Section 22 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.
Section 22 of the Food Safety and Standards Act, 2006 regulates a list of special food categories. Save as otherwise provided under the Act and its regulations, no person may manufacture, distribute, sell or import novel food, genetically modified food, irradiated food, organic food, foods for special dietary uses, functional foods, nutraceuticals, health supplements, proprietary foods or other foods the Central Government notifies.
Section 22 covers novel, genetically modified, irradiated, organic, special dietary use, functional, nutraceutical, health supplement and proprietary foods, and any other food the Central Government notifies. Save as the Act and regulations provide, nobody may manufacture, distribute, sell or import them. The Explanation defines four of the categories. The section does not itself set out the approval route; it is found in the regulations notified by the Food Authority.
What section 22 covers
The prohibition is on four acts: manufacture, distribution, sale and import. It applies to these categories:
| Category named in s.22 | Defined in the Explanation? |
|---|---|
| Novel food | Yes, as "proprietary and novel food" (clause 4) |
| Genetically modified articles of food | Yes (clause 2) |
| Irradiated food | No |
| Organic foods | Yes (clause 3) |
| Foods for special dietary uses, functional foods, nutraceuticals, health supplements | Yes (clause 1) |
| Proprietary foods | Yes (clause 4) |
| Other foods the Central Government notifies | Not applicable; the list is open |
The opening words, "save as otherwise provided under this Act and regulations", do the real work. They mean these foods are not banned outright. They are barred unless they comply with the route the regulations provide. A manufacturer who has followed that route is outside the prohibition.
Because the route itself is in regulations not reproduced here, this article describes only what the Act says. For the approval process in practice, see our posts on novel food approval and health supplement approval.
If you are launching a product that may fall into one of these categories, our food product approval service can help you work out which category it is and what the regulations require.
The four definitions in the Explanation
1. Foods for special dietary uses, functional foods, nutraceuticals and health supplements. The Explanation has two limbs.
- Limb (a): foods specially processed or formulated to satisfy particular dietary requirements arising from a particular physical or physiological condition or specific diseases and disorders, and presented as such. Their composition must differ significantly from ordinary foods of comparable nature, if such foods exist. They may contain one or more of: plants or botanicals or parts of them (powder, concentrate or extract in water, ethyl alcohol or hydro alcoholic extract, single or in combination); minerals, vitamins, proteins, metals or their compounds, amino acids (in amounts not exceeding the Recommended Daily Allowance for Indians) or enzymes (within permissible limits); substances of animal origin; or a dietary substance to supplement the diet by increasing total dietary intake.
- Limb (b): a product labelled as a "food for special dietary uses or functional foods or nutraceuticals or health supplements or similar such foods", not represented as conventional food, which may take the form of powders, granules, tablets, capsules, liquids, jelly and other dosage forms but not parenterals, and is meant for oral administration. It does not include a drug or an ayurvedic, siddha or unani drug as defined in the Drugs and Cosmetics Act, 1940. It does not claim to cure or mitigate any specific disease, disorder or condition, except for health benefit or promotion claims permitted by the regulations. It does not include a narcotic drug or psychotropic substance as defined in the Schedule of the Narcotic Drugs and Psychotropic Substances Act, 1985, or substances listed in Schedules E and E1 of the Drugs and Cosmetics Rules, 1945.
2. Genetically engineered or modified food means food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology, or food and food ingredients produced from but not containing such organisms. The second half is notable: a product made from a GM source can be within the definition even if no GM organism remains in it.
3. Organic food means food products produced in accordance with specified organic production standards.
4. Proprietary and novel food means an article of food for which standards have not been specified but which is not unsafe. The proviso adds that the food must not contain any of the foods and ingredients prohibited under the Act and regulations.
Why the drug carve-out matters
Limb (b) draws a line between a health supplement and a drug. A product that claims to cure or mitigate a specific disease does not fit the definition, and a product that is a drug as defined in the Drugs and Cosmetics Act is not a health supplement at all. That affects labelling and advertising. Section 24 bars misleading advertisements and unfair trade practices, and s.53 provides a penalty up to ten lakh rupees for misleading advertisements; see our posts on restrictions on food advertising and misleading labelling, section 53.
Who is affected
- Supplement and nutraceutical brands need to check their product against both limbs of the definition.
- Organic producers and sellers should note that the definition rests on "specified organic production standards"; see organic food regulations.
- Importers of any listed category are caught by the word "import" in s.22 as well as by s.25.
- Start-ups with a new recipe or ingredient for which no standard exists may be dealing with a "proprietary and novel food".
- Retailers and e-commerce sellers are caught by "distribute" and "sell".
Consequences of a breach
Section 22 carries no penalty clause of its own. If a special food is made or sold outside the route the regulations prescribe, the charge depends on the facts: a contravention for which no penalty is separately provided attracts the residuary penalty in s.58 up to two lakh rupees; if the food is unsafe, s.59 applies. A food that is also misbranded or misleadingly advertised attracts ss.52 and 53.
Example. A company launches capsules labelled as a health supplement that "cure" a named disease. On the Explanation's own words, a product that claims to cure a specific disease sits outside limb (b). The label, the category and the approval route all need to be reconsidered before sale.
Need help with a new or special food product?
If you plan to launch a supplement, a novel ingredient, an organic product or an imported functional food, TaxClue can help you work out the category and the steps before the first batch. Begin on our food product approval page.
Key takeaways
- Section 22 bars making, distributing, selling or importing listed special foods except as the Act and regulations allow.
- The list covers novel, GM, irradiated, organic, special dietary use, functional, nutraceutical, health supplement and proprietary foods, plus any the Central Government notifies.
- Health supplements must not claim to cure or mitigate a specific disease and must not be drugs.
- GM food includes food produced from, but not containing, GM organisms.
- The approval route is in regulations, and penalties come from other sections.
Read next
- Novel food under FSSAI: approval process
- Genetically engineered food approval under FSSAI
- Section 21: pesticide residues, veterinary drugs and microbiological counts
- Section 25: imports of food subject to the Act
Disclaimer: Based on the Food Safety and Standards Act, 2006 as enacted, read with the Jan Vishwas (Amendment of Provisions) Act, 2023 where it applies (ss.59, 61 and 63 only). The approval route for special foods is in regulations not reproduced here. Verify current notifications, regulations and FSSAI orders before acting.