Guidance Document for Responding to the Consultation Titled,
Consulting Canadians on the Regulation of Self-Care Products in Canada
CHFA has developed this document to assist members with preparing and submitting comments to
Health Canada for the Consulting Canadians on the Regulations of Self-Care Products in Canada.
The information is for your consideration and review but should not be cut and pasted into any
response. Please note that any of the sections highlighted, should be personalized with your own
company information.
There are two ways to participate in
the Health Canada Consultation of the Self-Care Proposal.
1. You can draft a letter on behalf of your company or as a consumer. The general format is
outlined for you, on pages 2-5, and some key points have been outlined.
2. You can participate in the online consultation that is available here. The questions that are in
the online questionnaire are outlined in Appendix 1, on pages 6-11, along with some
information to assist you with filling out the responses.
The consultation is open until Monday, October 24, 2016.
CHFA encourages you to complete the consultation in advance
of this deadline and share comments with us.
If assistance is needed with preparing your submission, please contact CHFA. Once you’ve completed
your feedback, please ensure you send CHFA a note containing your letter or let us know you’ve
completed the questionnaire. Please send this to Krista Jajko, Manager, Regulatory Affairs, at
[email protected].
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1. Drafting a Letter on Behalf of Your Company or as a Consumer
Letter Structure
Put letter on your company letterhead, if available, and send as an attachment to the email address
listed below.
Insert Date
Health Canada
Health Products and Food Branch
Natural and Non-prescription Health Products Directorate
250 Lanark Avenue, A.L. 2003C
Ottawa, Ontario
K1A 0K9
Sent via email: [email protected]
To Whom It May Concern:
Suggested Subject Line - Re: [Insert Your Company Name] comments on Health Canada’s Consulting
Canadians on the Regulation of Self-Care Products in Canada Document and the Risk-Based
Approach to Regulating Self-Care Products
Format for your response:
Introduction
As a company that is committed to manufacturing/selling/distributing high-quality Natural Health
Products (NHPs), I am taking this opportunity to provide my feedback on Health Canada’s proposal to
change the way self-care products are regulated.
[Insert a brief summary of your company]
Additional Introductory Comments for consideration
This proposal fundamentally changes the regulation of NHPs as described in the Natural Health Products
Regulation, which the industry has been supporting for the past 12 years, at a cost of several millions of
dollars. Insert details on the amount invested by your company to bring your products into compliance
with the existing regulations. Consider not just financial but also time and other resources.
Along with the dramatic shift in the level of evidence that will be required for some of my products, I
expect that some/many of my products may no longer be available for sale, not only affecting my
business and livelihood, along with my employees, but also have a negative impact on freedom of choice
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for my customers. Insert details on specific products you have concern with and how these changes
could impact your business.
Body of the Letter
There are two overarching themes for your consideration when drafting your response to Health Canada
(See suggested key points for each of these below – rephrase and put in your own words)
Item 1: There are major issues with the risk-based approach being proposed in the Self-Care Framework.
Item 2: There are no major issues with the current regulatory framework.
Conclusion – Rephrase and Put in Your Own Words
In closing, NHPs are already regulated today within a risk-based system reflecting their low risk. It has
taken us 12 years to get to where we are today and to dismantle the existing framework is a disservice
to both industry and the consumer. While the purpose of the consultation is to receive feedback from
consumers, I do hope that one of the realizations of the feedback received is that education is a much
needed part of the process and Health Canada has a pivotal role in supplying useful and consumer
friendly tools to enable the average Canadian to continue using an assortment of health products to
support their overall health and wellness. On behalf of [insert your company name], thank you for the
opportunity to provide feedback for the consultation. I hope my comments will be given due
consideration as you carefully determine the next steps for the regulations on natural health products.
Key Points for Item 1: There are major issues with the risk-based approach being
proposed in the Self-Care Framework.

What are the fundamental issues you think will directly affect your business? Definition of
scientific evidence? Loss of claims for your products? Effect of having to put a disclaimer on
your product? Think about specific products which you may discontinue or where the cost of
manufacturing may prohibit sales. Think about impacts this may have on marketing of your
product. Consider collaboration with others in your company such as marketing, sales, R&D
and regulatory.

The risk-based approach proposed in the Self-Care Framework will have the effect of moving the
regulation of NHPs farther away from Health Canada’s ultimate objective, which is a “consistent
approach to self-care products to ensure that consumers are protected while still providing
access to a wide range of products, and to provide consumers with adequate information so
that they can make informed choices about self-care products.”

The Consultation does not provide proof suggesting that Canadians using NHPs are not already
protected under the existing Natural Health Products Regulations (NHP Regulations). Nor does it
resolve the concern of Canadians having more information to assist with their purchasing of
products, as the proposal outlines that some products would not be licensed, would not be
reviewed and would then need to carry disclaimers.

