definition, intended to supplement the ordinary diet rather than replace it, and the labelling is meant to prevent consumers from treating the product as a dietary substitute.
Product Approval Before a New Ingredient or Claim
A manufacturer's basic FSSAI licence to operate is not, by itself, sufficient authority to market a product in this category containing a genuinely new ingredient, or carrying a health or nutrition claim not already recognised under the regulations. A separate product approval or notification process must typically be completed first, during which the ingredient's safety data and the claim's scientific substantiation are reviewed, before the specific product can be lawfully marketed with that ingredient or claim.
Where the Drug Boundary Gets Tested in Practice
In practice, enforcement attention in this category concentrates heavily on the boundary with drug claims: products that use language suggesting therapeutic effect, or that are positioned through marketing and distribution channels associated with treating a specific condition, invite scrutiny regardless of how the label itself is worded. Manufacturers should audit not just their packaging but their advertising, influencer content and distribution channel messaging for the same disease-claim risk, since enforcement authorities look at the product's overall market positioning, not the label in isolation.
Frequently Asked Questions
Which FSSAI regulation governs health supplements and nutraceuticals?
The Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Food) Regulations, 2016 govern this category separately from general packaged food.
Can a health supplement claim to cure or prevent a disease?
No. A product marketed under this category cannot claim to cure, mitigate, treat or prevent disease, making such a claim risks the product being treated as an unlicensed 'drug' instead.
What must a health supplement's label include?
Labelling must include the recommended dosage, relevant safety warnings, and a mandatory statement that the product is not a substitute for a balanced diet, in addition to the standard food labelling requirements.
Is prior approval needed for a new ingredient or health claim?
Yes, a product approval or notification process must generally be completed before a new ingredient or a new health claim can be marketed under this category, separate from the manufacturer's basic FSSAI licence.
References & Further Reading
This article references the following statutory provisions. Readers should always verify current rules, fees and timelines against the applicable statute and rules as amended, since these are revised from time to time.
- The Food Safety and Standards (Health Supplements, Nutraceuticals, Foods for Special Dietary Use, Foods for Special Medical Purpose, Functional Foods and Novel Food) Regulations, 2016.
- The Drugs and Cosmetics Act, 1940, relevant to the boundary between a permissible structure/function claim and a disease-related claim that would characterise a product as a drug.