Stricter regulations on Natural Health Products signal increasing requirements on items spanning vitamins to antiperspirant. Learn what this means for those who fail to comply with the new regulations.

Natural Health Products (NHPs) are increasingly popular with Canadian consumers and significant opportunities exist for developing new products. Inventive NHPs will benefit from patent protection. It is also important to proactively prepare to obtain approvals under Canada's NHP rules. Since January 1, 2004 the Natural Health Product Regulations (the Regulations) have categorized NHPs as drugs. All NHPs now require a product license before they can be sold in Canada. Persons manufacturing, packaging, labeling or importing a NHP require a site license. The Regulations also impose obligations to report serious adverse reactions and maintain lot and batch records.

NHPs that fall under the Regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids for use with respect to a human disease or disorder or for modifying "organic functions". Regulated NHPs can also include products such as energy drinks, dietary supplements, antiperspirants or sunburn protectants depending on their ingredients and health claims.

The significant government backlog in processing applications for NHP licenses and concerns regarding the suitability of the enforcement mechanisms for noncompliance resulted in some uncertainty in the NHP industry. However, as part of the Food and Consumer Safety Action Plan, the Government recently tabled a proposed law (Bill C-51) that includes a significant increase in fines for noncompliance with the Regulations. To minimize the impact of backlogs, license applications should be submitted as early as possible.

Health Canada continues to be guided by the principle that the higher the risk to human health and safety posed by a NHP, the more immediate the compliance and enforcement action. Nevertheless, it appears that in the future Health Canada will be taking a stricter approach across the board to enforcing the Regulations, and that the consequences of noncompliance may also become more severe.