NAFDAC NON NUTRITIVE SWEETENERS IN DRUG PRODUCTS PROHIBITION REGULATIONS 2019
Regulation · Health
Policy date: 2019-01-01
Regulations prohibit the use of non-nutritive artificial sweeteners in pharmaceutical drug products in Nigeria. They target manufacturers, importers, and pharmacists to ensure compliance with safety standards. This protects patients, especially those with metabolic conditions, from additional health risks.
What Is This Policy?
Regulations prohibiting the use of non-nutritive artificial sweeteners in pharmaceutical drug products in Nigeria, ensuring that sweetening agents in medicines do not pose additional health risks to patients beyond the therapeutic risks of the drug itself.
Who Does It Target?
Pharmaceutical manufacturers and importers of drug products Hospital and retail pharmacists dispensing sweetened medicines NAFDAC as the regulatory authority
What Does It Aim to Achieve?
To protect patients, particularly those with metabolic conditions such as phenylketonuria and diabetes, from exposure to potentially harmful artificial sweeteners in drug formulations, and to simplify drug safety assessment.
Key Features
Full Prohibition: Non-nutritive sweeteners are categorically prohibited in all pharmaceutical drug products. Exemptions Process: Manufacturers requiring a therapeutic exception must apply for a specific waiver supported by evidence. Reformulation Requirement: Existing registered drug products containing non-nutritive sweeteners must be reformulated within the prescribed transition period. Post-Market Verification: NAFDAC tests drug samples on the market to verify absence of prohibited sweeteners. Penalties: Manufacturing or selling non-compliant drug products attracts fines and prosecution.
Current Status
In force. Actively enforced by NAFDAC, with pharmaceutical manufacturers required to use only permitted sweetening agents in drug formulations sold in Nigeria.
Manufacturers review and reformulate affected products to eliminate prohibited sweeteners Submit reformulated product for variation of registration with NAFDAC Apply for a waiver only in exceptional, evidence-based circumstances Application method: NAFDAC headquarters, Abuja
Important Terms
No extension of the reformulation deadline without formal NAFDAC approval Products found containing prohibited sweeteners post-deadline are recalled Waivers are product-specific and non-transferable
Official Resources
Website: www.nafdac.gov.ng Policy Summary Document | Federal Republic of Nigeria
Legal Framework
The NAFDAC Non-Nutritive Sweeteners in Drug Products Policy is issued under the NAFDAC Act and operates alongside the Pharmacy Council of Nigeria Act, the NAFDAC Drug Registration Regulations, and the National Drug Policy. International alignment is with the Joint FAO/WHO Expert Committee on Food Additives (JECFA) specifications for non-nutritive sweeteners, Codex Alimentarius permitted food additives standards, and ICH Q6A on specifications for pharmaceutical ingredients.