Some time ago, the FDA extended the deadline to comply with the Modernization of Cosmetics Regulation Act (MoCRA), so the deadline seemed far off. But now, July 1, 2024, is now a thing of the past and we have entered a new era in FDA Cosmetic Regulatory Compliance. Starting from that day, all facilities that produce cosmetics for sale in the United States will need to comply with MoCRA rules.
These new MoCRA requirements affect all facilities involved in manufacturing, processing, packaging, distributing, and selling cosmetics in the U.S. Complying with these standards helps the FDA ensure that cosmetic products are safe and transparent, and it also allows companies to remain competitive in the U.S. market.
A key requirement is to register your facility with the FDA. This registration is essential for the FDA to track where cosmetic products come from and ensure they are made under health and safety standards. This registration must be renewed every two years.
To register your facility, you need the Facility Establishment Identifier (FEI). But be careful not to confuse this number with the FDA registration number; the FEI is just the first step in obtaining the registration.
After registering the facility, the FDA will request a list of products intended for the U.S. market. This list must be submitted by the "responsible person" (the manufacturer, packer, or distributor) through the Cosmetics Direct portal and must be updated annually.
It's very important to make this list correctly. Any errors or missing information can lead to consumer lawsuits, penalties, or even the FDA pulling the product from the market if it's deemed unsafe. This could damage your brand's image and consumer trust.
Additionally, you must comply with labeling standards according to FDA guidelines. The label must include accurate information about ingredients, claims, and allergen warnings. If not done correctly, you could face penalties or have the FDA consider your product as a drug, which involves more complex and costly requirements.
MoCRA rules apply to both domestic and foreign producers. If you're a foreign producer, you need a representative in the U.S. to act as your agent with the FDA, serving as a liaison between your company and the FDA.
It's important to note that MoCRA exempts small businesses from some facility registration and product listing requirements. These small businesses must meet certain conditions such as their total sales in the last years and productâs intended use, but there are cases where, even meeting these, they must still comply with FDA rules. If you have any questions, contact us so we can advise you on whether your company needs to meet these requirements.
If you are already in the U.S. cosmetics market or plan to enter it, you must comply with what the FDA requires to ensure your company's success. We recommend seeking the support of our professionals, who can streamline the registration process and help you meet all requirements correctly, avoiding mistakes that could put your business at risk. Contact us now.
Some time ago, the FDA extended the deadline to comply with the Modernization of Cosmetics Regulation Act (MoCRA), so the deadline seemed far off. But now, July 1, 2024, is now a thing of the past and we have entered a new era in FDA Cosmetic Regulatory Compliance. Starting from that day, all facilities that produce cosmetics for sale in the United States will need to comply with MoCRA rules.
These new MoCRA requirements affect all facilities involved in manufacturing, processing, packaging, distributing, and selling cosmetics in the U.S. Complying with these standards helps the FDA ensure that cosmetic products are safe and transparent, and it also allows companies to remain competitive in the U.S. market.
A key requirement is to register your facility with the FDA. This registration is essential for the FDA to track where cosmetic products come from and ensure they are made under health and safety standards. This registration must be renewed every two years.
To register your facility, you need the Facility Establishment Identifier (FEI). But be careful not to confuse this number with the FDA registration number; the FEI is just the first step in obtaining the registration.
After registering the facility, the FDA will request a list of products intended for the U.S. market. This list must be submitted by the "responsible person" (the manufacturer, packer, or distributor) through the Cosmetics Direct portal and must be updated annually.
It's very important to make this list correctly. Any errors or missing information can lead to consumer lawsuits, penalties, or even the FDA pulling the product from the market if it's deemed unsafe. This could damage your brand's image and consumer trust.
Additionally, you must comply with labeling standards according to FDA guidelines. The label must include accurate information about ingredients, claims, and allergen warnings. If not done correctly, you could face penalties or have the FDA consider your product as a drug, which involves more complex and costly requirements.
MoCRA rules apply to both domestic and foreign producers. If you're a foreign producer, you need a representative in the U.S. to act as your agent with the FDA, serving as a liaison between your company and the FDA.
It's important to note that MoCRA exempts small businesses from some facility registration and product listing requirements. These small businesses must meet certain conditions such as their total sales in the last years and productâs intended use, but there are cases where, even meeting these, they must still comply with FDA rules. If you have any questions, contact us so we can advise you on whether your company needs to meet these requirements.
If you are already in the U.S. cosmetics market or plan to enter it, you must comply with what the FDA requires to ensure your company's success. We recommend seeking the support of our professionals, who can streamline the registration process and help you meet all requirements correctly, avoiding mistakes that could put your business at risk. Contact us now.
