REGULATORY GUIDE · FOOD SAFETY & FSSAI COMPLIANCE
Content current as of 15 October 2026
Last updated: 16 October 2026
Reviewed by the LexComply regulatory team
Quick Answer: The Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 were notified by FSSAI on 5 May 2022 and have been in force since their Gazette publication on 6 May 2022. They apply to any food business that manufactures, packs, sells, markets, distributes or imports Ayurveda Aahara - food made from recipes in 71 authoritative Ayurvedic texts listed in Schedule A. The core duties: formulate to a Schedule B category (A, B, B1 or B2), use only Schedule C additives, meet Schedule D microbiological and contaminant limits, label with the AYURVEDA AAHARA logo and mandatory warnings, make no disease prevention, treatment or cure claims, and obtain FSSAI approval before making health claims where Schedule B requires it. Breaches carry penalties of ₹1 lakh to ₹10 lakh under the Food Safety and Standards Act, 2006, and imprisonment where the food is unsafe.
Citation-ready summary
- What it is: FSSAI regulations creating a dedicated food category, Ayurveda Aahara, separate from Ayurvedic medicines.
- What it demands: 19 distinct compliance obligations, tracked as 24 checklist entries, every one rated High criticality.
- What it costs to ignore: penalties up to ₹10 lakh per contravention, criminal liability for unsafe food, and personal liability for directors under section 66 of the FSS Act.
- What is new: the penalty provisions of the FSS Act were revised by the Jan Vishwas Acts of 2023 and 2026; the 2026 changes were notified to apply from 1 October 2026.
Key Facts at a Glance
| Item | Detail |
|---|---|
| Full name | Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 |
| Issued by | Food Safety and Standards Authority of India (FSSAI), F. No. Stds/SP-05/A-1.Y(01), 5 May 2022, under section 92(2)(v) of the FSS Act, 2006 |
| Gazette and effective date | Gazette of India, Extraordinary, Part III, Section 4, No. 240, 6 May 2022; in force from the date of publication |
| Who must comply | Food business operators (FBOs) that manufacture, pack, sell, offer for sale, market, distribute or import Ayurveda Aahara (Regulation 7) |
| Where it applies | The whole of India (FSS Act, section 1(2)) |
| Not covered | Farmers, fishermen and farm-level produce (FSS Act, section 18(3)); everyday packed staples such as pulses, rice and flour, and minimally processed items (Explanation 3 to Regulation 2(b)) |
| Structure | 14 regulations and 5 schedules: A (authoritative books), B (categories and claims), C (additives), D (microbiological standards and contaminants), E (logo) |
| LexComply checklist | 24 entries, all High criticality: 2 one-time, 4 event-based, 18 ongoing; 5 have an online filing or approval component |
| Penalty law | FSS Act, 2006, sections 50 to 66, as amended by the Jan Vishwas (Amendment of Provisions) Acts of 2023 and 2026 |
| Enforcement | Food Safety Officers and Designated Officers inspect and sample; Adjudicating Officers decide penalties; appeals go to the Food Safety Appellate Tribunal |
In This Guide
- What is Ayurveda Aahara, and who must comply?
- Product categories A, B, B1 and B2: which approvals apply?
- The 19 compliance obligations, in one table
- Schedule D limits: microbiological standards and contaminants
- Step-by-step action plan and compliance calendar
- Caution points: the mistakes that cost the most
- Penalties under the FSS Act and what the 2023 and 2026 amendments changed
- Frequently asked questions
- How LexComply helps
What Is Ayurveda Aahara?
Ayurveda Aahara is a food prepared according to recipes, ingredients or processes described in the authoritative Ayurvedic books listed in Schedule A of the Regulations, including products with other botanical ingredients used in line with the concept of Ayurveda Aahara. It is a food, regulated under food law, not a medicine.
What the definition includes
- Recipes and ingredients from the 71 Schedule A books, for promoting health or meeting specific physiological needs, including foods eaten during or after specified diseases or disorders (pathya) (Explanation 1).
- Industrial-scale manufacture and packing of those recipes, provided the product keeps quality and characteristics closely similar to the books (Explanation 2).
What the definition excludes
- Ayurvedic drugs, proprietary Ayurvedic medicines and medicinal products.
- Cosmetics, and narcotic or psychotropic substances.
- Herbs listed in Schedule E-1 of the Drugs and Cosmetics Act, 1940 and Rules, 1945.
- Metal-based Ayurvedic drugs or medicines, bhasma and pishti.
- Any other ingredient the Authority notifies, and everyday packed staples or minimally processed items such as cleaning, polishing, dehusking or grading (Explanation 3).
Who Must Comply?
- Manufacturers and packers of Ayurveda Aahara, including contract manufacturers producing for a brand owner.
- Brand owners and marketers, because Regulation 7 reaches anyone who sells, offers for sale or markets the product, and Regulations 8 and 9 govern labelling, presentation and advertisement.
- Distributors, retailers and e-commerce sellers handling the product, since Regulation 7 bars distributing a product that does not comply.
- Importers, because Regulation 7 expressly covers import.
- Ayurvedic pharmaceutical companies and wellness brands launching food products, who must keep those products clear of the medicine exclusions above.
- Existing licensed food businesses who want to reposition a current product as Ayurveda Aahara (Regulation 14).
Related reading on the underlying licence: FSSAI registration rules in 2026.
Product Categories A, B, B1 and B2: Which Approvals Apply?
Schedule B sorts every Ayurveda Aahara product into a category. The category decides whether you need safety data and whether FSSAI must approve your claim before you use it.
| Category | What it covers | Safety data (prior approval of product) | Health benefit claim | Disease risk reduction claim |
|---|---|---|---|---|
| A | Prepared exactly as in the Schedule A authoritative texts | Not required | Not required if the claim is as stated in the texts | Evidence-based prior approval required |
| B | A new recipe using Schedule A ingredients, along with other botanicals used under Ayurvedic dietetic principles (Rasa, Guna, Virya, Vipaka, Karma) | Required: rationale and safety data, including mutagenicity, carcinogenicity and teratogenicity testing, or supporting published scientific evidence | Prior approval required, based on the authoritative texts | Evidence-based prior approval required |
| B1 | Ayurveda Aahara presented in a format different from the texts | Not required | Prior approval required; rationale and efficacy data for the new format, including target population | Evidence-based prior approval required |
| B2 | Ayurveda Aahara for Specific Medical Purpose: intended to give a health benefit or act as an adjuvant for a disease condition or disorder | Not required | Prior approval required; rationale and efficacy data for the specific medical purpose, including target population | Evidence-based prior approval required |
- FSSAI may publish a list of Category A products. A Category A product not on the list needs a request for inclusion, supported by literature from the Schedule A books (Schedule B, Note 1).
- Simply packing a recipe for ready use, including concentration and drying for reconstitution, may not count as a change of format (Schedule B, Note 2).
- Where Schedule B requires prior approval, the application follows the Food Safety and Standards (Approval for Non-Specific Food and Food Ingredients) Regulations, 2017 (Regulation 10).
What Are the 19 Compliance Obligations, in One Table?
LexComply's checklist tracks 24 entries under the Regulations. Several entries repeat the same duty for a different trigger (for example, purity criteria at licensing and on change), so they consolidate into 19 distinct obligations. Every entry is rated High criticality. The last column is LexComply's indicative penalty mapping; the Adjudicating Officer decides the actual section and amount on the facts.
| # | Obligation | Reg. | Type | What to do | Indicative exposure |
|---|---|---|---|---|---|
| 1 | Formulate Ayurveda Aahara only to Schedule B categories and requirements Checklist ID 918592 | 3(1) | Ongoing | Map each recipe to a Schedule A text; classify as A, B, B1 or B2; file the rationale. | ss. 50, 51 (₹5 lakh); s. 58 (₹2 lakh) |
| 2 | Do not make or sell Ayurveda Aahara for infants up to 24 months ID 918593 | 3(2) | Ongoing | Bar infant-targeted SKUs and claims across product, marketing and sales. | s. 58 (₹2 lakh); s. 59 if unsafe |
| 3 | Do not add vitamins, minerals or amino acids; declare natural ones if present IDs 918595, 918585 | 3(4) | Ongoing | Remove fortification; declare naturally occurring vitamins and minerals on the label only. | s. 51 (₹5 lakh); s. 58 |
| 4 | Use only Schedule C additives within maximum levels ID 918596 | 4 | Ongoing | Check every additive against the 32 permitted items; GMP means the lowest level needed. | ss. 51, 57 (₹2 to ₹10 lakh) |
| 5 | Manufacture in line with Schedule 4 of the Licensing and Registration Regulations, 2011 ID 918594 | 3(3) | Ongoing | Run GMP and GHP audits at each site, including contract manufacturers. | s. 56 (₹1 lakh); s. 59 if unsafe |
| 6 | Meet microbiological standards and contaminant limits ID 918597 | 5; Sch. D | Ongoing | Test against Tables 1A, 1B and 2; keep batch records and shelf-life data. | s. 51 (₹5 lakh); s. 59 if unsafe |
| 7 | Correct process hygiene when Process Hygiene Criteria are exceeded ID 918590 | Sch. D | Ongoing | Trigger a corrective action plan and re-verify Food Safety Criteria. | s. 56 (₹1 lakh) |
| 8 | Set testing frequency; use in-house methods for in-house testing only IDs 918591, 918600 | Sch. D | Ongoing | Document a testing plan above the Licensing Regulations minimum; use reference methods for compliance. | s. 58 (₹2 lakh) |
| 9 | Adopt purity criteria for ingredients from an accepted source ID 918586 | 3(5) | Ongoing | Choose FSS Regulations, a named pharmacopoeia, BIS or ICMR standards and record the choice. | ss. 51, 58 |
| 10 | Conform to the Packaging Regulations, 2018 ID 918598 | 6 | Ongoing | Verify packaging materials against the Packaging Regulations; keep supplier declarations. | s. 58 (₹2 lakh) |
| 11 | Make no claim of preventing, treating or curing a human disease IDs 918584, 918588 | 8 | Ongoing | Screen labels, websites, social media and sales scripts for disease names or cure language. | s. 53 (₹10 lakh); s. 52 (₹3 lakh) |
| 12 | Make claims in line with the Advertising and Claims Regulations, 2018 ID 918589 | 9(1) | Ongoing | Keep a claims substantiation file for every statement. | s. 53 (₹10 lakh) |
| 13 | Obtain FSSAI prior approval for health benefit and disease risk reduction claims where Schedule B requires it IDs 918578, 918579 | 9(2), 10 | One-time and event-based; online | Apply before any such claim appears anywhere, under the 2017 Non-Specific Food Regulations. | s. 58 (₹2 lakh); s. 50 (₹5 lakh) |
| 14 | Label in line with the Labelling and Display Regulations, 2020 ID 918587 | 12 | Ongoing | Run every label through a general-labelling checklist plus the Ayurveda Aahara additions. | s. 52 (₹3 lakh) |
| 15 | Carry the specific label content: logo, name, warnings and statements ID 918583 | 13(a)-(f) | Ongoing | Check the six mandatory elements and the purpose, consumer group and duration of use. | s. 52 (₹3 lakh) |
| 16 | Tell the authority the purity criteria adopted, at licensing and on any change IDs 918581, 918582 | 3(5) | Event-based; online | Submit with the licence application; update when criteria change. | s. 58 (₹2 lakh); s. 61 if false (₹10 lakh) |
| 17 | Inform the licensing authority in writing before assigning an existing licensed product as Ayurveda Aahara ID 918580 | 14 | Event-based; online | Intimate first; wait for the Expert Committee recommendation and permission, then relabel. | s. 58 (₹2 lakh); s. 52 |
| 18 | Manufacture, pack, sell, market, distribute or import only compliant product ID 918599 | 7 | Ongoing | Add a compliance gate before release and before listing on any sales channel. | s. 50 (₹5 lakh); s. 58 |
| 19 | Confirm the Act applies to your business and any exemption relied on ID 918577 | Act ss. 1(2), 18(3) | One-time | Document applicability, including any farm-level exemption. | Not applicable alone |
ID numbers refer to LexComply's checklist entries. Amounts are maxima, not fixed fines. 'If unsafe' means the food falls within the Act's definition of unsafe food, which moves the case to the criminal provisions of section 59.