The consultation proposes less regulatory oversight and claim restrictions, namely no
therapeutic health claims, for low-risk NHPs (traditional medicines and homeopathic medicines),
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and more oversight, such as evidence requirements for assessing safety and efficacy equivalent
to that of prescription drugs, for moderate- and high-risk NHPs.

For the low-risk category, Health Canada will no longer review some products before going to
market and would require a disclaimer on labels saying something to the effect of, “Health
Canada has not reviewed for safety and efficacy.” Removing this element of the review process
will negatively affect my business as consumers may not trust unlicensed products and
consumers are only used to licensed NHPs.

These shifts seem to be based on Health Canada’s belief that self-care products of the same risk
level (regardless of whether they are currently an NHP or a non-prescription drug) should supply
the same scientific information as part of the pre-market approval process, and entirely
removes the pre-market review process of some low-risk products.

The adoption of the Self-Care Framework, particularly the heightened evidentiary burden for
moderate- and high-risk NHPs, will have a negative effect on the number of products available
for sale in Canada, resulting in a less diverse and less inclusive marketplace for health products.

We speculate that the U.S. as well as international sources will be a growing source for
unlicensed products as Canadians turn to purchasing products they cannot access in Canada
online and while travelling abroad. The issue the Canadian industry faces on the use of personal
importation to avoid the NHP Regulations will increase as a consequence of the adoption of the
proposal in the consultation.

This massive and unwarranted overhaul could greatly curtail Canadian consumers’ freedom of
choice by restricting their access to a wide variety of health products.

The Self-Care Framework could also push Canadians to purchase products from foreign markets,
if they are no longer able to buy the products in Canada. This has business impacts and reduces
protection for Canadian consumers.

The risk-based approach to regulating NHPs is problematic. Not only does it fail to distinguish
NHPs from OTCs, but it also fails to fulfill Health Canada’s goal of ensuring consumers feel they
receive sufficient information to support their purchases.
Key Points for Item 2: There are no major issues with the current
regulatory framework.

How is the existing framework working for you? Do you feel there is a consistent approach to
getting products licensed today? Are you getting products to market in a predictable amount
of time? Are consumers receiving the information they need to make an informed choice
about your products?

The existing regulations were put into place in 2004 after a thorough review performed by the
then Standing Committee on Health (SCOH) in 1998. This review led to the development of the
report, “Natural Health Products: A New Vision.”

Some of the guiding principles of the report include:
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



NHPs are different in nature from and must not be treated strictly as either food or
pharmaceutical products;
NHP regulations must not unduly restrict access by consumers;
NHP consumers must be given pertinent information about the products they purchase;
and
NHP regulations must respect freedom of choice, and philosophical and cultural
diversity.

This report was prepared after the SCOH met with hundreds of witnesses from across Canada,
including consumer groups, Health Canada, the Canadian Food Inspection Agency and
international regulators, and received and subsequently reviewed numerous submissions over a
six-month period.

The report prepared by the SCOH was measured, inclusive, fulsome and transparent. The report
set out a robust and thoughtful framework for the regulation of NHPs that resulted in the
passage of the NHP Regulations, the establishment of the then-Natural Health Products
Directorate, and, in discussions with stakeholders and expert committees, the categorization of
risk factors that established the level of scientific evidence necessary to support the approval of
a product licence application.

The NHP Regulations have given our country one of the most advanced regulatory frameworks
for NHPs in the world. By virtue of the NHP-specific, pre-market approval system, Health Canada
has the ability to ensure that safe products enter the marketplace without unduly restricting
entry.

The Pathway for Licensing Natural Health Products Making Modern Health Claims and the
Pathway for Licensing Natural Health Products Used as Traditional Medicines reflect the type
and amount of supporting evidence required for the approval of an NHP. Its approval depends
on the proposed health claim that an NHP is making and its risk. We currently have a risk-based
system that distinguishes health claims based on supporting evidence. As a result, this proposal
creates an unnecessary burden to address something that is already covered by our current NHP
Regulations.

