Food Supplement Registration in Nigeria

Regulatory Authority National Agency for Food & Drug Administration & Control. Regulatory Website

https://www.nafdac.gov.ng/ 

Dietary supplements are categorized as “Herbal Medicine and Related Products” under the 2019 Herbal Medicine and Related Products Labelling Regulations.

The definition of herbal medicine is:

(i) Completed medicinal products that comprise plants and their preparations and are advertised as having therapeutic or preventive properties. This category covers all preparations that incorporate plants, either entirely or in part.
(ii) The preparation or combination of herbal medicinal preparations that are advertised as having therapeutic or preventive properties.
(iii) Preparations or mixes intended to modify, restore, or adjust an animal’s or human’s organic functions.

1.   Registration Declaration
2.  Power of Attorney from the manufacturer to the local applicant.
3.  Contract Manufacturing Agreement.
4.  Evidence of Business Incorporation in Nigeria
5.  Certificate of Analysis matching the sample batch number.
6.  GMP or ISO certificate.

The following must be included on mandatory labeling, which must be in English:

(i) The product name, botanical name, or common name, if applicable, must be classified as a medicinal product made from herbs, homeopathic remedies, animals, minerals, or mixtures of these.
(ii) A quantitative list of every ingredient in the product, listed by common or botanical name.
(iii) The product’s net content, expressed in metric units and expressed in terms of weight, measure, or numerical count.
(iv) The manufacturer’s name and complete address of the factory.
(v) Sufficient usage instructions, including dosage recommendations for different age groups, to ensure the product is used safely.
(vi) The lot or batch identification.
(vii) The date of manufacturing and expiry.
(viii) The storage conditions. The Herbal Medicine and Related Products Labelling Regulations of 2019 govern dietary supplement labeling in Nigeria. According to the Agency’s Regulations on Herbal Medicines and Related Products, labeling must be truthful, enlightening, and compliant.