Supplement, Ayurveda or Pharmaceutical: Which Route Your Product Takes
By the Silk Foods Ceylon Editorial Team
Buyer’s snapshot
- In Sri Lanka the claim on the label, not the capsule inside, decides the regulator. Under the Food (Labelling and Advertising) Regulations 2026, any health claim needs the Chief Food Authority’s prior written approval, and a cure claim is barred outright.
- Three routes exist: food (Food Act), Ayurveda (Department of Ayurveda) and medicine or borderline product (National Medicines Regulatory Authority, NMRA). A brand cannot hold one product on two of them.
- Silk Foods Ceylon (SFC) manufactures capsules from a 180-bottle first run, and its R&D team takes a signed brief to an approved formulation in 3 to 4 weeks at most. The route is settled before that clock starts.
- The table below sets out what each route requires, who files, and what a label may say.
A brand owner usually arrives with the product already named: ashwagandha, turmeric, a sleep blend, a joint blend. The recipe is the easy part. What the brief rarely settles is which of three rulebooks the product lives under, and that choice fixes the label wording, the paperwork, the claims the brand is allowed to make and the order in which things must happen.
The spec-level version of this question, for blended nutricosmetic capsules, is in the earlier post on the nutricosmetic capsule blend spec sheet. This post is the decision itself: how to tell the three routes apart before you commission a run.
Which three routes can a capsule or herbal product take in Sri Lanka?
A capsule, powder or herbal liquid sold in Sri Lanka sits on one of three routes: food under the Food Act No. 26 of 1980, a traditional product registered with the Department of Ayurveda, or a medicine or borderline product regulated by the NMRA. Each route has its own regulator, its own filing and its own limits on label language.
| Route | Regulator and law | What the label may say | What has to be filed |
|---|---|---|---|
| Food supplement | Chief Food Authority; Food Act No. 26 of 1980 and the 2026 labelling regulations | Ingredients, amounts, usage. A health or nutrient function claim only with prior written approval | Label compliant with the regulations; SLSI clearance where the product category calls for it |
| Ayurveda product | Department of Ayurveda; Ayurveda Act No. 31 of 1961, amended by Act No. 19 of 2023 | Traditional claims, in the wording the Department reviews | Form A for the manufacturing premises and Form B for each product, with a professional opinion from a registered Ayurveda practitioner |
| Medicine or borderline product | NMRA; National Medicines Regulatory Authority Act No. 5 of 2015 | Therapeutic claims, within the registered dossier | Classification report first, then a registration dossier; registered borderline packs carry a model label |
The honest limit of any table like this is the first row. The NMRA treats food and dietary supplements with combined food and medicine characteristics as borderline products, so the boundary between row one and row three is drawn by the regulator’s classification, not by the brand’s preference.
What actually decides the route?
The wording on the label and in the advertising decides the route far more than the ingredient list does. Regulation 13(12) of the Food (Labelling and Advertising) Regulations 2026 (Gazette Extraordinary No. 2494/47, 26 June 2026) bars any food label from claiming a restorative or medicinal property that alleviates or prevents illness without prior written approval from the Chief Food Authority, and bars any claim that a food is a cure for an illness.
That makes the draft claim sentence the first test. Read the sentence you want on the pack, then read down this ladder.
| If the draft label says | Where it points |
|---|---|
| ”Contains 500 mg ashwagandha root extract per capsule” | Food supplement: a statement of content, not a claim |
| ”Supports normal energy metabolism” (a nutrient function claim) | Food supplement, but regulation 13(6)(a) requires prior written approval of the claim by the Chief Food Authority |
| ”Balances vata”, “rasayana”, or any claim taken from a classical Ayurvedic text | Ayurveda route, registered with the Department of Ayurveda |
| ”Lowers blood sugar”, “treats insomnia”, “relieves joint pain” | Medicine or borderline product; the NMRA weighs intended use and therapeutic claims |
| ”Cures” or “prevents” a named disease | Barred on a food label; at most a registered medicine |
Two points follow. First, softening the language does not move a product between routes if the formula, dose or marketing still implies the stronger claim; the NMRA’s own criteria include the intended use, the pharmacologically active substances and their concentrations, not only the sentence on the pack. Second, the sentence has to be settled before the artwork is drawn, because a wrong route found after printing costs the whole label run.
How does the food supplement route work?
