Why is Product Listing Optimization Important for U.S Market Access?
Legal background
Complying with MoCRA’s FDA product listing requirements is critical for maintaining uninterrupted access to the U.S. cosmetics market. Ensuring accurate and up-to-date FDA product listings protects your market access, brand integrity, and regulatory standing. With expanded enforcement powers, the FDA can take immediate action against non-compliant companies.
Potential consequences include:
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- Product detention at the port of entry
- Mandatory product recalls
- Non-listed products cannot be legally sold in the United States.
- Costly penalties for ongoing non-compliance.
- Loss of consumer trust and retailer confidence.
Our services
How Obelis Manages Your FDA Product Listing Compliance
At Obelis, we simplify the FDA product listing process so you can focus on growing your business. Our regulatory experts:
We compile all required information for your cosmetic products, submit listings via the FDA’s Cosmetics Direct portal, and handle annual renewals. We also manage updates whenever product details change and keep you informed about evolving MoCRA requirements. With our FDA compliance services, your products will always be inspection-ready and legally positioned for the U.S. market.
FAQ
Frequently Asked Questions
No. Cosmetic product listing with the FDA is not an approval process. It is a mandatory notification to the FDA that a cosmetic product is being marketed in the U.S. The FDA does not pre-approve cosmetics but requires accurate listing for regulatory oversight and compliance monitoring.
Any company marketing cosmetic products in the U.S., whether domestic or foreign, must complete mandatory product listing with the FDA. This includes manufacturers, packers, and distributors acting as the Responsible Person for the product.
Cosmetic product listings must be updated annually and whenever there are changes to product formulation, labelling, or category. Keeping listings accurate ensures ongoing compliance and uninterrupted U.S. market access.
Failure to complete FDA cosmetic product listing can result in product detentions, mandatory recalls, loss of market access, regulatory fines, and reputational damage. Non-listed products cannot be legally sold in the U.S.
To submit a cosmetic product listing to the FDA, you must use the Cosmetics Direct portal, create an account, and provide all required details about the product. This includes ingredient information, the Responsible Person’s contact details, and the product category. Obelis can manage the entire submission process to ensure accuracy and compliance.
