Understanding the regulatory landscape is crucial for companies operating in the U.S. cosmetic industry. This article provides an overview of the federal regulations, the role of the FDA, the definition of cosmetic products, and the recent changes brought about by the Modernization of Cosmetics Regulation Act (MoCRA). We also highlight the importance of facility registration, product listing, and the services offered by REACH24H to support compliance in this sector.

Regulatory Background

The US legislation for cosmetics consists of Federal regulations and state-specific regulations. The two most important Federal laws applicable to cosmetic products in the USA are the Federal Food, Drug and Cosmetic Act (FD&C Act), which prescribes the minimum regulatory standards for cosmetics and applies across all 50 states, and the Fair Packaging and Labeling Act (FPLA).

The legal authority that regulates cosmetics in the USA is the US Food and Drug Administration (FDA) under the FD&C Act and FPLA. The products that are already on the market or when cosmetic products are imported into the country must be compliant with the legislation, including the ingredients, labelling and claim requirements. On top of the Federal legislation, States are allowed to pass their own acts on cosmetic products and set specific requirements that products must be compliant with.

Definition of Cosmetic Products in the U.S.

Articles intended to be rubbed, poured, sprinkled, or sprayed on or introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap.

Cosmetic Product Categories  

 It is important to note, that certain products meet the definitions of cosmetics and over-the-counter (OTC), such as anti-dandruff shampoo, anti-caries toothpaste, antiperspirant, and sunscreen. Certain products are regulated as OTC drugs and cosmetics and must meet the requirements both of OTC and cosmetics.

INCI Name Application

INCI names (International Nomenclature Cosmetic Ingredient) are systematic names internationally recognized to identify cosmetic ingredients.

Companies can apply for an INCI name for a cosmetic ingredient from the Personal Care Products Council (PCPC) by making an electronic submission. Companies shall propose their own INCI names in accordance with PCPC’s nomenclature rules.

Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

Enacted on December 29, 2022, as part of the 2023 omnibus bill (H.R.2617), the Modernization of Cosmetics Regulation Act (MoCRA) is the first major overhaul of the FD&C Act for cosmetics regulation since the FD&C Act was passed in 1938.

MoCRA includes new provisions for cosmetic products, such as facility registration, product listing, mandatory adverse event reporting and record keeping, safety substantiation, good manufacturing practice (GMP) regulations for cosmetics, fragrance allergen labelling. MoCRA also requires a few changes to existing labelling requirements (including the requirements for professional-use products). Besides, the FDA is required to issue regulations to establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products and a public report no later than three years after the enactment of MoCRA to assess the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, and the scientific evidence regarding the safety of such use in these products.

The new provisions and the statutory dates are outlined below：

Responsible Person (RP)

Responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product.

Responsibility：

• Product safety and compliance
• Product listing
• Facility registration (if necessary)
• The name & address of RP should be highlighted on the label
• Report post-marketing serious adverse events and adverse event report receiving and keeping
• Prepare and maintain adequate substantiation of product safety
• Labelling of Fragrance allergens

Facility Registration

According to the Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products，

The following information must be submitted in a facility registration：

• the name of the owner and/or operator of the facility
• the facility’s name, physical address, email address, and telephone number
• with respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact information (email)
• the facility registration number, if any, previously assigned
• all brand names under which cosmetic products manufactured or processed in the facility are sold
• the product category or categories (refer to Appendix A below) and the responsible person for each cosmetic product manufactured or processed at the facility; and
• type of submission (initial, amended, biennial renewal, or abbreviated renewal)

Additional optional information is included： parent company name (if applicable); facility DUNS Number; and additional contact information for individuals associated with the registration.

Statutory Dates for Facility Registration：

• Initial Registration：
  • Every person that, on December 29, 2022, owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register each facility no later than December 29, 2023
  • Every person that owns or operates a facility that first engages, after December 29, 2022, in the manufacturing or processing of a cosmetic product for distribution in the United States, must register such facility within 60 days of first engaging in such activity or by February 27, 2024, whichever is later.
• Amended Registration：
  • Every person who is required to register must update their registration within 60 days of any changes to the information required for registration (section 607(a)(4) of the FD&C Act) (an “amended” registration). This includes any changes that result in the cancellation of the registration.
• Renewal of Registration：
  • Every person who is required to register a facility must renew such registration biennially.

Product Listing

According to the Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products，

The following information must be submitted in a cosmetic product listing:

• the facility registration number of each facility where the cosmetic product is manufactured or processed
• the name and contact number of the responsible person and the name for the cosmetic product, as such name appears on the label
• the applicable cosmetic category or categories for the cosmetic product
• a list of ingredients in the cosmetic product, including any fragrances, flavours, or colours, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient
• the product listing number, if any previously assigned; and
• type of submission (initial, update to content (annual), abbreviated renewal)

Additional optional information is included： parent company name (if applicable); type of business (as listed on the label), i.e., manufacturer, packer, or distributor; image of the label; product webpage link; whether the cosmetic product is for professional use only; responsible person DUNS Number for the address listed on the product label; Unique Ingredient Identifiers (UNIIs); and additional contact information for individuals associated with the listing.

Statutory Dates for Product Listing：

• Initial Listing：
  • The responsible person for a cosmetic product that is marketed on December 29, 2022, must submit a cosmetic product listing not later than December 29, 2023, or for a cosmetic product that is first marketed after December 29, 2022, within 120 days of marketing such product in interstate commerce
  • Consistent with the approach for registration of a facility that starts manufacturing or processing cosmetic products after December 29, 2022, FDA expects the product listing for a cosmetic product first marketed after December 29, 2022, to be submitted within 120 days of marketing the product, or within 120 days of December 29, 2023, whichever is later
• Update to Content and Renewal：
  • The responsible person must provide any updates to such listing annually. This includes an update that the product was discontinued
  • The responsible person must renew the product listing annually.

Our Services

• Facility registration (including FEI application), amendment, and renewal.
• INCI Name Application
• Cosmetics formula and packaging review
• Product listing and annual renewal
• Cosmetic safety substantiation
• Technical and regulatory consulting
• U.S. local agent service

Why Choose REACH24H

• Extensive Expertise: Our team of technical and legal professionals based in Japan brings a wealth of experience and industry qualifications to ensure your compliance with Japanese beauty industry standards.
• Strong Collaborations: Benefit from our extensive network and partnerships with prominent organizations in the Japanese beauty industry, including the Japan Cosmetic Industry Association, Japan Association for Nail and Skin Care, and leading Japanese testing institutions.
• Regulatory Information Platform: Access our dedicated platform for real-time regulatory tracking, in-depth analysis, and reliable database support, keeping you up-to-date with the latest requirements in the industry.
• Trusted by Global Brands: We have successfully served over 1000 cosmetic companies worldwide, including well-known Fortune Global 500 companies, earning their trust and satisfaction through our reliable services.
• Global Reach: With our global branches and multilingual capabilities, we offer efficient international services, ensuring effective communication and comprehensive support throughout the compliance process.

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