Abstract
BackgroundThe use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. As a result of consumer concern about the quality of these products, the Canadian Department of Health created the Natural Health Products (NHP) Regulations. The new Canadian regulations raise questions about whether and how the NHP industry will be able to comply and what impact they will have on market structure. The objectives of this study were to explore who in the interview sample is complying with Canada's new NHP Regulations (i.e., submitted product licensing applications on time); and explore the factors that affect regulatory compliance.MethodsTwenty key informant interviews were conducted with employees of the NHP industry. The structured interviews focused on the level of satisfaction with the Regulations and perceptions of compliance and non-compliance. Interviews were tape recorded and then transcribed verbatim. Data were independently coded, using qualitative content analysis. Team meetings were held after every three to four interviews to discuss emerging themes.ResultsThe major finding of this study is that most (17 out of 20) companies interviewed were beginning to comply with the new regulatory regime. The factors that contribute to likelihood of regulatory compliance were: perceptions and knowledge of the regulations and business size.ConclusionThe Canadian case can be instructive for other countries seeking to implement regulatory standards for natural health products. An unintended consequence of the Canadian NHP regulations may be the exit of smaller firms, leading to industry consolidation.
Highlights
The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time
A number of factors that affect compliance with new regulations have been identified in the literature including: perceptions of the law, the perceptions of the regulated companies towards compliance with the law, as well as whether the law specifies enforcement activity and the regulated respond to the law[5]
3 small and medium sized enterprises (SMEs) were noncompliant with the deadline, 4 SMEs were under complying, 1 SME was semi-complying, and 3 SMEs were compliant
Summary
The use of natural health products, such as vitamins, minerals, and herbs, by Canadians has been increasing with time. A number of factors that affect compliance with new regulations have been identified in the literature including: perceptions of the law (whether the law is thought to be necessary, whether those having to comply with the regulations agree with the law and feel they would benefit from the law), the perceptions of the regulated companies towards compliance with the law (whether noncompliance will result in penalties, whether the type and amount of compliance is clearly stated in the law, and whether compliance can be supported), as well as whether the law specifies enforcement activity and the regulated respond to the law[5] Compliance of those being regulated has been identified as an important stage of policy implementation and achieving the goals of a regulation[6]. This has created a substantial backlog and as of January 2005 there were thousands of application in cue waiting for NHPD assessment
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