Food, Drugs and Chemical Substances Act

Section 1. Short title Section This Act may be cited as the Food, Drugs and Chemical Substances Act.

Section 2. Interpretation Section any food, drug, cosmetic, device or chemical substance and any labelling or advertising materials in respect thereof;

Section 3. Prohibition against sale of unwholesome, poisonous or adulterated food Section has in or upon it any poisonous or harmful substance; or

Section 4. Deception Section Any person who labels, packages, treats, processes, sells or advertises any food in contravention of any regulations made under this Act, or in a manner that is false, misleading or deceptive as regards its character, nature, value, substance, quality, composition, merit or safety, shall be guilty of an offence.

Section 5. Standards of foods Section Where a standard has been prescribed for any food, any person who labels, packages, sells or advertises any food which does not comply with that standard, in such a manner that it is likely to be mistaken for food of the prescribed standard, shall be guilty of an offence.

Section 6. Prohibition against sale of food not of nature, substance or quality demanded Section Any person who sells to the prejudice of the purchaser any food which is not of the nature, or is not of the substance, or is not of the quality, of the article demanded by the purchaser shall be guilty of an offence.

Section 7. Preparation of food under insanitary conditions

Section 8. Prohibited sale of drugs Section is adulterated; or

Section 9. Deception Section Any person who labels, packages, treats, processes, sells or advertises any drug in contravention of any regulations made under this Act, or in a manner that is false, misleading or deceptive as regards its character, constitution, value, potency, quality, composition, merit or safety, shall be guilty of an offence.

Section 10. Standards of drugs Section 10(1) Where a standard has been prescribed for a drug, any person who labels, packages, sells or advertises any substance in such a manner that it is likely to be mistaken for that drug shall be guilty of an offence unless the substance is the drug in question and complies with the prescribed standard. Section 10(2) Where a standard has not been prescribed for a drug but a standard for the drug is contained in any of the publications specified in the Schedule, any person who labels, packages, sells or advertises any other substance or article in such a manner that it is likely to be mistaken for such drug shall be guilty of an offence. Section 10(3)(a) is in accordance with the professed standard under which it is labelled, packaged, sold or advertised; and Section 10(3)(b) does not resemble, in a manner likely to deceive, any drug for which a standard has been prescribed or which is contained in any of the publications specified in the Schedule.

Section 11. Prohibition against sale of drugs not of nature, substance or quality demanded Section Any person who sells to the prejudice of the purchaser any drug which is not of the nature, or is not of the substance, or is not of the quality, of the article demanded by the purchaser shall be guilty of an offence.

Section 12. Preparation of drug under insanitary conditions

Section 13. Prohibited sale of cosmetics Section according to the directions on the label of or accompanying such cosmetic; or

Section 14. Standards of cosmetics Section Where a standard has been prescribed for a cosmetic, any person who labels, packages, sells or advertises any article in such a manner that it is likely to be mistaken for a cosmetic of the prescribed standard shall be guilty of an offence unless the article complies with the prescribed standard.

Section 15. Preparation of cosmetic under insanitary conditions

Section 16. Prohibited sale of devices Section Any person who sells any device that, when used according to directions on the label or contained in a separate document delivered with the device or under such conditions as are customary or usual, may cause injury to the health of the purchaser or user thereof shall be guilty of an offence.

Section 17. Deception Section Any person who labels, packages, treats, processes, sells or advertises any device in contravention of any regulations made under this Act, or in a manner that is false, misleading or deceptive as regards its character, value, composition, merit or safety, shall be guilty of an offence.

Section 18. Standards of devices Section Where a standard has been prescribed for a device, any person who labels, packages, sells or advertises any article in such a manner that it is likely to be mistaken for that device shall be guilty of an offence unless the article complies with the prescribed standard.

Section 19. Preparation of device under insanitary conditions

Section 20. Adulteration of chemical substances Section is adulterated; or

Section 21. Deception Section Any person who labels, packages, treats, processes, sells or advertises any chemical substance in contravention of any regulations made under this Act, or in a manner that is false, misleading or deceptive as regards its character, value, quality, composition, merit or safety, shall be guilty of an offence.

