The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.
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Guidance documents are meant to provide assistance to industry and health care practitioners on how to comply with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada mandates and objectives should be implemented in a manner that is fair, consistent and effective.
Guidance documents are administrative instruments and therefore allow for flexibility. Alternate approaches to the principles and practices described in this document may be acceptable; licence applicants are invited to discuss these with the Natural Health Products Directorate (NHPD) prior to submitting an application.
As a corollary to the above, it is equally important to note that Health Canada may request information or material, or define conditions not specifically described in this document, in order to enable the Department to adequately assess the safety, efficacy or quality of a health product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.
This document should be read in conjunction with the Natural Health Products Regulations and relevant sections of other applicable guidance documents.
Document Change Log
Document: Pathway for Licensing Natural Health Products Used as Traditional Medicines, Version 1.0
Date: December 2012
Replaces: Evidence for Safety and Efficacy of Finished Natural Health Products, Version 2.0
Note: this document is also replaced by the following document: Pathway for Licensing Natural Health Products Making Modern Health Claims, Version 1.0
Date: December 2006
Change: Extensive revisions
Location (section, paragraph): There were extensive revisions to the content including the addition of revised appendices and an extensive reorganization of the document.
Nature of and/or Reason for Change: The December 2006 document, Evidence for Safety and Efficacy of Finished Natural Health Products, Version 2.0, was revised in order to reflect some of the recommendations of the Natural Health Product Program Advisory Committee which were posted on the Health Canada website under the name Report of the Natural Health Products Program Advisory Committee to the Natural Health Products Program, January 26, 2010. It was also split into two guidance documents.
This guidance document provides information to help product licence applicants determine the evidence (type and amount of data) to be provided to support the safety (risk) and efficacy (benefit) of traditional medicines.
The intent of this document is to ensure that the levels of evidence are rigorous enough to protect public health and maintain consumer confidence, while providing industry with a clearly defined pathway to bring to market natural health products (NHPs) which are formulated based on traditional principles.
While not specifically included in this guidance document, other options for supporting safety and efficacy may be considered depending on the circumstances of a particular NHP.
The Natural Health Products Regulations (NHPR) set out the requirements governing the sale, manufacture, packaging, labelling, importation, distribution and storage of NHPs. The objective of the NHPR is to provide reasonable assurance that products offered for sale in Canada are safe, efficacious and of high quality. Evidence submitted as part of a product licence application must support the requirements set out in section 5, paragraphs (a) to (j) of the NHPR.
To provide reasonable assurance that natural health products (NHPs) offered for sale in Canada are safe and effective when used under their recommended conditions of use.
The level of evidence (type and amount) that can be provided to support the safety and efficacy of a natural health product (NHP) varies depending on the proposed health claim(s) of the product and the overall risk profile of the product or its ingredients.
This guidance document applies to product licence applications for traditional medicines. It does not apply to product licence applications for:
In addition, the requirements and restrictions outlined in this document do not apply to health care practitioners (including, but not limited to, practitioners of Traditional Chinese Medicine (TCM) or Ayurvedic Medicine) who compound products for their patients in the context of a practitioner-patient relationship. For more information, see the Natural Health Product Compounding Policy.
For NHPs with modern health claims, refer to the Pathway for Licensing Natural Health Products Making Modern Health Claims.
For NHPs with traditional use claims which do not meet the definition of a traditional medicine (e.g., products containing ingredients that are not supported for use within the same paradigm), refer to the Pathway for Licensing Natural Health Products Making Modern Health Claims.
For medicinal ingredients prepared in accordance with homeopathic pharmacy, refer to the Evidence for Homeopathic Medicines Guidance Document.
For more information on the 60-day disposition clause, refer to the Compendium of Monographs Guidance Document.
Note: All guidance documents can be found on the Health Canada website.
