Natural Health Products

• Author: T. Nessim Abu-Zahra/Simon Carvalho/David Edwards
• Pages: 121-137

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NINE

Natural Health Products

A. INTRODUCTION

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.

B. SCOPE, INCLUDING RELATIONSHIP WITH 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 .