MoCRA, the Modernization of Cosmetic Regulations Act of 2022 was signed into law as part of the Omnibus Spending Bill last December. Since then I’ve gotten a lot of questions about it, what it means and what you have to do now.
First off, you don’t have to do ANYTHING about it right now. So breathe. Relax.
Some time down the road there will be a few things you might have to do – but you’ll have plenty of time! Probably somewhere between 3 – 5 years before actual regulations go into effect – and we’ll know what the actual regulations are well before then.
Keep in mind that businesses making less than $1 million annually from cosmetic sales are exempt from the most burdensom requirements – good manufacturing practices and the need to register facilities and products.
What is the Time Frame?
MoCRA updates the Federal Food Drug and Cosmetic Act. Changes become effective December 2023 or 2024 (depending on the change). Now the FDA is tasked with coming up with the detailed regulations which put it all into place. It’s a long, slow process.
First, the FDA has to come up with proposed regulations. That alone can take a while. For example, MoCRA specifies that the FDA has to come up with proposed regulations for GMP by December 2024 (2 years) and a list of fragrance allergens to be included on ingredient declarations by June 2024 (18 months). There aren’t deadlines for publishing proposed regulations for other parts of MoCRA so who knows how long those will take. It’s likely that the FDA will get input from stakeholders before finishing the proposed regulations. Likely 1 – 2 years.
The proposed regulations are then published in the Federal Register. (As soon as they are published, I will definitely announce it!)
Once published, a comment period is opened. The comment period can be 30, 60 or more days. It can be extended if necessary. Comments are open to the public and anyone can make a comment about any part of the proposed regulations. Likely 2 – 3 months.
After the comment period, the FDA has to issue a final rule. They take all of the comments and evaluate them to determine if there is a need to change the proposed regulations. If so, the FDA changes the proposed regulation accordingly. As you can imagine, it can take a while for the FDA to go through the comments and come up with the final regulations. For some of the regulations MoCRA specifies they have to be done in 180 days after the comment period closes, but not for all of the new regulations. Likely 6 – 12 months.
If there are many changes, the FDA may issue a revised proposed regulations and repeat the comment periods (although that happens rarely). Normally the FDA just publishes the final rule in the Federal Register and it gets incorporated into the Code of Federal Regulations.
As part of the final rule there is usually an effective date at which time the regulations actually go into effect. This gives everyone time to make the necessary changes and updates. The effective date can be anywhere from 6 months to 3 years from the time the final rule is issued. Likely 1 – 2 years.
So, relax! Breathe! It will be fine!