Health Claims explained: this guide covers what it means, who it applies to, the step-by-step process, documents required, fees, due dates and penalties in India — so you can stay compliant with confidence and avoid costly mistakes.
Regulation 7 of the Advertising and Claims Regulations, 2018 sets the conditions and declarations for health claims. The Schedules that go with it are Schedule II (synonyms), Schedule IIA (permitted claims for edible vegetable oils), Schedule III (permitted reduction-of-disease-risk claims with conditions) and Schedule IV (health claims for fortified food articles).
The text is read as amended up to 13 December 2022 (FSSAI Compendium Version IV dated 14.12.2022). FSSAI compendia are reference consolidations and the Gazette text prevails. Later notifications should be checked on fssai.gov.in. A claim that falls outside the Schedules may need prior approval; see food product approval support.
A health claim must have two parts: the physiological role or accepted diet-health relationship, and information on the composition relevant to it. It needs a statement of the quantity of the nutrient, target group, directions for use and, if necessary, the maximum safe intake. No reduction of disease risk claim may be made unless it is in accordance with Schedule III. Fortified foods may make the claims in Schedule IV, and edible oils the claims in Schedule IIA.
Regulation 7(1): conditions and declarations
Health claims must comply with these conditions and declarations.
| Clause | Requirement |
|---|---|
| (a) | The claim consists of two parts: (i) information on the physiological role of the nutrient or substance or an accepted diet-health relationship; and (ii) information on the composition of the product relevant to that role or relationship, unless the relationship is based on a whole food or foods and the research does not link to specific constituents |
| (b) | If the benefit is attributed to a constituent with an established recommended dietary allowance, the food must be (i) a source of or high in the constituent, per Schedule I, where increased consumption is recommended; or (ii) low in, reduced in or the zero-level claim for the constituent per Schedule I, where reduced consumption is recommended |
| (c) | A statement of the quantity of the nutrient or substance that is the subject of the claim, per 100 g or 100 ml or per pack (single consumption pack) |
| (d) | Where applicable, the target group; where a contraindication exists, advice to vulnerable groups on consumption or avoidance |
| (e) | Directions for use of the food to obtain the claimed benefit in the context of the diet and other lifestyle factors where appropriate |
| (f) | Maximum safe intake of the food or the constituent, if necessary |
Regulation 7(2) to 7(5)
- 7(2) Nutrient function claims and other function claims may be made based on current relevant scientific substantiation, with sufficient evidence on the type of claimed effect and its relationship to health as recognised by generally accepted scientific review. The food business operator reviews the substantiation as new knowledge becomes available and updates the claims.
- 7(2A) (inserted) Claims, including nutrient function claims, for edible vegetable oils may be made as provided in Schedule IIA.
- 7(3) No reduction of disease risk claims shall be made that is not in accordance with the conditions in Schedule III.
- 7(4) Food articles fortified under the Fortification of Foods Regulations, 2018 may make the health claims in Schedule IV, and flexibility in wording is acceptable if the meaning is not altered. See our article on fortification Schedule II and III.
- 7(5) Where a claimed health benefit is attributed directly to the product, it shall be based on statistically significant results from well-designed human intervention studies, conducted by or under guidance of established research institutions, in line with the principles of GCP (Good Clinical Practices), and peer reviewed or published in a reputed peer reviewed scientific journal.
Schedule II: synonyms
Schedule II lists synonyms for the claim words used in Schedule I (zero-level, Low, Reduced, High, Increased, Source). It is explained in our article on nutrition claims.
Schedule IIA: edible vegetable oils
Schedule IIA, headed "List of Claims for Edible Vegetable Oils", lists claim statements that may be used on labels or advertisements for nineteen oils, with a proviso that food business operators may use the same or similar terms if the intent and meaning do not change. Terms such as "Rich" and "Contains" follow Schedule I. Examples as printed:
| Sl. | Oil | Claim statement, as printed |
|---|---|---|
| 1 | Coconut Oil/Virgin Coconut Oil | Contains medium chain fatty acids that are easily metabolized |
| 5 | Linseed/Flax Seed Oil | Rich in Omega-3 Polyunsaturated Fatty Acid (Omega-3 PUFA, Alpha linolenic acid) |
| 7 | Mustard Oil | Contains Omega-3 Polyunsaturated Fatty Acid (Omega-3 PUFA) |
| 8 | Olive Oil/Olive Pomace Oil/Extra virgin Olive oil | Rich in Monounsaturated Fatty Acids (MUFA) that helps to maintain blood cholesterol levels |
| 15 | Sunflower Oil | Rich in Omega-6 Polyunsaturated Fatty Acids (Omega-6 PUFA, linoleic acid) |
| 17 | Avocado Oil | Rich in Monounsaturated Fatty Acids (MUFA) that helps to maintain normal blood cholesterol levels |
Each oil has between one and four statements, some about composition ("Contains Tocopherols which are natural antioxidants") and some about function. For the oil standards, see our sister article on edible oils.
