Nigeria: Substantiating Nutritional Claims On Food Products: Regulatory Considerations For Labelling And Advertisement

Food product labels and advertisement often make claims on the nutritional content of the items they are created to promote. These claims are carefully designed to accomplish two purposes - first, to provide customers and prospective users with a verifiable claim on the content of the food product and the possible effect of its consumption on the human body, thereby attempting to effectively build a solid brand trust and customer loyalty. Second, to entice consumers in a 'marketing language' to buy the food product.

From a regulatory standpoint, nutritional/health claims on food advertisement and packages are regulated to restrict the marketing language of manufacturers to ensure that same remains as close as possible, to the scientifically verified content-level of nutrients contained in the food products. Therefore, the current regulatory framework is geared towards ensuring that all nutritional claims on adverts and labels of food products, manufactured, imported, distributed, sold or used in Nigeria adhere strictly to all relevant regulatory guidelines and prescribed wordings. In addition, these guidelines are put in place to ensure that consumers are properly informed of the nutritional contents of food they intend to purchase and consume, no matter the level of the consumer's or prospective user's scientific knowledge.

Consequently, the National Food and Drug Administration and Control (NAFDAC), the primary regulatory body saddled with the responsibility of regulating the sale and distribution of food in Nigeria, requires manufacturers to substantiate nutritional claims on the content of food products before such claim is allowed to be made on the product's label or in its adverts.

This article examines the regulatory framework for nutritional claims in Nigeria and provides relevant insights on the considerations for labelling and advertisement of food products and the roles played by the regulator in the validation of these claims and approval of adverts.

What is a Nutritional Claim?

There is currently no regulatory definition for Nutritional Claim, however, Regulation 27 of the Food Products Advertisement Regulation 2021 ("Advertisement Regulation") and the Guide to Food Labelling (A Publication of the Food Safety and Applied Nutrition Directorate, 2014) issued by NAFDAC, defines "Claim" to mean;

"any representation which states, suggests or implies that the cosmetic product has particular qualities relating to its origin, nature, processing, composition or any other quality;"

From the definition above, nutritional claims are representations that suggest that a food product contains certain nutritional qualities based on the food's nature or composition. By way of illustration, the following statements on a food label would be considered as nutritional claims: "Low Fat", "High in Calcium" "Sodium Free", et cetera.

The role of NAFDAC in regulating Nutritional Claims

NAFDAC is an agency of the Federal Government of Nigeria established by the NAFDAC Decree No. 15 of 1993 now the NAFDAC Act, CAP L 1, LFN, 2004. Section 5(a) of the NAFDAC Act empowers NAFDAC, among other things, to: regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of food, drugs, cosmetics, medical devices, bottled water and chemicals.

In addition, NAFDAC is saddled with both the power and responsibility of ensuring that advertisements of foods are a correct reflection of the nutritional value and effectiveness of its contents. As a general rule, NAFDAC requires manufacturers/distributors to substantiate nutritional claims by providing justifications for special claims on the food product alongside its formal application. (Regulation 6 of the Advertisement Regulation).¹ In view of these powers, NAFDAC prescribes and issues regulations and guidelines on best practices relating to nutritional claims on the food products. Some of the roles of NAFDAC include:

1. Approval of Adverts/Labels
   
   The Advertisement Regulation 2021, expressly prohibits the advertisement of food products unless it has been registered and approved by the NAFDAC. Similar provisions are contained in Regulation 2 (1) (a) of the Food Fortifications Regulation 2021 ("Fortifications Regulation"). The Advertisement Regulation further specifies guidelines for the application for approval of food advertisement.
2. Withdrawal of Approval for Advertisement
   
   Regulation 8 of the Advertisement Regulation provides that NAFDAC reserves the right to withdraw its approval for an advertisement where –
   1. the grounds on which the approval was granted was later found to be false or incomplete;
   2. any of the conditions under which the approval was granted has been contravened;
   3. there is new scientific evidence against claims contained in the advertisement; or there is an order of court.

4. Other Discretionary Powers
   
   NAFDAC may prohibit the sale, manufacture, distribution or advertisement of a food product if such food product is found to be in violation of any of its regulations, specifically the Advertisement and Fortifications Regulations. Where such violation relates to the nutritional content of such food product, NAFDAC has discretionary powers to refuse the approval of an advertisement, especially where it does not comply with the provisions of extant laws and regulations.²
   
   Furthermore, where the regulatory stipulations for package labelling in relation to specific mineral/vitamin nutritional content and prescribed wordings in the Fortifications Regulation are not adhered to, persons found in contravention may be liable to imprisonment for a maximum of one year or to a fine of ₦800,000 or both (₦5,000,000 for corporate bodies).

Key Notes on Substantiation of Nutritional Claims for Package Labelling and Advertisement

Below are key regulatory guidelines to consider in drafting nutritional claims for vitamin and mineral fortifications in food products:

1. advertisement of food products must be accurate, complete, clear and designed to promote credibility and trust by the general public and health care practitioners and statements or illustrations contained on a product's package must not mislead directly, indirectly or by implication;³
2. food advertisements must not contain false or misleading information, vague or unsubstantiated statement or suggestions of superiority over competing product but rather must contain only reliable and accurate information that can be substantiated;⁴
3. Nutrition claims in food product advertisement will be allowed provided such claims are adequately substantiated;⁵

Threshold requirements for the use of specific wordings.

Generally, food products must satisfy specific mineral and vitamin content threshold stipulated in the Food Fortifications Regulation before certain words can be used as a nutritional claim on the food product's label or advertisement. Below are a few key regulatory guidelines on the use of certain specific words;

1. Where a food product's mineral nutrient content meets the calcium or phosphorous requirements stipulated in the regulation, such product can be labelled or advertised with a claim that the product 'is a factor in normal development and maintenance of bones and teeth, especially in infants and children' or where the product meets the requirements in the case of calcium, phosphorous or iron, the food product may be labelled or advertised with a claim that the product 'is a factor in the maintenance of good health'. (Regulation 5 of the Food Fortification Regulation)
2. The use of words such as 'Source, Good Source and Excellent Source' on the labels or adverts of a food may be approved provided certain thresholds are met. The thresholds vary depending on whether vitamin or mineral were added to the food or otherwise. For instance, in the case of a food to which a vitamin has been added, the Food Fortification Regulation provides that a Manufacturer may claim that a product is an excellent source of Vitamin and Mineral when such product meets the threshold of at least 30% of Nutrient Reference Value (NRV) per 100g. Therefore, where a manufacturer makes a nutritional claim that their Food Product has an excellent source of Calcium, while having only less than 11% NRV per 100g, such nutritional claim would be deemed invalid by NAFDAC and the Agency may refuse to grant approval to label or advertise such product or may prohibit the sale or distribution if approval has already been granted. (Regulation 3 & 4 of the Food Fortification Regulation).

Where Manufacturers choose not to abide by the Prescribed Wordings in the Regulations

Generally, Regulations (such as the Food Fortification Regulation) being a subsidiary legislation to the enabling NAFDAC Act are to be complied with. However, these Regulation cannot be deemed to be wholly restrictive as to specifically require the exact wordings of the Regulation to be repeated verbatim in advertisement scripts or on Food Labels. Rather, what is important is to ensure that the wordings of a nutritional claim abide by the spirit and intent of the Regulation and this will be sufficient, provided the wordings are not misleading. For example, the use of words such as "Source", "Good Source" and "Excellent Source" can only be used provided certain thresholds are met. However, this may not be known to the average consumer who is not aware of the specific percentages that qualify to use certain adjectival phrases like "excellent" or "good".

It is therefore the responsibility of the manufacturer to explain it to the consumer in a manner that is easy to understand. Manufacturers may however encounter challenges substantiating claims that do not follow the exact wordings prescribed in the regulations as NAFDAC may be reluctant to grant advertisement or labelling approvals to nutritional claims that do not use prescribed wordings. For instance, Nutritional claims such as "Nutrition for a better Life" or "Energy for Strong Bones and Faster Brain Functions" may be difficult to substantiate as they do not follow the prescribed wordings such as; "Source" or "Good Source". This makes it difficult for the regulator to determine the appropriate threshold to apply in determining whether the nutritional claim is an accurate representation of the foods content.

A thorough perusal of the Regulations discussed above, indicates that there is no express provision for appeal of decisions taken by NAFDAC as the relevant regulator. Hence, it appears to be that the powers exercised by the regulator may almost be absolute. Ideally, the drafters of the Regulation should have indicated and inserted an appeal option into the application process. Instead of having such an option, the regulation rather has express provision for offences and penalties. This anomaly therefore creates a semblance of an all-powerful regulatory authority and creates significant incentives for abuse of powers, corruption, indiscretion, etc.

In our view, however, applicants are not bound by the interpretation or decision of NAFDAC and can challenge same through administrative channels, by writing to the NAFDAC to review its decision. Where this is not successful, applicants can apply for judicial review of administrative actions through legal instruments like Writ of Certiorari, Writ of Prohibition, Mandamus, et cetera. Unfortunately, most applicants for regulatory approvals are either unaware of or reluctant to seek judicial interventions for review of administrative actions. This may be partly as a result of the fact that the judicial system is significantly slow and applicants do not sometimes want to be seen to be in conflict with their primary regulators Additionally, food product manufacturers usually want to put their products into the market immediately and will usually step down advert claims if this will hinder the sale of their products in the market.

In order to provide a more efficient appeal process where there is a dispute between NAFDAC and a food product manufacturer on advert claims, we advise that the relevant regulations be amended to create a fair, independent and quick appeal process and if need be refer same to an independent third party. Such an action, will improve the ease of doing business and reduce abuse of powers and use of discretion, etc., by regulatory bodies.

Conclusion

There is a need to strike a balance between the manufacturers need to promote their food product and the regulators restrictions on the wordings used on nutritional claims. Consequently, there is an urgent need for legislative / administrative clarity to ensure that these regulations are updated to capture the various types of claims (not just nutritional claims) as implemented in other jurisdictions. This will provide certainty and clarity and improve the overall food advert administration and regulation in Nigeria.

Footnotes

1. Regulation 6 of the Food Products Advertisement Regulation 2021.

2. Regulation 17 (7) of the Food Products Advertisement Regulation 2021.

3. Regulation 3 of the Food Products Advertisement Regulation 2021.

4. Regulation 12 of the Food Products Advertisement Regulation 2021.

5. Regulation 17(7) of the Food Products Advertisement Regulation 2021

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.