Exporting to USA

 Cosmetics Regulation In

the United States

The United States of America holds the largest beauty and personal care market, forecasting revenues of $91 billion in 2023 and anticipating a market size of $105 billion by 2028.

This dynamic market is dominated by Indie beauty and innovative products, with a strong presence of well-established e-commerce and social media practices. To tap into this expansive market with 332 million people, your product must comply with the legal requirements outlined in the US.

On December 29th, 2022, with the enactment of the most substantial amendment to the USA Cosmetic Regulations (21 U.S.C., Sec. 321-392) since 1938, the introduction of the Modernization of Cosmetic Regulation Act (MoCRA) in the USA is anticipated to exert a most significant and transformative cosmetic regulation by the FDA.

At Influentive, our experts help you to enter the US Market successfully!

Modernization of Cosmetics Regulation Act

of 2022 (MoCRA)

The MoCRA represents a substantial enhancement of the FDA’s regulatory power over cosmetic products, marking the most significant expansion since the enactment of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. This legislation is instrumental in ensuring the safety of the cosmetic products commonly utilized by American consumers.MoCRA introduces enhanced authorities to the FDA, notably:

  • Records Access: Subject to meeting specified conditions, the FDA is empowered to obtain and duplicate specific records associated with a cosmetic product, encompassing safety records.
  • Mandatory Recall Authority: In cases where the FDA determines that a cosmetic product is adulterated or misbranded, posing a significant risk of severe adverse health consequences or fatality through its usage or exposure, the FDA has the jurisdiction to issue a mandatory recall if the Responsible Person declines to initiate a voluntary recall.

 

Significant changes of implementing MoCRA

USA Responsible Person for cosmetics

Responsible Person is the new requirement and this refers to the manufacturer, packer, or distributor of a cosmetic product whose name is displayed on the product’s label.

As clarified in June 2023 by the FDA, the Responsible Person is not required to be located within the US territory. However, foreign Responsible Persons must designate an Agent located in the USA.

The USA Responsible Person/ US Agent responsibilities including:

­čö╣Maintaining Safety Records: Manufacturers must ensure and keep records supporting the safety of their cosmetic products. These records must be made available to authorities if necessary.

­čö╣Adverse Reaction Management: Manufacturers should receive and handle adverse reactions associated with their products to the FDA within 15 business days. They also need to provide additional information within one year

­čö╣Cosmetovigilance Dossier: Manufacturers are required to maintain an updated cosmetovigilance dossier, which contains relevant information regarding the safety of their products.

­čö╣Fragrance Component Consultation: Manufacturers must allow authorities to access the components of the fragrance used in their products if requested.

­čö╣Product Notification: Manufacturers must notify the FDA about their products and ensure that the notification is kept up to date.

­čö╣Allergen Labeling: Manufacturers need to correctly label allergens on the packaging of their products.

­čö╣Market Recall Management: Manufacturers should organize a product recall when necessary or as requested by the FDA

MMoImplications on cosmetic ingredients and finished products

­čö╣Talc (Sec. 3504):

The FDA is mandated to develop standardized testing methods for identifying asbestos in talc-containing cosmetic products within one year of the MoCRA’s enactment on December 29th, 2023. Final regulations for these methods will be adopted no later than 180 days after the closure of the public comment period on the proposed regulations.

 

­čö╣PFAS (Perfluoroalkyl and Polyfloroalkyl substances) (Sec. 3506):

Within 3 years of the Act’s enactment, the FDA is required to assess the safety and use of perfluoroalkyl and polyfluoroalkyl substances in cosmetic products, including associated risks. The evaluation results will be summarized in a report published on the FDA website.

 

No Limitation (Sec. 614 (b)):

The MoCRA does not prevent states from prohibiting or limiting ingredients in cosmetic products. State provisions remain fully applicable.

Additionally, MoCRA introduces the requirement to comply with Good Manufacturing Practices (GMPs), with specific GMP requirements to be finalized by the FDA no later than 3 years after such date of enactment

Another significant aspect is the emphasis on safety substantiation, where Responsible Persons must maintain records supporting the adequate justification of safety. INFLUENTIVE experts possess the expertise to conduct a thorough TRA (Toxological Risk Assessment), a review of ingredients and finished products, enabling them to determine the necessary warnings for inclusion on cosmetic labels.