Schedule III: reduction of disease risk claims
Schedule III has eight rows. Each gives a nutrient or food-health relationship, conditions for the claim and a claim statement. Examples as printed:
| Sl. | Relationship | Condition (in short) | Claim statement (in short) |
|---|---|---|---|
| 1 | Calcium or Calcium and Vitamin D and osteoporosis | the food is a source or high in calcium or in calcium and vitamin D, with a statement that the beneficial effect is obtained with a daily recommended intake | Adequate calcium intake throughout life, through a balanced diet, is essential for bone health and to reduce the risk of osteoporosis |
| 2 | Sodium and Hypertension | a food which is low in sodium (0.12 g sodium/100 g or 100 ml), with a statement that the effect is obtained with a low sodium diet | Diets low in sodium may help in reducing the risk of high blood pressure |
| 5 | Alpha-linolenic acid (ALA) and blood cholesterol level | at least 1 g of omega-3 fatty acids per 100 g or 100 ml or 100 kcal, with a statement that the effect is obtained with daily intake of 2 g of ALA | ALA contributes to the maintenance of normal blood cholesterol levels |
| 6 | Soluble Dietary Fibre and blood cholesterol | soluble fibre from sources such as oats, barley, millets; at least 1 g per serving; statement on daily intake of 3 g | Soluble dietary fibre taken as part of a diet contributes to reduction of blood cholesterol levels |
| 8 | Beta-glucans (oats, barley) and blood glucose | the food is oats or barley; at least 4 g beta-glucans for each 30 g of available carbohydrates; a statement that it is taken as part of the meal | Beta-glucans from oats or barley when taken as part of a meal may help in reduction of rise in blood glucose after that meal |
The other rows are dietary saturated fat and blood cholesterol (3), potassium and risk of high blood pressure (4) and phytosterol or stanol and blood cholesterol (7). A Note lets operators use the same or similar terms if the intent and meaning are not changed.
Schedule IV: health claims for fortified food articles
Schedule IV, headed "Health Claims for Fortified Food Articles", pairs eleven nutrients with printed claims. Examples: Vitamin A, "Vitamin A helps against night blindness"; Vitamin D, "Vitamin D supports strong bones"; Iron, "Iron fights Anemia"; Iodine, "Iodine is required for normal growth, thyroid and brain function"; Zinc, "Zinc supports a healthy immune system". The others are Vitamin B12, folate and folic acid, thiamine, riboflavin, niacin and pyridoxine.
An invented example: Sunrise Oils sells sunflower oil. It may print "Rich in Omega-6 Polyunsaturated Fatty Acids (Omega-6 PUFA, linoleic acid)" as in Schedule IIA, serial 15. A claim about heart disease that does not appear in Schedule III, such as a new diet-disease link, is a reduction of disease risk claim and cannot be made without approval under regulations 11 and 12 (see our article on approval of claims).
Where this sits
Regulations 3 and 4 apply as well: the claim must be truthful, substantiated and consistent with the label (principles). Prohibited claims are in regulations 8 to 10. The overview post is health and nutritional claims on food labels.
Need help with a health claim?
Health claims need the right Schedule row or a prior approval. Our food product approval service can help assess whether a claim is already in Schedule III or IIA and, if not, prepare the dossier.
Key takeaways
- A health claim has two parts and must carry quantity, target group, directions for use and, where necessary, the maximum safe intake.
- Reduction of disease risk claims must follow Schedule III.
- Schedule IIA lists claims for edible vegetable oils; Schedule IV lists claims for fortified foods.
- Claims attributed directly to the product need statistically significant human intervention studies.
Read next
- Regulation 6: non-addition claims
- Regulations 8–10: dietary, conditional and prohibited claims
- Regulations 11 and 12: approval of claims
- Health and nutritional claims on food labels
Disclaimer: Based on the FSSAI regulations named above as consolidated in FSSAI's compendium versions or as published in the Gazette, with the later notifications the article names (consulted on fssai.gov.in on 2-3 October 2026). Later notifications and the Food Safety and Standards Act, 2006 provisions referred to should be checked. This article is general information, not legal advice; check the official text before acting.