The Obligations Explained
1. Product eligibility and formulation (Regulations 3(1), 3(2), 3(4), 4)
- Every recipe must trace to a Schedule A book. Recipes in an Appendix or Annexure to those books are not considered, and only listed editions and texts published before 1940 qualify (Schedule A, Notes 1 and 2).
- The 32 Schedule C additives are the only additives permitted. Most carry the instruction GMP, meaning the lowest level that achieves the effect; a few have numeric caps such as 2% for guar gum and tragacanth, 5% for molasses and 100 mg/kg for norbixin-based annatto.
- Fortification is prohibited. Natural vitamins and minerals already present may be declared on the label, but nothing may be added.
- The infant ban is absolute: no person may manufacture or sell Ayurveda Aahara intended for infants up to 24 months.
2. Safety, hygiene and testing (Regulations 3(3), 3(5), 5, 6 and Schedule D)
- Manufacture must follow Schedule 4 of the 2011 Licensing and Registration Regulations, which sets the good hygiene and manufacturing practices for the plant.
- Process Hygiene Criteria show whether the process is working. They are not release criteria, but exceeding them requires corrective action, and the Food Safety Criteria must still be met.
- Food Safety Criteria decide whether a batch is acceptable at the end of manufacture and throughout shelf life, in the market as well as the factory.
- You choose your own testing frequency, subject to the minimum in the 2011 Regulations. In-house methods are fine for internal checks but do not count for regulatory compliance.
- Purity criteria for ingredients may follow the FSS Regulations, the Indian, Ayurvedic, British or United States Pharmacopoeia, BIS specifications or ICMR's Quality Standards of Indian Medicinal Plants, but you must tell the authority which you chose.
Related reading on plant hygiene: FSSAI inspection checklist for cooking, kitchen and storage areas.
3. Claims and approvals (Regulations 8, 9, 10)
- Regulation 8 bars any claim that the product prevents, treats or cures a disease, and also any reference to such properties.
- Claims otherwise follow the 2018 Advertising and Claims Regulations, and health benefit or disease risk reduction claims follow the Schedule B approval route.
- The Ministry of Ayush Expert Committee (Regulation 11) advises FSSAI on claim and product approvals and on licensing, testing and quality concerns.
4. Labelling (Regulations 12 and 13)
- The base layer is the 2020 Labelling and Display Regulations. The Ayurveda Aahara layer sits on top.
- The label must state the intended purpose, target consumer group and recommended duration of use.
- It must also carry: (a) the words AYURVEDA AAHARA next to the product or brand name and the Schedule E logo on the front of pack; (b) the advisory ONLY FOR DIETARY USE; (c) a statement that the product is not a substitute for a varied diet; (d) warnings, precautions, known side effects, contraindications and published product or drug interactions as applicable; (e) a statement to store out of reach of children; and (f) a warning that it is for oral consumption only and not for parenteral use.
5. Communications with the authority (Regulations 3(5) and 14)
- Purity criteria must be disclosed when you apply for the licence and again whenever they change.
- To reposition an existing licensed product, inform the licensing authority in writing. The authority permits the change, with applicable modifications including labelling, within 30 days of receiving the Expert Committee's recommendation.
What Are the Schedule D Limits for Microbiological Standards and Contaminants?
Schedule D sets the numeric safety limits your testing is judged against. The tables below reproduce the limits from the Gazette text. n is the number of sample units, c the number allowed above m, m the limit separating satisfactory from unsatisfactory, and M the upper limit in a three-class plan. Counts are in cfu per gram or ml.
Table 1A: Process Hygiene Criteria
| Product | Aerobic plate count | Yeast and mould count | Enterobacteriaceae count |
|---|---|---|---|
| Unprocessed, not for direct consumption | n 5, c 3, m 10^6, M 10^7 | n 5, c 3, m 10^4, M 10^5 | n 5, c 3, m 10^3, M 10^4 |
| For direct consumption | n 5, c 2, m 10^4, M 10^5 | n 5, c 2, m 10^2, M 10^3 | n 5, c 2, m 10^2, M 10^3 |
| Fermented products | Not applicable | Not applicable | Not applicable |
Table 1B: Food Safety Criteria
| Product | Salmonella | Listeria monocytogenes |
|---|---|---|
| Unprocessed, not for direct consumption | Not applicable | Not applicable |
| For direct consumption | n 5, c 0: absent in 25 g | n 5, c 0: absent in 25 g |
| Fermented products (contain only the labelled organism at the claimed level) | n 5, c 0: absent in 25 g | n 5, c 0: absent in 25 g |
Table 2: Maximum Permissible Contaminant Levels
| Contaminant | Maximum | Contaminant | Maximum |
|---|---|---|---|
| Lead | 2.5 mg/kg or mg/L | Cadmium | 1.5 mg/kg or mg/L |
| Copper | 30 mg/kg or mg/L | Mercury | 1.0 mg/kg or mg/L |
| Arsenic | 1.1 mg/kg or mg/L | Methyl mercury (as the element) | 0.25 mg/kg or mg/L |
| Tin | 250 mg/kg or mg/L | Melamine | 2.5 mg/kg |
| Total aflatoxins* | 20 µg/kg | Aflatoxin B1* | 10 µg/kg |
*Applies to products containing arecanut or betelnut, cereals and cereal products, dried figs, nuts for further processing or ready to eat, oilseeds or oil, pulses, and spices or spice mixes.
- Regulator sampling: samples are drawn aseptically at manufacturing units and retail points by a trained person, stored at -18°C (±2°C) or 2-5°C as applicable, so that analysis can begin within 24 hours of sampling.
- Three sets of n samples are drawn and tested in three accredited laboratories. For Food Safety Criteria, all three results must show compliance. There is no retesting or resampling for microbiological testing.
- For high-value, low-volume packs under 100 g and large retail packs over 1 kg, the sampling plan may be modified with FSSAI's prior approval.
Logo and Label Compliance: What Schedule E and Regulation 13 Require
Regulation 13(a) makes the Ayurveda Aahara logo, as drawn in Schedule E, a mandatory element on the front of every pack. LexComply's checklist tracks it as part of ID 918583 (Display Compliance, High criticality, ongoing). A missing or wrongly drawn logo is a labelling default, so the exposure is misbranding under section 52 (up to ₹3 lakh, plus corrective action or destruction of stock).
Label Checklist: Regulation 13(a) to (f)
| Reg. | Requirement | What to do | Common default |
|---|---|---|---|
| 13 | Intended purpose, target consumer group and recommended duration of use | State all three in plain words on the label | Purpose or duration left out, or a consumer group wider than the approved or text-based use |
| 13(a) | Words AYURVEDA AAHARA in immediate proximity to the product or brand name | Print next to the name on the front of pack | Words placed on the back or in small print away from the name |
| 13(a) | Schedule E logo on the front of the pack | Use the logo exactly as drawn: colours, proportions and size per the tables below | Re-drawn, stretched or recoloured logo; logo only on the back; logo too small to read |
| 13(b) | Advisory ONLY FOR DIETARY USE | Write prominently | Tiny or low-contrast text |
| 13(c) | Not a substitute for a varied diet | Carry the statement | Omitted on small packs |
| 13(d) | Warnings, precautions, side effects, contraindications and published product or drug interactions, as applicable | Review each ingredient for known interactions and list them | Generic or blank warning section |
| 13(e) | Store out of reach of children | Carry the statement | Left out |
| 13(f) | For oral consumption only, not for parenteral use | Carry the warning | Left out |
The Schedule E Logo: Specification at a Glance
- Two layouts are allowed: a vertical logo with the text below the symbol, and a horizontal logo with the text to the right of the symbol. The text reads आयुर्वेद आहार and Ayurveda Aahara.
- Either layout may be used with proportionate scaling only. Do not stretch, squeeze or alter the symbol or text.
- Either layout may be printed in the specified colours, in one colour or in two colours.
- The 10 mm vertical version is a single-colour logo without text, at 50% of the master logo.
- Print the logo on the front of the pack, as Regulation 13(a) says.
Logo colours
| Colour | Hex | CMYK | Use |
|---|---|---|---|
| Dark green | #046A3D | C 90, M 15, Y 90, K 40 | Symbol and text, one-colour or two-colour version |
| Light green | #5D9933 | C 65, M 5, Y 100, K 18 | Leaf and accent, two-colour version |
Vertical logo: approved sizes
| Scale | Logo width | Logo box height | Text box height | Total height | Note |
|---|---|---|---|---|---|
| 150% | 30 mm | 30 mm | 11.2 mm | 41.2 mm | Two-colour |
| 100% (master) | 20 mm | 20 mm | 7.5 mm | 27.5 mm | Master vertical logo |
| 75% | 15 mm | 15 mm | 5.6 mm | 20.6 mm | Two-colour |
| 60% | 12 mm | 12 mm | 4.5 mm | 16.5 mm | Single-colour |
| 50% | 10 mm | 10 mm | Not applicable | 10 mm | Single-colour, without text |
Horizontal logo: approved sizes
| Scale | Logo width | Logo height | Note |
|---|---|---|---|
| 100% (master) | 50 mm | 20 mm | Master horizontal logo |
| 50% | 25 mm | 10 mm | Marked in Schedule E as a good size where little pack area is available |
| 30% | 15 mm | 6 mm | Smallest horizontal version shown |
Dimensions are read from the Schedule E drawing in the Gazette. Ask FSSAI for the official artwork file and give it to your packaging vendor; do not redraw the logo from this table.
Logo and label caution points
- Use the official Schedule E artwork file. A re-created or traced logo can drift on proportions or colour and still be a default.
- Choose a size from the tables, then scale proportionately. Shrinking only the symbol or only the text is not allowed.
- Put the logo and the words AYURVEDA AAHARA on the front of the pack. Back-panel placement does not satisfy Regulation 13(a).
- Check every SKU and pack size, including sachets, minis and e-commerce listing images, since small packs are where logos get dropped or shrunk below the smallest approved size.
- Do not use the logo on a product that is not Ayurveda Aahara, such as a medicine-based or fortified product, or one outside the definition.