Mandatory Cosmetics Registration

According to Section 607 of the MoCRA, starting from December 29, 2023, every company and cosmetic product intending to enter the USA market must register with the FDA. The previous Voluntary Cosmetic Registration Portal (VCRP) has been discontinued, and no new notifications or requests will be processed.

The FDA will archive the data from VCRP (Voluntary Cosmetic Registration Program) database without automatic migration to the new system. The MoCRA’s mandatory cosmetics registration will now take place through a new portal that enables the registration of establishments and products.

The Responsible Person must maintain an annually updated list of their cosmetic products for FDA documentation. This list should include key details like product names, types, and ingredients. The deadline for cosmetic product listing is July 2024, and any newly marketed products must be added within 120 days of entering interstate commerce.

A single cosmetic product listing submission can cover multiple items with identical formulations or formulations differing only in colors, fragrances, flavors, or quantity of contents.

Registration of company and product listing

The USA Modernization of Cosmetic Regulation Act (MoCRA) introduces two key obligations. First, manufacturers and processors must register their facilities with the FDA, renewing the registration every two years. Second, manufacturers must provide a product listing to the FDA, including details such as the product’s name, type, and ingredients, which should be updated annually. Both of these processes will be carried out using the same system and can occur simultaneously:

­čö╣ Any facility participating in the manufacturing, processing, or distribution of cosmetic products within the USA is required to register on the FDA’s dedicated IT platform and keep this registration current (Sec. 607 (a)). Existing facility registrations must be submitted by July 2024.

­čö╣ Renewal of these facility registrations is mandatory every 2 years, and newly established facilities must register within 60 days of commencing their operations (or within 60 days after the initial transition period concluding in July 2024).

The Act also empowers the FDA to suspend facility registrations in cases where products pose a serious risk. These measures aim to enhance oversight and safety in the cosmetic industry. It becomes prohibited to distribute or sell products from a suspended facility.

Cosmetic Labeling Requirements

The USA Modernization of Cosmetic Regulation Act introduces new labeling requirements for cosmetic products. In addition to existing obligations, products must now include the following mandatory information on their labels:

  • Contact details: The label should provide contact information for the Responsible Person, including the possibility of a website to report adverse reactions.
  • Professional use statement: If a cosmetic product is intended exclusively for use by licensed professionals, the label must clearly and prominently state this fact.
  • Allergen disclosure: A list of ingredients, including labeled allergens, must be displayed on the packaging. The specific list of allergens to be labeled will be established through regulations.

These labeling provisions aim to enhance consumer safety and provide necessary information for users of cosmetic products.

FDA Timeline

   December 29,2022

  • MoCRA Enacted

 

December 29, 2023

  • Facilities Registration
  • Cosmetic Product Listing
  • Tracking, Reporting & Recording of serious adverse events
  • Hold the documentation to substantiate the safety of their products
  • Talc-testing standardized methods proposed by the FDA

Considering this, companies outside the United States must appoint a US Agent.

    June 29, 2024

    • Proposal Regulation on labelling of allergens

    December 29, 2024

    • FDA proposal regulation on GMP
    • Mandatory elements labeling required for all products
    • Contact details of a US-based person on packaging

     

    December 29, 2025

    • FDA risk assessment report of PFAS in cosmetic products
    • GMP regulation finalized

    Partnering with Influentive

    With 17 years of experience as a cosmetics regulatory expert, INFLUENTIVE offers invaluable support to help your brand successfully sell cosmetics in the USA. Our services encompass a comprehensive compliance check of your formulas and labels, ensuring adherence to both state and federal regulations. Additionally, we conduct thorough safety assessments to guarantee the safety of your products.

    Furthermore, our team of experts is well-equipped to provide you with all the necessary information regarding the Publication of the USA Modernization of Cosmetic Regulation Act (MoCRA). As regulatory changes may occur at different times, we can guide you through the next steps and inform you about the various compliance deadlines related to new Good Manufacturing Practices (GMP), labeling requirements, and safety substantiation, such as the publication of the PFAS Report on the FDA website.

    You can rely on our extensive expertise to navigate the complex regulatory landscape, ensuring your products meet the necessary standards for successful market entry and compliance in the USA.