How Probiotics Are Regulated by Those with Careers in Regulatory Affairs

If a company slaps a label on a tub of yogurt or bottle of pills claiming the product to be a “safe and effective probiotic with proven health benefits,” the Canadian consumer has faith that the information is true thanks to regulatory oversight. People working in regulatory affairs are tasked with ensuring all kinds of products—from cosmetics to pharmaceuticals, natural health products, and foods—meet legislative requirements, which includes substantiating claims on safety and efficacy.

Probiotics are live microorganisms that can be found in foods and natural health products, offering potential health benefits to those who consume them. To understand more about the requirements surrounding probiotics products, let’s take a closer look.

What Those Seeking Careers in Regulatory Affairs Should Know on Probiotics in Foods

Food products containing probiotic microorganisms are generally categorized by the Canadian Food and Drugs Act and Regulations as foods. Probiotics are most commonly added to dairy products such as:

• yogurts
• cheeses
• fermented dairy drinks

Yogurts and other dairy products are common sources of food-based probiotics

If you’re considering regulatory affairs certification, you might be interested to know that in Canada, probiotics are, for the most part, governed under the Food and Drugs Act, applying to all foods containing microorganisms, including probiotics. Under that act, people manufacturing or importing probiotic foods are responsible for the safety of any of the products they sell. They are also required to label these products with claims that are wholly truthful and not likely to mislead or deceive a consumer. Additionally, labels and advertising claims must not be likely to create a false impression regarding the product’s:

• Character
• Value
• Quantity
• Composition
• Merit
• Safety

When Foods Containing Probiotics Can Be Called Natural Health Products

When manufacturers come out with a food product said to have a therapeutic purpose against disease or in the treatment of some other condition, the national Food and Drug Act will usually classify that as a natural health product (NHP). 

Ultimately, the decision on whether a probiotic food should be classified as a food or a natural health product lies with Health Canada, and depends on such factors as possible risks associated with the live bacteria, how the product is represented for therapeutic use, and the history of how the public has perceived such a product to be used.

Regulation on Probiotics as Natural Health Products

Consumers can also find probiotics packaged in tablets and capsules, sold in this pharmaceutical dosage format under the classification of natural health products. Health Canada’s Natural Health Products Regulations division governs the manufacturing, packaging, labeling, and importation for sale of all NHPs.

Pills, tablets and bottle on turquoise background. Copy space

Probiotic NHPs must meet the same requirements mandated for all NHPs, which includes obtaining a product license as well as a license for the site of manufacturing, packaging, and importation. To make sure the labelling on these products meets requirements, a Probiotics Monograph is needed. It will have:

• details on acceptable health claims
• information on dosage
• risk information
• evidence supporting claims for efficacy, safety, and quality 

How Canada Regulates Health Claims About Probiotics

Those training in a regulatory affairs program will no doubt be interested in knowing how manufacturers validate certain claims about probiotic-containing foods and NHPs. Regulatory requirements that leads to the permitting of certain health claims comes down to the manufacturer consulting with the Food Directorate of Health Canada, who will work with stakeholders to ensure claims are valid and allowable under the existing Food and Drugs Regulations. New claims must be submitted to the Food Directorate, with the claim requiring the support of acceptable scientific evidence.

Proper evidence is needed before health claims can be made

Are you interested in receiving specialized training to explore one of many exciting careers in regulatory affairs? 

Contact AAPS today for more information on their Regulatory Affairs program!