What is the full meaning of NAFDAC?
NAFDAC stands for National Agency for Food and Drug Administration. It is a Nigerian body charged with protecting the public health of Nigerian citizens by assuring the safety of foods and drugs.
NAFDAC also regulates and controls quality standards for cosmetics, medical devices, detergents, vaccines, chemicals and pesticides, agrochemicals, veterinary products, herbal preparations, packaged water, and related products whether imported or manufactured in Nigeria.
In other words, for any business to legitimately manufacture and/or import food or drugs for trade in Nigeria, its products must be registered with and certified by NAFDAC.
So, for most Nigerians, the NAFDAC stamp of approval on any food and drug item gives a sense of security and a feeling of confidence that the product is safe for consumption.
When Was NAFDAC Established?
The National Agency for Food and Drug Administration was officially established as a parastatal of the Federal Ministry of Health in Nigeria, however, the legislation supporting its formation was passed in January 1993, as legislative Decree No. 15 of 1993.
Enabled by the NAFDAC Act, Cap N1, Laws of the Federation, 2004, it is the lead agency for food safety and quality and has a mission to safeguard public health by ensuring that only the right quality food, drugs, and other related products are manufactured, exported, imported, advertised, sold and used.
The Agency collaborates with a number of Government Agencies and Civil Society Organizations such as:
- Standards Organisation of Nigeria (SON)
- National Drug Law Enforcement Agency (NDLEA)
- Pharmacists Council of Nigeria (PCN)
- Nigeria Police Force (NPF)
- Nigeria Customs Service (NCS)
- Consumer Protection Council (CPC)
- Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN)
- Association of Food Beverages and Tobacco Employers (AFBTE), etc
NAFDAC Regulatory Partnerships
NAFDAC encourages sectoral groups, small and medium scale entrepreneurs, etc to form umbrella associations such as:
- Association of Food, Beverage and Tobacco Employers (AFBTE)
- National Association of Small Scale Industrialists (NASSI)
- Association of Table Water Producers (ATWAP)
- Association of Fast Foods and Confectionaries Operators of Nigeria (AFFCON)
- All Farmers Association, etc.
These organizations are encouraged to self-regulate their practices and can easily arrange for consultative meetings with the Agency where their views and concerns are addressed and taken into account when making regulatory decisions that concern them.
Such an arrangement also enables NAFDAC to organize targeted and focused capacity-building training programs for the various groups.
Consultative meetings could also be targeted at giving information and enlightening the public on NAFDAC requirements, discussing perceived regulatory challenges, identifying international best practices and regulatory trends, etc.
NAFDAC Registration Process
One of NAFDAC’s main regulatory strategies for the enforcement of food laws in Nigeria is the product registration process. The agency uses product registration to establish and monitor the ownership and/or distributorship of the products it regulates, generally known as regulated products, their safety, quality, labeling, claims, etc.
The Agency employs a structured and systematic procedure for product registration at the end of which the product is assigned a NAFDAC Registration Number – which is an attestation to the safety, quality, and appropriateness for its intended use. The registration process involves:
Documentation: Documents are required such as:
- Power of Attorney from the manufacturer authorizing an applicant to speak for his principal on all matters relating to the latter’s specialties
- Certificate of Manufacture and Free Sale which is evidence that the product is manufactured and freely sold in the country of origin
- Certificate of Incorporation of the representative company in Nigeria
- Evidence of Trade Mark registration
- Comprehensive Certificate of Analysis of the batch of product to be registered
- The permit to import samples for registration purposes is issued if documentation is satisfactory.
Labeling: Labels should meet the following criteria:
- Informative, clear, and accurate
- Indicate the name of the product
- Name and address of the manufacturer, packer, distributor, importer, exporter, or vendor
- Make provision for NAFDAC Registration Number
- Include batch number, manufacturing date, and expiry or best before date
- List the net content
- Ingredients list in the metric weight in case of solids, semi-solids, and aerosols and metric volume in case of liquids.
Inspection: Good Manufacturing Practice (GMP) inspection of the production facility is carried out prior to registration of the product.
Product Approval Committee Meetings: A three (3) tier product approval meeting is held to consider the documentation, laboratory reports, GMP inspection reports, and product labels prior to its registration. Once a product is certified satisfactory, it is assigned a NAFDAC Registration Number and can be freely sold or marketed within the country.
Over the past few years, NAFDAC’s management has increased surveillance to curb widespread adulteration of food products, given that the contravention of the provisions of its existing food laws is subject to prosecution and punishment as specified in the code.
In recent years, the Agency seems to have become more active and stringent in enforcing existing food laws, which has increased the level of awareness of the consumer to make informed choices and has also encouraged local producers.
Labeling Requirements
A. General Requirements
NAFDAC regulations require food labeling to be informative and accurate and not fraudulent or misleading. Below is an outline of NAFDAC’s minimum labeling requirements:
1. A product’s brand name or common name must appear in bold letters.
2. Name and full “location” address of the manufacturer showing the country of origin must be provided on the product label.
3. The production “batch” or “lot” number, date of manufacture and best before/expiry date.
4. Net content, specifying essential ingredients in metric weight for solids and metric volume for liquids.
5. Ingredients must be listed by their common names in order of their prominence by weight.
6. Food additives and colors must be declared on the label. Spices, flavors, and colors may be listed as such, without naming the specific material, but any artificial color or flavor should be identified as such.
7. NAFDAC registration number must be included on the product label.
8. Labelling should be in English. If it is in another language, an English translation must be shown on the label or package insert (where applicable).
9. With the standard U.S. label addresses and the above-mentioned items, no additional labeling is necessary for imports of U.S. food items.
10. Stick-on labels meeting NAFDAC requirements are permitted provided they don’t remove easily. Foreign labels must be adhered to prior to the product arriving in the Nigerian port of entry.
11. A foreign label must be applied prior to export.
12. For production and expiry dates, Nigerians write the date before the month. U.S. exporters are advised to specify the month in words (July 1, 2005, or indicate mm/dd/yr) to avoid conflicts that may arise in mistaking the day for the month.
13. NAFDAC regulation stipulates that all food products should carry best-before dates and/or shelf-life on their packaging. The regulation states that the expiry date should be “at least half the shelf life as at the time of inspection.” The last sentence is interpreted to mean that at the time of inspection (by NAFDAC after clearing Customs), that the period from the inspection date until the expiration date should be equal to or greater than half of the total shelf life of the product (date of production until expiry).
14 NAFDAC does not grant exceptions to labeling requirements.
B. Requirements Specific to Nutritional Labeling:
• The standard U.S. nutritional fact panel is acceptable by NAFDAC.
• Any nutritional claim on the product’s label must be justified. Nutritional labeling is mandatory for any prepackaged food item for which the manufacturer makes a nutrition or dietary claim.
• Foods for special dietary uses with claims of disease prevention, treatment, mitigation, cure or diagnosis must comply with NAFDAC’s guidelines for registration of drugs and be registered as medicinal products or nutriceuticals. Labels must contain directions for safe usage, cautions such as interactions when taken with other drugs.
• Additional nutritional labeling information is voluntary.
Packaging and Container Regulations
• At present, NAFDAC regulations are not specific on the packaging, but the agency is in the process of developing regulations on the packaging. No specific waste disposal laws or product recycling regulations impact imported food products and NAFDAC does not impose any specific restrictions on packaging materials. However, plastics must be of food-grade and should not leach into the product.
• Nigerian importers, however, often express a marked packaging preference for certain high-value food products, namely:
- Relatively small-sized products prepared and packaged for one-time use.
- Products that can be shipped in bulk and re-packaged locally.
- Perishable food products that undergo processing/packaging treatment to achieve an extended shelf life without refrigeration…
In April 2016, NAFDAC launched the guidelines for its regulatory activities which was developed through the support of the World Health Organisation (WHO), Path2 and UKaids for stakeholders.
According to the Acting Director-General of the agency, Mrs Yetunde Oni, the guidelines provided detailed direction to assist relevant stakeholders in complying with NAFDAC regulations and spelt out details of how the agency expected regulations are to be implemented. They are to be used in conjunction with other relevant and extant statutes in the country.