U.S. Cosmetic Regulation
How to Start Selling Cosmetics in the United States?
The United States of America is the largest beauty and personal care market, with projected revenues of $91 billion in 2023 and a market size expected to reach $105 billion by 2028.
It is a robust market where indie beauty and innovative products thrive, and where e-commerce and social media practices are particularly well-developed. To enter this market of 332 million people, your product must comply with the legal requirements imposed in the U.S.
To sell in the U.S., you must consider the federal legislation on cosmetics, which applies equally across all states, as well as state-level provisions, which are often specific. A common mistake is to overlook this second responsibility.
Formula review
Pharmilab performs an evaluation of your complete formula to ensure that raw materials and ingredients meet all federal requirements and additional requirements of some states (including California-specific requirements: Proposition 65, California Safe Cosmetic Program)
Label and Claim review
Pharmilab carries out an assessment of your product labels to make sure that the mandatory elements and commercial communications you propose cannot put you in serious trouble.
Cosmetic Product Safety Report
As required by MoCRA, each cosmetic product must be analyzed to demonstrate its safety, and appropriate records must be established by qualified toxicologists.
Facilities registration and products listing
Pharmilab will be able to comply with this new legal obligation, defined by MoCRA, as soon as the FDA's IT platform is available... however, don't wait until the last minute to begin regulatory work.
Volatile Organics Compounds
These substances, which can easily turn into vapors or gases, are regulated at both the Federal and State levels due to environmental concerns. Do not let this obligation jeopardize your presence in the USA.
US Agent and Responsible Person
Pharmilab can become your contact for adverse events in the US if you are a foreign cosmetics brand and fully support the role of Responsible Person, which brings with it many obligations, defined in MoCRA.
FAQ
What is MoCRA?
MoCRA is the Modernization of Cosmetics Regulations of 2022 and was signed into law on December 29, 2022. MoCRA is the largest reform of existing cosmetics regulations in the United States in 84 years and establishes many new requirements, such as:
- Facility registration
- Product Listing
- Good manufacturing practices (GMP)
- Safety substantiation
- New labeling requirements
- Reporting adverse events
- Record keeping
How will the MoCRA affect cosmetics factories?
According to the MoCRA, the major changes for cosmetics manufacturers are the need to register facilities and comply with GMP, which will be issued by the FDA at the end of 2025.
Who is considered the responsible person under the MoCRA?
The term "responsible person" means the manufacturer, packager or distributor of a cosmetic product whose name appears on the product's label, in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
Under the MoCRA, it is mandatory to designate a Responsible Person for each cosmetic product placed on the US market, who is responsible for:
- Listing cosmetic products
- Managing adverse effects
- Substantiating the safety of cosmetic products
- Labeling
Are there any exemptions for registering installations and listing products?
Yes, small businesses will have more flexible and simplified requirements, being exempt from the obligation to register facilities and list products. The FDA defines a small business as a company with average annual gross sales in the US of less than $1,000,000 for the previous 3-year period, adjusted for inflation.
However, regardless of their sales volume, companies involved in the manufacture or processing of the following cosmetic products are not exempt:
- Cosmetic products that come into contact with the eyes
- Cosmetic products that are injected
- Cosmetic products intended for internal use
- Cosmetic products that alter appearance for more than 24 hours under normal conditions of use and whose removal by the consumer is not part of those conditions.
When are plant registers and product lists needed?
For existing facilities, facility registration and product listings must be completed by December 29, 2023. New facilities that manufacture or process cosmetic products for distribution in the U.S. must register within 60 days of marketing the product. product or 60 days after the deadline for existing installations, whichever is later.
What if I have several cosmetic products? Can I list them in a simplified way?
The MoCRA allows for "flexible listings". In these cases, it is possible to submit a single listing for cosmetic products with identical formulations, or formulations that differ only in terms of colors, fragrances or flavors, or nominal content.
What can I do to prepare for MoCRA?
Contact Pharmilab to determine what responsibilities your company will need to meet to be compliant with the new legislation.
What are the new labeling requirements and when do they come into force?
Section 609 of the MoCRA establishes new labeling requirements for cosmetic products, in addition to the requirements imposed by the FD&C Act and the Fair Packaging and Labeling Act:
- The addition of a U.S. address, a U.S. telephone number, or electronic contact information through which the Responsible Person can receive adverse event reports. This labeling requirement is mandatory as of December 29, 2024.
- The labeling of fragrance allergens, which will be identified by the FDA in a proposed regulation by June 29, 2024.
- On products for professional use, a clear and prominent indication that they must be administered or used by authorized professionals. This labeling requirement comes into force on December 29, 2023.
MoCRA Regulation
Modernization of Cosmetics Regulation Act of 2022
Get ready now to meet the new FDA requirements for cosmetics companies.
The United States recently enacted the 2022 Modernization of Cosmetics Regulation Act (MoCRA), expanding the regulatory authority of the U.S. Food and Drug Administration (FDA) over the cosmetics industry. MoCRA requires the FDA to establish comprehensive new regulations for companies that manufacture and distribute cosmetics in the U.S.
Many regulations went into effect in 2023.
What does MoCRA mean for cosmetics companies?
Under MoCRA, the FDA will establish regulations affecting the entire lifecycle of your cosmetic products, from manufacturing to marketing.
The new requirements include:
- Mandatory FDA registration for cosmetic manufacturing facilities
- Mandatory product listings for every cosmetic product marketed in the U.S. (meeting certain requirements)
- Adverse event reporting
- Adherence to the FDA’s Good Manufacturing Practices (GMP)
- Record keeping, including adverse event records and safety substantiation
- Mandatory product sampling
- Fragrance allergen declaration
- Reduced fall due to breakage
Although the FDA has not yet established regulations for these requirements, the law provides an overview so that cosmetics companies can start preparing for the new FDA requirements.
Not sure where to start? Pharmilab is the ideal partner to help your brand comply with the new obligations in the U.S.
We will help to:
- Properly register cosmetic manufacturing facilities with the FDA as quickly as possible
- Act as a U.S. agent for cosmetics brands based outside the U.S.
- Submit and manage cosmetic product listings
- Provide updates as the FDA implements additional MoCRA guidelines
