NATIONAL AGENCY FOR FOOD AND DRUG ADMINSTRATION AND CONTROL (NAFDAC) Bio-fertilizer Advertisement Regulations 2014 1 NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC) BIO-FERTILIZER ADVERTISEMENT REGULATIONS 2014 Commencement: In exercise of the powers conferred on the Governing Council of the National Agency for Food and Drug Administration and Control (NAFDAC) by Sections 5 and 30 of National Agency for Food and Drug Administration and Control Cap N1 Laws of Federation of Nigeria 2004 and powers enabling it in that behalf, the GOVERNING COUNCIL OF THE NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL with the approval of the Honorable Minister of Health hereby makes the following Regulations:Scope 1. These Regulations apply to all advertisement or promotion of bio-fertilizers imported into Nigeria or locally manufactured, distributed or sold in Nigeria. Prohibition 2. No person shall advertise a bio-fertilizer unless: 1. It has been registered by the Agency; and 2. The advertisement has been approved by the Agency. Nature of advertisement 3. (1) An advertisement in Nigeria of a bio-fertilizer shall be accurate, complete, clear and designed to promote credibility and trust by the general public. (2) The statements illustration shall not be misleading directly or by implication. Non-referential advertisement 4. No advertisement of a bio-fertilizer shall: (a) Imitate the general layout, text slogan or visual presentation of another bio-fertilizer in a way likely to mislead or confuse the user. (b) Be framed in such a manner to induce fear among users, causing them to purchase biofertilizers being advertised. Application for the approval of advertisements 5. (1) All applications for advertisement of bio-fertilizers shall be submitted to the Director General. (2) The application shall be accompanied with all advert materials including scripts, storyboards, artwork and upon approval audio and video recording of the approved advertisement material. . 2 (3) The Director General shall, if satisfied with the application, grant approval for the advertisement of the bio-fertilizers. (4) Where an advertisement is considered unacceptable by the agency, the words “unacceptable as presented” shall be stamped on it and returned to the applicant with the unacceptable information or illustration clearly identified Particulars of application 6. Application for the advertisement of bio-fertilizers submitted by any advertisement agent, distributor, manufacturer or the sponsor of the advertisement shall be accompanied with the following: (a)The bio-fertilizer with its label containing the bio-fertilizer class name. (b) Genus and species name of the microorganism in such bio-fertilizer. (c)Brand name of the bio-fertilizer. (d) Methods and intervals of application. (e)Name and location address of the manufacturer. (f) Name and location address of the local distributor. (g) Name and location address of the advertising company. (h) Date of first introduction of the bio-fertilizer to the Nigerian market. (i) Previous advertisement of the bio-fertilizer in Nigeria if any. (j) Copy of the scripts, storyboard, and artwork and upon approval audio and video recording of the approved advertisement material. (k) The proposed media for the advertisement. (l) Evidence of registration of the bio-fertilizer. (m) A copy of the Certificate of Incorporation of the sponsors. and (n) Justification for any special claims on the bio-fertilizer. Validity of Approval 7. The approval of an advertisement of bio-fertilizer shall be in three tiers; for a one year, two year or five year period with corresponding pro-rated tariffs as approved by the Agency. Alteration in approved script, storyboard etc 8. (1) No alteration shall be made in the format of the approved scripts, storyboard, artwork, audio or video recording without the approval of the agency. (2) Any alteration made on the approved scripts, storyboard, artwork, audio or video recording without the approval of the agency renders the approval void. Withdrawal of approval within the validity period 9. (1) The Agency may withdraw an approval for the advertisement of bio-fertilizer if: (a) The conditions under which the bio-fertilizer was granted approval has change. (b) The advertisement material was altered. (c) The Registration of the bio-fertilizer is withdrawn or suspended. (2) Where an approval for bio-fertilizer advertisement is withdrawn in accordance with Regulation 9 (1) above, appeal in writing may be lodged by the applicant to the 3 Governing Council of the Agency. Caution on advertisement of bio-fertilizer 10. Bio-fertilizer advertisements shall depict in writing, pictorial etc the caution that: (a) Feeding the bio-fertilizer to animals is illegal, (b) The bio-fertilizer is not to be used on pasture land or other grazing areas for animals, (c) The bio-fertilizer is not to be ingested, and (d) A person should wash his or her hands after use; and (e) Bio-fertilizer must be kept out of reach of children. Restriction 11. (1) No advertisement for a bio-fertilizer shall contain (a) False or misleading information; (b) Half truths, inadequate qualification and limitations regarding safety or effectiveness of the bio-fertilizer; (c) Vague, unsubstantiated statements, or suggestions of