What is MoCRA?

In late December 2022, Congress passed the Modernization of Cosmetics Regulations Act of 2022 as part of the Omnibus Spending Bill. This represents the largest change in Cosmetics Regulations in decades.

The Omnibus bill can be found here. The cosmetics section begins on page 1389.

 Key provisions include:

  • Mandatory GMPs
  • Mandatory Adverse Event Reporting & Labeled Contact Information
  • Manufacturing Facility & Product Registration
  • Safety Substantiation
  • Labeling of Fragrance Allergens
  • Records Access by FDA
  • Mandatory Recall Authority

 

What is not included?

  • User Fees for cosmetics

 

What IBA is doing

For almost 50 years, IBA has represented the voice of the indie beauty sector when speaking with legislators and government entities.

IBA is meeting with FDA leadership regularly to provide industry input during the MoCRA rulemaking process.

IBA was part of a coalition of Trade Associations, NGOs and other stakeholders to help advise the Senate HELP Committee and the House Energy and Commerce Committee to draft the language for cosmetics reform. One of our specific goals, as we worked with Congress, was to minimize the economic impact this law could have on our members, who are predominantly small or very small businesses. In that regard, we thank congressional sponsors for not imposing user fees on our industry, as user fees could significantly impact our ability to innovate. We expect the same approach to prevail as FDA develops implementing regulations.

As we move forward toward implementation, some of our other goals include aligning the new regulations so that manufacturers can have a single set of manufacturing standards for US and EU products; align safety requirements; potentially follow the Toxicology Risk Assessments already used in other countries that would allow many companies to comply with few to no changes; and harmonize label requirements to the degree possible with other geographies.

IBA continues to meet with legislators, government entities, and other stakeholders on behalf of our members. We’re working tirelessly to keep members informed as the FDA moves forward toward rulemaking and implementation.

 

Resources: