NAFDAC (Bio-Fertilizer Advertisement) Regulations, Statutory Instrument no. 51 of 2024

] Extraordinary Federal Republic of Nigeria Official Gazette No. 191 Lagos - 8th November, 2024 Government Notice No. 56 The following is published as supplement to this Gazette: S. f No. Short Title 51 NAFDAC (Bio-Fertilizer Advertisement) Regulations, 2024 .. Printed and Published by The Federal Government Printer. Lagos, Nigeria FGP 82/1 l 2024/150 Vol.111 Page BI 029-1035 Annual Subscription from !st January. 2024 is Local: NI00.000.00 Overseas: Nl30,000.00 [Surface Mail) N l 50.000.00 [Second Class Air Mail). Present issue N3,500 per copy. Subscribers who wish to obtain Ga=ette after I st January should apply to the Federal Government Printer, Lagos for amended Subscriptions. NAFDAC (BIO-FERTILIZER ADVERTISEMENT) REGULATIONS, 2024 ARRANGEMENT OF REGULATIONS Regulation : PArn I - OBJECTIVE ANU APPLICATION I. Objective 2. Application PART 11-ADVl:RTISF.Ml:NT, APPLICATI0I',, PARTICULARS, APPROVAi., DURATION, PR0IIIBITION, ETC. 3. Nature of advertisement 4. Non-referential advertisement 5. Particulars of an application 6. Validityofapproval 7. Alteration to approved advertisement material 8. Withdrawal of approval within the validity period 9. Caution on advertisement ofbio-fertilizer 10. Prohibition of misleading comparison 11. Restriction 12. Accurate interpretation ofresearch findings 13. Content of scienti fie articles and I itcrature 14. Product launch and press release 15. Prohibition PART Ill - OFFENCF.S AND PI:NALTIES 16. Offences and penalties PART IV - MISCl:LLANEOLS 17. Forfeiture after conviction 18. Enforcement of these Regulations 19. Interpretation 20. Citation B 1029 B 1031 S. I. No. 51 of 2024 NAFDAC (BIO-FERTILIZER ADVERTISEMENT) REGULATIONS, 2024 [ 16th Day of October, 2024] Commence- ment In exercise of the powers conferred on the Governing Council of the National Agency for Food and Drug Administration and Control ("the Governing Council") by section 30 of the National Agency for Food and Drug Administration and Control Act, Cap.NI, LFN, 2004 and section 12 of the Food, Drugs and Related Products (Registration, Etc.) Act, Cap. F33. LFN, 2004 and all other powers enabling it in that behalf, the Governing Council, with the approval of the Minister, makes the following Regulations - PART I - OBJECTIVE AND APPLICATION 1. These Regulations provides regulatory framework for the regulation Objective of the advertisement ofbio-fertilizer manufactured, imported, distributed, sold or used in Nigeria. 2. These Regulations shall apply to advertisement and promotion of bio­ fertilizers manufactured, imported, distributed, sold or used in Nigeria. PART II -ADVERTISEMENT, APPLICATION, PARTICULARS, APPROVAL, DURATION, PROIIIBITION, ETC. 3.--{ I) Advertisement ofbio-fertilizer products shall be clear, accurate, complete and designed to promote credibility and trust to the general public. (2) Statement or illustration contained on the package of bio-fertilizer shall not be misleading either directly or indirectly. 4. Advertisement of bio-ferti I izer shall not - (a) imitate the general layout, text, slogan or visual presentation of another bio-fertilizer in a way that is likely to mislead or confuse the user; or (b) be stated in such a manner to induce fear in the users, thereby causing them to purchase the bio- fertilizer. 5.--{ I) Application for the advertisement ofbio-fertilizer submitted by any advertisement agent, distributor, manufacturer or the sponsor of the advertisement shal I be accompanied with the fol lowing- (a) the approved product label; (b) name and location address of the advertising company; (c) date of first introduction of the bio-fertilizer to the Nigerian market; (d) previous advertisement approval of the bio-fertilizer in Nigeria, if any; (e) copy of the old scripts, if any; (f) the proposed medium for the advertisement; Application Nature of advertisement Non­ referential advertisement Particulars ofan application B 1032 Validit~ of appro1 al Alteration to appro1 ed a(hcnisemcnt material Withdrall'al of apprornl 11 ithin the ,alidit~ period (g) evidence of Certificate of Registration; (h) justification for any special claims relating to the bio-fertil izer; (i) evidence of payment of prescribed fee; and (i) any other requirement that the AgenC) may from time to time prescribe. (2) Materials submitted in relation to the bio-fertilizer under this regulation shall be authenticated by the Chief Executive or an authorised technical person of the company sponsoring the advertisement. 6.-{ I) Approval for advertisement ofbio-fcrtilizer shall be valid for a period of one year at first instance from the date of the approval and may be rene\\ ed. (2) Subsequent advertisement application shall be ,alid for two years, prO\ ided that no alteration is made to the advertisement and conditions of rene\\al remains the same. (3) Notwithstanding the pro, is ion of subregulation (I) of this regulation, consumer promotions shat I ha, e ,al id it} of not more than 15 weeks. 7. Any alteration to already approved script or recording v. ithout the approval of the Agency shal I render such approval invalid. 8. The Agency ma) ,, ithdra,, the apprornl for an advertisement. where - (a) the grounds upon \,\hich the approval v.as granted v.as later found to be false or incomplete: (b) any of the conditions upon ,vhich the apprO\al ,,as granted has been contravened: or (c) there is ne,, scientific e, idence that ma) require a change to the approved ad,ertisement. Caution on 9. Bio-fertilizer advertisement caution shall be in writing or pictorials to ad1cnis.:ment indicate that - of bio- fcrtili1.:r (a) feeding animal with bio-fertilizer is illegal except the Urea in the formulation of the feed for ruminants - (h) the bio-fertilizer is not to be ingested: (c) user shall wear appropriate Personal Protective Equipment ,, hi le handling bio-fertilizer; and (d) bio-fertilizer shall be h.ept out ofrcach of children. 10.-( 1) Bio-fertilizer advertisement shall not contain misleading comparison either directly or indirectly. (2) Comparison in a bio-fertilizer advertisement shall be supported by verifiable current data. (3) Reference to competitive manufacturer or their specialties shall be restricted to factual com pan son without the use of any identifiable bio-ferti I izer. (4) Data illustration presented in advertisement including chart, graph, table extracted from reference studies, reproduced by artwork or other sources shall- (a) be clear, accurate and complete with their sources specifically identified; and (b) not be misleading, ambiguous or distort the original and intended meaning either directly or indirectly. 11.-{ I) Advertisement ofbio-fertilizer shall not contain - (a) false or misleading information; ( b) partial-truth, inadequate qua I ification and I imitations regarding safety or effectiveness of the bio-fertilizer; (c) vague, unsubstantiated statement, or suggestion of superiority over other competing bio-fertilizer; or (cl) false impression that the advertised bio-fertilizer is for universal purpose or as a more effective and safer alternative to other fertilizer in the same category. (2) Bio-fertilizer advertisement shall not- (a) contain word as "magic", "miracle" or description such as "upper potency" or other words as to induce the daily or continuous use of the bio­ ferti lizer outside its prescribed use; (b) contain a message that if the reader, viewer or listener does not use the bio-fertilizer, the plant may not grow effectively; (c) disparage or attack unfairly any competitive brand of bio­ fertilizer; or (cl) contain a statement that claims or implies a superlative function such as "most effective", "least toxic", '·best tolerated" or other special status except the claim has been scientifically proven. 12.-{ I) Advertisement material, including script, story-board, art work, radio script and other advertisement material for bio-fertil izer shall be written to accurately interpret valid and representative research findings. (2) Statistics in an advertisement ofbio-fertilizer shall be written as to reflect their true validity and significance. B 1033 Prohibition of misleading comparison Restriction Accurate interpretation of research findings B 1034 Content of scientific articles and literature Product launch and press release Prohibition OITences and penalties (3) Copy of any reference cited by an applicant or in the advertisement ofbio-fertilizer shall be provided to the Agency for verification. 13. A claim or quotation - (a) from scientific articles or literature shall contain both the negative and positive findings verifiable by the Agency: and (b) selected from a scientific article or series of articles which emphasises only the positive features while ignoring negative findings shall not be acceptable. 14.-( I) The material approved by the Agency for bio-ferti I izer advertisement shall be the same for the product launch or press release. (2) Where there is a change in the material for the product launch or press release, the change shall be approved by the Agency. 15. A person shall not - (a) advertise bio-ferti I izer except it has been registered and the ad, ert material has been approved by the Agency: (b) advertise bio-fertilizer contrary to the provisions of these Regulations; and (c) display, screen or otherwise present an advertisement of a bio­ fertilizer unless in accordance with the provisions of these Regulations. PART lll - 0HFMTS AND PENALTIES 16.-( I) A person who contravenes any of the provisions of these Regulations commits an offence and is liable on conviction, in the case of- (a) an individual, to imprisonment for a term not exceeding one year or to a fine not exceeding N-800.000 or to both; and (b) a body corporate, to a fine not exceeding N-5,000,000. (2) Where an offence under these Regulations is committed by a body corporate, firm or any other association of individuals, every- (a) director, manager, secretary or other similar officer of the body corporate: (b) partner or officer of the firm: (c) trustee of the body concerned; (d) person concerned in the management of the affairs of the association; or (e) person who purports to act in a capacity referred to in paragraphs (a) to (d) of this regulation, is liable to be proceeded against and be punished for the offence and in the same manner as if the person committed the offence, unless the person proves that the act or omission constituting the offence took place without his knowledge, consent or connivance. 17.-{ I) A person convicted of an offence under these Regulations shall forfeit to the Federal Government- (a) asset or property constituting proceeds derived from or obtained, directly or indirectly, as a result of the offence; and (b) any of the person's property or instrument used in any manner to commit or to facilitate the commission of the offence. (2) In this regulation, "proceeds" means any property derived or obtained, directly or indirectly, through the commission of the offence. PART IV - MISCFLLANEOUS 18. The Agency shall be responsible for the enforcement of these Regulations. 19. In these Regulations - "Advertisement" means the publicity ofbio-fertilizer which includes any form of notices in circulars, handouts, labels, wrappers, catalogues and billboards, posters, newspapers, magazines, and any other documents made orally or otherwise or by means of projected light; "Agency'' means the National Agency for Food and Drug Administration and Control; "Bio-fertili=er" means substances which contain living microorganisms which when applied to the seed, plant surface, or soil, colonizes the rhizosphere or the interior of the plant and promote the growth by increasing the supply or availability ofnutrients to the host plants; ·'Claim" means any representation, which states, suggests or implies that the bio-fertilizer has particular qualities relating to its origin, nature, processing, composition or any other qua I ity; ·'Label" means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on, or attached to a package or container of food; and "Location address" means a place where the business of manufacture, sale, distribution, storage and display ofbio-fertilizer is carried out which includes the house number, plot number, street name, town or city, state, country. B 1035 Forfeiture after conviction Enforcement of these Regulations Interpretation 20. These Regulations may be cited as the Bio-Fertilizer Advertisement Citation Regulations, 2024. MADE at Abuja this 16th day of October, 2024. MUHAMMAD Au PATE, CON Coordinating Minister of Health and Social Welfare