Ultimate OTC Drug NHP Cosmetic Product Classification Guide Unlocked

Ultimate OTC Drug NHP Cosmetic Product Classification Guide Unlocked

This blog unpacks the distinctions between NHPs, Health Canada & FDA-approved drugs, and cosmetic product regulations that define these products.  This will include product classification, product and representation composition along with other considerations that need to be considered.  If you have any questions about the classification of these products after reading this blog feel free to book a consultation.  

What is a Drug?

Under Section 2 of the Food and Drugs Act, a drug is defined as “any substance or mixture of substances manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; restoring, correcting or modifying organic functions in human beings or animals, or; disinfection in premises in which food is manufactured, prepared or kept”.

What is an NHP?

A Natural Health Product (NHP) is regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) under the Natural Health Products Regulations. Under the regulations, it is defined as products containing naturally occurring substances including Probiotics, Herbal remedies, Vitamins and minerals, Homeopathic medicines, Traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risks, and maintain general good health.

What is a Cosmetic Product?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.”. This is different from drug and natural health products even though they are all regulated under the Food and Drug Act

Classification of your Product

To classify your product, your product must meet one of the definitions above. Product risk, public health safety, and applicable regulatory framework must also be taken into consideration. Two main factors in determining product classification include representation and composition of the product.

Representation and Composition of your Product

The classification of your product depends on two main factors: Representation and Composition. Representation can be its function, purpose, and representation for use (such as proposed claims). These claims can be in words, sentences, pictures, symbols, and any implications on the product label, inserts, and associated advertisements. 

These claims inform consumers of what this product does and is intended for. The composition of your product is the ingredients and their concentrations contained in the formula. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas Green Tea Leaf Extract may be licensed as a cosmetic product. However, composition alone may not be sufficient in determining its product classification.

Other Considerations

Another consideration is the level of action. The level of action is how the product exhibits its efficacy through absorption from its dosage form. Some routes of administration such as ingestion, inhalation, and injection cannot be considered cosmetics. Other considerations include new policy/knowledge, classifications by other global authorities, and risk-benefit balance related to product efficacy.

QSS offers regulatory services on product classifications, notification submissions for your cosmetics, application submissions for your NHPs/drugs, and label review of your NHP/drug/cosmetic label artwork. Our experts are here to help and offer any cosmetic/drug/NHP-related regulatory advice!

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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About the author

Andrew Lau
Andrew Lau


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