The Responsible Person as defined in MoCRA is ‘the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of MoCRA or section 4(a) of the Fair Packaging and Labelling Act.’
Under this definition, the US Responsible Person (RP) can be one of the following three entities in the supply chain; the manufacturer, the packer or the distributor. If one of these is listed on the product packaging, they will be viewed as the US RP by the FDA under MoCRA.
Looking into each of these roles within the industry the manufacturer would be the establishment or entity which produces the formulation, the packer would be the entity which packs the formulation and the distributor would be the entity who is selling the product. The distributor is usually the brand name and is the most likely out of the three roles to appear on the label.
Once the US RP has been correctly identified, it is important to also understand the framework around the role of RP and what is involved when an entity is the RP under MoCRA. Full legal compliance and liability for the cosmetic product remains with the US RP - it is their responsibility to ensure full compliance with MoCRA. Unlike the UK &EU where the RP role can be legally designated to a 3rd party via a mandate, there is no provision for this within MoCRA, the US RP role must be held by the manufacturer, packer or distributor. Consultancies and agencies can help the US RP understand and meet their obligations under MoCRA but the ultimate responsibility remains with the US RP.
The US RP does not need to be located within the US. There is currently no provision within MoCRA which states this. However, there are certain requirements and contact information which must appear on the label to be compliant. The label should display the name of the RP alongside a domestic address (if they are US based) or a domestic telephone number (if they are US based) or electronic contact information such as an email address or website address. The purpose of this is to ensure that consumers areable to reach and report any adverse and serious adverse events.
Looking at the most common example of the US RP being the brand owner as they are the distributor named on the cosmetic product packaging, there is no requirement to update product labels before the 29th December 2023 with a US domestic address and/or telephone number. If the brand name, which is also the US RP under the MoCRA definition, is based outside of the US and they already have a website address on the label, this will be viewed as compliant under MoCRA based on the information the FDA have provided industry with so far. A product label would not be compliant if the label only displayed the brand name and non-US based address as there is no easy way for a US consumer to be able to contact the brand directly with any adverse or serious adverse event information.
The below table shows examples of label information which will be viewed as compliant under MoCRA as it currently stands:
