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Food, drugs, cosmetics and devices 1. Prohibition of sale of certain food, drugs, cosmetic and devices. 2. Prohibition of sale or advertisement of food, etc., as treatment, etc., for certain diseases. 3. Prohibition of importation, exportation, distribution, etc., of specified drugs. 4. Power of Minister to obtain particulars in respect of certain substances. 5. Prohibition of various misleading practices. 6. Manufacture, etc., of food, etc., under insanitary conditions. 7. Minister's certificate for manufacture, etc., of drugs specified in the Fourth or Fifth Schedule. 8. Declaration by manufacturer. 9. Designation of inspecting officers and analysts. 10. Powers of inspecting officers. 11. False statement. 12. Obstruction of inspecting officers. 13. Power of inspecting officers on importation of food, etc. 18. Trial of offences. 19. Defence in proceedings for sale of food, etc. 20. Certificates and presumptions. Diseases, etc., referred to in section 2 Publications referred to in section 5 Drugs referred to in section 7 (1 ) Drugs referred to in section 7 (2) An Act to make provision for the regulation of the manufacture, sale and adver-
tisement of food, drugs, cosmetics and devices and repeal the existing State laws
on those matters.
Food, drugs, cosmetics and devices 1. Prohibition of sale of certain food, drugs, cosmetic and devices
(1) No person shall sell, import, manufacture or store any article of food which- [1999 No. 21.] has in it or upon it any poisonous or harmful substance not being a food addi- tive or contaminant of a type and within the level permitted by regulations made under this Act; consists in whole or in part of any filthy, disgusting, rotten or diseased substance. (2) No person shall sell, import, manufacture or store any article of food or any drug (3) No person shall sell, import, manufacture or store any article of food or any drug or cosmetic which was manufactured, prepared, preserved, packaged, or stored under insanitary conditions. (4) No person shall sell, import, manufacture or store any cosmetic which- has in it or upon it any substance which may cause injury to the health of the user thereof when the cosmetic is used- (i) according to the directions on the label or otherwise accompanying the (ii) for such purposes and by such methods of use as are customary or consists wholly or in part of any filthy or decomposed substance or of any foreign matter. (5) No person shall sell, import, manufacture or store any device which, when used according to the directions on the label or otherwise accompanying the device, or under such conditions as are customary or usual therefor, may cause injury to the user thereof. [1999 No. 21.] 2. Prohibition of sale or advertisement of food, etc., as treatment, etc., for certain
diseases
Except as otherwise provided by regulations, no person shall- advertise to the general public any food, drug, cosmetic or device as treatment, preventative or cure for any of the diseases, disorders or abnormal physical states specified in the First Schedule to this Act; or sell any food, drug, cosmetic or device that is represented on the label or is advertised to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states specified in the said First Schedule to this Act. 3.Prohibition of importation, exportation, distribution, etc., of specified drugs
Except as authorised by regulations, no person shall import into Nigeria or export
therefrom, manufacture, sell, distribute or cause to be distributed (whether as samples or
otherwise) any of the drugs specified in the Second Schedule to this Act.
