Non-Nutritive Sweeteners in Drug Products (Prohibition) Regulations 2021. S.I. no. 81 of 2021.

These Regulations, made by the Governing Council of the National Agency for Food and Drug Administration and Control (NAFDAC), prohibit the manufacture, import, export, advertisement, sale, distribution of any drug product which contains non-nutritive sweeteners, except as provided for in these Regulations. Also, no person shall manufacture, trade in or place on the market a product which contains non-nutritive sweeteners which are recognised as novel excipients, i.e. any substance which is used as an excipient to impart sweetness for the first time in a drug product, or by a new route of administration. NAFDAC may authorise the manufacture, importation, exportation, sale, distribution, advertisement and use of registered or permitted non-nutritive sweeteners for special dietary requirements and drug formulations. A drug product shall be deemed as adulterated and hazardous to health, if it contains non-nutritive sweeteners not permitted by the Agency.