Regulation of Natural Health Products in
Canada
Presentation at Dietary Supplement Public Meeting
Manon Bombardier
Director General,
Natural and Non-prescription Health Products
Health Canada
May 16, 2019
Outline
Natural and Non-prescription Health Products Directorate
1. Regulatory Context
– Natural Health Products Regulations (NHPR)
– What can be included in Natural Health Products (NHPs)?
Approach to Synthetic Duplicates
Approach to Probiotics
2. Pre-Market Review
– Product pathways
– Approach to Safety and Efficacy and Experience to Date
– Approach to Quality and Experience to Date
– Processing Overview
3. Post-Market Activities
– Reactive Approach
– Proactive Approach
4. Current Regulatory Modernization Efforts
2
Food and Drugs Act
Cosmetics
Regulations
Natural Health
Products
Regulations
Food & Drug
Regulations
Part C – Drugs
Food & Drug
Regulations
Part B – Foods
Regulatory Context
Natural and Non-prescription Health Products Directorate
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• All NHPs sold in Canada are subject to the NHPR, which came into effect in
2004
• Result from extensive consultation with broad range of stakeholders.
• Take into account concerns about NHP availability and safety, as well as the
House of Commons Standing Committee on Health's 53 recommendations on
the regulation of NHPs in Canada
• Purpose is to balance access to NHPs with the need to ensure appropriate
standards are in place for:
Safety;
Efficacy; and
Quality
Natural Health Products Regulations (NHPR)
Natural and Non-prescription Health Products Directorate
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• Vitamin and mineral supplements
• Homeopathic medicines
• Plant and herbal remedies
• Traditional medicines
• Probiotics
• Certain personal care products
In Canada, “natural health
product” refers to a range of
health products including:
A 2010 survey showed that 73% of Canadians regularly take NHPs.
A 2016 survey showed that Canadians have low perceived knowledge of
safety and effectiveness of NHPs (19%) and generally feel uninformed
when purchasing these products (33-58%)
Authorized NHPs bear either a natural product number (NPN)
or homeopathic medicine number (DIN-HM) on their labels
There are currently over 150,000 NHPs authorized for sale in Canada
Scope of NHPs
Natural and Non-prescription Health Products Directorate
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• As an example, the NHPR allows for an extract or isolate of a plant, alga, a
bacterium, fungus or a non-human animal material
• The activity of the synthetic substance should be identical to that of the
naturally isolated substance
Vitamin C (as ascorbic acid)
commonly found in citrus fruits
and many vegetables
Sodium ascorbate (synthetic),
provides ascorbic acid
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Natural and Non-prescription Health Products Directorate
Approach to Synthetic Duplicates
• Generally regarded as live microorganisms that provide a health benefit.
• Health Canada’s monograph
1
for probiotics includes:
General Health Claim for all listed species:
o Source of Probiotics
General Health Claims for almost all listed species:
o Helps support intestinal/gastrointestinal health
o Could promote a favorable gut flora
Other strain specific claims:
o Acute infectious diarrhea (Lactobacillus rhamnosus GG)
o Antibiotic associated diarrhea (L. rhamnosus GG, S. boulardii/cerevisiae (all))
Approach to Probiotics
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Natural and Non-prescription Health Products Directorate
1
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=probio&lang=eng
• Modern NHPs (e.g., vitamins, fish oils) – evidence is stratified by risk and
decision informed by a variety of sources including clinical trials, information
from other regulatory agencies and scientific literature
• Traditional Medicines (e.g., Traditional Chinese Medicine) – based within a
defined healing paradigm and supported by references to specified
pharmacopoeia or other texts deemed acceptable by Health Canada. Safety
considers the scientific literature as well
• Homeopathic Products (e.g., nosodes) – evidence must come from an
accepted homeopathic reference (homeopathic pharmacopoeia), proving
(homeopathic testing), or clinical trial data
Pre-Market Review: Product Pathways
Natural and Non-prescription Health Products Directorate
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Approach to Safety and Efficacy
Natural and Non-prescription Health Products Directorate
• Products that comply with all parameters of an individual
monograph
• Risk-based review
Class I
60 calendar days
• Products fully supported by a combination of monographs
• Full review
Class II
90 calendar days
• Other Products
• One or more non-monographed ingredients
1
, and/or
• Monographed ingredients but outside monograph parameters
(e.g. higher dose, different source, unacceptable claim, etc.)
