About The Issues

Food and Drugs Act

Under the current Food and Drugs Act, NHPs are positioned as a subset of drugs, a position that CHFA is actively trying to change. The Standing Committee of Health (which consists of several Members of Parliament) concluded in 1998 that NHPs are neither foods nor drugs and therefore should be defined separately in the Food and Drugs Act.

Consistent with that conclusion, CHFA believes that the Food and Drugs Act should be modernized so that NHPs are no longer positioned as a subset of drugs. The time has come for NHPs to be recognized with a separate category under the Act.

NHP Regulations and Enforcement – Standards of Evidence

Until the Natural Health Product Directorate (NHPD) has clarified the rules for what evidence is required to support the licencing of a product via establishing guidance on standards of evidence issues, full enforcement in the absence of a specific safety concern is premature. The Health Products and Food Branch Inspectorate should only commence full enforcement against those companies who have made little or no attempt to comply with the regulations. Enforcement for other products should only commence when the guidance document from NHPD on standards of evidence is published and appropriate transition is afforded. (Minimum 6 months)

CHFA remains firm in its position that:

Until such time as the appropriate Standards of Evidence (SOE) guidance documents are implemented, enhanced compliance and enforcement is premature, except in situations where companies have made no effort to comply with the current NHP regulations or where a safety concern is identified.

Full compliance and enforcement should not begin until a minimum of six months after Standards of Evidence guidance documents are implemented. This timeframe will allow companies a reasonable amount of time to come into compliance with the clearly defined Standards of Evidence or where a safety concern is identified.

Stay tuned as this issue develops. CHFA is continuously monitoring the government activities on this file and will be updating the information as new developments become available.

CHFA’s Recommendations for the 2011 Budget

Provide adequate funding to regulatory bodies: CHFA recommended that A-Base Funding be provided to NHPD to ensure it has the necessary expertise and resources to implement and enforce the NHP Regulations which affects more than 40,000 NHPs currently in the Canadian marketplace.

Since the Natural Health Product Regulations came into effect in 2004, the NHPD has had to deal with a constant backlog of approximately 10,000 product license applications awaiting their turn for review. The 2010 Unprocessed Product Licence Application Regulations (UPLAR) (the regulatory amendment that was put into place to allow the sale of the 8,000+ products in the application review backlog) went a long way towards dealing with this issue but not in a permanent manner. This regulation contains a 30-month sunset clause, and in order to arrive at a point where applications are processed in a timely manner 30 months from now, adequate resources and funding will have to be allocated to NHPD. If not, we will simply repeat the delays and uncertainty that have negatively impacted the industry since 2004.

Health Canada Links

In Canada, Natural Health Products are regulated under the Food and Drugs Act and its associated regulations (Natural Health Products Regulations and the Unprocessed Product Licence Applications Regulations).

The Natural Health Products Regulations came into effect in Canada in January 2004. The regulations control product licensing, how products are manufactured and the information that is on the label.

The Unprocessed Product Licence Applications Regulations (UPLAR) came into effect in Canada in August 2010.  UPLAR provides a temporary solution for NHPs  that have a product licence application awaiting full review by Health Canada by exempting them from the prohibition against sale in the Natural Health Products Regulations. These products are identified by an exemption number (EN) which is assigned if a product application has been with NHPD for 180 days awaiting full review.

The Natural Health Products Directorate (NHPD) is the regulating authority for natural health products for sale in Canada. Their role is to ensure that Canadians have ready access to NHPs that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.

The Licensed Natural Health Products Database (LNHPD) contains product specific information on those natural health products that have been issued a product licence by Health Canada.

The Natural Health Products Exempted Products Database allows stakeholders to search for natural health products that have been granted an exemption, in the form of an exemption number (EN), by the Minister under the provision of the Natural Health Products (Unprocessed Product Licence Applications) Regulations (UPLAR).

The Health Products and Food Branch Inspectorate (HPFBI) is responsible for branch-wide compliance and enforcement activities, enabling consistency of approach across the spectrum of regulated products. The Inspectorate core functions are compliance monitoring, and compliance verification and investigation, supported by establishment licensing of drugs and medical devices, and laboratory analysis.

The Marketed Health Products Directorate (MHPD) works to assure that Health Product and Food Branch (HPFB) programs take a consistent approach to post-approval safety surveillance, assessment of signals and safety trends and risk communications concerning all regulated marketed health products.

Definitions

Acknowledgment letter: A letter issued to all applicants to confirm the receipt of their application. The acknowledgment letter includes the file number, transaction number and date or receipt of application and request for clarity to company information, if required.

Adverse Reaction: A noxious and unintended response to a natural health product that occurs at any dose used to test for the diagnosis, treatment or prevention of a disease or for modifying an organic function.

Amino acids: A class of organic molecules containing amino and carboxylic groups, forming the chief constituents of proteins found in a plant or a plant material, an alga, a bacterium, a fungus, or a non-human animal material.

Conditions of Use: As defined in the Natural Health Products Regulations, ‘conditions of use’ or ‘recommended conditions of use’ for a product includes: health claim, route of administration, dose, dosage form and duration of use.

DIN (drug identification number): A numerical code assigned to each drug product marketed under or in accordance with the Food and Drugs Act and Food and Drug Regulations.

Distributor: A person who sells a natural health product to another person for the purpose of further sale by that other person.

Dosage form: The final physical form of the natural health product which may be used by the consumer without requiring any further manufacturing.

Enzyme: A protein that acts as a catalyst, increasing the rate at which a specific biochemical reaction occurs. Enzymes may be derived from a plant or a plant material, an alga, a bacterium, a fungus, or a non-human animal material.

Essential fatty acid: Cannot be synthesized in the body and have to be supplied through the diet or a supplement. Current knowledge indicates that there are only two essential fatty acids: linoleic acid and a-linolenic acid.

EN (exemption number): The number that has been assigned by Health Canada under the Natural Health Products (Unprocessed Product Licence Applications) Regulations that allows for the legal sale of products that have not been issued a product licence but have been initially assessed to ensure that information supporting the safety, quality and efficacy have been provided and meet the required criteria.

Expiry date: Means the earlier of:

• the date, expressed at minimum as a year and month, up to and including which a natural health product maintains its purity and physical characteristics and its medicinal ingredients maintain their quantity per dosage unit and their potency, and
• the date, expressed at minimum as a year and month, after which the manufacturer recommends that the natural health product should not be used.

Good manufacturing practices: Measures to ensure an overall effective approach to product quality control and risk management. They apply to places, people, processes and products with respect to which activities are being conducted. Please refer to Part 3 of the Natural Health Products Regulations and the Good Manufacturing Practices for Natural Health Products Guidance document.

Homeopathic medicine: Medicines that are manufactured from or contain as medicinal ingredients only those substances or sources referenced in the Homeopathic Pharmacopoeia of the United States, the Homöopathische Arzneimittel, the Pharmacopée française or the European Pharmacopoeia, as amended from time to time, and that are prepared in accordance with these pharmacopoeias.

Importer: A person who imports a natural health product into Canada for the purpose of sale.

Ingredient: A single substance that is a component part of any combination or mixture. For example, vitamin C is a common ingredient in a multi-vitamin product.

Manufacturer: A person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of the patient, compounds a natural health product for the purpose of sale to that patient.

Marketing authorization: A legal document issued by the Natural Health Products Directorate authorizing the sale of a natural health product in Canada.

Medicinal Ingredient: Any substance set out in Schedule 1 of the Natural Health Products Regulations that is intended to furnish pharmacological activity or other direct effect in:

• the diagnosis, treatment, mitigation, or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; or
• restoring or correcting organic functions in humans; or
• modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Mineral: A naturally occurring, sold, inorganic substance with a definite and predictable chemical composition and physical properties.

Natural health product: A substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
• restoring or correcting organic functions in humans; or
• modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.

NPN/DIN-HM: Natural Product Number is an eight (8) digit numerical code assigned to each natural health product approved to be marketed under the Natural Health Products Regulations. DIN-HM is an eight (8) digit numerical code assigned to each homeopathic medicine approved to be marketed under the Natural Health Products Regulations.

Pre-market Authorization: The regulatory requirement to receive a product licence before placing it on the market.

Probiotic: A monoculture or mixed-culture of live micro-organisms that benefit the microbiota indigenous to humans.

Product licence applicant: An individual with legal ownership of and responsibility for the natural health product. The product licence applicant may be located in or outside of Canada. Applicants who are located outside of Canada must identify a Canadian representative.

Safety: The ability for a natural health product to produce a beneficial health outcome, outweighing the risk associated with using it, in humans, according to the recommended conditions of use.

Self-care: Self-care involves the activities individuals undertake for the prevention, treatment and symptomatic relief of diseases, injuries or chronic conditions that individuals can recognize and manage on their own behalf, either independently or in cooperation with a health care provider.

Site licence number: A number issued by Health Canada’s Natural Health Products Directorate based on the requirements set out in the Natural Health Products Regulations as proof of authorization to conduct specified activities at the listed locations.

Standards of Evidence: Clearly defined criteria used by regulators to evaluate the safety, quality and effectiveness of a claim regarding a health product or food. The criteria define the amount and type of data required to support the safety of a product and all health claims that are associated with it. Although Standards of Evidence may differ from one type of product to another, they are consistent within a similar category of products.

Structure-Function Claim: A claim which describes the effect of a product on a structure or physiological function in the human body, or a product’s support of an anatomical, physiological, or mental function. This category includes claims of maintaining or promoting health.

Traditional medicine: The sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. Traditional medicine has a long history (50 consecutive years) of use.

Treatment Claim: A claim which relates to the diagnosis, treatment, mitigation or prevention of a disease, disorder, or abnormal physical state or its symptoms in humans.

Vitamin: An organic substance needed in small amounts to maintain normal health.