But after all, what is MoCRA?

If you've come to this article, you've probably heard the word MoCRA, but you're still not sure what it is. The acronym MoCRA stands for "The Modernization of Cosmetics Regulation Act of 2022" , but what does that mean?

Just like in Brazil, the United States (USA) has its own agency responsible for regulating products such as medicines, cosmetics, health products and food. In Brazilian territory, ANVISA regulates through standards and RDC's, while in the USA the responsible body is the FDA ( Food & Drug Administration ), they have their own regulatory standards. In relation to cosmetics, specifically, the last regulation was presented in 1938, called the Food, Drug and Cosmetics Act (FD&C) . Now, 84 years later, this standard has been updated and named MoCRA.

➔ But what changed in the 1938 regulation for the 2022 MoCRA?

The biggest change in this act was the requirement for registration with the FDA for manufacturers, distributors and/or those responsible for cosmetic products on North American soil, a fact that was not required in the 1938 standard. During the FD&C Act of 1938, companies, manufacturers of Cosmetics and their products did not need to be listed in FDA records, but they did need to comply with the basic requirements of any product that comes into direct and indirect contact with the human body through the labeling, packaging, manufacturing and distribution of these products. However, the FDA only intervened in the establishment or removed it from the market (Recall) if an adverse event occurred and/or was reported. Now, with MoCRA, all cosmetic products available on the North American market will be periodically monitored by the FDA, undergoing manufacturing and distribution inspection every 2 years.

This act implies a big change for the USA since, until then, no cosmetics were listed in the FDA databases and you may be wondering:

➔ But how are they going to track all the products that are already on the market?

Through the registration criteria. It is not the resellers, markets, supermarkets, pharmacies and beauty salons who are responsible for registering and listing each product that is sold, but rather the manufacturers who needed to register with the FDA and list each product that is manufactured for sale on the ground. North American.

In parallel, there must be a company responsible for distributing the products on American soil, this responsible can be the manufacturer or the official distributor of the product in the USA, these two companies will be registered and linked to each other in the FDA bases as responsible for the product and both must be discriminated against on the packaging and labeling of each product. If the manufacturer is the distributor of the product, the rule only applies to the manufacturer, as he would be the manufacturer and distributor at the same time.

Furthermore, in relation to the distributor, only the Companies that have revenues greater than or equal to USD 1 million in the last 3 years need to register. Companies with a turnover lower than this fall into the small business category and the registration requirement comes into effect when they reach such a turnover.

➔ REMEMBER: The fact that you are a small company does not exclude the fact that the labeling, packaging and good manufacturing practices of your products must be followed according to the requirements of the FDA and, now, MoCRA; Even before MoCRA this was already required, the only and main difference is the registration.

All this information can be obtained on the FDA website and SC Consulting can assist you with the registration process and compliance with FDA regulations. If you have any questions, or if you need assistance with compliance, contact SC Consulting, we are available to help you!

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