Natural Health Products

AuthorT. Nessim Abu-Zahra/Simon Carvalho/David Edwards
Natural Health Products
Products such as herbal medicines, probiotics, and multivitamins are widely
available on the Canadian market. ese products, which are known as nat-
ural health products (NHPs), meet the denition of “drug” under the Food
and Drugs Act (FDA) in other words, they are a subset of drugs. ere
are many dierent products that fall under the denition of “natural health
product.” ese include multivitamins, herbal products such as echinacea,
and even certain shampoos and toothpastes. NHPs are generally low-risk
products that are suitable for self-selection by consumers and are available
over the counter.
Prior to a new regulatory framework being developed for NHPs in ,
NHPs were regulated as drugs under Part C of the Food and Drug Regulations
(FDRs). Many NHPs were on the market with the required drug identi-
cation number (DIN), but many more were sold without one. In , the
question of the regulation of these products was referred to the Standing
Joint Committee on Health. After studying the issue, the committee made
fty-three recommendations, including that Health Canada develop a regu-
latory regime designed specically for this class of products.
Health Canada accepted all of the committee’s recommendations and cre-
ated an organization called the Oce of Natural Health Products(ONHP).
e oce was later renamed the Natural Health Products Directorate (NHPD)
RSC , c F-.
CRC, c .
The Regulation of Drugs in Canada
and, when the directorate assumed responsibility for over-the-counter drugs
as well as NHPs, was renamed the Natural and Non-prescription Health
Products Directorate (NNHPD). e new directorate began developing a
new regulator y regime — the Natural Health Products Regulations (NHPRs),
which came into force in .
e regulatory impact analysis statement (RIAS) that was published
with the new regulations stated, in part:
ese Regulations are intended to provide Canadians with ready access to
natural health products that are safe, eective, and of high quality, while
respecting freedom of choice and philosophical and cultural diversity. . . .
Based on recommendations from the House of Commons Standing
Committee on Health (“Standing Committee”), set out in its  report
entitled: A New Vision: Report of the Standing Committee on Health, the
main components of the Regulations are denitions, product licensing,
adverse reaction reporting, site licensing, good manufacturing practices,
clinical trials, and labelling and packaging.
e Federal Court of Appeal has since conrmed that“e purpose of
the NHP regulatory framework is to provide Canadians with access to safe,
eective and high quality NHPs, and to regulate these products in a manner
commensurate with their level of risk.”
As discussed below, NHPs are not, with a few exceptions, subject to the
rules in the FDRs.
1) Things That Are NHPs
e NHPRs dene NHPs as follows:
natural health product means a substance set out in Schedule  or a com-
bination of substances in which all the medicinal ingredients are substances
set out in Schedule , a homeopathic medicine or a traditional medicine,
that is manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disor-
der or abnormal physical state or its symptoms in humans;
 SOR/-.
Canada RNA Biochemical Inc v Canada (Health),  FCA  at para , a’g 
FC .

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