superiority over other competing bio-fertilizer; (d) False impression that the advertised bio-fertilizer is for universal purpose or should be regarded as a more effective and safer alternative to other bio-fertilizer in the same category. (2) No bio-fertilizer advertisement shall: (a) Contain such word as "magic" "miracle" or an exotic description such as "upper potency" or such other words as to induce the daily or continuous use of the biofertilizer; (b) Contain a message that if the reader or viewer or listener does not use a particular biofertilizer his crop will not grow effectively; (c) Disparage or attack unfairly any competitive bio-fertilizer. (3) No bio-fertilizer advertisement shall contain any statement claiming or implying a superlative function such as "most effective" "least toxic, "best tolerated" or other specials status shall not be used. Prohibition of misleading comparison 12. (1) No bio-fertilizer advertisement shall contain misleading comparison either directly or by implication. (2) All comparison in a bio-fertilizer advertisement shall be supported by verifiable current data. (3) Any reference to competitive manufacturer or their specialties shall be restricted to factual comparison without the use of identifiable bio-fertilizer or brand. (4) All data illustrations presented in advertisement including charts, graphs, tables extracted from reference studies or other source or reproduced by artwork shall; (a) be accurate, complete and clear with their source specifically identified. 4 (b) not be misleading or ambiguous or distort the original intended meaning or interpretation either directly or by implication. Interpretation of research findings 13. (1) Any copy of advertisement shall be written as to accurately interpret valid and representative research findings. (2) Statistics in an advertisement shall be written to reflect only their true validity and significance. Scientific articles and literature to contain both positive features and negative findings 14. (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 emphasizes only the positive features while ignoring negative findings shall not be acceptable Prohibition of misleading statements in advertisement 15. No person shall; (a)Display, screen or otherwise present an advertisement of a bio-fertilizer unless in accordance with the provisions of these Regulations; (b) Give any bio-fertilizer a name which is capable of giving a false impression of the biofertilizer. Penalty 16. (1) Any person who contravenes a provisions of these Regulations shall be guilty of an offence and liable on conviction, In case of: (a) An individual, to imprisonment for a term not exceeding one year or to a fine not exceeding N50,000 or to both such imprisonment and fine; and (b) A corporate body to a fine not exceeding N100, 000. (2) Where an offence under these Regulations is committed by a corporate body, firm or other association of individuals:(a) Every director, manager, secretary or other similar officer of the corporate body; or (b) Every partner or officer of the firm; or (c) Every trustee of the body concerned ;or (d) Every person concerned in the management of the affairs of the association ;or (e) Every person who was purporting to act in a capacity referred to in paragraphs (a) to (d) of this regulation, is severally guilty of that offence and liable to be proceeded against and punished for that offence in the same manner as if he had himself committed the offence, unless he proves that the act or omission constituting the offence took place without his knowledge, consent or connivance. Forfeiture 5 17. In addition to the penalty specified in Regulation 16 above of these Regulations, a person convicted of an offence under these Regulations shall forfeit to the Agency the Bio-fertilizer and whatsoever is used in connection with the commission of the offence. Interpretation 18. In these Regulations, unless the context otherwise requires: "Advertising" means the publicity of goods and description of all bio-fertilizer (which) includes, labels, wrappers, catalogues and price lists, billboards, posters, newspapers, magazines and any other documents) made orally or otherwise by means of projected light and sound recordings; "Agency" means the National Agency for Food and Drug Administration and Control (NAFDAC); “Bio-fertilizer” 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 of primary nutrients to the host plants. "Claim" means any presentation, which states, suggests or implies that the bio-fertilizer has particular qualities relating to its origin, nutritional properties, nature, processing, composition or any other quality; "Justification" means written explanation in respect of any claim, which shall be in the light of current knowledge acceptable to the Agency; "Label" means any writing, printed or graphic matter relating to, and accompanying the biofertilizer. "Location Address" means a place where the business of manufacture, sale, distribution, storage and display of bio-fertilizer is carried out which includes the house number, plot number, street name, town or city, state, country etc. Citation 19 . These Regulations may be cited as the Bio-fertilizer Advertisement Regulations 2014. 6
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