USA Cosmetic Regulations - Comprehensive Guide

USA Cosmetic Regulations

The US Cosmetics Market

Cosmetic Regulations USA: The United States of America is the largest beauty and personal care market, with expected revenues of $94 billion and a market size expected to reach $107 billion by 2029..

This is a robust market where indie beauty and innovative products reign, and where e-commerce and social media practices are particularly well-developed. To tap into this market of 332 million people, your product must comply with the legal requirements enforced in the US.

To sell in the US, you must consider the Federal cosmetics legislation that applies equally to all states, as well as the state provisions that are usually specific. It is a common mistake to forget this second responsibility. Take a guided tour and read what follows to succeed in the US.

On December 29th, 2022, the biggest amendment of the USA Cosmetic Regulations since 1938 has been enacted. The publication of the Modernization of Cosmetic Regulation Act (MoCRA) in the USA is expected to have a large impact on the cosmetic industry, while it implies the reinforcement of FDA’s power.

How Biorius Supports Compliance with US Cosmetic Regulations

Understanding US Federal Cosmetic Regulations

Federal Cosmetics Legislation

Two main legal frameworks apply to cosmetic products at a federal level:

On December 29th, 2022, the Food, Drug and Cosmetic Act received its biggest amendment since 1938: The Modernization of Cosmetic Regulation Act (MoCRA). This new piece of legislation (summarized here) deeply affects the cosmetics industry, but Biorius provides a turnkey service including everything you need to sell in the US without taking any risk.

The MoCRA added new obligations and many of them must be fulfilled by the Responsible Person. Though, the MoCRA does not repeal existing requirements, which remain fully enforced and do not change the way Over-The-Counter (OTC) drugs (such as sun care products) and soaps are regulated.

Compliance with USA cosmetic regulations

Please read this: consumer information vs. consumer protection

The MoCRA’s philosophy is relatively close to the European Cosmetics Regulation’s one: it gives more authority to the FDA than before and intends to better protect US consumers.

Though, for many aspects, one will quickly realize that the USA is a litigious society, where consumers suing a cosmetic brand (and earning millions that way) is not unusual. For this reason, you must be 100% sure that your product labels – which include any mandatory elements and marketing communications – allow the consumer to make a well-informed purchasing decision.

In the US, a misleading claim may be such a costly mistake that it may jeopardize your entire business. This is why you need good regulatory support in your US adventure, and Biorius is there to help you succeed!

MoCRA Cosmetics compliance process

State-Specific Cosmetic Regulations in the USA

On top of the Federal legislation, States are allowed to pass their own acts on cosmetic products and set specific requirements. The MoCRA has an overriding authority and specifies very clearly what States can do and what they cannot. In summary, States are allowed to enact provisions that concern:

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As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

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⚠️MoCRA Timeline Reminder⚠️

June 2024: Allergen labeling Rulemaking proposed by the FDA