Understanding FDA and Health Canada rules for eczema products
The eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without a plan. FDA and Health Canada rules for eczema products vary widely depending on the formulation and claims. Many companies risk product delays or enforcement action by misclassifying their product or using unapproved claims.
If you’re marketing an eczema treatment in Canada or the United States, your first step is understanding whether your product is a drug, cosmetic, or natural health product (NHP). That classification affects your registration pathway, labelling requirements, and compliance obligations.
Let’s break it down to help you choose the right path and avoid regulatory issues. Keep reading to make an informed decision.
Product classification drives your compliance path
For both Canada and the U.S., the classification of eczema products hinges on their intended use and claims. If your product claims to treat, relieve, or prevent eczema symptoms, like inflammation, redness, or itching, it will likely be considered a drug.
In Canada, some eczema treatments may qualify as NHPs if they contain ingredients such as colloidal oatmeal or calendula and follow approved monographs. If your product only moisturizes the skin without making therapeutic claims, it may be regulated as a cosmetic.
Health Canada maintains a Natural Health Products Ingredients Database (NHPID) where you can verify whether your ingredients are permitted under the NHP framework: Visit the Health Canada NHPID to search ingredients and monographs.
In the U.S., products that meet the conditions of an Over-the-Counter (OTC) Monograph, such as those containing hydrocortisone or colloidal oatmeal, may be marketed without pre-approval. If your product falls outside a monograph or makes new claims, you’ll need to file a New Drug Application (NDA). See the FDA’s OTC Drug Monograph Directory for reference.
What you need to sell eczema products in Canada
If your eczema product is classified as an NHP, you must apply for a Natural Product Number (NPN) before selling it. This requires submitting detailed information about your product’s ingredients, claims, format, and recommended use. You’ll also need bilingual labelling and evidence of Good Manufacturing Practices (GMP).
If your product is a cosmetic, you must submit a Cosmetic Notification Form (CNF) within 10 days of first sale. The formula must comply with the Cosmetic Ingredient Hotlist, and the label must list all ingredients in descending order of concentration.
Some products fall into a grey area, especially if they include both moisturizing ingredients and therapeutic claims. We can help you determine the proper path to avoid compliance delays.
What’s required in the U.S.
In the U.S., eczema treatments can be classified as OTC drugs or cosmetics, depending on claims and ingredients. For OTC drugs, you’ll need:
- An active ingredient listed in a final OTC monograph
- Drug Facts labeling format
- FDA establishment registration and product listing
- Manufacturing in a compliant facility
If your product is a cosmetic only, it must follow the Modernization of Cosmetics Regulation Act (MoCRA), which includes registration and safety substantiation requirements.
Trying to navigate these rules without proper guidance can lead to missteps and slow your time to market.
Get it right the first time
Misclassifying your eczema product or making unapproved claims can result in:
- Refused submissions or delisting
- Warnings from regulators
- Product recalls or label changes
- Lost time and money
That’s why it’s critical to classify your product correctly and align with all relevant compliance steps from the start.
Support to streamline your compliance process
At Quality Smart Solutions, our team guides you through every stage of compliance. Whether you need help deciding if your product is an NHP or OTC drug, preparing an NPN application, or updating your Drug Facts label, we’re here to support you.
We offer:
- Ingredient and product classification
- NPN application support
- Cosmetic notification filings
- OTC monograph compliance
- FDA and Health Canada label reviews
And much more.
Contact us or schedule a free consultation with one of our regulatory experts today to avoid costly mistakes and get your eczema product to market with confidence.