The Evidence for Safety and Efficacy of Finished Natural Health Products Guidance Document (December 2006) is replaced by two new guidance documents: Pathway for Licensing Natural Health Products Making Modern Health Claims and Pathway for Licensing Natural Health Products Used as Traditional Medicines.
The current guidance document describes the levels of evidence for safety and efficacy of natural health products meeting the Natural Health Products Directorate's definition of traditional medicine.
Natural Health Product (NHP)
An NHP is a substance or a combination of substances described in Schedule 1 of the Natural Health Products Regulations (NHPR), a homeopathic medicine, or a traditional medicine, that is intended to provide a pharmacological activity or other direct effect in:
Schedule 2 of the NHPR sets out substances which do not fall within the meaning of an NHP.
A medicinal ingredient is a substance which is set out in Schedule 1 of the NHPR, is biologically active and is included in an NHP for the purposes of:
A medicinal ingredient is characterized by its physical form, its chemical attributes, its source, its preparation, as well as its dose and pharmacological action.
A non-medicinal ingredient is defined as any safe substance that is added to a product to confer suitable consistency or form to the medicinal ingredients (suitable as per dosage form and route of administration). Non-medicinal ingredients:
Recommended Conditions of Use
The recommended conditions of use are defined as:
Traditional medicine is defined as medicine based on the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness. This definition is one modified from the World Health Organization Traditional Medicine Program, recognizing traditional medicines at their core as ancient medical practice that existed in human societies before the application of modern science to health and that have evolved to reflect different philosophical backgrounds and cultural origins.
Product licence applicant:
It is the responsibility of the applicant to provide a complete product licence application, including evidence demonstrating that safety (risk) has been established and any risks sufficiently mitigated; that efficacy (benefit) has been demonstrated; and that quality is supported.
Natural Health Products Directorate:
It is the responsibility of the NHPD to review the information provided as part of the product licence application in order to assess the safety, efficacy and quality of a natural health product, to ensure benefits outweigh risks, and to clearly document the product licensing decision.
For further information on roles see the Management of Product Licence Applications for Natural Health Products policy. It explains how applicants can meet with the NHPD prior to submitting a product licence application and communicate with their submission coordinator throughout the application review process.
In order to obtain authorization to sell a natural health product (NHP) in Canada, a product licence application must be submitted to Health Canada. As part of this product licence application, evidence supporting the safety and efficacy of the NHP according to its recommended conditions of use must be included.
You may be able to get a product licence quickly by using our pre-cleared information: check out our monographs and labelling standards via the Natural Health Products Ingredients Database.
The purpose of the assessment is to determine whether the evidence supports the safety and efficacy of the product, including whether there is reasonable assurance that benefits of the product outweigh any risk inherent in the product's ingredients or associated use of the product. The assessment of safety (risk) for a product depends on a variety of factors, including the conditions of use and the physical form and pharmacology of each ingredient in the product as well as the product as a whole. The benefit-to-risk profile of a product is always considered prior to a product licensing decision being made (i.e., licence issuance or application rejection).
Refer to the Management of Product Licence Applications for NHPs for more information on the product application and assessment process.
A health claim is a statement that indicates the intended beneficial effect of a product when used in accordance with its recommended conditions of use. The term "recommended use or purpose" is often used interchangeably with "health claim" or "indications for use."
Given the definition of a traditional medicine, traditional use claims should reflect the sum total of knowledge, skills, and practices based on theories, beliefs, and experiences indigenous to a specific culture, used in the maintenance of health, as well as prevention, diagnosis, improvement, or treatment of physical and mental illness. For a claim to be categorized as "traditional use," it should be founded upon the theories, experiences and beliefs embodying the respective ancient practice of medicine.
Products with general health claims include those that have low therapeutic impact and are therefore subject to the appropriate evidence requirements.
Annex I of the Pathway for Licensing Natural Health Products Making Modern Health Claims outlines a regulatory pathway for NHPs with general health claims. These claims can be used provided that the health and safety of Canadians would not be at risk; this is consistent with a risk-based product approach where health claims are indexed against the level of evidence provided to support the safe use of the products. For information on general health claim principles, see Annex I.
There are multiple ways to support a long history of use. Examples of ways to demonstrate a long history of use of a natural health product (NHP) (or medicinal ingredient) includes:
Products with multiple medicinal ingredients with "traditional use" claims are permitted for assessment as traditional medicines when certain conditions are met:
The intent is to capture modifications to classic traditional formulations that are supported by the knowledge and experience of the traditional system of medicine. For example, modifications of the classical formula of a TCM that are still based on TCM principles would fall into this category, but the modifications of ingredients based on other evidence would not. The intent is also to capture formulations in Traditional Herbal Medicine or Traditional Ayurvedic Medicine that are logical within those systems of medicine, but not additions of unrelated herbs, vitamins, minerals or other ingredients.
If the recommended conditions of use (i.e., the recommended use or purpose, dose including the method of preparation, dosage form, or route of administration) for the product are not comparable to the recommended conditions of use contained within the references on the traditional use of the product, the product will not be assessed as a traditional medicine, a traditional use claim may not be permitted, and additional evidence requirements may apply.
Figure 1 outlines the risk-based decision process for determining when traditional use claims are acceptable for traditional medicines.
Figure 1: Risk-Based Approach for determining when Traditional Use Claims are Appropriate for Traditional Medicines
As per section 2.4, there are many ways to demonstrate a long history of use. Ideally, the references help to establish the paradigm in question, in addition to providing information on the conditions of use (indications, dose, cautions and contra-indications, etc.) of specific ingredients within that paradigm.
References should also refer to a health condition that can be diagnosed in the relevant system of traditional medicine independent of whether the reference indicates "traditionally used" or not. For example, hyperlipidemia is a health condition that cannot be diagnosed within a traditional system of medicine.
Other methods of preparation may be considered traditional if supported by at least one reference describing the method's use within the practice of traditional medicine and assessed as acceptable by the Natural Health Products Directorate (NHPD).
Safety is supported in several ways. History of use is an important consideration. References demonstrating that the ingredient has an extensive history of use should be submitted (see section 2.4). Although the indication need not be the same, other conditions of use (dose, duration of use, source material, method of preparation, etc.) should be comparable to the conditions of use being proposed.
Cautions, warnings and contra-indications found in the accompanying references are a primary source of safety information. In many cases, safety concerns can be mitigated by limiting dose and/or duration of use, by adding risk statements or by limiting sub-populations, e.g., pregnant and breastfeeding women.
Finally, a search should be made of the totality of evidence to ensure that no new, unknown safety concerns have been identified by the findings outside of evidence for traditional use. In many cases other data will not exist to confirm safety, in which case existing safety data as described above will be considered sufficient. Should the available evidence suggest that a medicinal ingredient is unsafe when used according to the product's recommended conditions of use, it will be necessary to submit further evidence of equal or higher validity, causality, and credibility to demonstrate that the balance of evidence supports a favorable benefit to risk ratio for the product. Theoretical concerns will not be considered in the absence of clinical data.
It is important to note that non-medicinal ingredients listed in the Natural Health Products Ingredient Database (NHPID) have not necessarily been reviewed for safety or suitability in natural health products (NHPs). Additional information may be requested to support the safety or nature of any non-medicinal ingredient. Information to support the recommended conditions of use for all non-medicinal ingredients should be available upon request, such as quantity, purpose in formulation, alternative formulations and specifications, identity information, safety information or other manufacturing information.
When evidence to support safety is requested, it should reflect the daily dose and purpose of the non-medicinal ingredient, should be appropriate to the route of administration, and should consider exposure. Non-medicinal ingredients should not be indiscriminately included within a product's formulation. The safety requirements for non-medicinal ingredients generally mirror those of medicinal ingredients. However, when risk or uncertainty is identified, additional evidence may be requested to help characterize the risk.
Manufacturers may add substances to their medicinal ingredients to aid stability or manufacturing processes. If these remain in significant quantities in the finished NHP (e.g., including any quantity that still provides a technical effect), they must be declared as non-medicinal ingredients on the product licence application form and label. It may be necessary to communicate with the manufacturer directly in order to identify these types of ingredients.
The individual components of mixtures should be listed separately except when the mixture has a common name in the NHPID (exceptions may be made when the NHPID does not adequately describe the components of the mixture) or the mixture is a proprietary blend of flavours that may be qualitatively described (e.g., artificial strawberry kiwi flavour blend).
Traditional use claims for traditional medicines are divided into two sub-categories according to the evidence provided:
To help ensure that product licence applications for traditional medicines are processed in a timely manner, applicants are asked to provide a cover letter with their applications that clearly indicates which of the two evidence categories their product is intended for.
Products providing only pharmacopoeial evidence and answering "yes" to all elements of the Checklist for the Traditional Pharmacopoeial Evidence Category (Appendix A [WCA - insert URL]) only require one supporting reference. Answering "no" to any of the questions posed on this checklist excludes the product from being assessed within the pharmacopoeial stream.
Applications suitable for assessment within the pharmacopoeial evidence category should provide one of the following as evidence in supporting the claim:
Note: An English or French translation of the relevant monograph pages should be provided (in addition to a copy of the original) if the language of publication is neither English nor French. The accuracy and completeness of any and all translated documents should be verified as lack thereof may result in refusal of the submission.
The information on Part 4 of the Product Licence Application form (e.g., medicinal ingredients, route of administration, dose, duration of use, method of preparation, etc.) should be comparable to that stipulated in the supporting monograph or reference. As an exception, when a monograph specifies an indication related to a serious disease, condition, or abnormal physical state (e.g., cancer, depression, alcoholism) revisions are permitted to make the claim more appropriate for a non-prescription product. Serious diseases/conditionsare those for which treatment requires supervision by a doctor, or are debilitating or potentially life threatening without effective treatment.
A multiple ingredient rationale is not required and the Checklist for the Traditional Pharmacopoeial Assessment Evidence Category does not need to be included with the application when pharmacopoeial evidence is provided.
Products providing more than pharmacopoeial evidence as the evidence supporting efficacy or answering "no" to any of the elements of the Checklist for the Traditional Pharmacopoeial Evidence Category should provide at least two independent references that support the recommended conditions of use. Independent references are those that do not cite the same source, or each other, as the main source of information regarding the traditional use of the ingredient. The references should be authoritative and from a reputable source as determined by Natural Health Products Directorate. Appendix B provides a partial list of selected references that are recommended.
In the case where only one written reference exists or where multiple references refer back to a single original source, an expert opinion based on practitioner experience and knowledge may be considered as a possible substitute for a second reference. Refer to Appendix G for more information on expert opinions.
When a product meets the Natural Health Products Directorate (NHPD) definition of traditional medicine and relies on traditional evidence to support safety or efficacy, claims should be prefaced with qualifiers indicating the specific traditional system of medicine such as "traditionally used in Ayurvedic medicine," to identify for consumers that efficacy is based on a specific system of traditional medicine. If the claim uses terminology specific to a particular culture or system of medicine, that specific terminology along with the culture or system of medicine should be specified in the claim (e.g., "Traditional Chinese Medicine (TCM) used to replenish Qi (vital energy)..." or "traditionally used in Ayurvedic medicine to improve agni [digestive fire]").
If both traditional use evidence and modern evidence are available to support a proposed claim, the use of the wording "traditionally used" is optional; however, a product making a traditional use claim based primarily on traditional use evidence is to be assessed as a traditional medicine. If a health claim is solely supported by modern evidence, it should not include the words "traditionally used."
The NHPD recognizes that some systems of traditional medicine may communicate risk information in language that is specific to that healing paradigm or culture. In cases where it is not evident to the consumer that the risk information is based on use within a traditional system of medicine, a traditional qualifier can be included in the risk information as an option (e.g., "do not use in cases of external pathogenic heat [TCM]").
Refer to Appendix C for recommendations on how to link safety and efficacy evidence to a product's conditions of use.
Refer to Appendix D for recommendations on how to link safety and efficacy evidence to an ingredient's chemical and physical form.
Refer to Appendix E for information on linking safety and efficacy evidence to the use of an extract (i.e., comparability of an extract to the evidence).
Refer to Appendix F for the evidence criteria for traditional use claims, which can be used as a final check before submitting a product licence application to ensure that the application is not missing any evidence and meets a minimum level of validity.
Appendix A: Checklist for the Traditional Pharmacopoeial Evidence Category
Appendix B: Partial List of Recommended References for Supporting Traditional Use Claims
Appendix C: Linking Evidence to Conditions of Use
Appendix D: Linking Evidence to Ingredient Form
Appendix E: Linking Evidence to Use of Extracts
Appendix F: Evidence Criteria for Traditional Medicines
Appendix G: Expert Opinion
This checklist is for use by applicants but does not need to be submitted with the product licence application. However, responding "no" to any of the questions posed on this checklist excludes the product from being assessed within the pharmacopoeial stream. Products that can answer "yes" to all criteria require only one approved reference.
|Information Captures||Pharmacopoeial evidence identical/comparable to the Pharmacopoeia of the People's Republic of China (PPRC) or the Drug Standard of People's Republic of China (also called the State Drug Standard (SDS)) or The Ayurvedic Pharmacopoeia of India|
|All medicinal ingredients|
|Quantity of the medicinal ingredients as per crude material equivalent, when applicable|
|All recommended uses or purposes|
|Recommended route of administration|
|Recommended duration of use (if any)|
|Directions of use|
|Risk information (cautions, warnings, contraindications, known adverse reactions)|
|Methods of preparation (traditional)|
|Copy of the relevant pages from the Pharmacopoeia (in English or French)|
|Product claim does not refer to or imply diseases listed on Schedule A to the Food and Drugs Act|
This appendix lists recommended references for supporting i) Traditional chinese medicines, ii) Traditional ayurvedic medicines and iii) Traditional herbal (eclectic) medicines.
i) Traditional Chinese Medicines
ii) Traditional Ayurvedic Medicines
iii) Traditional Herbal (Eclectic) Medicines
Note: Where more recent editions/versions of the following texts are submitted, the information should be presented in the reference in a way which appropriately reflects the total knowledge, skills and practices of the paradigm.
Evidence is required to support the claim and all of the recommended conditions of use. Table 1 provides a summary of important recommendations.
|Part of the Application||Criteria|
|Recommended use or purpose (claim)||The references indicate the same claim as indicated in the product licence application form (but may use different words to describe it). For example:
Reference 1: Increases urinary flow
Reference 2: Diuretic (this has the same intent as Reference 1)
|Proper name||The references include the proper name of the medicinal ingredient, since common names are not always used consistently. If a particular reference supports all of the conditions of use but indicates only a common name instead of a proper name, then the reference may be used along with another acceptable reference that links the proper name with that common name.|
|Source||The references support the source indicated in the product licence application form for each medicinal ingredient. For example: for a given herb, if the references support only the use of its roots as a source of the medicinal ingredient, then the flowers will not be acceptable as the source.|
|Dosage form||The dosage form is consistent with the route of administration.
For example: the dosage form is a "capsule" and the route of administration supported by the references is "oral."
|Route of administration||The references support the same route of administration that is indicated in the product licence application form.|
|Dose||The references support the same dose (or dosage range) that is indicated in the product licence application form. Indicate the crude material equivalent, when applicable. For example:
The recommended dose is 3-4 g crude material equivalent.
Reference 1: 2-4 g crude material equivalent
Reference 2: 3-5 g crude material equivalent
|Tinctures and extracts||The references provide sufficient information about tinctures or extracts to calculate the crude material equivalent, when applicable. Any variations in the solvent used, solvent concentration and extract ratio or potency from the cited references should be justified.|
|Risk information||Relevant safety information from all available sources, including references to traditional use and modern references, is used to determine the risk information associated with the natural health product (NHP).|
The evidence should adequately match both the ingredient form (physical and chemical form and sometimes source material) as well as the conditions under which it will be used (recommended use, dosage form, route of administration, dose, duration of use, target population).
This table provides recommendations for ensuring that evidence will support the ingredient's chemical and physical form.
|Ingredient Characteristic||Recommendations for Safety and Efficacy Evidence|
|Identity||Evidence should support:
- The unambiguous Latin binomial name or chemical name;
- The part or derivative used;
- The specificity of the ingredient's action.
For example, for botanicals, the evidence should be specific to the part of the plant used; if the evidence indicates "leaf" then "aerial parts" would not likely be supported unless evidence was provided to show that stem and other relevant parts have the same chemical/constituent profile at the same concentration.
|Source Material||Evidence should:
- For a non-extracted or extracted medicinal ingredient (MI) - Describe the source material(s) that are utilized in sufficient detail to clearly identify the medicinal ingredient as comparable to that represented on the Product Licence Application form. As an example, the medicinal ingredient may be referred to as Fructus Toosendan in the evidence and further described as the dried ripe fruit of Melia toosendan. Consequently, this information would not support the use of Melia azedarach fruit or Melia toosendan aerial parts. Similarly reference to an ingredient such as mint should be sufficiently detailed to describe the type of mint (e.g., Mentha viridis, Mentha x piperita, etc.) and associated material (e.g., leaf or leaf oil, etc.).
- For an isolated MI - Describe the source material and preparation of the isolate (when available) in sufficient detail to allow for a comparison to the medicinal ingredient represented on the product licence application form. As an example, the medicinal ingredient Camphor should be described in sufficient detail to distinguish between reference to Cinnamomum camphora - the plant, and Camphor (white crystalline compound) - obtained from the gum resin of Cinnamomum camphora, Dryobalanops aromatica or synthesized.
|Blends of Ingredients||Efficacy evidence should:
- Describe a blend of medicinal ingredients (X, Y, Z) only when X, Y, Z are all present in the recommended product at a similar dose.
|Chemical Form||Evidence should :
- Support the ingredient form as much as possible when the ingredient has undergone chemical processes that could affect its safety or efficacy (e.g., oxidation, reduction, purification, emulsification, etc.).
|Physical Form||Evidence should:
- Support the ingredient form as much as possible when the ingredient has undergone physical processes that could affect its safety or efficacy (e.g., micronization, extraction, binding, stabilization, microencapsulation, etc.).
|Dosage Form||Evidence should:
- Support the ingredient form as much as possible when the dosage form has been altered in a way that could affect safety or efficacy (e.g., addition of coatings, etc.)
Types of evidence that may be useful to describe the form of the ingredient in the evidence or in the recommended product include: technical information sheets, raw material specifications, bioequivalence studies, other details obtained directly from the author of a clinical trial, information describing the method of preparation, phytochemical composition studies.
To support the comparability of an extract to the evidence, whether it is of plant, animal or microbial origin, information about the extract standardization or extract solvent system and the extract ratios should be provided. Considerable discrepancy in the methods of preparations could mean that the extracts are not comparable. Also, in order to compare modern studies on whole materials, or to relate the applicability of a study material to a commercial product, the study materials have to be adequately characterized.