The food route is the lightest filing and the narrowest claim space. The product is made in a food factory, the label follows the Food (Labelling and Advertising) Regulations 2026, and any packaged-food listing that needs an SLSI mark follows the process in the step-by-step SLSI submission guide. SLSI publishes no fixed processing time, so confirm the current window with SLSI before fixing a shelf date.
The constraint is the claim. A brand that wants to say anything beyond what the capsule contains, such as a function claim, needs the Chief Food Authority’s written approval first. The route suits a blend sold on content, dose and quality, where the brand is content to leave the health story to the consumer.
When does Department of Ayurveda registration apply?
Ayurveda registration applies when the brand wants traditional claim language, or sells a product formulated to a classical monograph. The Department of Ayurveda registers locally made Ayurveda drugs and products under the Ayurveda Act No. 31 of 1961 as amended in 2023; the premises are filed on Form A and each product on Form B, and a registered practitioner gives a professional opinion on the product (Department of Ayurveda, 2026).
The claim wording the Department reviews has to match the final formulation. A brand that changes the herb ratio after review risks resubmitting. The same logic is set out for a bottled format in the post on the kashaya herbal SKU and the Ayurveda registration track, and for capsules in the post on private-label Ayurvedic capsules, Ayurveda Department and SLSI in parallel.
What does the NMRA route involve?
The NMRA route applies to anything that behaves as a medicine. The NMRA defines medicines to include nutraceuticals with therapeutic claims, and a medicine registration certificate is valid for 5 years (NMRA, 2026). For products in between, the NMRA runs a borderline product process that starts with a preliminary classification.
The published borderline rules set the pace. A classification report is valid for one year, and the registration dossier has to be filed inside that year. Up to two further submissions are allowed, each within 3 months of the previous report. Registration validity then depends on the schedule: 1 year for Schedule I, 2 years for IIA and 5 years for IIB. Local manufacturers apply directly, and from 31 August 2025 registered borderline products must carry the NMRA model label on commercial packs (NMRA, 2026).
The classification application asks for the master formula and batch formula, a certificate of analysis, a specimen label and any promotional material. In other words, the formula and the claim wording go in together and are judged together.
What does a wrong route look like in practice?
Take a brief of the shape the SFC R&D team sees often. A brand owner has a turmeric and black pepper capsule, a tested kitchen blend, and a draft label that says “reduces joint inflammation”. The founder believes the product is a food supplement because it contains only kitchen ingredients.
The ingredients are not the issue. The label sentence is a therapeutic claim, which sends the product toward NMRA classification, with a formula and dossier the brand has not prepared. The fix costs one decision, taken early: either rewrite the pack to a content statement and run the food route, or accept the longer filing and keep the claim.
The cost of the late discovery is not the paperwork. It is the print run. Silk Foods Ceylon’s working plan for a first printed label is 8 to 13 working weeks from dieline to material in the plant, so artwork that carries the wrong claim is a reprint at that scale, not an edit.
What should you have ready before the first meeting?
Buyer’s checklist: before you brief a manufacturer
- The exact claim sentence you want on the pack, in English, Sinhala and Tamil where the label needs it.
- The formula with each ingredient and its amount per capsule, including the capsule shell type.
- The intended dose and the stated use: general wellbeing, a nutrient function, or a named condition.
- Whether any traditional text or monograph supplies the formula or the claim.
- The outcome of any classification enquiry already made with the NMRA, or a note that none has been made.
- Where the product will be sold: modern trade shelf, hotel gift shop, online marketplace, or export.
- The first-run volume you can commit to, in bottles.
With those seven items the R&D conversation shortens, because the route is the first thing the team can confirm rather than the last thing anyone discovers. The classification outcome, where one is needed, is a filing for the brand owner to take to the regulator; the recipe and claim wording locked at manufacture then need to match what was filed.
Where SFC walks away
Silk Foods Ceylon is a food manufacturer. A product that classifies as a medicine sits outside a food manufacturing licence, and that route needs a pharmaceutical manufacturer. A brief that opens with “cures” or “treats” and has no plan to take the NMRA route is a brief to rewrite or decline, not to quote.
Which route suits which product?
Match the product to the route by what the brand wants to say, then by how much time it can spend on filing.
| Brand goal | Route | Planning consequence |
|---|---|---|
| Sell a quality capsule on content and dose, fastest to shelf | Food supplement | Settle the label, then SLSI where applicable; no claim approval needed if no claim is made |
| Own the traditional positioning, for spa, gift shop or Ayurvedic retail | Ayurveda registration | File Form A and Form B alongside R&D, and freeze the claim wording to the formula |
| Make a stated therapeutic claim | NMRA classification and registration | Classification report within a year of the dossier; a pharmaceutical-grade manufacturer |
Where the brand wants to start light and move up later, the sequence matters: a food-route launch with a content-only label can later be re-filed under a stronger route with a new label and dossier, but a stronger-claim label cannot be walked back to a food route without reprinting. For the first-run economics of the capsule format itself, see the post on capsule contract manufacturing at a 180-bottle first run, and for the wider certificate picture, the post on certifications behind a Sri Lankan contract manufacturer.
