| Health Canada's objective is to complete
compliance activities with respect to all noncompliant
products as of January 1, 2009, five years after the coming
into force of the Regulations. As of that date there should
be no NHPs on the market that have not submitted a product
licence application. Neither this final target date nor the
others indicated below should be construed as authorization
for any NHPs to be sold without product licences for a
specified period of time. Rather, the Regulations apply to
all NHPs as of January 1, 2004. Any other dates specified
below are targets for compliance efforts. Table 1 provides
the dates on which Health Canada will focus compliance
efforts with respect to non-compliant NHPs within each
product category. The rationale for the position of each
product category in the priority list is included.
Table 1. Priorities for Compliance and
Enforcement Action
Regarding Non-Compliant NHPs.
| Priority |
Date |
NHP Category |
Rationale for priority assignment |
| # 1 |
June 1, 2004 |
NHPs on TPD's Listing of Drugs
Currently Regulated as New Drugs, Revised April
1999* |
Health Canada considers these top priority NHPs
as they are substances and formulations for which
the lack of, or inadequate information on, their
safe use indicates that safety and efficacy for
medicinal purposes have not been established.
Traditional uses are explicitly excluded in the New
Drugs list. |
| # 2 |
January 1, 2005 |
Isolates, amino acids, fatty acids,
concentrated volatile (essential) oils indicated for
internal use, and extracts other than those prepared
by traditional methods** |
These are priority 2 NHPs as they may increase
the concentration of select constituents and thus
might be consumed in a higher dose than would
normally occur with the whole organism (e.g. a
plant); moreover, adequate pharmacological and
safety information may not be present. |
| # 3 |
June 1, 2005 |
Algal, bacterial, probiotic, fungal
and non-human animal materials |
These substances are considered priority 3 NHPs
because, while they generally present less risk than
selective concentrates, problems may arise as a
result of improper concentration, inadequate
ingredient identification, or lack of adherence to
Good Manufacturing Practices (GMPs). Safety issues
surrounding non-human animal materials relate to
risk mitigation for products potentially
contaminated with the causative agents of
transmissible/ bovine spongiform encephalopathy. |
| # 4 |
June 1, 2007 |
- Plants, plant materials;
- extracts prepared by traditional methods**,
- volatile (essential) oils other than those
that are concentrated and indicated for internal
use
|
Plants and plant materials are
considered Priority 4 because intrinsically plant
materials present less risk than their extracts or
isolates. Still, the safety information for many
species is limited. |
| # 5 |
January 1, 2008 |
|
Vitamins and minerals are considered priority 5
NHPs because most are well-known with regard to safe
conditions of use as dietary supplements. However,
there may be potential concerns associated with
- dosing of certain less-well known fat
soluble vitamins and micronutrient minerals as
dietary supplements; and
- recommendations for use without adequate
supporting evidence in the treatment of serious
diseases
|
| # 6 |
June 1, 2008 |
Homeopathic medicines |
Homeopathic medicines are considered to present
low risk because most do not contain a material dose
of a medicinal ingredient and standards for product
quality are well established in pharmacopoeias.
However, concerns may arise over low dilution
products that do contain a material dose or nosodes
where cross-contamination may present a health risk |
* Refer to the Natural Health Product Compliance Guide:
Annex B, Appendix 11.
** Defined under the Evidence Guidance Document for safety
and claim |