- Re-check the logo on every label change. Add the logo and Regulation 13 elements to the artwork approval gate.
What Does a Step-by-Step Ayurveda Aahara Action Plan Look Like?
Work through the seven steps below in order. The timings assume a business with a handful of products; larger portfolios should run steps 2 to 4 in parallel by product line.
| Step | When | Action | Tasks | Owner | Deliverable |
|---|---|---|---|---|---|
| 1 | Week 1 | Scope and classify | List every SKU and recipe. Check each against the definition and exclusions, then assign Category A, B, B1 or B2. Record the Schedule A source text for each recipe. | Regulatory and R&D | Product classification register |
| 2 | Weeks 1-2 | Gap-assess formulation | Test recipes against Regulations 3 and 4 and Schedules A to C. Remove added vitamins, minerals and amino acids and any non-Schedule C additive. Confirm no infant-targeted product. | R&D and QA | Formulation gap report |
| 3 | Weeks 2-3 | Audit plant and testing | Audit each site against Schedule 4 of the 2011 Regulations. Set a Schedule D testing plan, with accredited labs and reference methods. Confirm packaging conforms to the 2018 Regulations. | QA and Operations | Audit report and testing plan |
| 4 | Weeks 2-4 | Re-check labels and advertising | Apply Regulation 13 elements: Schedule E logo on front of pack, AYURVEDA AAHARA wording, warnings and statements. Strip disease names and cure language from labels, websites, social posts and sales decks. Build a claims file for every remaining claim. | Marketing, Regulatory and Legal | Approved label set and claims file |
| 5 | Weeks 3-6 | File approvals and intimations | Apply for product approval (B, B1, B2) and claim approval where Schedule B requires it. Disclose purity criteria to the licensing authority. Notify existing products under Regulation 14 before relabelling. | Regulatory | Filing tracker with acknowledgements |
| 6 | Weeks 6-8 | Train and lock SOPs | Train sales, marketing, e-commerce and customer-care teams on permitted claims. Add compliance clauses to contract-manufacturer and distributor agreements. Add a release gate before dispatch and before online listing. | Compliance and HR | SOPs, training records, signed agreements |
| 7 | Ongoing | Monitor and evidence | Calendar every event trigger and testing cycle. Run change control on labels and recipes. Track FSSAI orders and amendments; report to the board quarterly. | Compliance | Audit file and board report |
Compliance Calendar
The checklist classifies 18 entries as ongoing, 4 as event-based and 2 as one-time. Use the calendar below to turn those types into dates and owners.
| Trigger or frequency | Obligation | Checklist type | Owner |
|---|---|---|---|
| Before the licence application | Disclose purity criteria adopted for ingredients (Reg. 3(5)) | Event-based; online | Regulatory |
| On any change to purity criteria | Inform the authority of the change (Reg. 3(5)) | Event-based; online | Regulatory |
| Before any health benefit or disease risk reduction claim | Obtain prior approval where Schedule B requires it (Regs. 9(2), 10) | One-time and event-based; online | Regulatory and Marketing |
| Before repositioning an existing licensed product | Inform the licensing authority in writing and await permission (Reg. 14) | Event-based; online | Regulatory |
| Every batch and through shelf life | Meet Schedule D limits; correct process hygiene when criteria are exceeded (Reg. 5) | Ongoing | QA |
| Every label, ad or web page change | Re-check Regulations 8, 9, 12 and 13, including the Schedule E logo | Ongoing | Regulatory and Marketing |
| Continuously | Additives, fortification ban, infant ban, packaging, manufacturing hygiene (Regs. 3, 4, 6) | Ongoing | R&D, QA and Operations |
These triggers and frequencies are the entries LexComply tracks in its Global Compliance Management System.
Caution Points: The Common Mistakes That Cost the Most
Claims and positioning
- Do not drift into medicine. Bhasma, pishti, metal-based preparations and Schedule E-1 herbs sit outside the definition; a product containing them is not Ayurveda Aahara.
- Regulation 8 also bars referring to disease-treating properties. Naming a disease or condition on pack or in an ad is a red flag, even without the word cure.
- Category B2 products are intended to support a specific disease condition, yet Regulation 8 still bars claims of preventing, treating or curing. Use any approved claim exactly as approved and do not stretch it.
- Category A removes the need for approval of health benefit claims that match the texts. Disease risk reduction claims still need prior approval in every category.
- A health claim without the approval Schedule B requires can be penalised even when the recipe itself is perfectly legitimate.
Formulation and sourcing
- Only Schedule A books count. Recipes in an Appendix or Annexure to those books are not considered, and texts must be the listed editions or published before 1940.
- No fortification of any kind: vitamins, minerals and amino acids cannot be added, however modest the dose.
- No infant products up to 24 months. The prohibition covers manufacture and sale, and applies to every person, not only licence holders.
- Only the 32 Schedule C additives are permitted. Check any additive borrowed from a general food range against the list; if it is not there, it is not permitted.
Testing and enforcement
- Food Safety Criteria for Salmonella and Listeria monocytogenes (absent in 25 g) apply through the whole shelf life, not only at dispatch.
- Regulator sampling uses three accredited laboratories and all three must show compliance. There is no retesting or resampling for microbiological testing.
- In-house test methods are valid for internal checks only. A clean in-house report will not help in a regulatory proceeding.
- Process Hygiene Criteria are not release criteria, but exceeding them forces corrective action. Keep the corrective-action record.
- Directors and officers can be personally liable under section 66 of the FSS Act where the offence occurred with their consent, connivance or neglect.
- Giving false information or documents to the authority is separately penalised under section 61, now up to ₹10 lakh. Check every filing before it goes in.
Process traps
- Do not relabel an existing product as Ayurveda Aahara before the licensing authority permits it under Regulation 14. The permission can include labelling changes.
- Operating without the right licence is penalised under section 63, now up to ₹10 lakh. Confirm before launch that your licence category covers Ayurveda Aahara.
- Marketplace and distributor listings can expose you. Regulation 7 reaches anyone who sells or markets a non-compliant product, so audit marketplace copy and claims.
What Are the Penalties for Non-Compliance?
The Ayurveda Aahara Regulations carry no penalty clause of their own. Breaches are punished under Chapter IX of the Food Safety and Standards Act, 2006. Most contraventions are civil penalties decided by an Adjudicating Officer. Unsafe food and a few other acts remain criminal offences.
Penalty Table: FSS Act Provisions Most Relevant to Ayurveda Aahara
| Section | Contravention | Consequence | Type |
|---|---|---|---|
| 50 | Selling food that is not of the nature, substance or quality demanded, or does not comply with the Act or Regulations | Penalty up to ₹5 lakh (₹25,000 for persons covered by section 31(2)) | Civil |
| 51 | Sub-standard food | Penalty up to ₹5 lakh | Civil |
| 52 | Misbranded food | Penalty up to ₹3 lakh; the Adjudicating Officer may direct corrective action or destruction of the food | Civil |
| 53 | Misleading or false advertisement | Penalty up to ₹10 lakh | Civil |
| 54 | Food containing extraneous matter | Penalty up to ₹1 lakh | Civil |
| 55 | Failure to comply with a Food Safety Officer's directions | Penalty up to ₹2 lakh | Civil |
| 56 | Manufacturing or processing under unhygienic or unsanitary conditions | Penalty up to ₹1 lakh | Civil |
| 57 | Importing, manufacturing, storing, selling or distributing an adulterant | Penalty up to ₹2 lakh; up to ₹10 lakh if injurious to health | Civil |
| 58 | Any contravention with no separate penalty | Penalty up to ₹2 lakh | Civil |
| 59(i) | Unsafe food, no injury | Imprisonment up to 3 months and fine up to ₹3 lakh | Criminal |
| 59(ii) | Unsafe food, non-grievous injury | Imprisonment up to 1 year and fine up to ₹3 lakh | Criminal |
| 59(iii) | Unsafe food, grievous injury | Imprisonment up to 6 years and fine up to ₹5 lakh | Criminal |
| 59(iv) | Unsafe food, death | Imprisonment of at least 7 years, up to life, and fine of at least ₹10 lakh | Criminal |
| 60 | Interfering with seized items | Imprisonment, reduced from 6 months to 3 months by the 2026 Act | Criminal |
| 61 | Giving false or misleading information or documents to the authority | Penalty up to ₹10 lakh | Civil |
| 62 | Impersonating, threatening, intimidating or assaulting a Food Safety Officer | Remains an offence; the words 'resists, obstructs or attempts to obstruct' were removed by the 2026 Act | Criminal |
| 63 | Carrying on a food business without a licence | Penalty up to ₹10 lakh | Civil |
| 64 | Repeat conviction | Enhanced punishment, additional fine for continuing contravention and licence cancellation (check the Act text for quantum) | Criminal |
| 65 | Compensation to victims of unsafe food | Minimum compensation for death, and set amounts for grievous and other injury (check the Act text) | Civil |
| 66 | Offences by companies | Person in charge and, with consent, connivance or neglect, directors and officers are liable; due-diligence defence | Both |
Sections 50 to 61 are taken from LexComply's checklist and the amending Acts. Sections 55, 62 to 66 summarise the Act as amended; confirm quantum against the consolidated Act before relying on it in a proceeding.
What the 2023 and 2026 Amendments Changed
Both amending Acts are Jan Vishwas (Amendment of Provisions) Acts, which decriminalise minor offences across many laws. The checklist's penalty text already reflects the 2023 changes. The 2026 changes came into force more recently.
| FSS Act section | Before | After | Amending Act |
|---|---|---|---|
| 59(i) | Imprisonment up to 6 months and fine up to ₹1 lakh | Imprisonment up to 3 months and fine up to ₹3 lakh | 2023 |
| 61 | Punishable with imprisonment up to 3 months and fine up to ₹2 lakh | Penalty up to ₹10 lakh | 2023 |
| 63 | Imprisonment up to 6 months and fine up to ₹5 lakh | Penalty up to ₹10 lakh | 2023 |
| 60 | Imprisonment up to 6 months | Imprisonment up to 3 months | 2026 |
| 39 (proviso) | Offence punishable with fine | Liable to penalty | 2026 |
| 62 | Covered resisting, obstructing or attempting to obstruct | Those words removed; impersonation, threats, intimidation and assault remain | 2026 |
| 38(5), 41(2), 68, 71, 73-75, 78, 79, 87 | References to the Code of Criminal Procedure, 1973 and Indian Penal Code | References to the Bharatiya Nagarik Suraksha Sanhita, 2023 and Bharatiya Nyaya Sanhita, 2023 | 2026 |
- The 2023 Act is the Jan Vishwas (Amendment of Provisions) Act, 2023 (Act 18 of 2023, assent 11 August 2023); the FSS Act changes were brought into effect by a November 2023 notification.
- The 2026 Act is the Jan Vishwas (Amendment of Provisions) Act, 2026 (Act 8 of 2026, assent 7 April 2026). The Health Ministry's notification applying its FSS Act provisions is reported to fix 1 October 2026 as the commencement date; confirm against the Gazette notification before citing a date externally.
- The 2026 extract we hold shows section 62 trimmed, not repealed. Some commentary describes it as omitted, so check the consolidated Act.
