Herbal medicinal products in the European Union - AESGP

IX. LEGAL REQUIREMENTS AND THE ASSESSMENT OF
HERBAL MEDICINAL PRODUCTS IN NORTH AND
CENTRAL AMERICA
It was regarded as useful for this study also to collect information for the countries of the
North American Free Trade Agreement (NAFTA). In light of the efforts to establish a
Transatlantic Market Place and a Transatlantic Partnership there have been debates on the
free movement of herbal medicinal products on both sides of the Atlantic. The information
on Canada, Mexico and the United States of America therefore seems to be useful in the
context of this study.
IX.1 Canada
Note:
These answers are based on the regulatory environment in Canada as of August 1998. It
should however be noted that the Standing Committee on Health, a parliamentary committee,
has been studying the regulatory situation of natural health products in Canada since
December 1997. This Committee is scheduled to report its recommendations, including a new
regulatory framework for these products, by the autumn of 1998. It is expected that significant
changes to the current regime will occur as a result. Some of the issues being considered
include a definition for natural health products, implementation of a post-market
notification system for low-risk products (involving attestation to monographs or standards),
labelling requirements including permitted health claims (structure/function, risk
reduction and treatment claims), as well as quality, safety and efficacy issues.
IX.1.1 Classification of herbal medicinal products
a) How are herbal medicinal products defined in your country and which
products containing plants are not classified as medicinal products? What are the
criteria for classification as a medicine (e.g., by function or presentation or both)?
Currently there is no definition for herbal medicinal products in Canada. (This is one of the
issues being reviewed by the Standing Committee on Health.)
Under existing regulations, a plant product is classified as either a food or a drug depending
on whether or not it makes a therapeutic claim. According to the Food and Drugs Act, a
“drug” includes any substance or mixture of substances manufactured, sold or represented
for use in the:
(a) diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal
physical state, or its symptoms, in human beings or animals;
(b) restoring, correcting or modifying organic function in human beings or animals; or
(c) disinfecting of premises in which food is manufactured, prepared or kept.
According to this Act, a “food” is defined as any article manufactured, sold or represented
for use as a food or drink for human beings, chewing gum, and any ingredient that may be
mixed with food for any purpose. In general, if a plant product does not make a therapeutic
claim according to the drug definition, it is classified as a food and subject to food
regulations. If it does make a therapeutic claim, however, it is classified as a drug product
and subject to drug regulations.
The herbal ingredient which is appropriate as a food (e.g., certain herbal teas and candies)
can be consumed more or less as desired because of the absence of pharmacological
properties which might produce side effects. When a herbal ingredient possesses
pharmacological activity which leads to its use as a remedy – and, in fact, makes its use as
a remedy more appropriate than as simply another article in the diet – then it is regulated as
a drug product in exactly the same way as non-herbal ingredients would be treated under
similar circumstances. For example, proper labelling is required so that the consumer may
select and use the product wisely.
In addition, a plant product may also be classified as a narcotic or controlled substance
under the Controlled Drugs and Substances Act and would not be available to consumers
except under special circumstances. Plants or plant materials that are scheduled under the
Act are: Cannabis (marijuana), Opium poppy (opium), Catha edulis (Khat) and Psilocybin
104