4. Power of Minister to obtain particulars in respect of certain substances
(1) Where any person carries on any business in the course of which any substance- is used in the preparation of any food, drug or cosmetic; or is imported, produced or sold for use in the preparation of any food, drug or cosmetic, the Minister or any person authorised by the Minister in that behalf may serve on that person a notice requiring him to furnish to the Minister within such time as may be specified in the notice such particulars as may be so specified in respect of every substance which, being a substance or a substance of a class specified in the notice, is in the course of that business used as mentioned in paragraph (a) of this subsection or imported, pro- duced or sold for use as mentioned in paragraph (b) of this subsection. (2) Without prejudice to the generality of subsection (1) of this section, a notice un- der that subsection may in particular require the furnishing of the following particulars of any substance to which it applies, that is to say- particulars of the composition of the substance and the chemical formula of every ingredient thereof; particulars of the manner in which the substance is used or intended to be used in the preparation of any food, drug or cosmetic; (i) any investigations (and over what period of time) carried out by or on behalf and to the knowledge of the person carrying on the business for the purpose of determining whether or not the substance or any product produced when the substance is used as mentioned in paragraph (b) of this subsection is injurious to or otherwise affects health, and the result of any such investigations; (ii) any investigations or inquiries (and over what period or time) carried out by or on behalf and to the knowledge of the person carrying on the business for the purpose of determining the cumulative effect on the health of any person consuming in ordinary quantities that substance or any product produced when the substance is used as mentioned in paragraph (b) of this subsection. (3) No person shall disclose any information supplied to the Minister in pursuance of a notice under subsection (1) of this section except- with the written consent of the person who supplied the information; or in accordance with the directions of the Minister; or for the purposes of any proceedings under this Act. 5. Prohibition of various misleading
practices
No person shall-
label, package, treat, process, sell or advertise any food, drug, cosmetic or de- vice in a manner that is false or misleading or is likely to create a wrong impression as to its quality, character, value, composition, merit or safety; where a standard has been prescribed for any food, drug, cosmetic or device; label, package, sell or advertise any substance or article in such a manner that the substance or article is likely to be mistaken for that food, drug, cosmetic or device unless the substance or article complies with the prescribed standard; where a standard for a drug is contained in any of the publications specified in the Third Schedule to this Act, label, package, sell or advertise any substance which is not of the published standard in a manner likely to cause it to be mistaken for a drug of the published standard; in the case of drug for which no standard has been prescribed under the regu- lations or in any of the publications specified in the Third Schedule to this Act- (i) sell that drug in any manner which is likely to deceive or mislead a purchaser into thinking that the drug conforms to a standard prescribed as aforesaid; or (ii) sell that drug as complying with some other standard unless the drug complies with the professed standard under which it is sold. 6. Manufacture, etc., of food, etc., under unsanitary conditions
No person shall under unsanitary conditions manufacture, prepare, preserve, package or store for the purpose of selling, any food, drug or cosmetic. 7. Minister's certificate for manufacture, etc., of drugs specified in the Fourth or
Fifth Schedule
(1) No person shall manufacture for sale any drug specified in the Fourth Schedule to this Act without first obtaining, in accordance with the regulations, a certificate of the Minister to the effect that premises in which the drug intended to be manufacture and the process and conditions by and under which the manufacture is to be carried on are in the opinion of the Minister suitable for ensuring that the drug will be safe for use. (2) No person shall sell any drug specified in the Fifth Schedule to this Act without first obtaining in accordance with the regulations a certificate of the Minister that the batch from which the drug was taken is safe for use. (3) Except as provided in the regulations no person shall distribute or cause to be used as samples any of the drugs listed in the Fourth or Fifth Schedule to this Act. 8. Declaration by manufacturer
(1) The Minister or any person authorised by him in that behalf may order the manu- facture of any article of food, drug, cosmetic or device to furnish a declaration in the prescribed form that the article in question was manufactured in accordance with the provisions of this Act and the regulations, and it shall be the duty of the manufacturer to comply with the requirements of the order. (2) Except as provided by the regulations, no article of food, drug, cosmetic or device shall be imported or otherwise brought into Nigeria unless- it is accompanied by a certificate from the manufacturer to the effect that it was manufactured in accordance with any existing standard or code of practice pertaining to such product or, where such standard or code of practice does not exist for the particular product, in accordance with any international standard laid down, in the case of food, under the directive of the Codex Alimentarius Commission; and a certificate issued by or on behalf of the Government of the country where it was manufactured to the effect that its sale in that country would not constitute a contravention of the law of that country. (3) Notwithstanding anything contained in the foregoing provisions of this section, the Minister may by regulations provide that any such article as is mentioned in subsec- tion (2) of this section shall be imported into Nigeria unless it was manufactured in ac- cordance with any standards that may be specified in the regulations. 9. Designation of inspecting officers and analysts
