Canadian Report Sets Stage for Future Supplements Regulations
Published: Tuesday, December 01, 1998
The Minister of Health may now accept or reject the report, but it is expected that most of its recommendations will be accepted by the minister and given back to Health Canada with a specific directive to implement the recommendations as quickly as possible.
Overall, the report, “Natural Health Products: A New Vision,” proposes that NHPs be treated as neither foods nor pharmaceutical products, that safety be the primary concern, and that the industry meet clearly established quality standards.
The report also proposes that
• Regulations should not unduly restrict access by consumers to either NHPs or to adequate information on their use;
• Regulations should not place inappropriate costs on industry, consumers and government;
• Decision-making power should be given to a regulatory body with expertise and experience in NHPs;
• Regulations must respect cultural traditions and diversity.
The report generally supports an earlier advisory panel’s recommendation that drug products be renamed therapeutic products and be divided into NHPs and pharmaceutical products. Toward that end, it recommended including three main components: that the products are substances found in nature; are presented in dosage forms as capsules, tablets and the like; and that they have properties for health maintenance and improvement as well as disease prevention and treatment.
In the report, the committee also recommended that Health Canada, the agency under which the regulations will have jurisdiction, work in conjunction with a new, separate NHP Expert Advisory Committee to create the new NHP definition. The final definition likely will necessitate revisions to sections of the current Canadian Food and Drug Act that currently prohibit or inhibit the sale of NHPs.
In addition, the report suggests that the government consider a new regulatory authority staffed by NHP experts and that the selection of its staff be agreeable to government and stakeholders. It also urged that relevant inspection personnel be provided with training specific to NHPs and that the necessary process to amend the Canadian Food and Drugs Act not delay the implementation of the regulatory and administrative changes.
Good manufacturing practices (GMPs) also should be developed that reflect the unique nature of NHPs. For herbals, standards should include specific quality control and testing. For manufacturers, packagers, importers and distributors in Canada or abroad, valid establishment licenses should be required to sell products in Canada. In addition, inspections should be consistently and regularly performed.
With respect to labeling, structure/function, risk reduction and treatment claims should be considered for NHPs, according to the report. Evidence in support of the claims should range from accepted and traditional references to professional consensus and may include available clinical or scientific evidence. The requirements for the evidence should vary depending on the type of claims, and labels should clearly reflect the type of evidence supporting the claim.
The recommendations include that product licenses would be based on a monograph system developed by Health Canada and the Expert Advisory Committee and would require premarket approval. Additionally, submissions for licenses would match the level of risk inherent in the product to a predetermined margin of safety as set by Health Canada. Product submissions without existing approved monographs would have to have supporting literature presented by the manufacturer consistent with the product’s margin of safety.
Bill Reynolds is president of Reynolds & Associates in Toronto. He can be reached at 416.480.0089 or at reynco@aol.com.