13.3 Natural and Non-prescription Health Products (NNHPs)

What are natural and non-prescription health products (NNHPs) and how are they regulated?

"Recent surveys have shown that more than one-half of Canadian consumers regularly take vitamins and minerals, herbal products, homeopathic medicines and the like, products that have come to be known as natural and non-prescription health products (NNHPs)."

"These products are used to prevent, diagnose or treat disease, restore or correct function, or maintain or promote health. NNHPs may be derived from plants, animals or micro-organisms."

(Reference: Health Canada, Health Products and Food Branch, Natural and Non-prescription Health Products Directorate, Expert Advisory Committee on Natural and Non-prescription Health Products. 2001. Quoted, with bold font added, from the November 2003 (issue 7) Health Policy Research Bulletin of Health Canada).

Think about the following questions:

• Should NNHPs be regulated as foods (with no or limited health claims allowed) or drugs (with the requirement of rigorous standards of evidence based on clinical trials, that does not readily recognize evidence based on a "history of safe use," which many NNHPs have enjoyed)?
• Can NNHPs be considered safe for consumption at any dose, since they are "natural"?
• Should health claims be allowed for NNHPs? If so, how will the consumer know what to expect in terms of quality or efficacy or standard level of bioactive ingredient in the NNHP?

These questions have led to the creation within Health Canada of a new Office of Health Products, now known as the Natural and Non-prescription Health Products Directorate, to establish new regulations and policies addressing the unique nature of NNHPs, with the goal of ensuring safe, effective and high quality products, while respecting Canadians' freedom of choice, and philosophical and cultural diversity.

The new Natural and Non-prescription Health Products Regulations were published in June 2003, in Canada Gazette, Part II, and came into effect on January 1, 2004, with a transition period for phasing in and compliance. The regulations provide details regarding: definitions, product licensing, adverse reaction reporting, site licensing, good manufacturing practices, clinical trials involving human subjects, types of evidence and claims, and labelling and packaging requirements.

Critical Thinking

Take a look at the Frequently Asked Questions about the NNHP Regulations. Can you answer the following questions? What types of natural and non-prescription health products are affected by these new Regulations? How will consumers know when a natural and non-prescription health product has been authorized for sale by Health Canada? How will products be labeled under the new Regulations? Note that while the licensing of natural and non-prescription health products (NNHPs) in pill or tablet form are reviewed by the Natural and Non-prescription Health Products Directorate, it is the Food Directorate that reviews NNHPs in food formats (e.g. juices, yogurts, etc). What is your opinion on this issue - should health claims be allowed for foods? What risks, if any, need to be considered along with the benefits being claimed for functional foods and natural and non-prescription health products?