Cosmetics: MoCRA

MoCRA introduces several new requirements and obligations for cosmetic manufacturers.

In particular,

• Products listing to the FDA;
• Registration of facilities involved in the manufacture or processing of cosmetic products for distribution in the United States;
• Adverse event receipt, evaluation, and response
• Serious adverse event reporting via the existing Medwatch system;
• Safety substantiation of the cosmetic product through tests, studies, research, analyses, or other evidence;
• Labelling of fragrance allergens once the FDA identifies the list and concentration threshold;
• Labelling of an address and contact information in the United States to which consumers and authorities can report adverse events;
• For professional products, make a statement on the label that they can only be used by licensed professionals;
• Compliance with Good Manufacturing Practices (GMP) when established by the FDA;
• Testing for asbestos in talc-containing products.

Small businesses are exempted from complying with the requirements on product registration and GMP unless their products are in contact with the mucus membrane of the eye, intended for internal use or change the appearance for more than 24 hours. Moreover, small companies have to keep a record of adverse events for 3 years instead of 6.

Small businesses are those whose average annual gross sales of cosmetic products in the United States for the previous 3-year period are less than $1,000,000, adjusted for inflation.

Have a look at the most important deadlines imposed by MoCRA:

If you want to sell your products in the United States, you must first check whether they fall within the definition of cosmetic products under US law.

In the U.S., personal care products can be classified as cosmetic products or over-the-counter (OTC) drugs (that do not require a medical prescription) — Below are the definitions from the law.

Some examples of OTC drugs are sunscreens, anti-acne products, antiperspirants, and toothpaste. Additionally, products that are both cosmetics and drugs must comply with both laws.

Read our complete analysis here.

If you are uncertain about the classification of your products, check our dedicated service — Our experts will support you

The main objective of MoCRA is to ensure a high level of safety for cosmetic products sold in the United States. Therefore, it introduces huge news about safety substantiation. Indeed, the Act provides that for each cosmetic product, there must be adequate substantiation of its safety. The Responsible Person is in charge of collecting and recording such documentation that must be presented to the FDA in case of inspection.

MoCRA defines “adequate substantiation of safety” as “tests, studies, research, analyses, or other evidence or information that is considered, among experts qualified by scientific training and experience to evaluate the safety of cosmetic products and their ingredients, sufficient to support a reasonable certainty that a product is safe.”  Since the EU Cosmetic Product Safety Report is widely accepted, it is our recommendation that brand owners adopt that model for substantiating the safety of products for sale in the US.

MoCRA introduces mandatory registration of both products and facilities.

Regarding cosmetic products registration:

• The Responsible Person must submit to the FDA a listing of cosmetic products already marketed before December 29, 2023;
• The list must be updated every year – if there are any changes to the products;
• New products must be added to the list within 120 days of their marketing;
• The registration must include the following information:
  • Cosmetic product commercial name;
  • The cosmetic product category;
  • Ingredients list;
  • Registration number of the facilities where the product is manufactured;
  • Details of the Responsible Person.

The FDA  is developing the system and will announce how brand owners will register their cosmetic products.  In the meantime, it is our recommendation that brand owners assemble all of the information listed above for immediate uploading when the system becomes available.

In March 2023, the FDA announced that it is not possible anymore to register into the Voluntary Cosmetic Registration Program (VCRP) established under FD&C Act. The information from VCRP will also not be transferred to the new system.

Regarding facilities registration:

• By December 29, 2023, each facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States must register with the FDA;
• From that date, new facilities have to register within 60 days of the start of activities;
• The registration has to be renewed every 2 years;
• By registering, each facility will receive an identification number;
• The registration must include the following information:
  • Facility’s name, address, email, and telephone number;
  • For foreign facilities, the details of the US Agent;
  • Brand names of the products manufactured or processed in the facility;
  • The cosmetic products category;
  • The Responsible Person for each product manufactured in the facility.

The FDA is developing the system and will announce the details.  It is our recommendation that manufacturing and processing facilities assemble their information ready for immediate uploading once the system becomes available

Small businesses are exempted from the registration requirement unless their products are in contact with the mucus membrane of the eye, intended for internal use or change the appearance for more than 24 hours.

MoCRA committed the FDA to publish a notice of proposed rulemaking on Good Manufacturing Practices (GMP) by December 29, 2024, and to finalize the requirements a year later.

The FDA has had a draft Guidance for Industry – Cosmetic Good Manufacturing Practices (GMP) for many years. It was last updated in 2013. Also, since the FDA already regulates cosmetics and recognizes GMP as a critical requirement to prevent adulteration or misbranding, manufacturers are expected today to follow the principle of current GMP. Nevertheless, MoCRA requires GMP for cosmetics to be codified for the first time.

