Making the world your market

Classification

"Micronutrient" means a natural or synthesized vitamin, mineral, or trace element that is essential for normal growth, development and maintenance of life and of which a deficit will cause characteristic biochemical or physiological changes;

"Mineral Nutrient" means any of the following chemical elements, whether alone or in a compound with one or more other chemical elements:

"Vitamin" means any of the following vitamins or their synonymous names

(a) calcium;
(b) phosphorus;
(c) iron;
(d) sodium;
(e) potassium;
(f) iodine;
(g) zinc;
(h) copper;
(i) magnesium; and
(j) manganese;
(a) vitamin A (include retinol and retinol);
(b) derivatives excluding carotenes);
(c) vitamin B1 or thiamine;
(d) vitamin B2 or riboflavine;
(e) nicotinic Acid or nicotinamide;
(f) vitamin B6 or pyridoxine;
(g) folic acid;
(h) d-pantothenic acid;
(i) biotin;
(j) vitamin B12 or cyanocobalamine;
(k) vitamin C or L-ascorbic acid; and
(l) any salt or derivative of a vitamin listed in paragraph (a) to (j) of this regulation.

Registration

Dietary Supplements manufactured, imported, exported, advertised, sold or distributed in Nigeria must be registered in accordance with the provisions of The National Agency for Food and Drug Administration and Control (NAFDAC) Act CAP N1 (LFN) 2004.

The following documents must be provided:

(1)Notarized registration form
(2) Notarized Power of Attorney from manufacturer
(3) Notarized contract manufacturing agreement
(4) Certificate of Free Sale, authenticated by the Nigerian embassy or high commission in the country of origin
(5) Certificate of analysis
(6) Evidence of business incorporation of the importing company in Nigeria
(7) Where applicable, evidence of registration of brand name
(8) GMP declaration
(9) Coloured artwork/label and leaflet insert of the product

Labelling

Product label should be clear, informative and accurate.
The minimum requirements on the package label are as follows:-
- (a) Name of (brand name) where applicable and generic name.
- (b)
  1. (i) Name and full plant address of the manufacturer, vendor, packer or distributor etc.
  2. (i) Name and address of manufacturer shall read manufactured by ………; Packaged by …………
- (c) Provision for NAFDAC Registration / Listing Number on product label.
- (d) Batch Number, Manufacturing date and Expiry date.
- (e) Dosage form & strength. (as appropriate).
- (f) Indications, frequency, route, conditions of administration (may be on the primary and secondary package label of OTC drugs but not on POM drugs).
- (g) Dosage regimen on the package (OTC labels only).
- (h) Package leaflet insert (as appropriate).
- (i) Quantitative listing of all the active ingredients per unit dose.
- (j) Adequate warnings (where necessary).
- (k) Net content.
- (l) A disclaimer stating “These claims have not been evaluated by NAFDAC” should be prominently written on the labels and literature insert of the product. (For herbal products only).

Label declaration of food to which Vitamin and/or mineral has been added

(1) No person shall sell a food to which a vitamin has been added unless the amount of the vitamin present in the food is expressed on the label of the food.
(2) Vitamins and minerals can only be declared if they meet the requirements as stipulated in Schedule II to these Regulations.
(3) The vitamin and mineral content must be at least 5% of the NRV per serving which shall be expressed as a percentage of the NRV per 100g or per 100 ml or per package if the package contains only a single portion and per serving as quantified on the label.
(4) Where vitamins and/or minerals are present in significant amounts of 15% or higher preserving, of food shall meet the conditions in order to qualify for the claim with the prescribed wording for claims as provided in Schedule VI to these Regulations.
(5) When nutrient declaration is applied, vitamins and minerals which are present in amounts less than 5% of the Nutrient Reference Value per 100 g or 100 ml or per serving as quantified on the label should not be declared.

(i) Registration of a product does not automatically confer Advertising permit. A separate approval by the Agency should be required for product advertisement.
(ii) NAFDAC may withdraw the certificate of Registration in the event that the product is advertised without express approval from Agency.
(iii) NAFDAC reserves the right to revoke, suspend or vary the certificate during its validity period.
(iv) Filling an application form or paying for registration processing does not confer registration status.
(v) Failure to respond promptly in writing to queries raised by NAFDAC on the application will automatically lead to suspension of further processing of the application.
(vi) A successful application attracts a Certificate of Registration with a validity period of five (5) years or listing for two (2) years.

Product launches and Press release

All product launch materials or press release of food products shall be as approved by the Agencyfor the product advertising materials.

