Health Product Licensing
Things you should know about…
CURRENT NATURAL HEALTH PRODUCT REGULATIONS in CANADA
A Natural Product Number (NPN) is required for sales in Canada. These new Canadian regulations came into effect on January 1, 2004.
The Natural and Non-prescription Health Products Directorate (NNHPD) evaluates new products previous to sales to ensure safety, quality, and efficacy. Natural health products that comply with the requirements are issued natural product numbers (NPNs); an eight-digit number. The licensing requirements of the natural health products regulations apply to any person or company that manufactures, packages, labels and/or imports NHPs for commercial sale in Canada. They do not apply to health care practitioners who compound products on an individual basis for their patients, or to retailers of NHPs.
Natural health products include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines like traditional Chinese and Ayurvedic (East Indian) medicines, probiotics and other products like amino acids and essential fatty acids. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops; many everyday consumer products, such as tooth pastes, antiperspirants, shampoos and facial products.
Safety As part of the Federal department that works to ensure the overall health of Canadian citizens, Health Canada has a direct influence on the manufacturing, importation, sale and distribution of natural health products throughout Canada. Health Canada often updates to new regulatory changes in order to guarantee that natural health products that are either made in Canada or are entering Canada are safe and effective.
How Does This Affect My Supply Chain? These new regulatory requirements have a direct impact on how natural health products are manufactured, imported and distributed throughout Canada. Each organization that is involved in the overall supply chain of these products (i.e. manufactures, packagers, labelers and importers) must have valid site licenses. Also, for a product to be imported into Canada, the importation must be performed by a fully compliant facility that has been officially licensed by Health Canada. Failure to do so will result in the goods not being allowed to enter the country
Safety of an ingredient is provided by scientific data or human studies/clinical trials proving the safe dosage of ingredients used in the product. Traditional use of an herb or ingredient may also provide support for safety.
All products should be safe under their recommended conditions of use. Safety evidence recommendations are based on the identified risks, including but not limited to:
Severity and seriousness of adverse effects, Probability or frequency of adverse effects, Severity and seriousness of the disease or condition for which the product is indicated for use, health impact associated with a lower than expected performance of the product, use by potentially vulnerable sub-populations (e.g., infants, children, pregnant and breastfeeding women, elderly) and Inherent risks of the medicinal ingredients in the product.
When necessary, safety evidence may also need to support: Chemistry and manufacturing information, Characterization of the disease implicated in the recommended use or purpose, Characterization of the risk factors associated with the disease implicated in the recommended use or purpose, Assessment of the potential for interactions, An independent causality assessment of adverse reactions, A description of the post-market surveillance program (for active surveillance data), Consumer research to support labelling; and/or a detailed benefit-to-risk assessment.
It is also important to note Health Canada now allows support of a medicinal ingredient if it has been demonstrated for food use.
Only safety risks that can be mitigated by advisory information such as warning statements or contraindications for mild to moderately harmful outcomes are acceptable for licensed Natural Health Products (NHPs). Serious or severe outcomes that occur only in a very limited and specific population and which can be clearly contraindicated on the product licence application form and product label are the exception to this rule. All other risks should be mitigated by appropriate conditions of use.
As a general rule, risk statements should be based on human evidence or established risks and are necessary when the awareness of these risks is required to help consumers make an informed choice. Additionally, advisory information should be based on moderately intolerable or unexpected adverse reactions and not on mild transient reactions (e.g., nausea). Evidence of risk in animals can contribute to understanding the mechanism of action, but does not commonly form the basis for including a risk statement when non-corroborative human evidence is submitted. Risk statements based on animal evidence may be necessary when the risks are serious.
Within any risk category, the evidence may be sufficient to support both safety and efficacy when it is appropriate for the claim and when it fully reflects the product’s recommended conditions of use.
For the low and medium categories, methodologically weak safety evidence should be supplemented to demonstrate consistency in results and plausibility.
For the high risk category, product specific evidence is recommended. Additionally, the evidence package should include a complete critical summary reflecting the totality of evidence and should usually reflect more than one type of evidence.
An expert opinion may be used to supplement information that is not available in the literature, (e.g., duration of use for an ingredient) or as supplementary information to support a new use for a previously approved ingredient. When using expert opinions, factors such as experience, education, the number of experts, and conflicts of interest should be considered. These factors, along with any other relevant information provided, will contribute to the weighting of the expert opinion.
An expert should have : Training in the field or healing paradigm related to the proposed NHP or medicinal ingredient(s), Scientific qualifications, including experience in research methods and/or training in evidence-based health care and no conflicts of interest or must disclose all conflicts of interest.
Human studies/scientific data must be provided to prove the efficacy of the ingredients dosage in the product.
All products must have at least one health claim. Efficacy evidence should support the reasonable association of the medicinal ingredient(s) with the health claim(s) and demonstrate that therapeutic efficacy of the product will be supported by at least one medicinal ingredient or the combination of more than one.
