What are Natural Health Products?
Natural Health Products (NHPs) are a subset of drugs regulated under the Natural Health Products Regulations in Canada. They are defined as “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:
- diagnosing, treating, mitigating, or preventing a disease, disorder, or abnormal physiological state or its symptoms in humans
- restoring or correcting organic functions in humans
- modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
What Kind of Claims Can Natural Health Products Make?
NHPs must have a health claim that links the product to a disease or health related condition. This claim cannot refer to diseases and conditions listed in Schedule A, such as diabetes and cancer, without approval from the Natural and Non-prescription Health Products Directorate (formerly the Natural Health Products Directorate). Claims for traditional use must include the statement “traditionally used…” with reference to the particular culture or system of medicine whose terminology appears in the claim (if applicable). For example, “Traditionally used in Ayurvedic medicine to stimulate the digestive fire or increase agni”. If the claim is also supported by scientific evidence, or the product is homeopathic, the qualifying statement of traditional use is optional.
Health claims for NHPs must be preapproved by Health Canada before the product goes to market. There are two main ways that NHP health claims can be classified; by health condition, or by health effect.
Health Condition Claims
Serious disease/condition claims: indicates treatment, prevention or cure of diseases/conditions which require supervision by a health care practitioner, or are debilitating or potentially life threatening without effective treatment.
Major disease/condition claims: indicates treatment, prevention, or cure of diseases/conditions that are not naturally resolved within a reasonable time or have potentially undesirable effects that may become worse or persist without proper treatment.
Minor disease/condition claims: indicates treatment, prevention, risk reduction, or cure of diseases/conditions/symptoms that are expected to naturally resolve within a reasonable time or for which lower than expected performance of the product will not pose a major risk to the person taking it under the recommended conditions of use.
The level of safety and efficacy evidence required to support the claim is dependant on how serious the claim being made is. Below are some examples of claims for the 3 Health Condition categories.
Health Effect Claims
The three categories of health claims for NHPs are therapeutic claims, risk-reduction claims, and structure-function claims. These categories can be further divided into the following subsets:
Diagnostic claims: relate to the diagnosis of a disease, disorder, or abnormal physical state or its symptoms.
Treatment claims: relate to the treatment or partial treatment and mitigation of a disease, disorder, or abnormal physical state or its symptoms.
Cure claims: describe a therapeutic effect resulting in the elimination of a disease, disorder, or abnormal physical state for a significant length of time.
Risk reduction claims: based on significantly altering a major risk factor(s) for a disease or condition. Altering one of several risk factors for a disease may or may not have a beneficial effect in preventing the condition. Risk reduction claims should ensure that consumers do not interpret them as prevention claims through use of appropriate language and reference to other risk factors.
Prevention claims: relate to interventions which are proven to significantly reduce the incidence of the disease.
General health maintenance, support and promotion claims: describe the effect of a medicinal ingredient on restoration, correction, or modification of a structure or physiological function in the body. Health function claims can vary from health maintenance (e.g., maintains healthy gums) to treatment of the symptoms or risk factors of a disease or condition (e.g., reduces plaque build-up along the gum line).
Antioxidant claims: at least one medicinal ingredient must have antioxidant properties. When the medicinal ingredient is an essential nutrient, antioxidant claims should be worded as general health support claims (e.g., “provides antioxidant(s) for the maintenance of good health”) or as “source of” claims for other types of antioxidant ingredients (e.g., “source of antioxidants”). For a more specific antioxidant claim, the statement will be evaluated according to the conditions/diseases it specifies or implies.
Any one of these claims (or a combination) can also appear as part of a serious, major, or minor disease/condition claim.
If you have any questions, please feel free to contact Focal Point Research Inc. We are industry leading Natural Health Product Regulatory Consultants that you can trust to help guide your company in the right direction.
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