2003-47
June 18, 2003
For immediate release
News Release
OTTAWA - The Honourable Anne McLellan, Minister of Health, announced the
adoption of the Natural Health Products Regulations, which were published today in
Canada Gazette, Part II.
Previously, natural health products (NHPs) have been sold as either drugs or
foods under the Food and Drugs Act and Regulations, since there is no other
category in which they can be classified. The Natural Health Product Regulations
are the result of a comprehensive and inclusive consultation process with Canadian
consumers, academics, health care practitioners and industry stakeholders, and are
a key element in fulfilling the House of Commons Standing Committee on Health's 53
recommendations. The new Regulations call for improved labelling, good
manufacturing practices, product and site licensing, and provisions for a
full range of health claims that will be supported by evidence.
�Consumers have asked for labelling of all ingredients, for any warnings to
be clear and understandable, for assurances of quality and safety, and for a system
of product licencing. With the introduction of these Regulations, Canadians will now
be in a much better position to make more informed decisions about the natural health
products they consume,� stated Minister McLellan.
The products that fall within the new Regulations include herbal remedies,
homeopathic medicines, vitamins, minerals, traditional medicines, probiotics,
amino acids and essential fatty acids (such as Omega-3).
All natural health products in Canada will now require a product licence
before being marketed. Obtaining a license will require detailed information on
the product submitted to Health Canada, including medicinal ingredients, source,
potency, non-medicinal ingredients and recommended use. Once a product has been
assessed by Health Canada, the product label will bear a product licence number
preceded by the distinct letters NPN, or, in the case of a homeopathic medicine,
by the letters DIN-HM. The product licence number on the label will inform consumers
that the product has been reviewed and approved by Health Canada for safety and
efficacy.
With improved, standardized labelling, consumers will be able to make more
informed decisions about the natural health products they buy. Labels will be
required to specify directions for use, the recommended use or purpose (health
claim), medicinal and non-medicinal ingredients, and any cautions,
contra-indications or known adverse reactions associated with the
product.
In making health claims, industry relies on a variety of standards of evidence,
such as history of use or traditional references, observational studies, expert
committee reports and clinical or trial data. However, ongoing research continues
to be necessary. To address this need for more research, Health Canada has committed
$5 million over 5 years to create the Natural Health Products Research Program.
Funding for this program will be drawn from the existing fiscal framework. The
Natural Health Products Research Program has been developed over the past 2 years
through active dialogue with all relevant stakeholder groups. Working closely in
partnership with the community at large and the Canadian Institutes of Health
Research, the Natural Health Products Research Program will support the creation
of a sustainable national natural health product research presence, which meets
the needs of Canadians.
There will be a transition period for the Regulations that will span from 2 to
6 years - 2 years for site licensing and 6 years for products with drug
identification numbers (DINs)- to allow manufacturers, labellers, packagers,
importers and distributors time to meet the new requirements. During the
phase-in period, Health Canada will provide support to industry, and undertake
a comprehensive public education and outreach program to ensure that the
Regulations are well understood. Health Canada is particularly mindful that
much of this industry consists of small and medium sized businesses and that
a sustained effort must be undertaken to provide working tools and processes
to support these enterprises.
�Canadians have contributed significantly in the development of the Natural
Health Products Regulations, and will continue to be consulted as Health Canada
moves forward with their implementation,� concluded the Minister.
Media Inquiries:
Ryan Baker
Health Canada
(613) 941-8189
Farah Mohamed
Office of Anne McLellan
Federal Minister of Health
(613) 941-8189
Public Inquires:
(613) 957-2991