(1) The Minister may, on the recommendation of the Food and Drugs Advisory Council, and subject to the provisions of this section, designate- any person (whether or not a member of the public service of the Federation) who pos- sesses such qualifications and fulfil such other requirements, if any, as are prescribed under this section and shall furnish to every person so designated a certificate of designation. (2) A person shall not be designated a food and drug analyst unless he is a graduate has at his disposal such laboratory facilities as are, in the opinion of the Min- ister, adequate to enable him to discharge his functions properly under this Act; produces evidence of post-graduate training or qualification in the analysis of food and drugs; and has had not less than five years' continuous post-graduate relevant experience in the analysis of food and drugs in an approved laboratory. (3) A person shall not be designated a drug analyst unless he holds a professional qualification in pharmacy acceptable to the Minister and- has at his disposal such laboratory facilities as are, in the opinion of the Min- ister, adequate to enable him to discharge his functions properly under this Act; produces evidence of post-qualification training or experience in the analysis of drugs; and has had not less than five years' continuous post-qualification experience in the analysis of drugs in an approved laboratory. 10. Powers of inspecting officers
(1) An inspecting officer may, in the course of his duty, at any reasonable time and on production of his certificate of designation if so required- enter (if need be by force) any premises in which he reasonably believes that any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged, stored or sold; examine any article in the premises which appears to him to be an article to which this Act or the regulations apply or anything in the premises which he reasonably believes is used or is capable of being used for the manufacture, preparation, preservation, packaging, storage or sale of any such article; take a sample or specimen of any article to which this Act or the regulations apply or which he has power to examine under paragraph (b) of this subsection; open and examine, while on the premises, any container or package which he reasonably believes may contain anything to which this Act or the regulations apply or which may help him in his investigation; examine any books, documents or other records found on the premises which he reasonably believes may contain any information relevant to the enforcement of this Act or the regulations and make copies thereof or extracts therefrom; and seize and detain for such time as may be necessary for the purposes of this Act any article by any means of or in relation to which he reasonably believes any provision of this Act or the regulations has been contravened. (2) In subsection (1) of this section, the expression "article to which this Act or
the
regulations apply" means-
any food, drug, cosmetic or device; anything used for the manufacture, preservation, packaging or storing of any food, any labelling or advertising material relating to or for use in connection with any (3) The owner or person in charge of any premises entered by an inspecting officer pursuant to this section, and every person found therein, shall give all reasonable assis- tance in their power to the inspecting officer and shall make available to the inspecting officer all such information as the officer may reasonably require for the purposes of this Act. (4) Any article seized under this Act shall be kept or stored in such a place as the in- specting officer may direct and shall be returned to the owner or the person from whom it was seized if the article, upon analysis or examination, is found to conform with the requirements of this Act and the regulations. (5) Any article seized by an inspecting officer pursuant to this Act or the regulations may be submitted to an analyst for analysis or examination and the analyst, upon making such analysis or examination, shall issue a certificate or report in the prescribed form setting forth the result of such analysis or examination and, without prejudice to the generality of section 19 (2) of this Act, the inspecting officer shall on demand deliver a copy of such certificate or report to the owner of the article if the article is to be the subject of proceedings under this Act. (6) In this section, "animals" includes birds and fishes.
11. False statement
No person shall wilfully make or insert any false statement in any certificate or other document required by this Act or the regulations to be issued, made or furnished. 12. Obstruction of inspecting officers
obstruct or resist an inspecting officer in the execution of his duty under this Act or make in any manner whatsoever to an inspecting officer acting in the course of his duties any statement which that person knows or has reasonable cause to believe to be false or misleading; or without the authority of an inspecting officer remove, alter or interfere in any way with any HOLD LABEL tag or article seized under this Act. 13. Power of inspecting officers on importation of food, etc.