Frequently asked questions
Can a capsule be sold as a food supplement and carry an Ayurvedic claim?
No. A traditional or Ayurvedic claim puts the product on the Department of Ayurveda route, with Form A for the premises and Form B for the product. A food-route label is limited to content, with any health or nutrient function claim needing the Chief Food Authority’s prior written approval under regulation 13(6)(a) of the 2026 regulations.
What does the NMRA classification report do?
It decides whether a product with both food and medicine characteristics is a borderline product. The NMRA weighs intended use, therapeutic claims, active substances and their concentrations. The report is valid for one year, and the registration dossier must be filed inside that year (NMRA, 2026).
Does Silk Foods Ceylon manufacture capsules for a food supplement or Ayurveda product?
Yes, for both the food route and the Ayurveda route. First runs start at 180 bottles of capsules, and the line fills up to 200,000 capsules a day. Silk Foods Ceylon does not manufacture products that classify as medicines, which need a pharmaceutical manufacturer.
How long does R&D take before a capsule recipe is approved?
The Silk Foods Ceylon R&D team takes a signed brief to an approved formulation in 3 to 4 weeks at most. That clock starts once the route and the claim wording are settled, which is why the claim sentence belongs in the brief rather than being added after the formulation is locked.
How Silk Foods Ceylon can help
For brand owners deciding between the food and Ayurveda routes for a capsule, Silk Foods Ceylon (SFC) runs contract manufacturing and private labelling for capsules at its Matale facility, from a 180-bottle first run, at up to 200,000 capsules a day. The in-house R&D team confirms the formulation in 3 to 4 weeks at most once the claim wording is fixed, and the plant is BRCGS- and FSSC 22000 V6-audited, with SLSI clearance and Sri Lanka Food Act compliance built into the engagement and Department of Ayurveda registration support for Ayurvedic-claim SKUs.
To brief a project, email b2b@esilkroute.com.lk or call +94 76 441 0389 / +94 76 918 5744.
Sources
Government of Sri Lanka, Food (Labelling and Advertising) Regulations 2026, Gazette Extraordinary No. 2494/47 of 26 June 2026, under section 32 of the Food Act No. 26 of 1980: regulation 13(6)(a) (prior written approval for health claims and nutrient function claims), regulation 13(12)(b) and (c) (medicinal-property and cure claims). Retrieved 6 October 2026. https://eohfs.health.gov.lk/food/images/2494-47_E.pdf
National Medicines Regulatory Authority, Sri Lanka, Borderline Products: definition, classification criteria, one-year classification report, registration validity by schedule, local manufacturer applications, model label from 31 August 2025. Retrieved 6 October 2026. https://nmra.gov.lk/pages/borderline-products
National Medicines Regulatory Authority, Sri Lanka, Medicines: scope of medicines including nutraceuticals with therapeutic claims; certificate of registration valid 5 years. Retrieved 6 October 2026. https://www.nmra.gov.lk/pages/medicines
Department of Ayurveda, Ministry of Health, Regulation of Local Ayurveda Drugs/Products Registration, under the Ayurveda Act No. 31 of 1961 as amended by Act No. 19 of 2023. Retrieved 6 October 2026. https://ayurveda.gov.lk/ayurveda-medicine-and-production-regulatory-council/
Silk Foods Ceylon, internal capability data for the Matale facility: capsule first run 180 bottles; up to 200,000 capsules a day; R&D 3 to 4 weeks maximum from signed brief to approved formulation; first printed label plan 8 to 13 working weeks from dieline to material in the plant.
Written by the Silk Foods Ceylon Team. Silk Foods Ceylon (Pvt) Ltd. is a BRCGS- and FSSC 22000 V6-audited contract manufacturer in Matale, Sri Lanka, offering contract manufacturing, private labelling, co-packing, and in-house R&D for local Sri Lankan brand owners, FMCG companies, hotel and restaurant groups, and distributors. To brief a project: b2b@esilkroute.com.lk, +94 76 441 0389, or +94 76 918 5744.
