Regulatory & Import

Prepared: 31 October 2026 · Scope: NBP Performance Line (INOV Pharma, Canada) · Currency: SAR unless stated

Bottom line. Every SKU is regulated by SFDA as a food (food supplement or complementary sport food), not as a drug. There is a clear, published registration route, a fixed fee of SAR 5,000 per product, and a stated service target of 10 working days after a complete application. Nothing in the catalogue is categorically banned. But no SKU is launch-ready today: the labels are English/French only, none carries an SFDA registration number, and the Health Canada NPNs — the main trust signal in the pitch — do not survive an audit (Section 10). The binding constraints are label remediation, claims rewrite, and the two botanical/stimulant SKUs. A five-SKU wave can realistically be registered in 8–12 weeks once corrected artwork and documents are in hand; the full 14-SKU range is a 4–6 month programme.

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1. Classification: what these products are in Saudi law

SFDA's pre-registration guide defines two relevant categories [S2]:

Two consequences follow directly:

1. TrimFit and Lipofel cannot be positioned as weight-loss products. S2 explicitly says complementary sport foods are not intended to be used for weight loss. Lipofel's "Daily Slimming Capsules / healthy weight loss" and TrimFit's "healthy weight loss" put them outside the sport-food category and into a food-supplement/weight-management review where the claims are scrutinised more closely.
2. Capsules and tablets are expressly in scope, but attract a heavier dossier: package leaflet, pharmaceutical GMP certificate, size/shape declaration, solubility study and a full safety analysis (heavy metals, pesticide residues, pathogenic micro-organisms) [S2]. This is why the capsule SKUs cost more in time than the powders, even though the registration fee is the same.

The 2021 registration guide confirms the scope includes "products of proteins, carbohydrates, and amino acids that are used as food supplements" and "powdered products used as food supplements for athletes" [S1]. The 2022 update extended the guide to all oral forms including capsules and tablets (secondary source: RegASK, updated 2 Nov 2024) [S43].

Not a medicine. None of the products is presented for a disease indication, and SFDA's food route is the correct one. A product that makes a therapeutic claim (e.g. "treats erectile dysfunction", "lowers blood pressure") risks reclassification as a drug. The L-Arginine page's "growth hormone release" and "nitric oxide vasodilator" language is the closest any SKU comes to that line.

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2. Who may hold the registration and import

• The applicant is a Saudi food establishment registered in SFDA's electronic food registration system (historically FRC/FRCS, now the Ghad platform) [S1][S4].
• A foreign manufacturer cannot register the product directly. It sells to a Saudi importer/distributor, who registers the establishment and the product, and who is the traceable party for recalls.
• The importer must:
• hold a Saudi Commercial Registration (CR) with the relevant activity;
• be registered on Ghad;
• register each food item/product on Ghad before import;
• submit each consignment through the Fasah trade platform;
• have a licensed warehouse meeting SFDA requirements (exemption: importers with ≤5 shipments per calendar year and ≤2,000 kg combined) [S4].
• The manufacturer must supply a certificate of free sale from the competent authority in Canada, a GMP/HACCP/ISO 22000 certificate, and a certificate of analysis from an ISO 17025-accredited laboratory covering the main ingredients and nutrients [S1].

Practical implication: the Canadian friend can own the brand and appoint an exclusive Saudi distributor, but the registration sits with the Saudi entity. Exclusivity, registration ownership and what happens on termination must be contractual, not assumed.

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3. Step-by-step pathway, cost and timeline

The table assumes a Saudi importer with a CR and warehouse already in place, and a manufacturer that can supply documents promptly. Timelines are working estimates; the SFDA service target is 10 working days for a complete application, not 10 days end-to-end [S1].

Budget for the launch portfolio. Five SKUs × (5,000 registration + 2,500 testing + 8,000 artwork) = SAR 77,500, plus consultant ~SAR 30,000 → ~SAR 107,500. The full 14-SKU range = ~SAR 217,000 plus consultant ~SAR 50,000 → ~SAR 267,000. This excludes company setup, warehouse, staff and working capital. The financial model uses SAR 15,500 per SKU for registration + testing + artwork, amortised over the first order.

Critical path. Not the SFDA fee or the 10-day review. It is (a) the manufacturer's willingness to correct labels and re-license products in Canada, and (b) the Arabic artwork cycle. Both are controlled outside Saudi Arabia.

