India’s health supplement industry has grown rapidly, driven by rising interest in preventive healthcare and nutrition-based products. This growth has blurred the line between nutritional and therapeutic products, prompting regulatory clarity from the Food Safety and Standards Authority of India (FSSAI). The framework established under the Food Safety and Standards Act, 2006 (“FSS Act”) and the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016 (“2016 Regulations”) lays down clear legal boundaries for what qualifies as a health supplement in India.
Definition under Section 22 of the FSS Act, 2006
Section 22 of the FSS Act provides the statutory basis for categorising products such as health supplements, nutraceuticals, and foods for special dietary use. Under Section 22(1)(a) of the FSS Act, a health supplement is defined as a food intended to supplement the normal diet, which may contain one or more of the following: vitamins, minerals, amino acids, or other nutrients and substances with nutritional or physiological effect, singly or in combination.
However, the FSS Act explicitly provides that such products shall not be represented for use in the diagnosis, cure, mitigation, treatment, or prevention of any disease or disorder. This restriction ensures that the role of a health supplement is confined to supporting general nutrition rather than delivering therapeutic outcomes.
Regulatory Character: Food, Not Drug
Health supplements are regulated as food under the FSS Act and not as drugs under the Drugs and Cosmetics Act, 1940. The distinction rests primarily on the intended purpose and representation of the product:
1. Products that supplement the diet and help maintain or improve nutritional status are governed by the Food Safety and Standards Authority of India (FSSAI).
2. Products that treat, cure, or prevent disease fall within the ambit of the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940.
This regulatory separation is essential to prevent consumers from being misled by food products masquerading as medicines.
The Thin Line Between Supplements and Drugs
In practice, there is often a narrow margin between a health supplement and a drug. Both may appear in similar dosage forms such as tablets, capsules, powders, or gummies, and are sometimes promoted using overlapping claims. When a product’s presentation or marketing suggests that it has curative or preventive properties, it risks crossing into the pharmaceutical domain.
The FSSAI has consistently cautioned against such misrepresentation. Phrases such as “controls blood sugar,” “reduces cholesterol,” or “treats arthritis” imply therapeutic benefit and may attract regulatory action. For emerging businesses and founders in the nutrition sector, ensuring that branding, formulation, and advertising remain within the permissible scope of “food” is essential to compliance.
Regulatory Boundaries under the 2016 Regulations
The 2016 Regulations provide detailed conditions to maintain this separation. These boundaries are designed to keep health supplements firmly within the category of food:
1. Permitted Ingredients: Under Regulation 7(1) of the 2016 Regulations, health supplements may include only those ingredients specified in Schedule I of the 2016 Regulations. Any new ingredient or substance not listed requires prior approval from the FSSAI under Section 22(1) of the FSS Act.
2. Prohibited Claims: Regulation 10(4) of the 2016 Regulations prohibits any claim on the product label or in advertising that it “cures, mitigates, or prevents” a disease, disorder, or condition. Supplements must not mimic drugs in either content or representation.
3. Nutrient Limits: As per Regulation 7(3) of the 2016 Regulations, the amount of vitamins, minerals, and other nutrients in a product must not exceed the Recommended Dietary Allowance (RDA) set by the Indian Council of Medical Research (ICMR). These limits prevent excessive dosing and maintain nutritional intent.
4. Labelling and Advisory Warning: Schedule IV of the 2016 Regulations mandates that every package of a health supplement must prominently display the advisory statement:
“NOT FOR MEDICINAL USE.”
Labels must also state the category of nutrients or substances used, recommended usage levels, and a caution that consumers should not exceed the stated daily intake.
5. Scientific Substantiation and Advertising: Under the Food Safety and Standards (Advertising and Claims) Regulations, 2018, all health or nutritional claims must be scientifically substantiated and not misleading.
These regulatory guardrails ensure that health supplements remain within the scope of food, protecting consumers from deceptive therapeutic claims while allowing innovation in India’s rapidly expanding nutraceutical space.