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Regulation of Cosmetic Products in the United States
From our office in Miami, we help companies from all over the world export their products to the American market with agility and professionalism. If you want to export your cosmetic products to the USA to boost your business in this important market, we'll be here to help!
The MOCRA Law (Modernization of Cosmetics Regulation Act)
The Modernization of Cosmetics Regulation Act (MOCRA) is a piece of legislation passed in December 2022 in the United States that seeks to modernize and strengthen the regulation of cosmetics by the Food and Drug Administration (FDA) . This law marks a significant change in how cosmetics are monitored and regulated in the U.S. market, with a focus on consumer safety.
Here we explain the most important aspects of the MOCRA Act and the steps to follow to register cosmetics in the U.S. under this regulatory framework.
Steps to follow to register cosmetics in the US
The United States has a specific regulatory framework for cosmetic products, the primary objective of which is to ensure consumer safety and market integrity. The competent authority in this area is the Food and Drug Administration (FDA), which regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as other complementary laws, such as the recent Modernization of Cosmetics Regulation Act (MoCRA) of 2022.
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Identify if your product is cosmetic
Before proceeding with any registration, ensure that the product meets the FDA 's definition of "cosmetic ." A cosmetic product is one that is applied to the human body to cleanse, beautify, promote attractiveness, or alter appearance, but is not intended to treat or prevent disease.
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Labeling and safety
Labeling must be accurate and comply with FDA requirements. The label must include complete information about the ingredients, as well as any warnings or recommendations.
You must ensure that your product is safe for use, based on scientific evidence and safety data.
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Product List
Manufacturers must list the cosmetics they sell in the U.S., providing details such as the ingredients in each product.
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Good Manufacturing Practices (GMP)
We ensure that your manufacturing facility complies with Good Manufacturing Practices, which will be overseen by the FDA under MoCRA.
The FDA may conduct inspections at manufacturing facilities to ensure compliance with these standards.
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Company and facility registration
The MOCRA law requires all cosmetic manufacturing facilities, both in the U.S. and abroad, to be registered with the FDA.
Facilities must provide information about the cosmetic products manufactured and the production process.
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Adverse effect reports and safety testing
If you receive reports of serious adverse effects, such as severe allergic reactions or injuries, you must report them to the FDA within 15 days.
Safety studies must be available if required by the FDA, and it is important to maintain complete documentation of all tests performed.
US Agent for Manufacturers
The US Agent for manufacturers is an entity or individual designated by foreign companies wishing to market regulated products in the United States, including cosmetics, medical devices, food, and pharmaceuticals. This agent acts as a local representative before the Food and Drug Administration (FDA), serving as the primary point of contact between the agency and the foreign manufacturer.
The role of the US Agent is crucial, as it facilitates communication regarding regulatory matters, including inspection notices, requests for additional information, and handling emergency situations related to product safety. Furthermore, the US Agent must be available to respond promptly to any FDA requests, ensuring that companies comply with US regulations.
For foreign companies wishing to enter the U.S. market, the appointment of a U.S. Agent is an essential legal requirement. Their role has become even more important with new regulations imposed by laws such as MOCRA in the cosmetics industry.
US Product Compliance
Product Compliance in the United States is the process by which manufacturers, importers, and distributors ensure that their products comply with the country's regulations and standards, such as those established by the FDA , CPSC, and other agencies. Under recent laws such as MOCRA (Modernization of Cosmetics Regulation Act) , compliance includes strict requirements regarding safety, labeling, product registration, and Good Manufacturing Practices. Ensuring Product Compliance is essential to operating legally in the U.S., protecting consumers, and avoiding penalties or product recalls.
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Label Review
Claims Review
Ingredients Review
State Regulations
Prop 65 California
Product Listing and US Representative
Product Listing in the United States is the process by which manufacturers register their products with the FDA, providing details about the product's ingredients and characteristics to ensure compliance with U.S. regulations. It is a key requirement, especially in the cosmetics industry under the MOCRA Act, which mandates complete transparency regarding product composition and safety.
The US Representative is the company, legal entity that acts as responsible for regulatory compliance and market surveillance of products placed on the market before the FDA and consumer authorities.
International Cosmetic Regulation
At Belab Services, we specialize in international cosmetic product regulations and offer comprehensive, customized solutions to ensure safe and effective compliance.
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With over 10 years of experience in cosmetic safety assessments and US regulations, BELAB SERVCES offers a comprehensive and reliable solution for effectively verifying and registering cosmetic products.
Our solution, based on a deep understanding of the legislation, relies on a team of scientific consultants and advanced IT tools, making it the fastest and most reliable route to access the European market.