Section 22. Standards of chemical substances Section Where a standard has been prescribed for a chemical substance, any person who labels, packages, sells or advertises any other substance in such a manner that it is likely to be mistaken for that chemical substance shall be guilty of an offence unless the substance complies with the prescribed standard for such chemical substance.

Section 23. Professed standards Section is not in accordance with the professed standard under which it is sold; and

Section 24. Disposal of chemical substances in certain manner prohibited Section Any person who uses or disposes of any chemical substance in a manner likely to cause contamination of food or water for human consumption or in a manner liable to be injurious or dangerous to the health of any person shall be guilty of an offence.

Section 25. Prohibited sales of chemical substances Section Any person who sells any chemical substance which, when used according to the instructions of the manufacturer or under such conditions as are customary or usual, might cause injury to the health of any person shall be guilty of an offence.

Section 26. Preparation of chemical substances under insanitary conditions Section Any person who sells, prepares, preserves, packages, stores or conveys for sale any chemical substance under insanitary conditions shall be guilty of an offence.

Section 27. Establishment of Board Section 27(1) There is hereby established a Board, to be known as the Public Health (Standards) Board, which shall consist of ten members appointed by the Cabinet Secretary unless otherwise provided. Section 27(2)(a) a Chairperson, who shall be the Director of Medical Services, or a person deputed by him in writing for the purposes of this Act; Section 27(2)(b) a vice-Chairperson, who shall be the Chief Public Health Officer of the Ministry of Health and Housing, or a person deputed by him in writing for the purposes of this Act; Section 27(2)(c) four members appointed to represent the Government; Section 27(2)(d) one member with special knowledge of the food-packing industry; Section 27(2)(e) one member representing municipal councils; Section 27(2)(f) one member nominated by the Pharmaceutical Society of Kenya; and Section 27(2)(g) one member representing the National Assembly. Section 27(3) All appointments made under this section shall be notified in the Gazette . Section 27(4)(a) shall each hold office for a period of three years, and shall then retire but shall be eligible for reappointment; Section 27(4)(b) may at any time resign by instrum...

Section 28. Regulations Section 28(1)(a) declaring that any food, drug or chemical substance or class of food, drugs or chemical substances is adulterated if any prescribed substances or class of substances is present therein or has been added thereto or extracted or omitted therefrom; Section 28(1)(b) the labelling and packing and the offering, exposing and advertising for sale of food, drugs, chemical substances, cosmetics and devices; Section 28(1)(b)(i) the labelling and packing and the offering, exposing and advertising for sale of food, drugs, chemical substances, cosmetics and devices; Section 28(1)(b)(ii) the size, dimensions and other specifications of packages of food, drugs, chemical substances, cosmetics and devices; Section 28(1)(b)(iii) the sale or the conditions of sale of any food, drug, chemical substance, or cosmetic or device; and Section 28(1)(b)(iv) the use of any substance as an ingredient in any food, drug, chemical substance or cosmetic or device, to prevent the consumer or purchaser thereof from being deceived or misled as to its quality, quantity, character, value, composition, effect, merit or safety or to prevent injury to the health of the consumer or t...

Section 29. Inspection of animals by authorized officers Section An authorized officer may, for the purposes of this Act, inspect any animal intended for slaughter and may seize and examine any meat which he considers to be unfit for consumption.

Section 30. Powers of authorized officers Section 30(1)(a) enter any premises where he believes any article to which this Act or any regulations made hereunder apply is prepared, preserved, packaged, stored or conveyed, examine any such article and take samples thereof, and examine anything that he believes is used or capable of being used for such preparation, preservation, packaging or storing or conveying; Section 30(1)(b) stop or search or detain any aircraft, ship or vehicle in which he believes that any article subject to the provisions of this Act is being conveyed and to examine any such article and take samples thereof for the purposes of this Act; Section 30(1)(c) open and examine any receptacle or package which he believes contains any article to which this Act or any regulations made thereunder apply; Section 30(1)(d) examine any books, documents, or other records found in any place mentioned in paragraph (a) of subsection (1) of this section that he believes contain any information relevant to the enforcement of this Act with respect to any article to which this Act or any regulations made hereunder apply and make copies thereof or take extracts therefrom; Section 30(1...

