Reg-Affairs & QualiPractixis Inc.
370 Stone Road, Suite 20
Guelph ON, N1G 4V9, Canada
Overview on classification of products related to Irish Health Trade Association in Canada & US
The Irish Health Trade Association represents the interests of manufacturers, importers, and distributors
of vitamin and mineral supplements, herbal preparations, homeopathic products, flower remedies,
natural body care products and health foods in Ireland. These products are classified into different
categories in Canada and US. The classification is mainly determined on ingredients and label claims;
quantity of some ingredients in a product may affect the classification in some cases.
Canada
Vitamin and mineral supplements, herbal preparations, homeopathic products, flower remedies, natural
body care products and health foods may be classified into 3 categories in Canada. These are:
 Natural Health Products (NHP)
 Food-Like NHP
 Cosmetics
 Natural Health Products (NHP)
Vitamin and mineral supplements, herbal preparations, homeopathic products, flower remedies, natural
body care products with acceptable dosage form, therapeutic claims and ingredients may be classified as
Natural Health Products (NHP) in Canada. Please note; topical Sunscreen products that contain Zinc
oxide, Titanium dioxide or PABA as sunscreen agents are also NHP.
NHP must be approved and given a Natural Product Number (NPN) before it can be imported/distributed
in Canada; Health Canada charges no fee for product approval. Approval can take as short as 10 days and
as long as 180 days, this depends on availability of safety and effectiveness evidence for product
ingredients and label claims.
A company based in any part of the world can hold a Natural Health Product Licence (NPN) in Canada. It is
only mandatory that they must have a Canadian importer with a NHP Site Licence.
 Food-Like NHP
Health foods presented as drinks and other food like presentation without a defined dosage regimen are
regarded as Food-Like NHP and requires a Temporary Marketing Authorization Letters (TMAL) issued to the
applicants before it can be distributed in Canada.
 Cosmetics
Topical flower remedies and natural body care products with cosmetic-like label claims are cosmetic
products in Canada. All cosmetic products must be notified before distribution in Canada (this is the
practice). Labeling and ingredient compliance are mandatory requirements. Manufacturing cosmetic
products in a GMP compliant facility is encouraged but not mandatory.
USA
Vitamin and mineral supplements, herbal preparations, homeopathic products, flower remedies, natural
body care products and health foods may be classified into 3 categories in US. These are:
 Dietary Supplements
 OTC Drugs
 Cosmetics
 Dietary Supplements
Most Vitamin and mineral supplements, herbal preparations, homeopathic products and health foods
with acceptable dosage form, therapeutic claims and ingredients may be classified as dietary supplement
in the US. Labeling and ingredient compliance are mandatory requirements; new ingredient must be
notified. Products must be manufactured in GMP compliant facility.
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Reg-Affairs & QualiPractixis Inc.
 OTC Drugs
Some topical natural body care products may be OTC drug in the US. All OTC drugs must be electronically
listed on FDA database and manufacturing facility must be GMP compliant and registered. Labeling and
ingredient compliance are mandatory requirements.
 Cosmetics
Topical flower remedies and natural body care products with cosmetic-like label claims may be classified
as cosmetic products in the US. Labeling and ingredient compliance are the only mandatory requirements;
notification is voluntary.
We will offer free regulatory opinion on classification of products to all IHTA members who
want to know the best regulatory pathway for their products in Canada and US. This
offer is free for up to 5 products.
Page 2 of 2
Contact us for:
*Free Regulatory Pathway
opinion for all product
*Free Site Licence GMP Project
Assessment
Free quote on all project.
ReguCare
Product Licence Application (PLA)
for new product
Product Licence Amendment
Site Licence (SL) Application,
Renewal & amendment
Addition of Foreign or Local sites
to existing Site Licence
Canadian label & ingredient
review for claim support evidences
& addition to NHPID
Pr oduct Ingredient & Label review
for US Compliance
New ingredient notification for
Dietary Supplements in the US
NATURAL HEALTH PRODUCT
SUPPLEMENTS SERVICES
&
QualiCare
DIETARY
MP & Related Quality
Assurance Services:
Canadian & US Regulatory Compliance Made Easy!
Establishing new GMP
compliant quality system for
manufacturing & importation
Products (NHP) & Dietary Supplements?
facilities
Execution and completion of
Quality
Assurance Report
Currently distributing or planning to introduce your products into the
(QAR) for Local & Foreign
G
US and /or Canadian market?
facilities Off-site on-going QA
unit &
!
Product release services

Let our expertise work for you.
Creation & revision of SOP
Are you a manufacturer, importer or distributor of Natural Health
Contact us today!
Reg-Affairs & QualiPractixis Inc.
pedite
 Canada
your
export
to
www.reg-affairsqp.com
Email: [email protected]; [email protected] Tel: Add your facility to our
+1(226) 780-0216
affiliates’
 SL free** (for foreign GMP
compliant manufacturers
Ex
only)
* Offer ends on August 30,
2014
*
*Contact us for detai ls.
RA&QP-NPS | Version-02: 07-2014
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Service to IHTA members - Irish Health Trade Association