MMoImplications on cosmetic ingredients and finished products

🔹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.

🔹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:

🔹 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.

🔹 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.