Smoke vs Vapor: 08/09/09

Action Report - Spring/Summer 2009

SPRING/SUMMER 2009

Announcement: NDMAC has changed its name to
Consumer Health Products Canada. We are phasing in the change so look for a new masthead in
the next edition of the Action Report.

Modernizing the Food and Drugs Act

The Issue:

The intent behind the upcoming modernization of the Food and Drugs Act is to move towards a
relative risk framework for regulating therapeutic products. Consumer Health Products Canada supports this approach as it ties the
level of regulatory burden imposed on a product to the level of health risk posed by that product. The industry also sees this as
the opportunity to correct a long-standing inequity.

Currently, some consumer health products are regulated by the Natural Health Products Regulations,
while other consumer health products fall under the same regulatory framework as prescription drugs (i.e. Part C of the Food and
Drug Regulations). While both sets of products are assessed to be of lower risk, requiring one set of consumer health products
to meet the regulatory burden of prescription drugs is contrary to the intent of the new legislation and creates unnecessary and
unfair regulatory hurdles for consumer health products.

Consumer health products - regardless of the source of their ingredient - are lower risk than
prescription drugs and should not be subject to the same regulations.

Consumer Health Products Canada is asking the federal government to ensure that the amended
Food and Drugs Act includes a provision that all consumer health products will be regulated separately from prescription drugs,
thereby allowing the consistent regulation of all products intended for self-care.

What's New:

The intent of the Government of Canada's Food and Consumer Safety Action Plan is to create a new
legislative foundation to better protect Canadians from unsafe consumer, health and food products.
Bill C-6: the Canada Consumer Product Safety Act
(formerly Bill C-52), and the upcoming bill to amend the Food and Drugs Act are two key components
of this plan.

Bill C-6, which passed third reading in June and is now being reviewed by the Senate, will allow for
prompt and effective action when a danger to human health or safety exists, as well as prohibiting the supply of consumer products
that pose an unreasonable danger to human health or safety. The Government is in the process of drafting legislation to amend the
Food and Drugs Act, which could be tabled in the fall.

While Bill C-6 does not apply to consumer health products, many of the provisions contained in the
bill will also be included in the bill to amend the Food and Drugs Act.

Consumer Health Products Canada in Action:

For over ten years Consumer Health Products Canada has been working closely with departmental and
elected officials on legislative renewal. The Association has been advocating for the development of regulations for consumer
health products that are distinct from those for prescription products, thereby ensuring the consistent regulation of all health
products intended for self-care.

Given that government is drafting a bill to amend the Food and Drugs Act, CHP Canada has turned
up the heat and is asking that a provision to provide consistent regulation for consumer health products that is separate from
prescription drugs be included in the bill.

Over the course of the spring, CHP Canada successfully executed a coordinated communications campaign
with advertising and direct mail components that culminated with two Association lobby days on Parliament Hill in May. In meetings
with key elected officials and senior civil servants, CHP Canada members and staff received support for our request, including an
endorsement by senior departmental officials in a meeting with Health Minister Leona Aglukkaq.

CHP Canada also appeared as a witness during the Standing Committee on Health's study of Bill C-6.
While consumer health products are explicitly exempt from this proposed legislation, the Association intervened because expected
amendments to the Food and Drugs Act are likely to contain similar provisions. CHP Canada was successful in getting
amendments made so that, in the event that the minister of health deems it necessary to release confidential business information
to third parties (eg., because of a recall or other such serious event), the minister must notify the affected companies within one
business day of the release of the information (the original Bill did not provide for any notice). The Bill was also amended to
ensure that only confidential business information that is crucial to the protection of public health can be released.

What you can do:

This is a once-in-a-generation opportunity to influence the fundamental structures underpinning the
regulation of our industry's products. It is critical that CHP Canada member companies and the rest of the consumer health products
industry become actively involved in supporting and asking the government to include in their amendments to the Food and Drugs
Act a provision for ensuring that all consumer health products will be regulated separately from prescription drugs.

The bill is not expected to be tabled until the fall. Until then:

1. Write to and meet with your local MP at some point during the summer and
emphasize:

The consumer health products industry is very supportive of modernizing the Food and Drugs Act
and are looking forward to seeing the bill tabled in the near future.

