1. Product Classification by Health Canada Alysyn Smith Manager, Product Assessment Division Bureau of Product Review and Assessment Natural and Non-prescription Health Products Directorate Health Products and Food Branch Health Canada University of Waterloo – December 4, 2015

2. Outline Provide guidance on the classification of a product  Regulation of products under the Food and Drugs Act  Regulation under another Health-related Acts such as Canada Consumer Product Safety Act (CCPSA) Controlled Drugs and Substances Act (CDSA) Pest Control Products Act (PCPA) 22

3. Acts Classification is the first step in any regulatory process – you need to determine which legislation or regulations (if any) apply to the product or activity in question. Each classification should be assessed based on legislative authorities set out in the Acts. It is recommended that applicants always consult the current consolidated versions of the Acts and regulations from the Justice Canada website. http://laws.justice.gc.ca/eng/http://laws.justice.gc.ca/eng/ 3

4. Food and Drugs Act - Definitions “Drug” includes any substance or mixture of substances manufactured, sold or represented for use in  the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,  restoring, correcting or modifying organic functions in human beings or animals, or  disinfection in premises in which food is manufactured, prepared or kept; “Food” includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever; “Cosmetic” includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes; 4

5. Food and Drugs Act - Definitions “Device” means any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, b) restoring, correcting or modifying a body function or the body structure of human beings or animals, c) the diagnosis of pregnancy in human beings or animals, or d) the care of human beings or animals during pregnancy and at and after birth of the offspring, including care of the offspring, e) preventing conception in human beings or animals; however, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal. 5

6. Regulations under the Foods and Drugs Act 6 Food and Drugs Act defines Cosmetic, Device, Drug, Food NHP Regulations Since 2004 Food and Drug Regulations Part C – Drugs Div. 1 – “old drugs” Div. 3 – Radiopharmaceuticals Div. 4 – Biologicals Div. 8 – New Drugs Medical Devices Regulations Revises definition to exclude animals Cosmetics Regulations Food and Drug Regulations Part B – Foods “Drug” is broken down in the Regulations

7. Cosmetic Regulations All cosmetics sold in Canada must be safe to use and must not pose any health risk. They must meet the requirements of the Food and Drugs Act and the Cosmetic Regulations.Food and Drugs ActCosmetic Regulations Under the Food and Drugs Act, a cosmetic includes "any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes." This includes cosmetics used by professional esthetic services, bulk institutional products (such as hand soap in school rest rooms), as well as "handmade" cosmetics sold at craft sales or home-based businesses. The Cosmetic Regulations and the Food and Drugs Act require that cosmetics sold in Canada be manufactured, prepared, preserved, packed and stored under sanitary conditions. The manufacturer and importer must notify Health Canada that it is selling the product and provide a list of the product's ingredients. Additionally, cosmetics are subject to the requirements of the Consumer Packaging and Labelling Act and Regulations and any chemicals found in cosmetics may be subject to the Canadian Environmental Protection Act.Consumer Packaging and Labelling ActRegulationsCanadian Environmental Protection Act Additional guidance on the difference between therapeutic claims and cosmetic claims can be found in the Guidelines for the Non-prescription and Cosmetic Industry Regarding Non-Therapeutic Advertising and Labelling Claims published by Advertising Standards Canada 7

8. Cosmetic Regulations continued “Cosmetics” with health claims are regulated as Part C-drugs or as NHPs e.g., antiperspirants, sunscreens with SPF, fluoride toothpaste Guidelines for the Non-prescription and Cosmetic Industry Regarding Non- Therapeutic Advertising and Labelling Claims published by Advertising Standards Canada http://www.adstandards.com/en/Clearance/Cosmetics/Guidelines-for-the- Nonprescription-and-Cosmetic-Industry.pdf Guidance on Classification of Products at the Cosmetics-Drug Interface http://www.hc-sc.gc.ca/cps-spc/cosmet-person/interface-frontiere/index-eng.php Cosmetic Ingredient Hotlist (list of restricted or prohibited substances in cosmetics) http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php 8

9. Medical Device Regulations These regulations apply to  (a) the sale and advertising for sale of a medical device; and  (b) the importation of a medical device for sale or for use on individuals, other than importation for personal use. These regulations also apply to an in vitro diagnostic product that is a drug or that contains a drug, as if the product were an in vitro diagnostic device. Medical devices are classified into one of Classes I to IV by means of the classification rules set out in Schedule 1, where Class I represents the lowest risk and Class IV represents the highest risk.  If a medical device can be classified into more than one class, the class representing the higher risk applies. 9

10. Definition of Natural Health Product (NHP) in the NHP Regulations 10 "natural health product" means a substance set out in Schedule 1 [to the NHP Regulations], a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans [i.e., not in animals]; b) restoring or correcting organic functions in humans; or c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.” Includes substances on Schedule 1 to the NHP Regulations Excludes substances on Schedule 2 to the NHP Regulations Excludes drugs listed on the Prescription Drug List

11. Schedule 1 to the NHP Regulations –Inclusions 11 Included natural health products substances Plant, alga, bacterium, fungus, non-human animal material Extract or isolate of the above Vitamins Amino acids Essential fatty acids Synthetic duplicates of the above Minerals Probiotics

12. Schedule 1 to the NHP Regulations –Exclusions 12 Excluded natural health product substances in Schedule C (radiopharmaceuticals) or D (biologics from micro-organisms or homeopathic pharmacy) to the Food & Drugs Act under the Tobacco Act in Schedules I-V of the Controlled Drugs & Substance Act administered by puncturing the skin antibiotics