How Penalties Are Decided
- Civil penalties are decided by an Adjudicating Officer, an officer not below Additional District Magistrate rank notified by the State, who has civil-court powers (section 68). Appeals lie to the Food Safety Appellate Tribunal (section 70).
- Criminal provisions, such as unsafe food under section 59, are prosecuted in court, so the stakes rise sharply once a sample is declared unsafe.
- A single breach may attract more than one section. A mislabelled, disease-claiming product can face misbranding (section 52) and misleading advertisement (section 53) exposure together.
- Corrective directions matter as much as money: for misbranding, the Adjudicating Officer can order the product corrected or destroyed.
Frequently Asked Questions
What is Ayurveda Aahara?
Ayurveda Aahara is a food prepared according to recipes, ingredients or processes described in the 71 authoritative Ayurvedic books listed in Schedule A of the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, including products with other botanical ingredients used in line with the concept. It is regulated as a food, not as a medicine.
Is Ayurveda Aahara the same as Ayurvedic medicine?
No. The definition excludes Ayurvedic drugs and proprietary medicines, cosmetics, herbs listed in Schedule E-1 of the Drugs and Cosmetics Act, metal-based preparations, bhasma and pishti. A product built on those ingredients falls outside these Regulations.
When did the Ayurveda Aahara Regulations come into force?
They were notified on 5 May 2022 and came into force on the date of their publication in the Gazette of India, 6 May 2022. They apply across India.
Who must comply with the Ayurveda Aahara Regulations?
Any food business that manufactures, packs, sells, offers for sale, markets, distributes or imports Ayurveda Aahara. Farmers and fishermen at farm level are exempt under section 18(3) of the FSS Act, and everyday packed staples such as rice, pulses and flour are not covered unless they meet the Regulations.
What are the Ayurveda Aahara categories A, B, B1 and B2?
Category A is prepared as in the authoritative texts. Category B is a new recipe using listed ingredients and other botanicals. Category B1 is a text-based recipe in a different format. Category B2 is Ayurveda Aahara for a specific medical purpose. Categories B, B1 and B2 need prior approval of health claims, and Category B also needs safety data. Disease risk reduction claims need prior approval in every category.
Do I need FSSAI approval before launching an Ayurveda Aahara product?
Not for every product. Category A products need no product approval and no prior approval for health benefit claims that match the texts. Categories B, B1 and B2 need prior approval under Schedule B, following the 2017 Non-Specific Food Regulations. Existing licensed products must be intimated to the licensing authority before being assigned as Ayurveda Aahara (Regulation 14).
Can I claim that Ayurveda Aahara prevents or cures a disease?
No. Regulation 8 bars any claim in labelling, presentation or advertisement that the product prevents, treats or cures a human disease, or any reference to such properties. Other claims must follow the 2018 Advertising and Claims Regulations and, where required, FSSAI approval.
Can vitamins, minerals or amino acids be added to Ayurveda Aahara?
No. Regulation 3(4) prohibits adding them. Natural vitamins and minerals that are already present may be declared on the label.
Can Ayurveda Aahara be made for infants?
No. Regulation 3(2) bars any person from manufacturing or selling Ayurveda Aahara intended for infants up to 24 months.
What must an Ayurveda Aahara label contain?
Besides the general requirements of the 2020 Labelling and Display Regulations, the label must state the intended purpose, target consumer group and recommended duration of use. It must show the words AYURVEDA AAHARA next to the product or brand name, the Schedule E logo on the front of pack, ONLY FOR DIETARY USE, a not-a-substitute-for-a-varied-diet statement, precautions and contraindications as applicable, a keep-out-of-reach-of-children statement, and an oral-use-only warning.
What are the logo requirements for Ayurveda Aahara?
Regulation 13(a) requires the Schedule E logo on the front of the pack, with the words AYURVEDA AAHARA next to the product or brand name. Schedule E gives vertical and horizontal layouts, two specified greens (#046A3D and #5D9933) and approved proportionate sizes. The logo may be printed in one or two colours but must not be stretched or altered.
Which additives are allowed in Ayurveda Aahara?
Only the 32 additives in Schedule C, such as guar gum, pectin, jaggery, honey, curcumin, citric acid and certain spice oils, within the stated levels. Most are limited to GMP, meaning the lowest level needed for the effect.
What microbiological limits apply to Ayurveda Aahara?
Schedule D sets Process Hygiene Criteria for aerobic plate count, yeast and mould, and Enterobacteriaceae, and Food Safety Criteria of absence in 25 g for Salmonella and Listeria monocytogenes in products for direct consumption and fermented products. It also caps contaminants such as lead at 2.5 mg/kg and total aflatoxins at 20 µg/kg.
What are the penalties for violating the Ayurveda Aahara Regulations?
Penalties come from the FSS Act, 2006. Typical civil penalties run from ₹1 lakh for unhygienic processing to ₹5 lakh for sub-standard food, ₹3 lakh for misbranding and ₹10 lakh for misleading advertisement, false information or operating without a licence. Unsafe food is a criminal offence with imprisonment of up to three months with no injury, and up to life where death results.
Is imprisonment possible for Ayurveda Aahara violations?
Yes, but mainly where the food is unsafe under section 59 of the FSS Act, or where there is interference with seized items or with a Food Safety Officer. Misbranding, misleading advertisement, false information and unlicensed operation are now civil penalties.
What changed in the FSS Act penalties in 2023 and 2026?
The 2023 Jan Vishwas Act cut the no-injury unsafe-food imprisonment in section 59(i) from six months to three months while raising the fine to ₹3 lakh, and turned sections 61 and 63 into penalties of up to ₹10 lakh. The 2026 Jan Vishwas Act reduced section 60 imprisonment from six months to three, converted a fine under the section 39 proviso into a penalty, trimmed section 62 and updated references to the new criminal codes.