We are hopeful that it will set the legislative basis for implementing a risk-based regulatory
framework (i.e., that the degree of regulatory oversight of a product will be appropriate to the degree of the potential risk of
the product).

We also hope that the bill will provide the legislative basis for ensuring that all consumer health
products will be regulated separately from prescription drugs.

We continue to be supportive of Parliament's actions in 2004 to remove natural health products from
the prescription drug regulations. We wish to preserve the separate regulation of NHPs, and seek the creation of new regulations for
other consumer health products that reflect their lower risk nature and are outside Part C of the Food and Drug Regulations.

CHP Canada has materials that you can use to visually demonstrate the current inconsistency in the
regulations. To obtain your "Know the Difference, Then Make a Difference" campaign kit, please contact
Mary McEwen.

Tip: The MPs will be in their ridings throughout the summer.
We recommend that you meet with them in their constituency offices to specifically discuss this need and that you watch for
opportunities to meet them in your community, such as at their fundraisers, community events, etc.

2. Spend the summer determining how other potential amendments, such as the
handling of confidential business information, the powers of the Minister and inspectors, product life cycle regulation, etc.,
could affect your company and the different corporate divisions of your companies (e.g. pharma and personal care product divisions)
and work on developing some general corporate positions on these issues. Please share your thoughts on these issues with CHP Canada
by September.

Tip: Review Bill C-6
and the former Bill C-51
for ideas of how the new bill on the Food and Drugs Act will stand such issues as the handling of confidential business
information, the powers of the Minister and inspectors, product life cycle regulation, etc.

Resources:

Know the Difference, Make a Difference campaign website

Find your Member of Parliament

Government of Canada's Food and Consumer Safety Action Plan

Background: How does Health Canada determine which regulations to
apply to which products?

Health Canada applies a series of criteria to determine whether or not a product requires the
prescription of a health professional in order to be used safely and effectively. If the product is captured by these risk criteria,
regardless of whether the active ingredients are naturally occurring or synthetic, it will be classified as a prescription drug and
regulated under Part C of the Food and Drug Regulations. If, on the other hand, the product falls outside those risk criteria,
the regulations to which it will be subject depends on whether or not the active ingredients are found in nature. Products that are
naturally occurring will fall under the Natural Health Products Regulations and those that are not will be placed under Part C,
just like prescription drugs.

Background: What is the problem with having some consumer
health products regulated by the same regulations as prescription drugs and others by the Natural Health Products Regulations?

Part C of the Food and Drug Regulations includes, under Division 8, a requirement that all "new"
drugs (using new chemical entities) be subject to extensive premarket authorization review in a New Drug Submission (NDS). New
consumer health products are not generally pulled into Division 8; however, there is one provision that indiscriminately pulls
low risk consumer health products into "new drug status," and that is when a company combines two or more well established
ingredients into a new formulation/product that has never been marketed in Canada before. For higher risk prescription drugs,
this provision makes sense as the potential for serious drug interactions is one of the criteria that can keep an ingredient in
prescription-only status. For consumer health products that combine ingredients that both have broad safety margins and have
already been established as having a very low potential for clinically significant interactions, it makes no sense at all. The
prohibitively high costs and excessive regulatory burdens are barriers to the development of new products for self-care, which is
proven to be one way to reduce costs on the formal health care system.

By contrast, the Natural Health Products Regulations take an approach to novel formulations or
uses that is far more appropriate to low-risk consumer health products. In fact, this particular issue was the single most important
factor behind the creation of the NHP regulations.

CHP Canada Contacts:

Gerry Harrington, Director of Public Affairs

Mary McEwen, Director of Communications & Member
Services

Copyright 2009 by Consumer Health Products Canada. Action Report is published four times a year. It is designed to increase awareness of specific issues that have a direct
impact on the consumer health products industry.

CHP Canada/NDMAC HOME PAGE

Ottawa, Ontario, Canada K2C 3T2

Tel.: 1-613-723-0777 Fax: 1-613-723-0779 info@chpcanada.ca

Managing Editor: Kelly Tchorewski