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Public Consultation on the Interim Natural Health Products (NHP) Raw Material Policy

Natural Health Products Directorate,
Health Products and Food Branch, Health Canada

Summary of Comments

#	Comment	Revision to Policy	No Revision to Policy	Rationale
1	Add numbers to scenarios for ease of reference.	X		NHPD agrees that this adds clarity.
3	Health Products and Food Branch (HPFB) Inspectorate must be aware of the policy.		X	NHPD will continue to work with the HPFB Inspectorate to assist inspectors and the Canadian Border Services Agency (CBSA) to be fully aware of, and have an appropriate understanding of, the policy.
4	There should be cross-referencing between the policy and the Evidence for Quality of Finished NHPs Guidance Document, which requires flow charts for raw materials.	X		NHPD agrees that this adds clarity.
5	Does the policy apply to raw materials and NHPs for export only?	X		Conditions under which exports are exempt from the Food and Drugs Act are outlined in Section 37: (1) This Act does not apply to any packaged food, drug, cosmetic or device, not manufactured for consumption in Canada and not sold for consumption in Canada, if the package is marked in distinct overprinting with the word "Export" or "Exportation" and a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner. The Export Certificate under Section 37 of the Food and Drugs Act is a certificate signed by the manufacturer and a Commissioner for Taking Oaths to attest that the product for which the certificate is prepared is not manufactured or sold for Canadian consumption and its package and the contents do not contravene any known requirement of the law of the country for which it is or is about to be consigned. This export certificate will satisfy Health Canada that the specified product(s) does not fall under the purview of the Natural Health Products Regulations (the NHP Regulations). By contrast, the NHP International Trade Certificate is issued by NHPD, upon submission of an application package including information on the regulatory status of the product in Canada. An international trade certificate speaks to the regulatory and marketing status of the natural health product in Canada. The NHP International Trade Certificate may facilitate the entry of natural health products in other countries, by providing information to foreign regulatory authorities on the regulatory and marketing status of the product in Canada.
6	There is no mention of cultural practices (e.g., "bulk herbs are widely used by many Southeast Asians as foods by means of both culinary and dietary ingredients").	X		NHPD agrees that cultural practices should be mentioned.
7	NHPD should look to Hong Kong and Australia for raw materials that should not be considered foods.		X	NHPD is aware of Hong Kong 's Chinese Medicine Ordinance lists and Autralian lists and may use them, along with other resources, to assist in determining whether a product is an NHP.
8	In scenarios 5 and 6, replace "for use by practitioner" with "for compounding by practitioner".	X		NHPD agrees that this adds clarity.
9	The NHP Regulations cover finished products, not in-process or raw materials.		X	The NHP Regulations do not make reference to the term "finished product". Products that meet the substance and function components of the NHP definition within the NHP Regulations are considered NHPs and covered under the NHP Regulations.
10	NHPD does not have a complete understanding of good agricultural practices (GAPs) and how they would impact positively on raw material production and good manufacturing practices.		X	NHPD is aware of GAPs and agrees it is valuable to have a good understanding of these.
11	It is not clear how NHPD will use the Canadian Food Inspection Agency (CFIA) Status of Substances List. Health Canada must make sure that what goes on this list is carefully reviewed.	X		The Status of Substances list is a tool developed and used by the Canadian Food Inspection Agency. Reference to this list was removed from the policy.
12	A case specific approach should not be used. There should be a clear definition of a raw material.	X		The term "case-specific" refers to an approach which considers particular features or circumstances (listed in the policy) to identify a product which may present as a raw material but in fact meets the substance and function components of the NHP definition within the NHP Regulations. Text was added to the policy to add general information about what a raw material is considered to be.
13	Raw materials should not be referred to as active medicinal ingredients (AMIs).	X		NHPD agrees. The term was confusing to stakeholders.
14	The policy should state that it does not cover cosmetics nor products manufactured for use as ingredients for cosmetics.		X	The policy only applies to raw materials that meet the NHP definition.
15	The policy should state that it does not apply to natural animal products.		X	The policy only applies to raw materials that meet the NHP definition.
16	In scenario 1, replace "Importation or sale of mint manufactured, sold or represented as tasty beverage" with "Importation or sale of botanical manufactured, sold or represented as beverage or soup with no claim." Suggested examples: "Package of loose mint as beverage (no claims)" "Chamomile tea bags (no claims)" Astragalus sliced root (no food use)	X		NHPD agrees that making the scenario more general adds clarity.
17	In scenario 2, replace "Importation or sale of herb, tincture, or freeze-dried extract (e.g., of chamomile) manufactured, sold or represented as treatment for stomach upset." with "Importation or sale of herb, tincture, or freeze-dried extract manufactured, sold or represented as an NHP." Suggested examples: Chamomile tea bags (with claim as treatment for upset stomach) Bulk astragalus sliced root (with claim as an adaptogen and Qi Tonic) Tincture (with claim)	X		NHPD agrees that this adds clarity.
18	In scenario 3, replace " Importation or sale of herb, tincture, or freeze-dried extract (e.g., of chamomile) manufactured, sold or represented as treatment for stomach upset for further processing by manufacturer." with, "Importation or sale of herb, tincture, or freeze-dried extract (e.g., of chamomile) manufactured, sold or represented as an NHP for further processing by manufacturer."	X		NHPD agrees that this adds clarity.
19	In scenario 5 clarify that the sale of an NHP requires a PL, while the sale of a compounded NHP does not, as per the NHP Compounding Policy.	X		NHPD agrees that this adds clarity.
20	Delete scenarios 8, 9, and 10.	X		NHPD agrees that these scenarios added confusion.