13. Food and Drug Regulations Part C- Drugs As outlined in the Food and Drugs Act “Drug” includes any substance or mixture of substances manufactured, sold or represented for use in  the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,  restoring, correcting or modifying organic functions in human beings or animals, or  disinfection in premises in which food is manufactured, prepared or kept; Part C of the Regulations Division 1 - Old drugs Division 3 – Radiopharmaceuticals Division 4 – Biologicals Division 8 – New Drugs 13

14. Food and Drug Regulations Part A - Food “Food” includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever. Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/food-nhp- aliments-psn-guide-eng.php 14

15. Consumer Product Safety Act The purpose of this Act is to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada, including those that circulate within Canada and those that are imported. Under the Canada Consumer Product Safety Act (CCPSA) a "consumer product" is defined as a product, including its components, parts or accessories that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging. Section 4 of the Act outlines the consumer products to which the CCPSA does not apply, including those listed in Schedule I. These include products that are covered under other legislation such as food, cosmetics, medical devices, drugs, natural health products, pest control products, fertilizers and vehicles. Tobacco products are also excluded, except with respect to their ignition propensity - i.e., their flammability properties. There are 36 sets of Regulations under the including the Toy Regulations, Ice Hockey Helmet Regulations, Hazardous Products (kettles) Regulations, Cribs, Cradles and Bassinets Regulations 15

16. Controlled Drugs and Substances Act Schedules I – VIII of the Act describe the different substances that are regulated under this Act There are 10 sets of Regulations under this Act including the Controlled Drugs and Substances Act (Police enforcement) Regulations, the Narcotic Regulations and the Marihuana for Medical Purposes Regulations 16

17. Pest Control Products Act From the Pest Control Regulations  (a) a device that is manufactured, represented, distributed or used to directly or indirectly control, destroy, attract or repel a pest or to mitigate or prevent the injurious, noxious or troublesome effects of a pest; and  (b) a compound or substance that is not an ingredient of a pest control product described in paragraph (a) of that definition but is added to or used with such a product to enhance or modify its physical or chemical characteristics or to modify an effect on host organisms in connection with which the product is intended to be used.  Exempted products that fall under the Food and Drugs Act 17

18. Classification of Health products -Classification is the first step in regulatory review process. -When unclear, the Therapeutic Products Classification Committee (TPCC) may be consulted. -TPCC makes recommendations on the classification of a product as either a drug (pharmaceutical, biological, or natural health product), medical device, or combination product. -If a product does not readily meet one of the definitions provided in the Food and Drugs Act, other regulatory areas of Health Canada are asked to participate in the committee's discussion. 18

19. Classification of Health products TPCC membership and representation: Biologics and Genetic Therapies Directorate; Pharmaceuticals; Medical Devices Bureau; Natural and Non-prescription Health Products Directorate; Veterinary Drugs Directorate; Health Products and Food Branch Inspectorate. Areas represented ad hoc when products may affect their area: Pest Management Regulatory Agency; Cosmetics; Consumer Product Safety; Tobacco; Food Directorate Legal Services are consulted for advice when needed. 19

20. Our classification webpages Classification of Health Products at the Device-Drug Interface http://www.hc-sc.gc.ca/dhp-mps/dev-drug-instr-drogue/index-eng.php What are products at the device-drug interface? Products that do not readily fall within the definition of "device" or "drug" as set out in the Food and Drugs Act. Three sets of regulations may apply under the Act : Medical Devices Regulations; Food and Drug Regulations ; or Natural Health Products Regulations. 20

21. How to contact us Natural and Non-Prescription Health Products Directorate nhp_initiative_psn@hc-sc.gc.ca nhp_initiative_psn@hc-sc.gc.ca Cosmetics cosmetics@hc-sc.gc.cacosmetics@hc-sc.gc.ca CDSA status@hc-sc.gc.ca Drug Prescription Status-Statut D'ordonnance Des Drogues@hc- sc.gc.caDrogues@hc- sc.gc.ca Drug-device classification drogue-instrument@hc-sc.gc.cadrogue-instrument@hc-sc.gc.ca Health Products Food Branch Inspectorate BIU-UIF@hc-sc.gc.caBIU-UIF@hc-sc.gc.ca Border Integrity Insp_Risk_NCC@hc-sc.gc.ca 21

22. Useful Links – to Acts Canada Consumer Product Safety Act http://laws-lois.justice.gc.ca/PDF/C-1.68.pdf Controlled Drugs and Substances Act http://laws-lois.justice.gc.ca/eng/acts/C-38.8/index.html Food and Drugs Act http://laws-lois.justice.gc.ca/eng/acts/F-27/index.html Pest Control Products Act http://laws-lois.justice.gc.ca/eng/acts/P-9.01/ Tobacco Act http://laws-lois.justice.gc.ca/eng/acts/T-11.5/index.html 22

23. Useful Links – to Regulations Cosmetic Regulations http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._869/index.html Food and Drug Regulations http://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/index.html Medical Devices Regulations http://laws-lois.justice.gc.ca/eng/regulations/SOR-98-282/index.html Natural Health Products Regulations http://laws-lois.justice.gc.ca/eng/regulations/SOR-2003-196/ Pest Control Products Regulations http://laws-lois.justice.gc.ca/eng/regulations/SOR-2006-124/ 23