Whither the Regulator: Food and Drug Law, the Natural Health Product Regulations and the Erosion of Safety, Efficacy and Quality

Abstract

The following thesis considers whether the regime established by the Natural Health Product Regulations (NHPR) is a suboptimal framework. It explores the effects that the creation and implementation of the NHPR have had on the safety, efficacy, and quality (SEQ) standard used in Canadian food and drug law. The original regulations, largely brought in to support the licensing of traditional medicines, herbs, vitamins, and other naturally occurring substances, have with time come to be dominated by non-traditional products making poorly demonstrated health claims. Over time, the Natural Health Products Directorate (NHPD) came to focus on access and speed of approval over demonstration of products’ merit or ensuring their quality and safety. The result is a set of regulations which do little to advance their original public health goals. The thesis uses a model of realistic empirical analysis (REA) in governance law to assess how the regulations have manifest in operation, with intended and unintended consequences. To achieve this goal, first, the nature, history, and regulatory issues associated with the SEQ standard and the emergence of Complementary and Alternative Medicine (CAM) are explored, in Chapters 2 and 3. Chapter 4 outlines the emergence and content of the NHPR. Chapter 5 explores the emerging policy goals of Health Canada, gaps in the NHPR and how the administration of the regulations has evolved from 2004 through 2023. Chapter 6 provides three case studies – energy drinks, homeopathics, and self-care products – which illustrate problems with the regulations. Chapter 7 looks at external sources that have assessed the regulations, such as court cases, audits, and evaluations. In Chapter 8 the deregulatory agenda in Canada as well as the concept of risk regulation are explored, which suggest that the NHPR’s weakness aligns with this agenda. In conclusion, it is observed that the NHPR are a poor set of health regulations and that their normalization of a lower SEQ standard is likely having a global effect of eroding health and safety across other areas of Canadian food and drug law. It is suggested that the NHPR should be strengthened to concentrate on quality and on reducing unfounded health claims. All regulation in Canada would greatly be improved by a more accurate assessment of its manifestation in line with concepts of really responsive regulation.