Originally published in Blakes Bulletin on Life
Sciences, October 2010
Since the Natural Health Products Regulations (NHPR)
were introduced in 2004, all natural health products (NHPs) require
a product licence to be marketed or sold in Canada. In order to
obtain a product licence, applicants must submit a product licence
application (PLA) to Natural Health Products Directorate of Health
Canada (NHPD), that contains sufficient information to satisfy the
NHPD that the product is safe, effective and of sufficient quality.
Once a product licence has been issued, the product will be
assigned a product number.
Since the introduction of the NHPR, there has been a significant
backlog at the NHPD in reviewing and approving NHP PLAs. On August
3, 2010, the Natural Health Products (Unprocessed Product
Licence Applications) Regulations (UPLAR) were introduced,
which provide a temporary mechanism whereby NHPs for which a PLA
has been filed, but for which a decision to issue or refuse a
licence has not been made, can obtain an exemption from the
requirement to have a product licence. Exempted products may be
legally sold in Canada and will be issued an exemption number,
which will stay in effect until the application is withdrawn, a
product licence issued, or the UPLAR repealed (which will occur 30
months after coming into force). Certain NHPs are ineligible for
the exemption, including products recommended for use in children
under 12 years of age or in pregnant or breastfeeding women.
Despite the introduction of the UPLAR, there remained some
questions about whether and how exempted NHPs could be advertised
to consumers. Particularly for broadcast ads, consumer advertising
for nonprescription drugs, including NHPs, is reviewed and cleared
by an advertising preclearance agency (APA), such as Advertising
Standards Canada, before use. This preclearance process is designed
to help industry ensure compliance with certain provisions of the
Food and Drugs Act (FDA) and associated regulations, as
well as various Health Canada guidance documents and APA codes of
advertising. As part of its preclearance exercise, the APA must
ensure that any health claims made in the advertisement are
consistent with the product's terms of market authorization
(TMA). For NHPs, the TMA is the product licence. Since exempted
NHPs do not have a product licence, it was not clear whether APAs
would preclear advertising for these products and, if so, on what
basis they would review health claims.
On September 30, 2010, Health Canada issued a Position Statement on the Preclearance and
Complaint Adjudication of Exempted NHP Advertising
Materials, which will apply to advertising of NHPs for
which an exemption number has been issued under the UPLAR. The
Position Statement indicates that APAs may perform the preclearance
of advertising materials pertaining to exempted NHPs, and that the
PLA submitted to the NHPD will temporarily serve as the TMA against
which health claims will be evaluated. A copy of the PLA should be
submitted to the APA with the advertising copy. APAs will review
advertising copy against the PLA to ensure that any health claims
are consistent with those set out in the PLA, but will not review
the scientific evidence supporting the claims.
APAs also provide complaint adjudication services and the
Position Statement indicates that the PLAs will temporarily serve
as the TMA for complaint adjudication involving advertising for an
exempted product. The Position Statement will be in effect only for
the duration of the UPLAR.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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