In general, if the extract is standardized and modern evidence is provided to support safety, the extract should be of the same standardization. In this case, the Quantity Crude Equivalent (QCE) and solvent system is not required to support safety but may be provided as additional information. The QCE, extract ratio and solvent system can be used to support the safety and efficacy of a standardized extract when the quantity of the extracts match and the extract ratio and extraction solvents used are comparable to that in the evidence for traditional use.
If the extract is not standardized and is prepared from a known QCE or extract ratio, starting material, solvent and method of preparation (e.g., decoction), the evidence provided to support the safety and efficacy of the extract should match.
An evidence-based justification may be required to support comparability of extracts to one another. This rationale may include the methods of manufacture (e.g., comparisons of the solvents used), the characterization of the extracts (e.g., comparisons of phytochemical profiles), and different studies that compare different extract types.
Prior to submitting a product that has traditional use claims and meets the Natural Health Products Directorate's definition of traditional medicine, cross check supporting evidence against the Evidence Criteria below to ensure that it meets a minimum level of suitability and there is no missing evidence.
Examples of missing evidence:
Examples of missing evidence:
Examples of ingredients that are not comparable:
NOTE: Authoritative references on Traditional Chinese Medicine (TCM), unless otherwise specified, provide dosage information for individual medicinal ingredients as a decoction and are not comparable to ethanol-based preparations or non-extracted powders.
The safety of a product with a traditional use claim should be established based on both references about its traditional use and the modern literature. When the available evidence suggests that the medicinal ingredient is unsafe when used according to the product's recommended conditions of use, a higher level of evidence should be provided and the totality of evidence should favor benefit over risk for the product.
Examples of missing evidence:
NOTE: For medicinal ingredients that are not comparable because the evidence is missing information to characterize the ingredient (as in criterion 3), it will be assumed that evidence in support of safety may also be lacking.
A serious disease, condition, abnormal physical state or Schedule A disease.
Examples of terms/phases that would be deemed inappropriate as a traditional use claim include references to:
A condition that cannot be diagnosed within the identified traditional system of medicine.
Examples of recommended uses or purposes falling into this category would include the following:
A specific pharmacological effect which should be substantiated based on modern evidence.
Examples of recommended uses or purposes or terms that would have a meaning so specific to require modern evidence and thus would be inappropriate as a traditional use claim would include:
Broad/vague symptoms and/or actions which do not specify any meaningful or beneficial effect of the product.
An interpretation/extrapolation of available evidence on the respective medicinal ingredient(s) to support a claim which is not in fact a traditional use.
This deficiency often results from inaccurate interpretation and/or extrapolation of traditional use evidence or misrepresentation of information based on modern evidence as traditional use experience.
Examples include weight loss claims and source of vitamin, essential fatty acids and/or minerals as well as claims related to nicotine addiction or other addictions etc.
Examples of missing evidence:
Example of missing evidence:
Examples of missing evidence:
For all products consisting of two or more medicinal ingredients, where the product formulation with respect to its traditional use cannot be supported on the basis of a single product monograph (e.g., Pharmacopoeia of the People's Republic of China, the State Drug Standard or the Ayurvedic Pharmacopoeia of India), the product formulation is to be based on combining medicinal ingredients that are logical and permissible (based on their respective uses within the same identified system of traditional medicine ). The ingredient rationale should clearly indicate which medicinal ingredients are additive and which are not. The mechanism of action should be discussed when known. Example:
NOTE: For a product with a claim drawn from the TCM paradigm, unless the formulation is captured in a suitable stand-alone reference and the corresponding reference has been provided, the ingredient rationale should explain the respective role (e.g., king, minister, assistant and messenger) of each medicinal ingredient in the formulation, and the contribution to the overall efficacy of the product. The traditional formula used as the basis for the formulation should be provided. Furthermore, the ingredient rationale should speak to any deviations from the base formula and how any noted deviation impact or do not impact the efficacy/claim and safety of the formulation.
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: