Natural Health Products: 53 Recommendations of the Standing Committee on Health

Recommendations re: Efficacy

19. NHPs be allowed to make health claims, including structure-function claims, risk-reduction claims and treatment claims.

Status:

1. The Regulations define NHPs as products manufactured, sold or represented for use in:
   1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans;
   2. restoring or correcting organic functions in humans; or
   3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
2. NHPs are, as recommended by the Standing Committee on Health, permitted to make structure-function, risk reduction and treatment claims. In addition, the NHPD has proposed a fourth claim type, 'nutritional support', based on comments received during consultations with consumers, practitioners and industry. Claims in this category would relate to the established function of a particular nutrient(s) in normal physiology (e.g. 'Calcium helps to build strong bones'). Claims can also be made for the source of an essential nutrient (e.g. 'Source of folic acid').

20. Claims be assessed to ensure that there is reasonable evidence supporting the claim.

Status:

1. With a view to ensuring that reasonable evidence is sought in support of claims, the NHPD conducted a series of cross-country consultations on Standards of Evidence during the fall of 2002. Standards of Evidence refers to evidence that a product licence applicant must provide to Health Canada in order to support the safety and efficacy of a NHP before offering the product for sale.
2. Consultation comments are being reviewed and evaluated.
3. A guidance document on the Standards of Evidence will be published before January 1, 2004, when the new Regulations come into force.
4. Prior to sale, all NHPs will be assessed to ensure there is reasonable evidence to support the claim and safety of the product.

21. The evidence not be limited to double-blind clinical trials but also include other types of evidence such as generally accepted and traditional references, professional consensus, other types of clinical trials and other clinical or scientific evidence.

Status:

1. The NHPD is developing the Standards of Evidence guidance document, which outlines that evidence such as traditional references, conclusions of reputable regulatory agencies, peer-reviewed published reviews, expert committee reports and clinical trials, be considered when evaluating claims associated with NHPs. The Standards of Evidence guidance document will be available on the NHPD website before January 1, 2004, when the NHP Regulations come into force.

22. The evidence required vary depending on the type of claim being made, with different evidence being required for structure-function claims and risk-reduction claims for minor self-limiting conditions than for therapeutic or treatment claims.

Status:

1. The level of required data varies depending on the type of health claim and the health risk associated with the product.
2. As an example, the NHPD requires that traditional products that have a long history of safe use, for which traditional claims are made, be supported by two (2) traditional references.

23. The label indicate clearly the type of evidence used to support the claim.

Status:

1. The NHPD previously proposed that the label indicate the type of evidence that was provided to support the claim. Following the consultation on Standards of Evidence, the NHPD has revised its requirements so that only the label of a product supported solely by traditional references include a statement such as "traditionally used as ......".