• Full scientific review
Class III
210 calendar days
• Issues with attestation model identified in early 2017 led to adjustment in pre-market review
• The Natural Health Products Ingredients Database (NHPID)
1
is an electronic repository of
monographs, information on medicinal and non-medicinal ingredients in NHPs, and
ingredients classification for selection in an electronic Product Licence Applications (e-PLA)
submission
1
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do?lang=eng
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Approach to Quality
Natural and Non-prescription Health Products Directorate
Identity:
Physical description; and
Chemical Identity for the respective medicinal ingredient(s)
Purity/Contamination:
Microbial;
Chemical; and
Other (Pesticides, Solvent residues, etc.)
Quantity/Potency:
Amount of each medicinal ingredient
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Approach to Quality - Experience to Date
• Review of 1192 site licence (SL) applications identified issues with the current attestation model:
– Specifications (52%)
– Stability (35%)
– Quality Assurance (13%)
• Proactive inspections at 46 NHP sites (~6%) conducted over past 3 years
1
identified issues
ranging in severity found at all facilities, notably:
– Specifications: unavailable or incomplete
– Stability: no data, scientific rationale or program available to establish a product’s shelf life
– Quality Assurance: products not properly assessed against their specifications with partial or no testing
• Paper-based audits of 35 licensed sites (~4%) currently underway, focusing on key areas of
concern
• Results will inform adjustments to pre-market quality review approach (Fall 2019)
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2017 Report on Compliance Monitoring: Natural health products at https://www.canada.ca/en/health-
canada/services/inspecting-monitoring-drug-health-products/compliance-monitoring-reports/2017-
reporting-compliance-monitoring-natural-health-products.html
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Natural and Non-prescription Health Products Directorate
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• NHP Management of Applications Policy
1
updated in April 2019.
• Updates intended to achieve better outcomes for the health and safety of
Canadians by ensuring that authorized NHPs meet all regulatory requirements.
Changes also
– Reflect evolving regulatory and market context
– Align with current practice as well as with changes in the web-based
application systems, i.e.
• Attainable performance standards
• Improved predictability of licensing application review outcomes through
o Clear and precise application criteria; and automatic refusals when not met
o No more paper applications
o More efficient and comprehensive correspondence
o No unsolicited changes
1
NHP Management of Applications Policy at https://www.canada.ca/en/health-canada/services/drugs-health-
products/natural-health-products/legislation-guidelines/guidance-documents/management-product-licence-
applications-attestations.html
Processing Applications
Natural and Non-prescription Health Products Directorate
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Post-Market Activities : Reactive
Natural and Non-prescription Health Products Directorate
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• Legislative prohibition against false, misleading or deceptive
s.9 of the Food and Drugs Act :
“
No person shall label, package, treat, process, sell or advertise any drug
in a manner that is false, misleading or deceptive or is likely to create an
erroneous impression regarding its character, value, quantity,
composition, merit or safety
”
• Proactive monitoring of marketed NHPs in development:
Proactively monitor products on the Canadian market to identify possible
non compliance issues; and
Take action as appropriate
• Health Canada also works in collaboration with independent
advertising preclearance agencies to educate and promote
compliance on advertising
Post-Market Activities : Proactive Monitoring
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Natural and Non-prescription Health Products Directorate
Current Modernization Efforts
Regulation of NHPs, Non-Prescription Drugs and Cosmetics
Natural and Non-prescription Health Products Directorate
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Product
Categorization
Product Claims
and Evidence
Improved
product
labelling
Compliance
Monitoring &
Verification
Site Licensing
Quality Standard
Vigilance
Proposal: Improved Labelling of NHPs
Requirements – Updates to the NHPR:
A
Minimum font size
Medicinal ingredient:
Ingredient A # mg
Directions for use
Medicinal ingredient:
Ingredient A # mg
Directions for use
Maximum contrast
Standardization
N
a
t
u
r
a
l
a
n
d
Natural and Non-prescription Health Products Directorate
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Product Facts Table
Natural and Non-prescription Health Products Directorate
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Natural and Non-prescription Health Products Directorate