To do this, the evidence should support the claim with respect to the specific target population intended, the specific directions of use and the specific system of medicine, when appropriate. The efficacy evidence should be able to support the health context of the product and, when necessary, provide enough background information to describe the characterization of the health condition implied by the claim and the health context of the recommended use.
Within any risk category, the same evidence may be sufficient to support both safety and efficacy when it is appropriate for the claim and when it fully reflects the product’s recommended conditions of use.
The minimum type of evidence from a higher risk category may be used to support a claim in a lower category as long as it is appropriate for the condition.
For the low and medium categories, methodologically weak efficacy evidence should be supplemented to demonstrate consistency in results and plausibility.
Efficacy Evidence for the High Risk Category
NHPs making claims for the treatment, prevention or cure of serious health conditions should meet the evidence criteria for the high risk category.
The evidence package should include a complete critical summary reflecting the totality of evidence. Evidence should be presented in the form of a systematic review outlining the validity and causality elements for each reference by providing a critical analysis of the study design types, and the quality and quantity of each evidence type that supports and refutes the claim. Product-specific evidence is recommended. Evidence provided should demonstrate statistically significant outcomes, clinically meaningful differences, relevance to the target population, and overall consistency of the results across all studies of acceptable quality. Data should support the characterization of the disease.
Efficacy Evidence for the Medium Risk Category
Natural Health Products (NHPs) making claims for major health conditions and diseases should meet the evidence criteria of the medium risk category. The evidence for products or ingredients in this category can be submitted as individual references, although additional information or evidence is recommended to help support: the recommended conditions of use, the health context of the product, and the comparability of the ingredient forms.
Efficacy Evidence for the low Risk Category
NHPs making claims for minor health conditions and diseases should meet the evidence criteria of the low risk category. This risk category also includes NHPs for the treatment of symptoms or risk factors of serious or major conditions or the risk reduction of these conditions; and NHPs for general health maintenance, support, or promotion that refers to modification of a biochemical or physiological function of a nutritional nature or implies benefit to a minor disease or health condition. Evidence requirements for this category reflect the low risk nature of these products; however, evidence should still demonstrate key aspects of validity and be appropriate for the recommended conditions of use.
This category includes most vitamins, minerals, essential nutrients, and other nutrients recommended for use by healthy adults. These types of ingredients are often associated with the Natural Health Products Directorate (NHPD) pre-cleared information.
Qualifying Claims/General Health Claims
What is meant by a general health claim? There are several types of general health claims. The main type of general health claim is known by the fact that the claims are more limited in describing the effect of the NHP and present the component as having a therapeutic effect as it relates to a disease or health condition without classical definition of the effect or outcome. As such, the first type of general health claims does not address mitigation, treatment, prevention or cure of serious or major conditions. Instead, they relate to modifying organic functions in a manner that maintains or promotes health, including nutrient structure-function and quality of life health claims.
What type of evidence is required for a general health claim? The information or data used to support a general health claim should be appropriate to the strength of the health claim. This includes the fact that the evidence standards could be different than those presented in the main body of the ‘Pathway for Licensing Natural Health Products Making Modern Claims’ or ‘Pathway for Licensing Natural Health Products Making Traditional Claims’ guidance documents.
General health claims must not be false or misleading and their accuracy must be established through an established methodology to meet the appropriate standard of evidence. Further, the claims must not lead to unsafe or inappropriate use of an NHP, nor to the sale or advertising of NHPs for use outside of their approved indications and conditions of use.
An NHP, its associated claim(s) and its packaging, labelling and advertising must be consistent with the terms of market authorization. Additionally, a claim made through the product name, the brand name or the name of the manufacturer will be considered false or misleading if it indicates or implies an unauthorized indication and/or use of the NHP that was not included in the terms of market authorization.
When necessary, qualifying statements may be necessary to add context to support a claim and to help consumers make informed decisions. The need to qualify a claim is based on the characteristics of the ingredients, the seriousness and severity of the health claim, the need for specificity within the claim, as well as the value that the wording will provide to the consumer.
Examples of this qualification would be: When the evidence refers to one risk factor in a risk reduction claim, the claim should be qualified with other modifiable factors that should be considered (e.g., “calcium intake, when combined with sufficient Vitamin D, a healthy diet, and regular exercise, may reduce the risk of developing osteoporosis”); and risk reduction claims in which a biomarker was used should indicate that the biomarker, the factor which contributes to the efficacy of the claim, is only one of many that may contribute to the development of the disease to which it has been linked.
Lab tests for microbials, chemical contaminants and pesticides are required. A Certificate of Analysis (CofA) on the raw materials can also be used for proving safety.
A Finished Product Specification form (FPS) is required to prove safety of a finished product; it describes the tests used and appropriate tolerance limits, ranges, or other criteria for the tests described. Specifications are critical quality standards that are provided in the application as part of the conditions prior to sale. These specifications should be filed by the person responsible for quality control that signs and dates the lot release.
Good Manufacturing Practices (GMP) make sure proper standards and practices for the testing, manufacture, storage, handling and distribution of natural health products are met while giving manufacturers, packagers, labelers, importers and distributors the flexibility to use quality systems appropriate for their product lines and businesses.