Natural health products (NHPs) include vitamins, minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, and products such as amino acids and essential fatty acids (1). Canadians spend $2.4 billion a year on natural health products (2), and market researchers agree that global demand for these products is growing (3). 

Before you decide to purchase a NHP for a health condition, it’s important to note that not all the health claims made by NHPs are supported by the same type of evidence. Let’s take a closer look at these health claims, what’s required for these claims to be approved by Health Canada, and what it means for your health as a consumer. 

Natural health Products

Health Canada Regulates NHP Claims

Depending on the severity of the health condition that the NHP claims to treat, Health Canada requires different levels of evidence to support these claims.

Serious Disease/ Conditions

Serious disease/ condition claims are defined as “disease/ conditions where treatment is vital to mitigate the health impact”. Examples of these claims include “Helps prevent rheumatoid arthritis”, “used to treat diabetes”, or “for the treatment of depressive disorders”. Health Canada requires scientific studies to demonstrate “statistically significant outcomes, clinically meaningful outcomes… and overall consistency of the results across all studies of acceptable qualities.”

A variety of evidence are acceptable to support health claims to treat these conditions, including well-designed clinical trials, meta-analysis, prospective observational and retrospective studies.

While well-designed clinical trials and meta-analysis provide fairly solid evidence that a certain product is effective for a health condition, prospective and retrospective studies only show correlation, they do not support causation (check out this video here for more on correlation vs causation). As a consumer, this regulatory “looseness” raises a few questions for me– if a NHP is only correlated with an improvement in a serious health condition, is it really good enough? 

Major Disease/ Condition Claims

Major disease/ condition claims are defined as diseases/ conditions that “have potentially undesirable effects that may worsen or persist if proper treatment or care is not pursued in a timely manner”. Examples of these claims include “Helps to reduce serum triglycerides/ triacyglycerols”, “For reducing acid reflux during pregnancy”, and “Helps prevent recurrent urinary tract infections”. Health Canada accepts evidence including: evidence that meets requirements for the high risk category, systematic reviews, peer-reviewed narrative reviews, clinical trials, and epidemiological studies. Published compilations referring for traditional use is accepted as evidence to support product safety only. 

Minor Disease/ Condition Claims

Minor disease/ condition claims are defined as diseases/ conditions or symptoms that are expected to “naturally resolve within a timely manner”. Examples of these claims include “soothes sore throat”, “helps to relieve the pain associated with osteoarthritis”, “reduces the symptoms associated with the common cold” and “helps relieve minor pain associated with menstruation”.

According to Health Canada, since these conditions are considered to be self-diagnosable, self-treatable, and or/ self-resolving, and the consumer can easily tell if a product is effective, the clinical evidence needed to support these claims may be weak in methodological design. The minimum requirements include some human evidence, and information about the mechanism of action.

When you purchase these products, know that their health claims may not be supported by the best scientific evidence. You may want to assess its efficacy yourself by keeping a journal of your symptoms to decide if it’s worthwhile.  

Herbal / Traditional Medicines

For Traditional Medicines, such as those found in Traditional Chinese Medicine, Ethnomedicines of the First Nations, Ayurvedic Medicine, and Traditional Herbal Medicine, you may see claims such as “Used in Herbal Medicine to help relieve upset stomach”, “Used in TCM as a sleep aid”, and “Used in Herbal Medicine to help relieve pain and/or inflammation in muscles and joints.”

Herbal Medicines claims are based on long standing use within a single recognized system of traditional medicine. Health Canada requires that efficacy should be based on belief systems, theories, and experiences specific to the healing system, and not modern evidence. 

Health Canada prohibits certain health claims to be made based on traditional use alone. These include: 

  • Claims for a serious disease, condition, or abnormal state:
    • menstrual irregularities, heart disease, diabetes, healing broken bones… 
  • Conditions that cannot be diagnosed within the identified traditional system of medicine:
    • helps reduce cholesterol levels, supports a healthy blood pressure level, supports healthy blood glucose levels… 
  • Specific pharmacological effect which should be substantiated based on modern evidence: 
    • used to stimulate the immune system, supports the endocrine system… 
  • Broad/ vague symptoms and/or actions which do not specify any meaningful or beneficial effect of the product: 
    • useful for all chronic states of inflammation, used as a healing aid for urinary disorders, and useful for various cardiovascular conditions… 
  • Interpretation/ extrapolation of available evidence to support a claim which is not a traditional use
    • claims for weight loss, treating nicotine or other addictions, is a source of vitamins, essential fatty acids and/or minerals…  

Since traditional medicines’ health claims are based on long-standing use rather than scientific evidence, this has raised concerns with some healthcare practitioners regarding their safety and efficacy. CBC’s Marketplace conducted an investigation into how a natural health product is approved for sale by Health Canada based on traditional health claims. The conclusion? “The investigation found that even a remedy making serious health claims — such as the ability to reduce children’s fever — can acquire a licence with no scientific evidence.” (2) 

While there may be active ingredients within traditional medicines, Health Canada doesn’t require this be proven using scientific methods. The skeptical consumer might question whether “traditional use” alone is enough to justify purchase a given product to treat an ailment. 

Conclusion

Health Canada regulates the type of health claims that natural health products (NHPs) make. Depending on the nature of the product and the health claim, different types of evidence are accepted as valid support for safety and efficacy. As consumers, it’s important to note that not all the evidence that Health Canada accepts are based on scientific evidence. And Health Canada admits that they allow non-serious health claims to be made based on weak studies. 

If you have a health condition you’re seeking to improve with a NHP, I suggest the following steps before making a purchase: 

  1.  Talk to a qualified healthcare professional about the product that you would like to purchase, including its potential therapeutic effects, appropriate dose, possible side effects, and interactions with other medications. 
  2. Explore other potential options of treating the health condition.  
  3. Check the Licensed Natural Health Products Database to make sure it’s a product that’s been assessed by Health Canada. 
A Quick Guide to Navigating Natural Health Products (NHPs) 
  • If you are looking for a higher therapeutic impact for a specific condition, look for the words “treat”, “prevent”, and “cure”. 
  • General claims to “support” “promote” or “maintain” health, such as “supports the immune system” doesn’t indicate a relationship between the product and a specific health outcome (ie: a product that claims to support the immune system doesn’t mean it will prevent colds). What it does imply, is that the product modifies a bodily function for health maintenance or improvement (ie: supports immune system by providing a nutrient that’s needed to produce white blood cells).  
  • Health claims for traditional medicines are approved based on evidence for long-time use rather than scientific studies. Claims based on traditional use are only approved for conditions/ diseases that are not considered to be “serious” by Health Canada. 
  • Check out this article on natural health products for weight loss.  

 

Sources Cited: 

  1. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription.html
  2. http://www.cbc.ca/news/health/health-canada-licensing-of-natural-remedies-a-joke-doctor-says-1.2992414 
  3. http://www.agr.gc.ca/eng/industry-markets-and-trade/statistics-and-market-information/by-product-sector/functional-foods-and-natural-health-products-sector/industry-overview-of-the-functional-foods-and-natural-health-products-sector/?id=1489778390460
  4. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/legislation/docs/modern-eng.pdf
  5.  http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodnatur/legislation/docs/tradit-eng.pdf 

Natural Health Products Claims– What You Need to Know