The Canadian Natural Health Products (NHP) regulations: industry perceptions and compliance factors

Twenty 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.The 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.The 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.Consumer use of vitamins, minerals, and herbs increased dramatically during the 1990s. A 2001 survey found that 75% of Canadians had used a natural health product (NHP), such as vitamins, minerals, and/or herbal remedies, for a health condition[1]. In the United States, the use of herbals increased 380% during the period of 1990 to 1997[2]. As the use of these products increased, so did concern among consumers over the quality and efficacy of NHPs.The Canadian federal department of health, Health Canada, conducted extensive consultations with industry members, consumers, health care providers, and researchers to assist in developing regulations specifically for NHPs. Health Canada began implementing the NHP regulations on January 1, 2004[3]. The new NHP regulations classify NHPs as a sub-category of drugs, and apply to products commonly known as traditional herbal remedies, traditional Chinese, Ayurvedic, and Native North American medicines, homeopathic medicines, and vitamin and mineral supplements. Health Canada seeks "t