CANADA Law and Practice Contributed by: Sylvie Rodrigue, Grant Worden, Nicole Mantini and Anne Merminod, Torys LLP
Industry-Specific Laws A number of specific categories of products have their own legislative regimes. Food, drugs, natural health products, and cosmetics The Food and Drugs Act (FDA) is implemented through an extensive framework of regulations and supported by numerous regulatory guidelines and policies that govern the manufacture, sale, import, and labelling of pharmaceuticals, medical devices, natural health products, and cosmetics (including personal care products). The four main sets of regulations that may apply to products governed under the FDA are: • the Food and Drug Regulations; • the Medical Devices Regulations; • the Natural Health Products Regulations; and • the Cosmetic Regulations. Whether a product is governed by the FDA and its regulations depends on whether it fits one of the fol - lowing definitions. • A “drug” includes any substance or mixture of substances manufactured, sold, or represented for use in: (a) diagnosing, treating, mitigating, or preventing disease, disorder or abnormal physical state, or any of their symptoms in humans or animals; (b) restoring, correcting or modifying organic func - tions in humans or animals; or (c) disinfection in premises in which food is manu - factured, prepared or kept. • A “device” means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, that is manufactured, sold or represented for use in: (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals; (b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals; (c) diagnosing pregnancy in human beings or animals;
(d) caring for human beings or animals during pregnancy, or at or after the birth of the off - spring, including caring for the offspring; or (e) preventing conception in human beings or animals. • A “natural health product” is defined as a sched - uled substance, a homeopathic medicine, or a traditional medicine, that is manufactured, sold or represented for use in: (a) the diagnosis, treatment, mitigation or preven - tion of a disease, disorder or abnormal physical state or its symptoms in humans; (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. • A “cosmetic” is defined as any substance or mix - ture of substances manufactured, sold, or repre - sented for use in cleaning, improving, or altering the complexion, skin, hair, or teeth. This includes a wide range of products such as creams, lotions, makeup, perfumes, shampoos, deodorants, tooth - paste, and mouthwash. • “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. The FDA and its regulations empower Health Canada, the federal regulator, to order mandatory recalls and changes to products; to stop the manufacture, import, packaging, storing, advertising, sale, labelling, test - ing, and/or transport of products; and to mandate any other measures necessary to remedy non-compliance with legislation. The requirements set out by the FDA are complex and vary by product type, including the following. • Foods: (a) labelling requirements, nutrition facts, and allergen declarations; (b) standards for product categories such as meat and poultry, dairy products, fresh fruits and vegetables, and novel foods; (c) guidelines on food additives, chemical contam - inants, and packaging materials; and
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