How FDA and Health Canada Regulate Cosmetics Differently
Thinking about launching your cosmetic line in North America? Whether you’re a seasoned brand or just getting started, understanding FDA cosmetic compliance vs Health Canada requirements is a must. Each country has its own set of rules, and missing even one detail can cause delays, product holds, or costly corrections.
This guide is here to help you stay ahead. We’ll break down how the FDA’s Modernization of Cosmetics Regulation Act (MoCRA) stacks up against Health Canada’s Cosmetic Regulations.
If you’re working with skincare, makeup, or personal care products, you’ll find out exactly what it takes to meet the requirements on both sides of the border, and how to do it with confidence.
What qualifies as a cosmetic?
Before diving into compliance rules, it’s important to define what’s considered a cosmetic in each jurisdiction.
- Health Canada defines a cosmetic as any substance used to cleanse, improve, or alter the skin, hair, or teeth without affecting the body’s structure or functions. This includes makeup, moisturizers, and shampoos.
- The FDA shares a similar definition but draws a sharper line between cosmetics and drugs. Any product claiming to treat or prevent a medical condition (like acne or eczema) could fall under drug regulations instead.
If you’re unsure whether your product is a cosmetic or something else, consult Health Canada’s Cosmetic or Drug Decision Tree or work with a regulatory expert.
Regulatory filing: Who needs to be notified?
One of the most notable differences between FDA and Health Canada compliance lies in mandatory submissions.
- In Canada, all cosmetic products must be notified to Health Canada within 10 days of sale through a Cosmetic Notification Form (CNF). This includes a complete ingredient list and company details.
- Under MoCRA, cosmetic companies in the U.S. must register their manufacturing facilities and list their products with the FDA. This became mandatory in 2023, marking a significant shift from the previous voluntary model. The FDA’s official page on MoCRA outlines these new requirements in detail.
Failure to complete these steps can result in enforcement actions, product holds at the border, and reputational damage.
Ingredient restrictions and safety substantiation
When comparing FDA cosmetic compliance vs Health Canada, ingredient requirements are another key area to watch.
- Health Canada maintains a Cosmetic Ingredient Hotlist, which outlines prohibited or restricted substances. Products must not contain any ingredients that pose health risks or violate this list.
- The FDA does not publish a similar hotlist, but MoCRA now requires companies to maintain safety substantiation. This means you must have evidence showing your cosmetic product is safe under its intended use.
In both markets, you need to verify that ingredients comply with each jurisdiction’s requirements, including allergens, preservatives, and colourants.
Labeling requirements: Canadian bilingual rules vs U.S. warnings
Labeling is one of the most common compliance pitfalls. It’s also an area where Canada and the U.S. diverge quite a bit.
- Health Canada mandates bilingual labeling (English and French) on all cosmetic packaging, along with INCI ingredient names, product function, and net quantity.
- FDA labeling requirements under MoCRA include ingredient lists, product identity, and a responsible person’s contact information. You’ll also need to comply with new fragrance allergen disclosures, expected in future rulemaking.
Make sure your artwork is reviewed by someone who understands these regional requirements, especially if you’re using the same packaging for both countries.
Responsible party and accountability
Under MoCRA, the U.S. now requires each cosmetic to identify a responsible person, typically the brand owner or manufacturer. This person must maintain safety records and submit product listings.
Canada doesn’t currently have an equivalent rule, but you must still provide accurate contact information for the party responsible for the sale of the product in Canada. If you’re an international brand entering the Canadian market, this may require partnering with a Canadian Cosmetic Agent.
Enforcement and penalties
While enforcement has historically been more reactive than proactive in both countries, MoCRA has introduced more structured oversight.
- In the U.S., the FDA can now issue mandatory recalls, suspend facility registrations, and conduct inspections with more authority.
- In Canada, Health Canada can take enforcement action if a product is found to be non-compliant or if consumer complaints arise. This could include product seizures or public safety alerts.
Staying proactive with your compliance can help you avoid penalties and product disruptions in both regions.
How to enhance your compliance strategy
Whether you’re launching a new cosmetic brand or expanding into the U.S. or Canadian market, understanding the key differences between FDA cosmetic compliance vs Health Canada is essential.
At Quality Smart Solutions, our regulatory experts can support your team with:
- MoCRA facility registration and product listings
- Health Canada Cosmetic Notification Form submissions
- Ingredient and formula assessments
- Bilingual label reviews and compliance
- Ongoing regulatory monitoring and updates
We simplify the regulatory process so you can focus on building your brand. Contact us today or fill out the form below for a free consultation.