A steady state of compliance and enforcement was achieved in September 2014 and industry
has had just over two years in this position. It has taken over 12 years to get the industry to this
point and to overhaul a system that has just found its footing is unwarranted. There are no
major issues with the existing regulatory framework and the proposed Self-Care Framework
causes more harm than good.
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2. Participating in the Online Consultation
Appendix 1: Online Questionnaire – Consulting Canadians on the Regulation of Self-Care Products in
Canada. Example responses are provided – please try to use your own words rather than cut and paste.
Access the questionnaire here.
1. What do you think of the risk-based approach proposal for self-care products proposed in the
consultation paper?
 I think the current system for natural health products (NHPs) is already working. The Natural
Health Product Regulations is a system that provides a solid foundation for regulating these
products.
 The NHP Regulations and related guidance documents, which are risk-based, should be used as
a model for other self-care products, and we should not be creating a new system for NHPs.
 All products currently available on the market are reviewed by Health Canada for safety and
efficacy. The product only gets approved if sufficient evidence is provided showing it is both
safe and effective. These approved products receive an NPN or DIN-HM, which must appear on
the product’s label.
 In order for an NHP to be licensed currently the company making the product must submit
evidence to support the product for its recommended purpose. This can be from a variety of
sources, including clinical studies to pharmacopeias, among others. The claim that is approved
is dependent on the amount of evidence that is provided.
 For 12 years, industry has invested in complying with the regulations and Health Canada has
worked hard to issue licences in a timely manner.
 I am concerned with what “low-risk product” actually means:
o I am concerned with the “not approved by Health Canada” disclaimer.
o I am concerned with the loss of certain “therapeutic claims” on products and the
possible vague descriptions that will be put in their place.
o I am concerned that some product labels will provide less information.
o I am concerned about the classification of many of the common herbal products.
2. What do you think about Health Canada’s proposal to group self-care products according to
the above-mentioned levels of risk, i.e. risk-based grouping?
 I am concerned with this approach.
 This approach could still be confusing to Canadian consumers.
 The current regulations were developed due to a prolonged consultation with Canadians and
experts and the decision was that NHPs needed their own regulatory structure. What concrete
proof is there that this should be changed now?
 The difference between NHPs, which are derived from nature and OTCs, which are made in
labs, is why they should be treated separately.
 Currently, all NHPs must be approved by Health Canada, versus this proposal, where a portion
will continue to be approved and rest will go to market without approval. This is concerning and
confusing.
 I trust NHPs today because each product has its own NPN number, which assures me Health
Canada has played a role in their review. This proposal does not give me this same assurance.
 “Higher risk” NHPs would require scientific evidence like drugs, which may not exist. This could
mean losing access to some of the NHPs on the market.
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3. How would risk-based grouping impact your decision-making and your purchases of these
products? (Multiple choice)
i. More Confidence
ii. Less Confidence
iii. Same Confidence
iv. Not Sure/Don’t Know
v. Other
 I would be confused and less confident about what I was buying. This change does not give the
consumer more information about the product; if anything, in some cases, the consumer will
receive less information about products.
 If products don’t have health claims then I will not understand how to use them and as such I
will not fully benefit from them.
4. What are your thoughts on the proposal to require scientific data in order to support a health
claim? (Multiple choice)
i. Support
ii. Do Not Support
iii. Not Sure/Don’t Know
iv. Other
 NHPs are already required to submit evidence to support the efficacy of the product.
 The level of evidence required depends on the claim being made, the overall risk of the
product, and the condition it is being used for. A product such as a multivitamin that makes a
claim, “helps with the maintenance of good health,” will have to provide different evidence
than an omega-3 supplement that makes the claim, “helps to reduce serum triglycerides and
support brain function.”
 NHPs also include many traditional medicines (Traditional Chinese Medicine and Ayurvedic
Medicine, for example) that have been safely used for thousands of years. Suddenly requiring
these products to be supported by modern research to accommodate the modernization of
regulation does not respect the cultural heritage behind these products.
5. Health Canada is exploring ways to provide Canadians with information that can assist them in
making choices about health products, including the use of a disclaimer on product labels to
identify claims that are not reviewed by the department. What do you think about this
approach?
 This approach will not provide more information to the consumer since it breaks down risk by
health claim and the evidence used to support the health claim.
 I am concerned that products with a disclaimer will mean consumers will have less trust in the
products I sell. NHPs are reviewed by Health Canada for their safety and efficacy and this is
important for consumers to know this.
 Claims will also be removed from the labels of some products which will actually provide the
consumer with less information about certain products.
 Currently a product label for an NHP paints a complete picture of how and why to use the
product (directions of use, cautionary statement, claims)
 A chart comparing our current system versus proposal for low-risk category (see next page):
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Current System (NHP Regulations)
Proposed Framework
All products approved by Health Canada
Medium to high risk products approved by Health
Canada
Low-risk products will no longer be approved by Health
Canada.
All claims approved by Health Canada
Only health claims will be approved by Health Canada
Low risk products with general claims e.g. structure
function claims, go straight to market (no approval).
NPN on the product label tells you the
product has been reviewed by Health
