Understanding the distinction between traditional cosmetics vs. cosmeceuticals is essential if you’re manufacturing or marketing skincare or beauty products in North America. While both types of products may appear similar on store shelves, they follow different regulatory pathways, and that has a direct impact on your compliance obligations. 

Whether you’re selling moisturizers, anti-aging serums, or acne treatments, knowing how your product is classified under Health Canada and the FDA can help you avoid costly enforcement issues, delays at customs, or claims that mislead consumers.  

Keep reading to learn how these categories differ, and what that means for your compliance strategy. 

What are traditional cosmetics?

In both Canada and the United States, traditional cosmetics are products intended to cleanse, beautify, or alter the appearance of the body without affecting its structure or function. These products do not claim to treat or prevent any disease and are not meant to alter bodily functions. 

Here’s a quick comparison of how traditional cosmetics are defined by regulators: 

Both agencies emphasize that products making only cosmetic claims (not therapeutic ones) generally fall into the traditional cosmetic category. Here are some additional insights: 

• Health Canada defines a cosmetic as “any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth.”  
• The FDA defines cosmetics similarly, but draws a stricter line between cosmetics and drugs. If your product makes therapeutic claims or affects the body’s structure/function, it may be regulated as a drug or both a cosmetic and drug. 

So, while makeup, shampoo, and moisturizers typically qualify as cosmetics, the moment a claim suggests treatment, healing, or bodily alteration, the classification (and even compliance path) can change significantly. 

What are cosmeceuticals?

Cosmeceuticals are often marketed as a hybrid between cosmetics and pharmaceuticals. They typically include active ingredients like peptides, retinoids, or alpha hydroxy acids that promise to improve skin health or provide anti-aging effects. 

However, here’s the catch, the term “cosmeceutical” is not officially recognized by either Health Canada or the FDA. This can create confusion, especially for businesses using the term in branding or advertising. 

In Canada, if a product makes therapeutic or drug-like claims (e.g., “reduces wrinkles” or “treats acne”), it may be regulated as a drug or a natural health product (NHP) and require additional licensing, such as a DIN or NPN. 

In the U.S., products making similar claims may fall under drug regulations, and companies must follow drug labelling and premarket approval requirements. 

Key compliance risks when misclassifying cosmeceuticals

Marketing a cosmeceutical with claims that go beyond cosmetic purposes could trigger regulatory action. These are some of the most common pitfalls: 

• Unapproved therapeutic claims: Phrases like “heals skin” or “stimulates collagen” can reclassify your product as a drug. 
• Missing licences: In Canada, NHPs require a product licence and a site licence. 
• Incorrect labelling: Your product label must reflect its classification, including specific disclosures, ingredient lists, and usage instructions. 
• Non-compliant advertising: Promoting cosmetic products with exaggerated benefits can be flagged by regulators in both countries. 

How to ensure compliance with your product 

If you’re unsure whether your product is a cosmetic, NHP, or drug, it’s important to assess your ingredients, claims, and format. Working with a regulatory partner like Quality Smart Solutions can help you navigate classification, licensing, and labelling requirements in Canada and the U.S. 

Here’s how we can support you: 

• Regulatory classification and risk assessment 
• Cosmetic Notification Form (CNF) submission in Canada 
• NPN or DIN applications for therapeutic claims 
• FDA cosmetic registration and ingredient safety 
• Label and claims review based on product type 

Curious about how to stay compliant in both markets? Check out our tailored solutions for Canada and the U.S. under MoCRA to see how we can support your product’s success. 

Final thoughts

When it comes to traditional cosmetics vs. cosmeceuticals, the difference isn’t just in the formula, it’s in the regulatory pathway. Using the wrong classification can expose your business to fines, recalls, or costly delays. 

If you’re unsure how your product is classified or need help getting compliant, we’re here to support you. Contact us to schedule a free consultation and ensure your products are ready for market.