September 9, 2013 — As part of the Regulations contained in the National Agency for Food and Drug Administration and Control (NAFDAC) Act, food and drug producers must take adequate steps to inform consumers of their products about the ingredients contained in bottled water and other beverages, pre-packaged foods, herbal medicines, cosmetics and other health-care products. While some of the provisions are mandatory to ensure that food and drug products stay within the boundaries of Nigerian laws, a number are voluntary.
Some of NAFDAC’s subsidiary regulations and guidelines that touch on product packaging and labelling include: Bottled Water (Labelling) Regulations, Drug Labelling Regulations 2005, Food Fortification with Vitamin A Regulations 2005, Food Products (Advertisement) Regulations, Guidelines for Registration of Imported Cosmetics, Herbal Medicines and Related Products (Labelling) Regulations 2005, Guidelines for Change of Product Package Label Design of all Regulated Products in Nigeria, Pre-Packaged Food (Labelling) Regulations 2005 etc.
Cosmetic Goods Labelling
In dealing with cosmetics in Nigeria, NAFDAC’s guidelines require labels to be informative, accurate and contain specific information including the name of the product, brand name, name and full address of the manufacturer, distributor, importer, exporter or vendor. NAFDAC also requires that the labels include the batch number, date of manufacture, best before/expiration date, and the net contents of essential ingredients in metric units.
According to NAFDAC, all ingredients must be listed by their common names in the order of their predominance by weight and must be translated into English Language. Cosmetic products must also make provision for the insertion of the NAFDAC Registration Number.
Bottled Water Labelling
The bottled water industry in Nigeria is big business. In 2012, The Coca-Cola company led the industry with an off-trade volume share of 12% with its Eva brand. Some of the other leading competitors in the bottled water industry in Nigeria were Nestle Nigeria Plc, Cway, Spring Waters Nigeria Ltd, Warm Spring Waters Nigeria Ltd, Ragolis Water Ltd, and Voltic Nigeria Ltd.
NAFDAC’s Bottled Water (Labelling) Regulations requires that every bottled water have a name and that such name must accurately indicate the contents of the bottled water. The label of every bottled water must clearly and prominently indicate in English language, the name, batch number, directions for use, and address of the manufacturer, distributor, importer or vendor of the bottled water.
NAFDAC requires that labels must have a contrasting colour to that of the background, be firm and not easily detachable. In addition, the date of minimum durability of every bottled water shall be specified and preceded by the words “best before”, “use by” or “expiry”.
NAFDAC regulations make it mandatory for the label of a drug to specify conspicuously the name and address of the manufacturer or the distributor. NAFDAC also requires that the outer and inner labels of drugs show the generic name and strength of the drugs. Where a drug contains a single active ingredient, the common or generic name must appear alongside and in close proximity to the brand name of the drug and in cases where there are more than one active ingredient, NAFDAC requires that all the common names must appear on the principal display panel of the drug. If the drug is packaged in a container that is too small to bear this information, it may appear elsewhere on the label.
NAFDAC also requires that the outer label of a drug must indicate the net content of the drug in the container in terms of unit weight, measure or number and for sterile drugs, a quantitative list of preservatives must be indicated by their generic or common names. In prescription only drugs cases, NAFDAC makes it mandatory for there to be a package insert with relevant information. Where an approved non-nutritive sweetener is an inactive ingredient, the outer and inner labels of all over-the-counter human drug products must bear a conspicuous declaration as to the identity and quantity of the non-nutritive sweetener in milligram per dosage unit and shall also bear boldly and conspicuously, any precautionary warnings for the non-nutritive sweetener as may be prescribed by the Agency. The labels of all drugs shall state prominently a warning statement to the following effect: “Keep this medicine out of reach of children”.
NAFDAC is quite clear in its requirement that no person shall sell any food, to which Vitamin A has been added, unless the amount of the Vitamin A present in the food is expressed on the label of the food in International Unit (I.U.). Where food is pre-packaged, NAFDAC makes it mandatory for the label to indicate the name of the food item which must reference the accurate nature of the food and where a coined or fanciful name is used for the food item, such name must not be misleading and shall be accompanied by an appropriate descriptive term. The label must also include directions for use, including reconstitution, where
applicable, in order to ensure correct utilization of the food item.
While the use of herbal medicine and medicinal plants is not a new idea in Nigeria, when it comes to its manufacture, importation, exportation, distribution, advertisement or sale, NAFDAC prevents such sale in cases where the medicine is not labelled as required by the provisions contained in the Herbal Medicines and Related Products (Labelling) Regulations 2005.
According to NAFDAC’s regulations, not only must the labels on herbal medicines and related products be informative, accurate and non-promotional in tone, they must not be false or misleading and whenever possible, they should be based on data derived from human experience.
In other to make a claim or suggestions regarding herbal medicines in Nigeria, there must be adequate evidence of safety or substantial evidence of effectiveness. Where a claim of effectiveness or therapeutic effectiveness is made by a herbal medicine, the label must boldly state and in close proximity to the claim, a statement to the fact that such claim has not been evaluated by NAFDAC, unless such claims has been clinically proven and deemed satisfactory by NAFDAC. Recently, the Director General of NAFDAC announced that sanctions await persons found making unverified health claims and reminded the public that NAFDAC has placed a ban on illegal advertisements of herbal medicinal products and bogus claims of cure for disease conditions.
When herbal medicines are in package form, the label of such products must specify conspicuously the name and place of business of the manufacturer, and may include the distributor or packer. Where a herbal medicine is not manufactured by a person whose name appears on the label, the name shall reveal the connection between the person and the manufacturer, such as “Manufactured for …”, Distributed by…”, or any other wording that expresses the facts.
In dealing with herbal medicines, you also cannot without the approval of NAFDAC directly or indirectly reference international bodies on your herbal medicine label and a quantitative list of ingredients of the herbal medicines by their botanical names or, by their common names, must be declared quantitatively on the label. In addition, the inner and outer labels of a herbal medicine must clearly show your NAFDAC registration number as indicated on the certificate of registration obtained from NAFDAC.
Some of the other relevant information required to appear on the herbal medicine package insert include a description, warnings against misuse, dosage and administration, adverse reactions, drug abuse and dependence etc
This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.