Health Claim Substantiation

August 7, 2012 By

By: Ashleigh Hampton, MSc
Manager, Scientific Affairs

Supporting evidence is required by both the Canadian and American regulatory bodies to substantiate marketed health claims. Health Canada reviews the evidence to substantiate your health claims prior to market access while the US Food and Drug Administration (FDA) requires the supporting evidence to be in the possession of the manufacturer of the marketed product and produced upon request.

Currently, Health Canada requires full-text scientific articles or authoritative traditional evidence to substantiate a health claim. More specifically, scientific evidence is required to support non-traditional health claims, while traditional evidence supports only traditional health claims. The following are examples of each type of health claim:

Non-Traditional Claim: Helps to promote alertness and wakefulness, and to enhance cognitive performance.

Traditional Claim: Traditionally used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints (e.g. sprains, bruises, joint pain).

When making traditional claims in combination products, Health Canada requires the claim to be qualified to identify the herb eliciting the action. An example of this is as follows: “Arnica is traditionally used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints (e.g. sprains, bruises, joint pain)”.

There are certain types of permitted health claims, which are substantiated using varying strengths of evidence. Health Canada allows natural health products (NHPs) to make therapeutic, risk reduction and structure-function claims whereas the US FDA permits only structure-function claims. Examples of these types of claims are as follows:

Therapeutic Claim: Helps to relieve joint pain associated with osteoarthritis.

Risk Reduction Claim: Helps to protect against the deterioration of cartilage.

Structure-function Claim: A factor in maintaining good cartilage and/or joint health.

To substantiate structure-function claims on dietary supplements marketed in the US, regulatory authorities require competent and reliable scientific evidence which has been defined by the Federal trade Commission (FTC) as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results”. In summary, high quality scientific evidence is required to substantiate your non-traditional health claims in both the United States and Canada.

dicentra has a team of scientists who specialize in health claim substantiation. If you are looking to market your NHP for novel claims, or are looking for evidence to substantiate your dietary supplement claims, our team of experts can assist in the process.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at