Who's Really the "Responsible Person" When it Comes to MoCRA?
Who's Really the "Responsible Person" When it Comes to MoCRA?
MoCRA marks a significant milestone in the FDA's regulatory landscape for cosmetics. With provisions set to take effect in 2024, much of MoCRA revolves around the role of the “responsible person”. However, ambiguity surrounds its definition, leaving cosmetic brands and manufacturers uncertain about their liability under the new regulations.
Is the "Responsible Person" the Manufacturer or the Brand? Clarifying MoCRA's Definition
According to MoCRA, the responsible person is defined as "a manufacturer, packer, or distributor whose name appears on the label" (section 609(a)). While it may initially suggest that the manufacturer assumes responsibility, a closer examination reveals that it all comes down to who is listed on the label, most likely pointing to the brand. Regardless if a brand manufactures their products in-house or through third party manufacturers, if their name is on the label, the onus falls on them to designate a responsible person.
What is the Role of the Responsible Person at a Brand?
The responsible person has a number of duties for each cosmetic product in the market. Some of the responsibilities include:
Maintain scientific-backed records supporting the safety of each cosmetic product in the market. This must be readily available should the FDA request it.
Maintain records of any serious adverse reactions and report them to the FDA within 15 days.
List and register each marketed cosmetic product with the FDA and provide any updates annually.
Ensure fragrance allergens are correctly labeled on product packaging.
Comply with any mandatory recalls as authorized by the FDA.
Act as the primary point person for the FDA.
So Are Manufacturers Off the Hook? Implications for Manufacturers
Irrespective of whether the manufacturer is designated as the responsible person, MoCRA introduces new regulations affecting all cosmetic product manufacturers (including brands who manufacture in house). The inclusion of "Good Manufacturing Practices" (GMP) imposes additional requirements and MoCRA also states that manufacturers must register their facilities with the FDA and renew registration every two years. Furthermore, even if the brand's name appears on the product label and they are technically deemed the responsible person, the FDA may still hold the manufacturer liable or take action against them should a recall or adverse event occur. While the precise allocation of responsibility by the FDA remains to be seen, to be safe, manufacturers should see themselves as the responsible person as well and maintain all relevant records and safety substantiation documents.
How Can Brands Prepare to Take on the Role of the Responsible Person?
To navigate the responsibilities associated with being the responsible person, brands must be proactive in their preparations. Good Face has compiled a comprehensive Preparing for MoCRA Checklist to give brands tangible steps on what documents need to be gathered and how to get ready. Identifying the responsible person is the initial crucial step, followed by gathering extensive documentation on product information and safety assessments. We also recommend brands to get more visibility into their raw materials so they can fully comply with product safety and fragrance allergen labeling requirements.
Additional Assistance from Good Face
Good Face is the innovation, formulation and regulatory compliance software for cosmetic brands, manufacturers, ingredient suppliers and retailers. Good Face is here to make getting ready for MoCRA less onerous. Through our software, teams can keep track of formula and raw material documentation in one place to easily create product information files and safety assessments, instantly screen for global regulatory and safety standards to stay ahead of changing regulations and their implications, generate fragrance allergen labeling lists instantly and more.
With Good Face, brands and manufacturers can get prepared for MoCRA easily so they can focus on creating the next winning products.