(1) An inspecting officer shall have the right to examine any customs entries of any food, drug or cosmetic imported for use in Nigeria and for the purposes of analysis or examination thereof to take samples of any such food, drug, or cosmetic while still in any customs shed or government warehouse in Nigeria. (2) Where sample are taken by an inspecting officer pursuant to subsection (1) of this section, the food, drug or cosmetic from which they are taken shall not be released to the importer except on production of an analyst's certificate or report to the effect that the food, drug or cosmetic complies with the requirements of this Act and the regulations. (3) Where, in the course of his duties under this Act or the regulations an inspecting officer takes a sample of any food, drug or cosmetic for the purposes of analysis, he shall, in the presence of the owner or importer or any person in apparent control of the food, drug or cosmetic, seal the article in triplicate, one copy of which shall be sent to the analyst, the second retained by him and the third delivered to the owner, importer, or person in apparent control, as the case may be. 14. Forfeiture
(1) Where the owner of an article seized under this Act consents to the forfeiture thereof the article shall thereupon be forfeited to the Minister. (2) Where a person has been convicted of an offence under this Act or the regulations the court may order that the article by means of or in respect of which the offence was committed, and anything of a similar nature belonging to or in the possession of the person convicted or found with that article, be forfeited to the Minister. (3) Without prejudice to the provisions of subsection (1) of this section, where any article has been seized under this Act, a judge of a Federal High Court may, upon appli- cation by an inspecting officer and after the giving of notice to such persons as the judge or magistrate may direct, order that the article and anything of a similar nature found therewith be forfeited to the Minister, if after hearing all the parties concerned he is of the opinion that the article is one by means of or in relation to which any of the provisions of this Act or the regulations is being or has been contravened. (4) Where, whether in pursuant of an order under this section or otherwise, any arti- cle or thing is forfeited to the Minister under this section it shall vest in the Minister free from encumbrances, and the Minister may retain it or cause it to be destroyed or other- wise disposed of as the Minister thinks fit. 15. Food and Drugs Advisory Council
(1) The Minister may set up a Council to be known as the Food and Drugs Advisory Council, to assist and advise him in the preparation and review of regulations for carrying out the purposes and provisions of this Act and with respect to any other matters connected with this Act. (2) The said Council shall consist of such persons as the Minister may appoint, being persons who appear to the Minister to be suitable for appointment- (a) by reasons of their knowledge or experience of the matters to which this Act (b) as representing the interests of producers or distributors of food, drugs, cos- as representing the interests of consumers or users thereof. 16. Regulations
(1) The Minister may make regulations for carrying out the purposes and provisions of this Act and with respect to any other matter connected with this Act. (2) Without prejudice to the generality of subsection (1) of this section the Minister for determining what constitutes the adulteration of any food or drug or class of food or drug and for determining what constitutes foreign matter in relation to any cosmetic or class of cosmetics; (b) prescribing the type and level of food additive or contaminant that may be (i) the labelling and packaging and the offering or exposing in any manner for sale of any food, drug, cosmetic or device; (ii) the specifications and fill of packages of food, drugs, cosmetics and (iii) the sale of any food, drug, cosmetic or device; with respect to the use of any substance as an ingredient in any food, drug, cosmetic or device, for the purpose of preventing consumers or purchasers thereof from being misled or deceived as to the quantity, character, value, composition, merit or safety of that substance when so used or of preventing injury to the health of consumers or users thereof; prescribing standards of composition, potency, purity or quality, or of any other property, for any article of food, drug, cosmetic or device; with respect to the importation of any food, drug, cosmetic or device for the purpose of ensuring compliance with the provisions of this Act and the regula- tions; with respect to the method of preparing, manufacturing, preserving, packaging, storing or testing of any food, drug, cosmetic or device, in the interests of, or for the prevention of injury to the health of, consumers or users thereof; requiring persons who sell food, drugs, cosmetics or devices to maintain and keep such books or records as may be prescribed; with respect to the form of certificate to be issued by the Minister for the pur- poses of section 7 (1) of this Act, and the manner of application therefor in- cluding the fees payable therefor, and with respect to the premises or processes or conditions of manufacture, including the qualifications of technical staff, which purposes of that subsection; for requiring manufacturers of any drugs specified in the Forth Schedule to this Act to submit test portions of any batch of any such drug and with respect to the form of certificate to be issued by the Minister for the purposes of sec- tion 7 (2) of this Act including the fees payable therefor; with respect to the manner of taking samples and the reporting of results of exempting any food, drug, cosmetic or device from all or any of the provisions of this Act or of the regulations whether unconditional or subject to prescribed conditions; prescribed forms for the purpose of this Act and the regulations; providing for the analysis of food, drugs, or cosmetics otherwise than for the purpose of this Act and prescribing a tariff of fees to be paid for such analysis; with respect to the distribution of samples of any drug; with respect to any advertisement of drugs and cosmetics; amending the First to Fifth Schedule to this Act in the interests of, or for the prevention of injury to the health of consumers or users; and prescribing anything authorised or required by this Act to be prescribed. 17. Penalties
(1) Any person who contravenes any of the provisions of this Act or the regulations made under it or fails to comply with any requirement imposed on him by a notice under subsection (1) of section 4 of this Act shall be guilty of an offence and liable on convic- tion to a fine of not less than fifty thousand naira or imprisonment for a term not exceed- ing two years or to both such fine and imprisonment. (2) Where an offence under this section committed by a body corporate is proved to have been committed with the consent or connivance of, or to be attributable to any ne- glect on the part of any director, manager, secretary or other similar officer of the body corporate, or any person purporting to act in any such capacity, he, as well as the body corporate, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly. 18. Trial of offences
The Federal High Court shall have exclusive jurisdiction to try offences under this 19. Defence in proceedings for sale of food, etc.
(1) Subject to subsection (2) of this section, it shall be a defence in any proceedings for an offence consisting of the sale of any article in contravention of this Act or the regulations to prove- that the accused sold the article in the same package and in the same condition that the accused could not with reasonable diligence have ascertained that the sale of the article would be in contravention of this Act or the regulations. (2) A person charged with an offence under this Act shall not be entitled to avail himself of the provisions of subsection (1) of this section unless he has given notice of this intention to do so at least ten days before the date of the trial and has at the same time disclosed to the prosecution the name of the person from whom he bought the article in question and the date of the purchase thereof. 20. Certificates and presumptions
(1) In any proceedings under this Act or the regulations the production of a certificate purporting to be signed by an analyst shall be prima facie evidence of the matters stated therein; but the party against whom the certificate is produced may require the attendance of the analyst for the purpose of cross-examination. (2) A certificate such as is mentioned in subsection (1) of this section shall not be re- ceived in evidence unless the party producing it has not less than three days before the trial supplied a copy thereof to the party against whom it is intended to be produced and has notified him in writing of the intention to produce it. (3) Where any employee or agent commits an offence under this Act, his employer or principal shall be deemed to have committed the offence and be liable to be proceeded against and punished accordingly, whether or not the employee or agent has been prosecuted for the same offence; and for the purpose of this subsection, any person selling or ostensibly employed to sell on behalf of another person shall be presumed to be employed by him. (4) Where, in any proceedings against any person for manufacturing any adulterated food or drug contrary to the provision of this Act or the regulations, it is established that the food or drug is one which, under the regulations, becomes adulterated if any pre- scribed substance is added thereto, and that that substance was found in his possession or on his premises, it shall be presumed, unless the contrary is proved, that the food or drug manufactured by him is adulterated. 21. Interpretation
