Natural Health Product Raw Material Policy

The summary of comments from the public consultation can be found in the Consultation Archives.

1.0 Issue

The Natural Health Products Regulations (NHP Regulations) do not specify whether raw materials are or are not included in the definition of a natural health product (NHP). The NHP definition^{Footnote 1} mentions neither raw material (e.g., ginger root that has just been harvested) nor finished product (e.g., encapsulated ginger that is packaged and labelled for the consumer). The NHP Raw Material Policy clarifies at which point a material becomes an NHP, and therefore when product and site licensing requirements are triggered^{Footnote 2}.

2.0 Rationale for Policy

• The safety and quality of NHPs must be assured through product and site licensing requirements.
• The safety and quality of those materials that truly are ingredients in the manufacture of NHPs is ensured through the manufacturing process, since a site licence (and therefore adherence to good manufacturing practices (GMPs)) is a requirement for manufacturing NHPs, and a product licence will be obtained for the final product.
• Health care practitioners must ensure the safety and quality of the materials used to compound product for their patients.

3.0 Policy Statement

This policy outlines Health Canada's current approach with respect to raw materials.

A substance becomes an NHP, and therefore product and site licensing requirements are triggered when the material meets the substance component of the NHP Regulations^{Footnote 3}, and it is manufactured, sold, or represented for use as an NHP (i.e., it meets the function component of the NHP definition^{Footnote 4}).

General notes about raw materials:

• Raw materials are not NHPs.
• It was not the intent of the NHP Regulations to regulate raw materials.
  
  Note that while the NHP Regulations do not apply to raw materials^{Footnote 5}, 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.).
• Raw materials can be used for many purposes, for example in compounding by a health care practitioner, or in the manufacturing of an NHP, a food, a cosmetic, a fertilizer, etc.
• Raw materials become NHPs when they are manufactured, sold or represented for NHP use. For example, bulk powdered melatonin that is being shipped to a manufacturer for encapsulation and packaging would be considered an NHP, as it is manufactured for NHP use.

There are a number of circumstances or features about a material that may lead Health Canada to conclude that a material is manufactured, sold or represented for use as an NHP, including the following:

• Nature of the substance and whether it is inherently therapeutic
• Packaging
• Labelling (including claims)
• Accompanying information/advertising
• Form (e.g., in dosage form)
• Sender
• Recipient (e.g., retail outlet)
• Manner in which it is being sold (i.e., to consumers versus as part of the chain of manufacturing)

Importation or sale of material not manufactured, sold or represented for use as an NHP for further processing by manufacturers ("further processing" is distinct from "directions for use") does not trigger product licensing (PL) and site licensing (SL) requirements; rather, these materials are treated as raw materials.

Note: Processing by manufacturers requires a site licence for the activity of manufacturing. An activity is not considered to be "processing of an NHP" until it is determined that a substance is in fact an NHP. For example, infusing licorice root with honey would not be considered processing of an NHP because licorice root could also be a food.

Importation or sale of material not manufactured, sold or represented for use as an NHP for compounding by health care practitioners does not trigger PL and SL requirements; instead, these materials are treated as raw materials.

Under this policy, those products that are manufactured, sold or represented for use as NHPs are regulated as NHPs. Those products that are manufactured, sold or represented for use as foods are regulated as foods. Those products that are clearly neither foods nor finished NHPs are considered raw materials.

Note: The Natural Health Products Directorate (NHPD) will keep in mind cultural practices when determining whether or not a substance has a food use.

See Appendix I for information regarding raw materials and NHPs for export only.

Appendix I: Raw Materials and NHPs for Export Only

The Natural Health Products Regulations do not regulate raw materials.

Section 37 of the Food and Drugs Act provides an exemption for products being exported from Canada. If claiming this exemption, companies do not have to meet the requirements of the Natural Health Products Reguations. However, certain conditions must be met. Section 37 states:

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.

Companies not claiming an exemption under Section 37 may request an International Trade Certificate from the Natural Health Products Directorate of Health Canada. International Trade Certificates speak to the regulatory and marketing status of the natural health products in Canada. They will be issued upon request to nhp companies holding a valid site licence for natural health products that have received a product licence. The Natural Health Products Directorate provides this information to foreign regulatory authorities to facilitate the export of natural health products from Canada.

Schedule 1 (Subsection 1(1))

Included Natural Health Product Substances

1. A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material
2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation
3. Any of the following vitamins: biotin, folate, niacin, pantothenic acid, riboflavin, thiamine, vitamin A; vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K1, vitamin K2
4. An amino acid
5. An essential fatty acid
6. A synthetic duplicate of a substance described in any of items 2 to 5
7. A mineral
8. A probiotic

Schedule 2 (Subsection 1(1))

Excluded Natural Health Product Substances

1. A substance set out in Schedule C to the Act
2. A substance set out in Schedule D to the Act, except for the following:
   1. a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and
   2. any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
3. A substance regulated under the Tobacco Act
4. A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act
5. A substance that is administered by puncturing the dermis
6. An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic