Compliant Always
Get in touch

Selling food supplements in Saudi Arabia

In Saudi Arabia, a supplement may be regulated by the Saudi Food and Drug Authority (SFDA) as a food, as a health product under its drug sector, or as a drug, depending on its composition, form and claims. Food supplements go through SFDA's pre-registration evaluation; health products are registered through the Saudi Drug Registration system.

Updated · Each section links to the official source it comes from

Regulator
Saudi Food and Drug Authority (SFDA)
Routes
Food supplement, health product or drug
Vitamins above the upper limit
Registered as a pharmaceutical
Food route
Pre-registration evaluation, then product registration
Health product route
Saudi Drug Registration (SDR)
Pack size
No more than 180 tablets or capsules, or 250 ml

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a food supplement, a health product or a drug? Read more
  2. 2Do the vitamin and mineral levels sit within SFDA's limits? Read more
  3. 3Which documents does the food route's pre-registration evaluation need? Read more
  4. 4Which dossier does the health product route need? Read more
  5. 5Do the label and claims meet SFDA's rules? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Classification

Which SFDA route a product takes, decided by composition, form and claims.

  • SFDA defines a food supplement as a product used to supplement the normal diet, containing ingredients with a nutritional or physiological effect, such as vitamins, minerals, fatty acids, amino acids, enzymes, probiotics, collagen, fibre, melatonin, propolis or herbal extracts.
  • A health product is a finished, labelled product in a pharmaceutical dosage form, usually of low-risk ingredients, intended to restore, correct or modify physiological functions.
  • Supplements containing vitamins or minerals above the upper limit of the total daily allowance are classified as drugs.
  • Claims count: SFDA's guidance gives the example of a probiotic powder presented as a food supplement but regulated as a health product because of claims to prevent tooth decay.
  • SFDA's Product Classification System is the e-service for asking how a product is classified.

How we help: Compliant Always reads the formula, the dose and the claims on the label against SFDA's classification guidance, so the route the product points to is visible before a dossier is built. Ask about this

Vitamins and minerals

SFDA's general rules for products containing vitamins and minerals.

  • A product with one or more vitamins or minerals above the upper limit in SFDA's table is registered as a pharmaceutical product.
  • A product whose vitamins or minerals do not exceed the upper limit is registered as a health product; the rules also apply to gummies intended to supply vitamins or minerals.
  • The limits are calculated on the daily dose stated on the label.
  • A pack may hold no more than 180 tablets or capsules, or 250 ml of liquid.
  • "Multivitamins" may be printed where the product contains three vitamins, and "Multiminerals" where it contains three minerals.

How we help: Compliant Always reads the daily dose on the label against SFDA's upper and lower limits, nutrient by nutrient, with the table beside each. Ask about this

Food route: pre-registration evaluation

What SFDA asks for before a food supplement is registered as food.

  • Food supplements are among the products SFDA evaluates before registration, with energy drinks, sports foods, infant food and food for special medical purposes.
  • Documents include a scan of the label, a product image, a technical data sheet, a free-sale certificate, a valid GMP certificate and a stability study for the proposed shelf-life, which may not exceed five years.
  • Products in tablet, capsule or other drug-like forms also need a package leaflet, a pharmaceutical GMP certificate and a safety report covering heavy metals, pesticide residues and pathogenic micro-organisms.
  • At clearance, foods for special uses, including dietary supplements, need a marketing certificate from the country of origin.

How we help: Compliant Always keeps the free-sale, GMP and stability documents with the product, dated, and shows which have expired before the dossier goes in. Ask about this

Health product route

Registration with SFDA's drug sector for products classed as health products.

  • Herbal and health products are registered through SFDA's Saudi Drug Registration (SDR) system.
  • The dossier includes an alcohol-free declaration and a pork-free declaration, each on the Marketing Authorisation Holder's letterhead.
  • The dossier names the Marketing Authorisation Holder and includes the commercial agency contract with the agent.
  • SFDA's recall guidance for drugs, herbal and health products covers manufacturers, marketing authorisation holders, importers, agents, distributors and retailers.

How we help: Compliant Always keeps the declarations and agency documents behind the dossier with the product, and shows what is missing or expiring. Ask about this

Labels and claims

What the pack shows and which claims are allowed.

  • On the food route, the label follows SFDA.FD/GSO 9 in Arabic, with nutrition labelling under SFDA.FD 2233 and claims under SFDA.FD 2333.
  • On the health product route, SFDA's labelling guidance sets the outer pack particulars and calls for an Arabic translation where the patient leaflet is not provided.
  • Claims not covered by the regulations can be submitted to SFDA for evaluation; SFDA publishes examples of claims it has rejected, such as stated amounts of weight loss.

How we help: Upload the label and Compliant Always reads the particulars and claims against the SFDA rules for the route the product is on. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Importer or registrantThe registration and the documents behind it, on whichever route SFDA assigns.Each certificate and declaration kept with the product, with its expiry date shown.
Marketing Authorisation HolderOn the health product route, the dossier and its declarations.Alcohol-free and pork-free declarations on file and matched to the formula.
ManufacturerGMP, stability data and the safety analyses SFDA asks for.Lab reports read against the requirements, ready to answer an importer's questionnaire.

Questions businesses ask

Are food supplements regulated as food or drugs in Saudi Arabia?
It depends on the product. SFDA classifies by composition, form and claims: a supplement may be a food, a health product registered by the drug sector, or a drug. Vitamins or minerals above the upper limit make it a drug.
What is a health product in Saudi Arabia?
SFDA defines it as a finished, labelled product in a pharmaceutical dosage form, usually of low-risk ingredients, intended to restore, correct or modify physiological functions.
Do vitamin products need registration in Saudi Arabia?
Yes. Under SFDA's general rules, a product above the upper limit is registered as a pharmaceutical; one within it is registered as a health product. Gummies intended to supply vitamins or minerals are health products.
Is there a maximum pack size for supplements in Saudi Arabia?
SFDA's rules for vitamin and mineral products limit a pack to 180 tablets or capsules, or 250 ml of liquid.
What documents does SFDA want for a food supplement?
For pre-registration evaluation: the label, a product image, a technical data sheet, a free-sale certificate, a GMP certificate and a stability study. Capsules and tablets also need a leaflet, pharmaceutical GMP and safety analyses.
How long can a supplement's shelf-life be in Saudi Arabia?
SFDA's pre-registration guide sets five years as the maximum shelf-life for the final package, supported by a stability study.
Does a supplement need to be alcohol-free and pork-free in Saudi Arabia?
On the health product route, SFDA's dossier requirements include an alcohol-free declaration and a pork-free declaration from the Marketing Authorisation Holder.
Can a claim make my supplement a drug in Saudi Arabia?
Yes. SFDA's borderline guidance gives the example of a probiotic regulated as a health product because it claimed to prevent tooth decay.
When can a supplement say "multivitamin" in Saudi Arabia?
When it contains three vitamins. "Multiminerals" needs three minerals, and both words together need three of each.
How do I find out how SFDA will classify my product?
SFDA runs a Product Classification System e-service, and publishes guidance on borderline products with worked examples.
How does Compliant Always help with selling in Saudi Arabia?
Our team reads the rules for the markets you sell in, including SFDA and SASO requirements. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Saudi Arabia and what your paperwork needs to show.

Get in touch

No card, no account, and no call to book. Tell us what you make and where you sell it, and we will come back to you.

Get in touch