USA and Canada Regulatory Compliance

Cosmetic products are regulated in the US under Federal and Drug Administration (FDA) regulations by the FD&C Act and by the FPLA, as well as various state and local laws. In Canada, cosmetic products are regulated by Health Canada rules.

​

Label mistakes are the leading cause of FDA sanctioning actions. Ensure label and product compliance with FDA regulations is usually the main measure that companies adopt when they want to sell their goods in the US or Canada.

​

The process for selling cosmetics in the US and Canada is:

​

1. Ingredient check and review

In accordance with the banned, restricted and/or regulated as drugs list.

​

2. Labelling review

Conforms to FDA requirements. Languages, format or location of the mandatory information are only some of the regulated items.

​

3. Claim review

Adapt the claims of the product to stay within the definition of designs. Avoid claims in the field of medicines and OTC products.

​

4. Implement the changes

To get a 100% compliant product.

 

5. MoCRA: listing of manufacturer's products and facilities

The MoCRA approval will mark the biggest change in US cosmetics regulation in recent years. Companies must have a Responsible Person established in the US, who will be responsible for the listing of products before the FDA. In addition, manufacturers must register as such with the administration through a US Agent.