USA cosmetics regulation

The US Cosmetics Market

USA Cosmetics Regulation: The United States of America is the largest beauty and personal care market, with expected revenues of $91 billion in 2023 and a market size expected to reach $105 billion by 2028.

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.

Here is how Biorius can help cosmetic companies in practice with regard to US compliance:

1. US Federal Legislation (MoCRA & existing regulations): Formula Review – Biorius performs an evaluation of your complete formula to ensure that raw materials and ingredients comply with all federal requirements.

2. US Federal Legislation (MoCRA & existing regulations): Label and Claims Review – Biorius performs an evaluation of your product labels to ensure that the mandatory elements and the marketing communications that you propose cannot get you into serious trouble.

3. US Federal Legislation (MoCRA): Report for Adequate Safety Substantiation – As required by the MoCRA, each cosmetic product must be analyzed to demonstrate its safety, and adequate records must be established by qualified toxicologists.

4. US Federal Legislation (MoCRA): Cosmetic Products Listing – Biorius will be able to take care of this legal obligation as soon as the FDA’s IT platform is online… though, do not wait until the last minute to preorder the regulatory work.

5. US Federal Legislation & California Provisions: Management of Volatile Organic Compounds (EPA, California Air Resources Board) – These substances, which can easily become vapors or gases, are regulated due to environmental concerns. Do not let this obligation jeopardize your presence in the US, as it has happened many times before!

6. States Provisions: Formula Review + Label and Claims Review in all States (including California’s specific requirements: Proposition 65, California Safe Cosmetic Program) – As outlined above, the Federal Legislation is one thing, but States are allowed to enforce provisions, and many of them have done so. Biorius will ensure that your products are US compliant, state by state.

7. Legal Representation of your products in the USA – Last but not least, Biorius can become your agent in the US if you are a foreign cosmetic brand and legally represent your products. The role of US Agent comes with many obligations… that most companies do not want to cover. If you are already based in the US, do not forget that you can delegate some of your tasks to Biorius – as answering consumer calls notifying an Adverse Event at midnight is not an appealing mission for a cosmetic company.

These services can be offered “à la carte” or as a combo, depending on your own needs and objectives.

You will find all the details of the US Cosmetics Legislation below:

Federal Cosmetics Legislation

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

The Food, Drug, and Cosmetic Act (21 USC 321-392 and related regulations) aim to prevent the placing on the US market of adulterated and misbranded products.
The Fair Packaging and Labeling Act (15 USC 1451-1460 and related regulation)aim to allow the consumer to make comparative value judgments in the marketplace regarding product purchases.

On December 29^th, 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 (or its US Agent if the Responsible Person is not located on the US territory). 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.

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!

Curious about the US legal framework and its law philosophy? Please consult this page.

States Provisions

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:

The restriction or the ban of specific ingredients in cosmetic products (e.g., Restriction of 1,4-Dioxane in New York).
The labeling on products/the reporting on the presence of specific ingredients in cosmetic products if this obligation existed at the time when the MoCRA was enacted (e.g., Proposition 65 obligations in California).
Any elements pertaining to cosmetic products that are not explicitly addressed by the MoCRA (e.g., Management of Volatile Organic Compounds in California).

Why should you choose Biorius ?

As specialists in the US cosmetics legislation for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in this market.

First Class specialists in cosmetic legislation in the United States and in more than 60 countries.
50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
No hidden costs: Biorius is an honest company that will not charge you for any question, call, or meeting.
A best-in-class IT tool, free of charge, and saving a lot of your time.
More than 1,500 international clients have already chosen Biorius!
We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.
Specifically regarding the MoCRA: we can cover all your needs from the formula review to the legal representation (US Agent), and we can guarantee that you will comply with the legal deadline of December 29^th, 2023.

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