Canada
Some products will carry product licences (NPN?) and
others will carry disclaimers that the product has not
been approved by Health Canada. For the latter
category, consumers are expected to do more research.
Health Canada accepts evidence based on
the type of claim (defined as reasonable
evidence), which ranges from scientific
evidence to traditional books.
Health Canada will only accept scientific evidence, which
means they approve certain products.
The remaining products go to market without Health
Canada approval.
6. Would this type of information be helpful to you as a consumer?
 We already have a system that is helpful for the consumer.
 The consumer can identify the NPN or DIN-HM on a natural health product to determine that it
has been reviewed and approved for sale by Health Canada.
 A disclaimer stating the product has not been reviewed by Health Canada does not help the
consumer.
 Having products remove statements for their proposed use does not help the consumer.
 Losing products from the marketplace does not help the consumer.
 If the thought process is that Canadians don’t understand the current regulatory system, then
education on the existing frameworks for each of the products outlined in the self-care
proposal is required. If an educated consumer is still confused, unaware or has an educated
opinion that the system does not work, then consideration to an adjustment could be
considered.
7. Do you think that a product identifier (i.e., a number on the product) is necessary to help
consumers identify a product in the event that they wish to report an issue with a product?
(Multiple choice)
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o Yes
o No
o Maybe
o Not Sure/Don’t Know
o Other
 Consumers should understand our current system:
o We already have identification numbers in the form of NPNs or DIN-HMs, which are
granted by Health Canada. An NPN has an added benefit since it tells you as a
consumer the product has been reviewed for safety, efficacy and high quality.
o Consumers can look up an NPN and get assurance that products have been reviewed by
Health Canada, which would not be possible for them to do if only a product identifier
is provided.
o Consumers can easily identify products using the NPN and lot codes that exist today.
8. Do you feel confident that the proposed safety oversight approach will allow you to continue
accessing good quality, safe and effective products? (Multiple choice)
o Yes
o No
o Maybe
o Not Sure/Don’t know
 Under the NHP Regulations, products available for consumers are safe, effective and high
quality, as demonstrated by the NPN and DIN-HM.
 The current system is not broken and has been in place for 12 years, providing stability for both
consumers to have access to such products and industry to providing these products.
 Minister of Health does have post-market powers that protects Canadians and can exercise
these rights when needed.
9. Do you believe that additional powers to change labels, require a recall and new penalties
would help address safety issues and discourage companies from breaking the law? (Multiple
choice)
o Yes
o No
o Maybe
o Not Sure/Don’t know
 The Minister of Health does have post-market powers that protects Canadians.
 NHPs are lower-risk and distinctly different than non-prescription and prescription drugs. This
difference was recently reviewed through Vanessa’s Law.
 Other departments within Health Canada do post-market surveillance to ensure products that
are on the market are safe and labelled appropriately. A recent report was done by the
Regulatory Operations and Regions Branch, which showed a high level of compliance for the
products that were tested.
10. Do you think the frequency of when a company is inspected should vary depending on the risk
category of the product?
o Yes
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o No
o Maybe
o Not Sure/Don’t Know
o Other
 The frequency of inspection should be determined based on the performance of the
manufacturer/importer and on their ability and track record of producing products that are
safe. This frequency should not be tied to what type of health claim a product makes.
11. Do you feel that the proposed framework addresses any concerns you have with self-care
products? (Multiple choice)
o Yes
o No
o Maybe
o Other
 I don’t have any concerns with how NHPs and other self-care products are regulated today.
 As a consumer, I want to make sure that the products are safe.
 As a consumer, I want to have access to the products that I depend upon. If this framework is
going to limit that availability, I do not support it.
 As a retailer/manufacturer who is proudly Canadian, this framework will lead to consumers
shopping internationally for products they can no longer gain access to in Canada. This
framework will further exploit consumer shopping for products made outside of Canada, where
Health Canada has no regulatory oversight.
Consumer Concern
Current System (NHP
Regulations)
Proposed Framework
Are the products safe?
Only safe products are
approved by H.C.
Safe products will be on the market
either with a disclaimer or a licence
number (NPN).
Consumers can tell by the
NPN on the label.
Consumers can tell by the product licence
(NPN?) on the label for medium to high
risk products.
For low risk products, consumers have to
do more research.
Will the label tell me
more information?
Under the current regulations,
the label must tell you how to
use the product, what
cautions to look out for and
why you should use the
product.
For medium- to high-risk products, the
label may look like our current system.
For low-risk products, the label may
contain less information and vague
descriptions.
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12. What else could Health Canada include in the framework to address your concerns?
 A new framework is not needed. Each of these product types are distinct from each other and
should continue to be treated and regulated separately. Combining in any way will be more
confusing for the consumer.
 The regulations in place already give me peace of mind when shopping for safe and effective
products.
 I am not concerned about how products currently make it to market. I want to know that the
product has been reviewed and deemed safe for use.
 The regulation of NHPs cannot limit my freedom of choice to buy and use the products that I
depend on.
 Changing the rules and making it harder and more expensive to bring products to the market is
not beneficial to Canadians.
 Health Canada could work to educate the consumer more on the current systems that are in
place and ensure Canadians know how to distinguish a natural health product from a cosmetic
or a non-prescription drug.
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