US RP
MoCRA sets out a requirement for a Responsible Person (RP), which has to be designated for each cosmetic product placed on the US market. A responsible person (RP) is defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label, in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The RP has various responsibilities, including:
- Product Listing
- Adverse event reporting
- Safety substantiation
- Disclosure of fragrance allergens
- Fragrance records access
- Labelling
- Contact information on the label
- Record-keeping
- Product recall in case of non-compliance (and upon request by the FDA)
Responsible person is usually the brand owner, and it does not have to be in the US. So foreign brand owners are RPs, even if they do not have a US office. Unlike in the EU and UK, US RPs cannot outsource their RP role to a third party. They are legally responsible for their products and remain RPs even if they choose to acquire help with their responsibilities with a third company, such as CE.way. We can provide RP support for all obligations listed above.
Labelling
Under MoCRA, there is a labelling requirement to list RP contact information on the labels of cosmetic products, but there are three possible options. The labels may include:
- US address,
- US phone number, or
- Electronic contact information (such as a website, through which the RP can be contacted)
Foreign RPs can therefore choose to list electronic contact information on their labels. However, if the wish, they can also assign a US company to act as their US agent and provide the US address to put on their product labels. CE.way has a US office so we can provide a US contact point.
US agent
MoCRA also sets out the requirements for a US agent, which is mentioned under Section 607. All facilities that produce cosmetic products, which are distributed in the US, have to register their facility with the FDA. However, all foreign facilities must assign a US agent and provide its contact information on the facility registration form. Other than that, the obligations of US agent are not further specified in this regulation. However, the role will most likely be similar to the role of a US Agent for medical devices, meaning they will have some of the following responsibilities:
- Communication between the FDA and the foreign facility
- Replying to any inquiry from the FDA (inspections of the facility; documentation on the imported products, etc.)
CE.way offers both RP support and US agent service. If you need help with the new US requirements, please contact us.
