Access the North American market with confidence
Ensure your cosmetic, OTC, and NHP products comply with the specific regulatory requirements of the United States (FDA, MoCRA) and Canada (Health Canada).
Cosmetic & OTC Compliance in the United States
With the entry into force of the Modernization of Cosmetics Regulation Act (MoCRA), U.S. regulation has become stricter, introducing new mandatory obligations. The Food and Drug Administration (FDA) is responsible for enforcing these rules, which affect the entire cosmetics and OTC industry.
At EcoMundo, we support you at every stage to ensure compliance and accelerate your time to market.
Ensure your Regulatory Compliance in the U.S. with EcoMundo
EcoMundo regulatory and toxicology experts can help you ensure compliance of your cosmetic products in the United States.
Product classification (cosmetic, OTC, etc.)
Product listing & facility registration via FDA Cosmetic Direct
OTC drug listing and establishment registration via FDA CDER Direct
Product review (formulations, labeling, claims)
US Agent
Safety assessments (CPSR, TRA)
Adverse events reporting & FDA communication
Regulatory monitoring & strategic advice
US Agent and Responsible Person
If your facility is located outside the U.S. and manufactures cosmetic products for the U.S. market, you will need to designate a U.S. agent.
Designate EcoMundo as your U.S. agent now to meet MoCRA requirements.
Cosmetic, OTC & NHP Compliance in Canada
Canada enforces strict regulations for the commercialization of cosmetics, OTC drugs, and Natural Health Products (NHPs). Health Canada ensures that these rules are followed to guarantee consumer safety and product transparency.
At EcoMundo, we support you through every step to ensure full compliance and facilitate your access to the Canadian market.
Ensure your Regulatory Compliance in Canada with EcoMundo
Our regulatory and toxicology experts help you meet Health Canada's expectations with peace of mind.
Product classification & registration: cosmetics, NHPs, OTC (CNF, DIN, NPN applications)
Claims substantiation & safety assessment
Canadian Agent service
Conformité des ingrédients & étiquetage
(Hotlist & CEPA, revue bilingue & réglementaire)
Compliance with Law 96
Regulatory watch & strategic advisory
Appointing a Canadian Agent
If your business is located outside Canada, you are required to appoint a Canadian Agent to liaise with Health Canada.
Starting March 2025, Health Canada will require a Canadian address for all new notifications and updates.
Appoint EcoMundo as your Canadian Agent and ensure your compliance.
La réglementation des produits cosmétiques selon la MoCRA
Listing des produits et enregistrement des installations
Justification de la sécurité
Agent américain et personne responsable
Étiquetage
Événements indésirables
Bonnes Pratiques de Fabrication (BPF) pour les cosmétiques
Petites entreprises
Portail de notification
Frequently Asked Questions
Can I sell my cosmetic product in the US without registration?
No.
Under MoCRA, you must register your facility and list your products through the Cosmetics Direct portal.
👉 Non-compliance may lead to enforcement actions or market withdrawal.
Do I need a US or Canadian agent?
To place cosmetic products on the North American market, having a local point of contact is often essential.
In Canada, a local contact can help facilitate communications with Health Canada and support ongoing regulatory obligations.
In the United States, foreign cosmetic facilities manufacturing products for the U.S. market must designate a U.S. agent as part of FDA facility registration.
What’s the difference between US and Canada regulations?
The US (MoCRA) focuses on post-market surveillance, while Canada requires product notification (CNF) before market entry.
👉 Two different regulatory approaches to manage.
How long does compliance take?
It depends on your product:
US: a few weeks to several months
Canada: a few days to a few weeks
👉 Preparation is key to speeding up the process.
Is my EU-compliant product automatically compliant in North America?
No.
There are key differences in labeling, claims, and classification.
👉 A gap analysis is strongly recommended.
What happens if my product is not compliant?
- Market withdrawal
- Import refusal
- Regulatory penalties
- Brand reputation damage
👉 Authorities are increasing enforcement.
Do I need to report adverse events?
Yes.
Under MoCRA, serious adverse events must be reported within 15 business days.
👉 This requires proper internal processes.
Where should I start for North American compliance?
Start with:
- product classification
- formula review
- labeling compliance
- regulatory obligations
👉 Or work with experts to accelerate your market entry.