In this Act, unless the context otherwise requires- "analyst" means any person designated as a food and drug analyst or as a drug ana-
"cosmetic" means any substance or mixture of substances manufactured, sold or ad-
vertised for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants; "device" means any instrument, apparatus or contrivance (including components,
parts and accessories thereof) manufactured, sold or advertised for use in the diagnosis, treatment, mitigation or prevention of any disease, disorder, abnormal physical state or the symptoms thereof, in man or in animals; "drug" includes any substance or mixture of substances manufactured, sold or
the diagnosis, treatment, mitigation or prevention of any disease, disorder, ab- normal physical state, or the symptoms thereof, in man or in animals; restoring, correcting or modifying organic functions in man or in animals; disinfection, or the control of vermin, insects or pests; or ''food'' includes any article manufactured, processed, packaged, sold or advertised for
use as food or drink for human consumption, chewing gum and any ingredient which may be mixed with food for any purpose whatsoever and excludes- "insanitary conditions" means such conditions or circumstances as might contaminate any
food, drug or cosmetic with dirt or filth or render it injurious to health; "inspecting officer" means any person designated as a food and drug inspecting officer
under section 9 of this Act by the National Agency for Food and Drug Administration and Control; "label" in relation to any food, drug, cosmetic, device or package includes any leg-
end, word or mark attached to, included in, belonging to or accompanying that food, drug, cosmetic, device or package; "Minister" means the Minister of Health;
"package" includes anything in which any food, water, drug, cosmetic or device is
wholly or partly contained, wrapped, placed or packed; "prescribed" means prescribed by the regulations;
"regulations" means any regulation made under this Act;
"selling" includes offering for sale, exposing for sale and having in possession for
21. Short title
This Act may be cited as the Food and Drugs Act. Diseases, etc., referred to in section 2 Gallstones, kidney stones, and bladder stones Any genital or urinary diseases not mentioned elsewhere in this Schedule Sexual impotence, loss of virility or sterility (3-(1, 2-dimethylhepty)-1-hydroxy-7, 8, 9, 10 (N,N-dimethyltryptamine) (+)-N,N-diethyllysergamide (d-lysergic acid diethylamide) (3,4, 5-trimethoxyphenethylamine) (3-hexyl-1-hydroxy-7, 8, 9, 1O-tetrehydro-6, 6, 9- (3-(2-dimethylaminethyl)-4-hydroxyindole) (3-(2-dimethylaminoethyl) indol-4-yl dihydrogen (2-amino-1-(2, 5-dimenthoxy-4-methyl) phenyl-propane) tetrahydrocannabinols, all isomers 1-hydroxy-3-pentyl-6a, 7, 10, 10a,-tetrahydro-6, 6, 9 tri- (2-phenyl-2-(2-piperidylo acetic acid, methyl ester) Any synethic compound or saIt (however structurally derived) of Amphetamine or of any substance of the like nature as Amphetamine. AMOBARBITAL (5-ethyl-5-(3-methllbuty)baituric acid) CYCLOBARBITAL (5-C GLUTETHIMIDE PENTOBARBIT AL SECOBARBITAL AMFEPRAMONE BARBITAL ETHINAMATE MEPROBAMATE METHAQUALONE METHYLPHENOBARBITAL METHYPRYLON PHENOBARBITAL PIPRADROL SPA COBALT PREPARATIONS CYCLIZINE SULPHAMETHOXYDIAZINE SULPHADIMETHOXINE AMINOPYRINE AND DIPYRONE ACECARBROMAL CYCLAMATES, CYCLOHEXYLEMINE AND THEIR DERIVATIVES COMPHETAMINES CHLORAMPHENICOL AND ITS PREPARATIONS CAFFEINE Publications referred to in section 5 Any other pharmacopoeia published under the authority of a recognised medical or Drugs referred to in section 7 (1) Liver extract in all forms Insulin in all forms Anterior pituitary extracts Radioactive isotopes Living vaccines for oral or parenteral use Drugs prepared from micro-organisms or viruses, for parenteral use Sera and drugs analogous thereto, for parenteral use Antibiotics for parenteral use. Drugs referred to in section 7 (2) Arsphenamine Dipchlorophenarsine hydrochloride Neoarsphenamine Oxophenarshine hydrochloride Sensitivity discs and tablets Sulpharsphenamine. FOOD AND DRUGS ACT SUBSIDIARY LEGISLATION

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