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4. Documents the file must contain

Based on S1 and S2, the minimum per-SKU file is:

1. Registration application with label scan and final product image, matching exactly what will be imported.
2. Certificate of Free Sale issued by the competent authority in Canada, legalised/attested as required.
3. GMP certificate (or HACCP / ISO 22000) for the manufacturing site.
4. Certificate of Analysis from an ISO 17025-accredited laboratory: main ingredients, nutrients, and quantities/percentages.
5. Product stability study supporting the proposed shelf life. S2 says the maximum shelf life is five years; S1 says products with an expiry period exceeding 24 months require prior SFDA approval with safety/efficacy proof. These two documents conflict. Plan for ≤24 months until SFDA confirms otherwise in writing.
6. Technical data sheet (TDS) listing all ingredients and amounts in metric units.
7. Scientific studies where an ingredient has no established safety limit, or where a claim is not in the permitted list.
8. Official documents explaining any logo, seal or phrase on the label, and the intended consumer/use.
9. For capsules/tablets: package leaflet (instructions, dose by age, contraindications, side effects, cautions, storage), pharmaceutical GMP, size/shape declaration, solubility study, and safety analysis (heavy metals, pesticides, pathogens) [S2].
10. Halal certificate where animal-derived ingredients or a halal logo are present [S3][S4].

Labelling caution: the catalogue's NPN is not a substitute for any of the above. SFDA reviews the label and the evidence; it does not rely on a foreign licence.

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5. Labelling: the Arabic requirement is absolute

SFDA's 2025 clearance guide quotes GSO 9 clause 1.2.7 verbatim [S4]:

"The labels of food products and their accompanying information must be in Arabic, and if another language or languages are used alongside Arabic, all data in the other languages must match the Arabic version."

The only exception in the guide is for food products imported for manufacturing purposes, which may use English with a commitment submitted via Fasah [S4]. Finished consumer products do not qualify.

Minimum label content, drawn from GSO 9 and the SFDA guides:

Date format. GSO 150-1 governs mandatory expiry dates. Use an unambiguous format (DD/MM/YYYY) plus production date and batch; do not rely on a "best before" month only. The catalogue does not show either date, which is itself a gap.

Shelf life. Powders and capsules are ambient products. Saudi summer warehouse temperatures can exceed 40 °C; specify storage ≤25 °C, dry, away from sunlight, and validate stability at accelerated conditions. Do not ship in a non-air-conditioned container in July–September.

Halal. The clearance guide requires a halal certificate for products containing meat derivatives, rennet, gelatine, animal fats/oils or any product requiring one under the technical regulations [S4]. Capsule shells are the main risk: L-Arginine, BCAA, L-Carnitine, Extra Pump+ and Lipofel do not disclose shell origin. Lipofel says "vegetable capsule"; the others do not. If the shells are gelatin, a halal certificate and a halal-compliant shell are prerequisites. Flavours and enzymes can also carry animal-derived carriers.

Country of origin. Required on the label and in the clearance file (certificate of origin). "Made in Canada" is a positive signal in KSA but must be substantiated; the Canadian manufacturer address is in Saint-Laurent, Quebec.

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6. Shelf life, storage and date rules — practical reading

• Default plan: 18–24 months shelf life from production, with stability data. S1 allows >24 months only with prior approval; S2's five-year maximum should not be read as an automatic entitlement.
• Remaining shelf life at import: a common buyer requirement is ≥75–80% remaining at arrival. Build this into the purchase order; otherwise the first shipment can arrive with 12 months left and be unsaleable in a 6-month channel.
• Date coding: production date, expiry date, batch number on each unit and carton. The catalogue currently shows none.
• Storage: ambient 15–25 °C, RH <60%, off the floor, away from sunlight. No cold chain for any current SKU. Pro Milk is a dry sachet, also ambient.

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7. Claims: the biggest rewrite

SFDA.FD 2333 (GSO 2333:2022) permits 33 nutrition claims and 259 health claims, based largely on the EU 1924/2006 register and EFSA assessments [S5][S6]. Anything outside the list is not permitted. The claim must relate to the ingredient that establishes plausibility, and the product name/trademark may not be used inside the claim [S6].

Two thresholds matter immediately [S6]:

• "Source of protein": at least 12% of energy from protein.
• "High protein": at least 20% of energy from protein.

Applying them to the catalogue:

Claims in the catalogue that are not supported by the permitted list as written and should be deleted or reworded:

Enforcement risk. SFDA reviews the label at registration and can reject or require changes; post-market, misleading claims can trigger warnings, recalls or fines. The cost of a second artwork cycle (SAR 6,000–12,000 + 4 weeks) is small relative to a rejected shipment.

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8. Caffeine, stimulants and botanicals

Caffeine

• SFDA's 2025 caffeine-disclosure regulation states the maximum daily caffeine intake for adults is 400 mg [S7]. This is a general adult guidance value, not a supplement-specific per-serving cap.
• GSO 1926 (energy drinks) sets a caffeine limit of 32 mg/100 ml; it applies to energy drinks, not powders [S1].
• Pre-Workout: 50 mg per 5 g serving. Even at 2 servings/day, 100 mg is well below 400 mg. The issue is not caffeine safety; it is the mass balance (Section 9).
• Extra Pump+: the Health Canada licence records caffeine 33 mg per capsule [S9]. At the labelled 4–6 capsules/day, that is 132–198 mg/day, not 33 mg. The catalogue's presentation is ambiguous and understates the dose. A caffeine warning and a clear per-serving declaration are required.
• Lipofel: the licence records 10 mg caffeine per capsule in the green coffee extract [S9]; at 3 capsules/day, 30 mg. Minor.

Creatine and arginine. No published per-serving maximum for creatine or arginine was found in the SFDA materials reviewed. The binding constraints are the claims and the warning statements, not a numeric cap; the catalogue's 5 g/day creatine and 1.5 g/day arginine are well below the doses used in the literature. Confirm with SFDA if a higher dose is contemplated.

Botanicals and "other food products"

SFDA's pre-registration guide creates a residual category: "Other food products" — products containing ingredients for which safety limits have not been established in the approved technical regulations, pending scientific investigation [S2]. This is the route by which botanicals without a established limit are assessed. It is not a ban, but it adds time and requires a safety dossier.

Conclusion on restriction: I found no published SFDA list that bans these botanicals outright. The risk is not "banned"; it is "requires a safety assessment, and the claims/dose do not support the product". Mark Extra Pump+ and Lipofel as likely blocked as formulated, not because the plants are illegal, but because the combination, dose ambiguity and claims make a favourable review unlikely without reformulation. This distinction matters: a reformulated product can re-enter.

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9. Label defects that will surface at registration

These are not cosmetic. Each is a likely SFDA query, and several are also Canadian compliance problems.

This is why the recommendation is not "register the catalogue". It is "fix the five SKUs you intend to launch, then register".

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10. What the Health Canada NPN is worth in KSA

Short answer: nothing in law, and less than expected in practice.

• SFDA's registration guide lists the documents it accepts. A foreign NPN is not among them [S1][S2]. SFDA assesses the product against Saudi technical regulations and its own claims list. There is no mutual recognition agreement between Health Canada's NHP regime and SFDA for food supplements (no such agreement was found in the SFDA materials reviewed; this is an inference from the absence of any reference, confidence: high).
• An NPN can still be useful commercially as a third-party trust signal, but only if the NPN actually matches the product. In this catalogue it often does not.

LNHPD audit, 31 October 2026 [S9]:

Interpretation. Seven of the twelve unique NPNs (eight of the thirteen SKUs, because both mass sizes print the wrong NPN) either carry the wrong NPN or a formula that differs from the licence. Two of the mismatches (Extreme Mass, ProWhey) are commercially central. This is a manufacturer integrity issue, not a Saudi paperwork issue, and it should be resolved before any purchase order. It also means the Canadian friend's pitch ("all NPN-approved") needs correction in the investor deck.

Recommended action: ask INOV Pharma for a current Canadian product licence printout and the latest label for each SKU, then reconcile. If they cannot, treat the NPN as marketing collateral, not evidence.

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11. Customs, VAT, excise and trade

Tariff and taxes

• Saudi Arabia applies the GCC common external tariff of at least 5% on most goods; most food products are 5% [S11].
• VAT is 15% (since July 2020) [S11].
• Excise applies to soft drinks (50%) and energy drinks (100%), not to powders [S11]. Pre-Workout is a powder, not a beverage; no excise. If a ready-to-drink line is launched later, excise becomes relevant.
• Duty is calculated ad valorem on CIF [S11]. The model uses CIF × 5%.

Indicative HS classification

Classification is the importer's/broker's responsibility; these are starting points to confirm with ZATCA.

Warning: a misclassified entry can attract a different duty rate, delay clearance, or create a record that complicates future imports. Get a written tariff opinion from a Saudi customs broker for the top five SKUs before the first shipment.

Ports and clearance

• Jeddah Islamic Port (west) and King Abdullah Port (Rabigh) serve Jeddah/Makkah; Dammam serves the Eastern Province; Riyadh dry port for central distribution.
• Airfreight into RUH/JED/DMM for launch samples and urgent replenishment; sea LCL/FCL for routine orders.
• Clearance documents: origin certificate, commercial invoice with quantities, expiry dates and batch numbers, B/L, health certificate, certificate of conformity where required, halal certificate where applicable [S4].
• Lead time: 3–7 working days after arrival if documents are complete; add 5–10 days if SFDA samples and tests. ESTIMATE.

SABER / conformity

SABER is Saudi Arabia's product-safety/conformity platform for SASO-regulated products [S11]. Food and food supplements are cleared through SFDA/Fasah, not SABER. Do not budget for a SABER certificate for these SKUs. If a product is later positioned as a medical device or a non-food consumer product, SABER may apply; that is not the case here. Confirm with the freight forwarder, because brokers sometimes ask for SABER by default.

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12. Online sales rules

• Amazon.sa: a Saudi commercial registration is mandatory to register and sell [S22]. Sellers also need a VAT number, Saudi national address, bank account/IBAN, and product documentation. FBA/Easy Ship are available; referral fees and fulfilment fees apply.
• Noon: similar seller onboarding (CR, VAT, national address, brand authorization). The seller portal was not accessible for this study; treat as unverified.
• E-commerce activity must be reflected in the CR/e-commerce licence regime administered through the Ministry of Commerce and the Saudi Business Center [S37]. The exact activity code and fee were not verified.
• Advertising claims are subject to the same SFDA.FD 2333 rules as the label. Influencer posts, TikTok videos and Instagram stories are advertising. "Fat burning", "slimming", "growth hormone" and "boosts testosterone" are high-risk in paid and organic content.
• Marketplace authenticity: Amazon.sa and Noon both have counterfeit/brand-protection programmes. Register the brand and use FBA/Noon Express to control the customer experience.

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13. Compliance matrix — summary

The full matrix is in compliance_matrix.csv. Headline:

No SKU is approved today. The shortest path to revenue is Creatine + ProWhey + Extreme Mass + Pre-Workout, subject to the conditions in the matrix.

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14. What could not be verified

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15. Recommended regulatory sequence (12 weeks to first shipment)

Go/no-go gate: do not place a purchase order until (a) the NPN/formula reconciliation is complete, (b) at least three launch SKUs have passed lab testing, and (c) the Arabic labels have been reviewed by a Saudi regulatory consultant. If any of these fails, the timeline slips by a quarter, not a week.

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Key sources for this chapter

[S1] SFDA, Registration Guide of Food Supplements and Energy Drinks, 2021 — https://www.sfda.gov.sa/sites/default/files/2021-04/Registration%20Guide%20of%20Food%20Supplements%20and%20Energy%20Drinks.pdf [S2] SFDA, Pre-registration Evaluation for Food Products, 2024 — https://www.sfda.gov.sa/sites/default/files/2024-07/F259E1.pdf [S3] SFDA, Conditions & Requirements for Importing Food to Saudi Arabia, 2022 — https://www.sfda.gov.sa/sites/default/files/2022-03/SFDAFood4654E.pdf [S4] SFDA, Conditions and Requirements for Food Clearance, 2025 — https://www.sfda.gov.sa/sites/default/files/2026-08/ConditionsRequirementsFoodClearanceE.pdf [S5] GSO 2333:2022 preview — https://gso-sims-preview-doc-aws.s3-eu-west-1.amazonaws.com/gso-2333-2022-en.html [S6] SFDA, A Guide to Nutrition and Health Claims — https://oldsfda.sfda.gov.sa/sites/default/files/2021-04/AGuidetoNutritionClaims.pdf [S7] SFDA news, Three New Regulations to Promote Healthy Community Nutrition, 27 Feb 2025 — https://oldsfda.sfda.gov.sa/en/news/2703257 [S8] SFDA registered food products database — https://www.sfda.gov.sa/ar/products [S9] Health Canada LNHPD product pages — https://health-products.canada.ca/lnhpd-bdpsnh/info?licence=80054471 (and the other NPNs in Section 10) [S11] U.S. ITA, Saudi Arabia — Import Tariffs, last published 11 May 2026 — https://www.trade.gov/country-commercial-guides/saudi-arabia-import-tariffs [S22] Amazon.sa seller page — https://sell.amazon.sa/en/ [S36] SFDA Prohibited Ingredients List (cosmetics) — https://www.sfda.gov.sa/en/ProhibitedIngredientsList [S37] Saudi Ministry of Commerce — https://mc.gov.sa/en/pages/default.aspx [S43] RegASK, SFDA Issued a Guide for Food Supplement Registration, updated 2 Nov 2024 — https://regask.com/sfda-food-supplement-guide/

All URLs accessed 31 October 2026. Full source register with reliability ratings is in 07_Sources_and_Methodology.md.