What Pharmaceutical Experts Should know about Natural Health Product Regulation

Pharmaceutical quality assurance programsNatural health products (NHPs) are over-the-counter substances that can normally be purchased in any health store or pharmacy. Some common substances that are categorized as natural health products include: vitamins and minerals, herbal medicines, energy drinks and probiotics. Pharmaceutical industry professionals know that all NHPs sold in Canada are subject to the Natural Health Product Regulations, under the authority of the Food and Drugs Act. These regulations are implemented to address Canadians’ concerns about NHP safety and availability as well as regulate their sale, manufacturing, packaging, labelling and distribution processes.

Students pursuing pharmaceutical careers will soon learn all about natural health products regulations, and their place in the healthcare and pharmaceutical industry. Here is a quick introductory guide:

Understanding Natural Product Licensing as a Quality Control Professional

Professionals with pharmaceutical training know that all NHPs are required to have a product license before they can be sold in Canada. Product licenses are issued by Health Canada after it has received detailed information about the product, including the medicinal ingredients, dosage, potency, and recommended use. Health Canada also provides a Natural Product Number (NPN) with each license it issues, and this number must appear on the health product’s label to let consumers know that it has been reviewed and approved.

Since there are so many natural health products in existence, it should not come as a surprise that Health Canada has not fully evaluated each and every health product on the market. However, the ones that have not been evaluated have an exemption number. This exemption number indicates that Health Canada has done an initial assessment of the product to ensure that information supporting its safety has been provided and the legal safety criteria have been met.

Pharmaceutical Experts Know that NHPs Require Safety Evidence

Students enrolled in pharmaceutical courses know that it is important for NHP license applicants to provide solid evidence confirming the safety and efficacy of the product. This evidence will enable both Health Canada and consumers to verify that the product is in fact safe for consumption. Accepted evidence would most commonly include clinical trial data and references to published studies.

Quality Control Experts Recognize the Importance of Efficient Labelling

Graduates of pharmaceutical quality assurance programs know that every natural health product must meet certain labelling requirements. The required labelling items include:

  • The name of the product
  • A list of non-medicinal and medicinal ingredients
  • The quantity of the product in each bottle
  • Storage instructions
  • Warnings, cautionary statements and side effects
  • Instructions on recommended use

For pharmaceutical training students who want more detailed information regarding NHP labelling guidelines, Health Canada has the entire Labelling Guidance Document available online.

Are you interested in pharmaceutical quality assurance for natural health products? Learn more about the training program offered at AAPS.