Prohibitions Regarding Advertisement:

(1) No person shall advertise any food product unless it has been registered by the Agency.
(2) No person shall advertise any food product unless it has been approved by the Agency.
(3) No person shall advertise any Breast Milk Substitute and Infant and Young children food. Anydescriptive matter appearing on or attached to or supplied with the package shall not include anyinformation on the promotion or advertisement of another product.
(4) No person shall-
- (a) display, screen or otherwise present an advertisement of a food product unless in accordance with the provisions of these Regulations; or
- (b) make any claim to assert, imply or otherwise convey the impression as to the suitability of the food product for use in the prevention, alleviation, management, treatment or cure of a disease,disorder or physiological condition; or
- (c) make a claim that the food product contains a particular value when that value is not wholly contributed by the food product, but is partially contributed by other food products with which it may be consumed.
- (d) describe a food product as “healthy” or represent it in a manner that implies that a food in itself will impact health.
- (e) make health claims that encourage or condone excessive consumption of any food or disparage good dietary practice.
(5) All nutritional claims shall comply with the Agency’s Pre-packaged Food (Labeling) Regulation2019.

Prohibition related to Nutrient claims

(1) No person shall;

sell or advertise any food that is represented on the label to the general public as fortified with vitamins and mineral unless it is registered with the Agency.
manufacture, import, export, advertise, sell, distribute, store or use any fortified food as treatment, preventive or curative for any of the diseases, disorders or abnormal physical states specified in Schedule I to these Regulations,
sell or advertise any food to the general public as fortified with vitamins and minerals referred to in these Regulations, if the Nutrient Reference Value (NRV) intake of that food by a person will result in the NRV by such a person of more than the quantity of vitamins and mineral nutrients specified in Schedule II to these Regulations.
In the case of the foods specified in Schedule IV to this Regulations, no person shall manufacture, import, export, sell, distribute of use, unless it is fortified with vitamin A as prescribed by the Agency.
No food product for the purpose of Global Listing for Supermarket Items and Restaurant Operators, shall be allowed unless it complies with the provisions of these Regulations or as prescribed by the Agency.
Only foods listed in Schedule V to these Regulations maybe fortified with the corresponding vitamins and/or minerals as specified in the same Schedule.

Scientific articles and literatures to contain both positive features and negative findings

(1) A claim or quotation shall contain both the negative and positive findings and shall be readily verifiable by the Agency.
(2) A claim based on, or quotation that has been selected from a scientific article or series of articles which emphasize only the positive features while ignoring negative findings, shall not be acceptable.

Claims

(1) Claims for food products shall be substantiated before approval.
(2) Superiority claims may be used only when a product proves to be superior to an identified comparator or to all products in same category.
(3) Top parity claims and ‘Natural claims’ may be permitted provided they are adequately substantiated.
(4) No advertisement for food products shall state or imply in absolute terms or by quotations that any food product has guaranteed effectiveness.
(5) Any statement claiming or implying a superlative function such as “the product of choice“, or any such statements, for a food product shall not be used unless it can be adequately substantiated.
(6) “Best-selling” claims shall not be allowed in food advertisement.
(7) Nutrition claims in food product advertisements shall be allowed provided such claims can be adequately substantiated.
(8) Any statement relating to content such as ‘contains x’ shall be substantiated.

Use of the term “nutritious” in advertisement

No advertisement which describes any food shall include the word “nutritious” or any other words of the same significance unless:

(1) the food contains a range of nutrients including carbohydrate, fat, protein, vitamin and mineral;
(2) the food contains a substantial amount of energy of more than 40 kcal/ 100 g or 20 kcal /100ml;
(3) the food contains source of protein not less than 5 g/100 g or 2.5g /100ml;
(4) the food contains at least four vitamins of an amount that meets the criteria for claim as source and two minerals (excluding sodium) of an amount that meets the criteria for claim as source; and the amount of the nutrients mentioned in sub-regulations (1) and (4) is declared.

Energy Claim in food product

(1) A food advertisement may state;
- (a) That the food product is a “source” or “dietary source” of energy if a Nutrient Reference Value(NRV) of that food product by a person would result in the daily intake of not less than 450kilo calories of energy;
- (b) That the food product is a “good source” or “good dietary source” of energy if a reasonable daily intake of that food product by a person would result in the daily intake of not less than1,200 kilo calories of energy;
- (c) That the food product is an “excellent source” or “an excellent dietary source” of energy if aNRV of that food product by a person would result in the daily intake of not less than 2,500kilo calories of energy;
(2) No person shall sell a food product for which an energy claim is made and represented as being solely for use in the feeding of children under two years of age, unless a reasonable daily intake of that food product by a child under two years of age would result in the total daily intake of not less than 1,360 kilo calories of energy.

Statement relating to mineral content of food

(1) Where the amount of a mineral nutrient referred to in these Regulations and that is contained ina food is not less than the amount mentioned in Schedule II, shall in advertising that food oron a label of that food, state:

in the case of calcium or phosphorous, that it is a factor in the normal development and maintenance of bones and teeth, especially in infants and children;
in the case of calcium, phosphorous or iron that it is a factor in the maintenance of good health.

Nigeria