Can directors be held personally liable?
Yes. Section 66 of the FSS Act makes the person in charge of the business liable and extends liability to directors and officers where the offence occurred with their consent, connivance or neglect. A due-diligence defence is available.
How do I convert an existing licensed food product into Ayurveda Aahara?
Inform the licensing authority in writing under Regulation 14. The authority permits the change, with applicable modifications including labelling, within 30 days of receiving the Expert Committee's recommendation. Do not relabel before permission.
Where do I apply for FSSAI product and claim approval?
Prior-approval applications under the 2017 Non-Specific Food Regulations are made online. An FSSAI order of 6 May 2026 directs that, from 1 June 2026, such applications go only through the ePAAS portal. Check FSSAI's website for the current portal and fees before filing.
How can LexComply help with Ayurveda Aahara compliance?
LexComply provides a ready 24-entry Ayurveda Aahara checklist in GCMS with owners, due triggers and evidence tracking, and advisory support for product classification, label and claim review, approval filings and regulator queries.
Timeline: Regulations, Amendments and FSSAI Developments
Items marked 'reported' come from secondary sources or summaries and should be confirmed on FSSAI's website or in the Gazette before you rely on them in a filing.
| Date | Development | Source and confidence |
|---|---|---|
| 6 May 2022 | Ayurveda Aahara Regulations, 2022 published in the Gazette and in force | Primary: Gazette notification |
| 11 Aug 2023 | Jan Vishwas (Amendment of Provisions) Act, 2023 receives assent; FSS Act changes to sections 59(i), 61 and 63 brought into effect by a November 2023 notification | Gazette; commencement date to confirm |
| 25 Jul 2025 | FSSAI order lists Category A Ayurveda Aahara products; businesses may request additions with Schedule A literature | Reported (PIB); the number of recipes is reported inconsistently |
| 1 Sep 2025 | FSSAI introduces a dedicated Kind of Business for Ayurveda Aahara on FoSCoS | Reported (PIB); confirm licence category and fee on FoSCoS |
| 7 Apr 2026 | Jan Vishwas (Amendment of Provisions) Act, 2026 (Act 8 of 2026) receives assent | Gazette |
| 1 Jun 2026 | Under an FSSAI order dated 6 May 2026, prior-approval applications, including Ayurveda Aahara, go only through the ePAAS portal | Primary: FSSAI order |
| 1 Oct 2026 | FSS Act provisions of the 2026 Act commence | Reported (Health Ministry notification S.O. 3274(E)); confirm in the Gazette |
How LexComply Helps: Technology and Advisory
Ayurveda Aahara compliance cuts across R&D, quality, regulatory, marketing and legal teams. A checklist that lives in one person's spreadsheet fails the first time that person is away. LexComply combines a compliance platform with advisory support.
GCMS: the compliance management layer
- Ready checklist: all 24 Ayurveda Aahara entries, mapped to Regulation, criticality, periodicity and indicative penalty, available to assign to named owners.
- Event triggers: reminders before licensing (purity criteria), on any purity-criteria change, before a health claim goes live, and before a Regulation 14 repositioning.
- Evidence vault: classification register, test reports, label artwork, claim substantiation files and approval acknowledgements stored by product and version.
- Label and claim change control: an approval gate so a new pack or campaign cannot go live without Regulation 8, 9, 12 and 13 sign-off.
- Testing calendar: Schedule D sampling plans and shelf-life studies tracked per batch and product.
- Amendment alerts: updates when FSSAI issues new orders or the Jan Vishwas changes affect the penalty text attached to each obligation.
FSSAI and food-regulation advisory
- Product classification: assigning Category A, B, B1 or B2 and tracing each recipe to its Schedule A source.
- Label and advertising review: Regulation 13 mandatory content, logo placement and a line-by-line scrub for disease references.
- Approval filings: preparing and filing Schedule B approvals and responding to FSSAI queries.
- Gap assessment and mock inspection: audits against the checklist before a Food Safety Officer visits.
- Enforcement support: representing the business in notices, adjudication and appeals, and advising directors on section 66 exposure.
More on the advisory side: LexComply advisory services. To map your own SKUs against the 24-entry checklist, get in touch with the team.
Sources
- Food Safety and Standards Authority of India, Notification F. No. Stds/SP-05/A-1.Y(01), 5 May 2022 - Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, Gazette of India, Extraordinary, Part III, Section 4, No. 240, 6 May 2022.
- Food Safety and Standards Act, 2006 (34 of 2006), Chapter IX (Offences and Penalties), as amended.
- Jan Vishwas (Amendment of Provisions) Act, 2023 (Act 18 of 2023), Schedule item 35 (Food Safety and Standards Act, 2006).
- Jan Vishwas (Amendment of Provisions) Act, 2026 (Act 8 of 2026), Gazette of India, 8 April 2026
- Ministry notification fixing 1 October 2026 for the Food Safety and Standards Act provisions of the 2026 Act (as reported; Health Ministry notification S.O. 3274(E), to be confirmed in the Gazette).
- FSSAI order dated 6 May 2026 on submission of prior-approval applications through ePAAS
- PIB: FSSAI order on Ayurveda Aahara Category A products (July 2025)
- PIB: FSSAI introduces a Kind of Business for Ayurveda Aahara (September 2025)
- LexComply compliance checklist: Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 and amendment thereto (24 entries).
Legal Disclaimer
This article is general information on the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022 and the penalty provisions of the Food Safety and Standards Act, 2006, and does not constitute legal advice. Statutory provisions, rules, orders and notifications are amended from time to time, and readers should verify the current position with the primary source or a qualified professional before acting.