Section 31. Power of Director or Medical Services or Director of Agriculture to have articles analysed Section The Director of Medical Services in relation to any matter appearing to him to affect the general interests of the consumer, and the Director of Agriculture in relation to any matter appearing to him to affect the general interests of agriculture in Kenya, and any other person authorized in writing by the Cabinet Secretary so to do, may direct a public officer to procure for analysis samples of any food, drug, device, cosmetic or chemical substance, and thereupon that officer shall have all the powers of an authorized officer under this Act and this Act shall apply as if the officer were an authorized officer.

Section 32. Duty of municipal council to enforce Act Section 32(1) It shall be the duty of every municipal council to exercise such powers with which it is invested as may be, in its special circumstances, reasonably practicable so as to provide proper safeguards for the sale of food, drugs, cosmetics, devices and chemical substances in a pure and genuine condition, and in particular to direct its officers to procure samples for analysis. Section 32(2) If the Cabinet Secretary is of the opinion that a municipal council has failed to execute or enforce any of the provisions of this Act in relation to any article and that its failure affects the general interests of the consumer, the Cabinet Secretary may by order empower an officer to execute and enforce those provisions or to procure the execution and enforcement thereof in relation to any article mentioned in the order. Section 32(3) The expenses incurred under any such order shall be recoverable by the Cabinet Secretary from the municipal council and the amount so recovered shall be treated as expenses incurred by the municipal council under this Act. [L.N. 41/1970.]

Section 33. Power of Cabinet Secretary to obtain particulars of certain food ingredients Section 33(1) The Cabinet Secretary may direct any person who at the date of the direction or at any subsequent time carries on a business which includes the production, importation or use of substances of any class to which this Act applies to furnish to him, within such time as may be specified in such direction, such particulars as may be so specified of the composition and use of any such substance sold or for sale in the course of that business or used in the preparation of food or drugs. Section 33(2)(a) particulars of the composition and chemical formula of the substance; Section 33(2)(b) particulars of the manner in which the substance is used or proposed to be used in the preparation of food; Section 33(2)(c) particulars of any investigations carried out by or to the knowledge of the person carrying on the business in question, for the purpose of determining whether and to what extent the substance, or any product formed when the substance is used as aforesaid, is injurious to, or in any other way affects health; Section 33(2)(d) particulars of any investigations or inquiries carried o...

Section 34. Power of court to order licence to be cancelled Section On the conviction of any person for any offence under this Act or any regulations made thereunder, the court may, in addition to any other penalty which it may lawfully impose, cancel any licence issued under this Act, or any regulations made thereunder, to such person.

Section 35. Prosecution Section 35(1) An authorized officer may take out proceedings for an offence under this Act or the regulations before any magistrate having jurisdiction in the place where any article sold was actually delivered to the purchaser or where the sample was taken. Section 35(2) In any proceedings under this Act, the contents of any container appearing to be intact and in the original state of packing by the manufacturer thereof shall be deemed, unless the contrary is proved, to be an article of the description specified on the label. [Act No. 20 of 1989 , Sch.]

Section 36. Penalties Section 36(1)(a) in the case of a first offence, to a fine not exceeding five hundred thousand shillings or to imprisonment for a term not exceeding two years, or to both such fine and imprisonment; Section 36(1)(b) in the case of a subsequent offence, to a fine not exceeding seven hundred thousand shillings or to imprisonment for a term not exceeding five years, or to both such fine and imprisonment. Section 36(2) In any prosecution under this Act the summons shall state the particulars of the offence or offences alleged and also the name of the prosecutor and shall not be made returnable in less than fourteen days from the date on which it is served. [Act No. 2 of 2002 , Sch.]

Section 37. Certificates of analysis and presumptions Section the party against whom it is produced may require the attendance of the public analyst for the purposes of cross- examination; and

Section 38. Saving of Public Health Act and Dangerous Drugs Act Section The provisions of this Act shall be in addition to and not in derogation of the provisions of the Public Health Act ( Cap. 242 ) and the Dangerous Drugs Act (Cap. 245).

Section 39. Cabinet Secretary's power to amend Schedule Section The Cabinet Secretary may, by order, amend the Schedule to this Act.