21	Would the following situation be permitted: A company has a mail order herb business. The catalogue includes descriptions of what each herb has traditionally been used for, as well as contraindications for each herb. The herbs can be purchased through the catalogue. The company sells to the general public, to herbalists and to manufacturers. The company may also grow, harvest, and sell bulk herbs, as well as create tinctures, teas and cosmetic products.		X	A product licence is required for product that is manufactured, sold or represented for use as an NHP. For example, sale of mint plants to a consumer would not require a product licence under the NHP Regulations; however, the manufacture and sale of mint tea which is represented for use as an NHP (i.e., labelled with a health claim) would trigger licensing requirements.
22	Replace "not manufactured, sold or represented for NHP use" with something along the lines of "use unknown" or "not labelled as an NHP or AMI".		X	This phrase is utilized as it is the phrase that appears in the NHP Regulations Part 1, Definition.
23	When a site licence is required for the importation or sale of an NHP, who requires the SL - the manufacturer or the practitioner?		X	A site licence is required for the activity of importing or manufacturing; therefore, it is the person who imports the NHP, or manufactures the NHP in Canada who requires the site licence.
24	Does "represented for use" mean only that something is labelled and in dosage form?		X	"Represented for use" is not limited to labelling and dosage form. The policy provides a list of circumstances or features about a product that may lead Health Canada to believe that a product is manufactured, sold or represented for use as an NHP.
25	In the Rationale section, replace "those materials" with "NHPs" in the first bullet: Replace " The safety and quality of those materials that go directly to consumers must be assured through product and site licensing requirements." with " The safety and quality of NHPs that go directly to consumers must be assured through product and site licensing requirements."	X		NHPD agrees that this provides clarity.
26	This policy will adversely affect small and cottage manufacturing.		X	Health Canada is aware of challenges certain industry stakeholders are experiencing. The issue will be considered as part of an overall review of the NHP Regulations which began in Spring 2006. NHP guidance documents and forms are currently being revised to provide more clarity, improve user-friendliness and to reflect changes made over the past two years.
27	In footnote ii) it is not clear whether retailers will require product licences to sell NHPs: "As per section 4, a product licence is required to sell an NHP."	X		NHPD agrees.
28	There should be upper and lower limits on Schedule 1 of the NHP definition. Example: Vitamin C - if you mean anything above detection this will capture what you do not intend to capture.		X	This suggestion is not related specifically to the policy, but rather to the NHP Regulations as a whole. The issue will be considered as part of an overall review of the NHP Regulations which began in Spring 2006.
29	In the 3 rd bullet under Policy Statement, revise the statement to read, "Importation or sale of material for further processing by manufacturers ("further processing" is distinct from "directions for use") or for compounding by practitioners does not trigger…[…].	X		NHPD agrees that this adds clarity.
30	Clarify that while the NHP Regulations do not apply to raw materials, other Acts and regulatory frameworks may (for examples, the Controlled Drugs and Substances Act, the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), etc.).	X		NHPD agrees that this adds clarity.
31	The NHP definition should be revised to more accurately and sensitively reflect the natural and holistic nature of all complementary and alternative health care modalities.		X	This suggestion is not related specifically to the policy, but rather to the NHP Regulations as a whole. The issue will be considered as part of an overall review of the NHP Regulations which began in Spring 2006.
32	The definition of a homeopathic medicine should be revised.		X	This suggestion is not related specifically to the policy, but rather to the NHP Regulations as a whole. The issue will be considered as part of an overall review of the NHP Regulations which began in Spring 2006.
33	In footnote iii, the reference to "substance component" is incomplete, leaving out homeopathic and traditional medicines and the exclusions of Schedule 2.	X		NHPD agrees.
34	NHPD should develop a "negative list" to indicate those substances that are not acceptable as foods. The substances on this list would be NHPs, while those not on the list would be acceptable as foods. The list would be used by the HPFB Inspectorate to facilitate distinguishing between raw materials which have food uses and NHPs.		X	NHPD is aware of difficulties in determining whether certain products are NHPs or food. The usefulness of developing a "negative list" is currently being explored.
35	It should be clarified that an activity should not be considered to be "processing of an NHP" until it is determined that the substance is in fact an NHP. For example, coating licorice root with honey would not be considered processing of an NHP because licorice root could also be a food.	X		NHPD agrees.
36	It should be clarified in scenario #5 that a herb, tincture, or freeze-dried extract (e.g., chamomile) manufactured, sold or represented as treatment for stomach upset that has been compounded by one practitioner and is sold to another does not result in the substance being regulated as an NHP, as practitioner-practitioner-patient relationships are considered compounding under the Interim NHP Compounding Policy.	X		NHPD agrees.
37	How will NHPD decide that a product has only an NHP use?	X		NHPD refers to scientific and traditional use literature (e.g., pharmacopeias) and may also use lists, such as Hong Kong's Chinese Medicine Ordinance lists, to assist in determining whether a product is an NHP. Reference to products with only an NHP use have been removed from the policy.
38	Regarding homeopathy, medicating potencies and medicated pellets should be considered raw materials.	X		NHPD agrees.
39	Add a note in the policy to the effect that: To facilitate the determination by the CBSA and the HPFB Inspectorate of whether a substance being imported into Canada is a raw material or an NHP, practitioners are encouraged to include a statement on the shipment invoice or packing slip that the product is "not for retail sale" or "for compounding by practitioner"; and to not include recommended conditions of use on the product label. These steps would in no way guarantee that a shipment will be permitted entry into Canada: all of the circumstances or features about a material that may lead Health Canada to conclude that a material is manufactured, sold or represented for NHP use would be considered.	X		NHPD agrees.


	Last Updated: 2006-10-20		Important Notices