The GMP will apply to all products placed on the US market, regardless of where they are made. They will apply to all facilities where the cosmetic product is made and/or filled into the primary container and labelled. MoCRA does not currently require GMP to be implemented in secondary packaging facilities such as the assembly of gift sets.

MoCRA directs the FDA to consult with cosmetics manufacturers, including smaller businesses, consumer organizations, and other experts, before issuing their proposals, and this process is underway. The Act also requires the GMP regulations to be consistent, practicable, and appropriate with national and international standards. One clear example of an international standard that the FDA will consider is ISO 22716:2007. The Act calls for the FDA to take account of the size and scope of cosmetics manufacturers, not impose undue economic hardship on small businesses, and address risks to public health, which is the fundamental reason for GMP regulations.

The FDA has been instructed to identify a list of fragrance allergens that must be disclosed on the label of a cosmetic product. The proposed rule is expected to be published no later than 18 months after the enactment of MoCRA (December 29, 2022) and a final rule on allergens labelling within 180 days after the close of the public comment period.

The FDA shall issue regulations to establish standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. The FDA must issue a proposed rule within one year after the enactment of MoCRA and a final rule by the close of the public comment period for the proposed rule.

MoCRA requires the FDA to issue a public report no later than three years after the enactment of MoCRA (December 29, 2022) to assess the use of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products, including the scientific evidence regarding the safety of use in such products.

The Responsible Person must record and maintain available to the FDA data on the adverse events associated with the use of a cosmetic product on the territory of the United States. These data must be collected, evaluated, and properly reported to the FDA if the event is assessed as serious.

Additionally, the Responsible Person must keep the records related to each report of an adverse event for 6 years. Consequently, the FDA can suspend a facility registration if it determines that a cosmetic product manufactured by that facility has a reasonable probability of causing serious adverse health consequences and believes other products may be similarly affected.

Moreover, the FDA may request in writing a list of ingredients or categories of ingredients in the specific fragrances or flavors in the cosmetic product if one of those has caused or contributed to a serious adverse event. The Responsible Person shall ensure that the requested information is submitted within 30 days of such request.

The Responsible Person must report any serious adverse event associated with the use, in the United States, of a cosmetic product within 15 business days after it is received. Furthermore, for one year after the initial submission, the Responsible Person must submit to the FDA any new and material medical information related to the initial report within 15 business days of its receipt.

According to MoCRA, a Responsible Person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label and is accountable for compliance.

The responsibilities of a Responsible Person are the following:

• Register products and facilities with the FDA;
• Keep the documentation supporting the safety of a cosmetic product;
• Report to the FDA any serious adverse events;
• Maintain records of adverse events;
• Reply to any queries from the FDA;
• Ensure a US-based name and address are included on the labels for customers to report adverse events;
• Recall the products in case of non-compliance and upon request of the FDA.

MoCRA introduced a new entity, the US Agent, representing manufacturing and processing facilities based outside the United States. The role is not explicitly defined in the US cosmetics law; however, taking a US Agent for medical devices as a model, they are the following:

• Supporting the communication between the FDA and the foreign company;
• Replying to queries about the products imported into the United States;
• Assisting the FDA in scheduling inspections of the foreign entity;
• Provide the FDA with the requested information and documentation on behalf of the non-US company.

Similarly, the brand owner is required to identify a US address, US telephone number or electronic contact information on the product label in order receive reports of adverse events.  Although the regulation does not use the term US Agent for this responsibility, we strongly recommend that non-US responsible persons (brand owners) appoint Obelis USA as their representative in order to meet the various deadlines for registration, serious adverse event reporting and responding to FDA inquiries.

The Food and Drug Administration (FDA) is a federal agency responsible for several products, including cosmetic products, medical devices, drugs, biological products, and the food supply. It is in charge of both regulating those products and enforcing the law.

MoCRA gives the FDA additional powers in case of adulterated or misbranded products, or risk of serious adverse health consequences, the FDA can:

• Inspect the documentation to verify compliance with MoCRA;
• Inspect facilities worldwide to check compliance with GMP;
• Request the beauty brands to provide ingredients details of the formulation, fragrances, or flavors;
• Require the beauty brand to recall the product voluntarily. If the manufacturer does not comply, the FDA can impose a mandatory withdrawal;
• Suspend the facility registration.

The Act also prevents states from issuing independent regulations in the areas covered by MoCRA.  However, states are free to regulate either the content or level of ingredients in cosmetic products which they allow to be sold in their market.

In its role of rulemaking, the FDA must issue regulations on the following topics:

• Good manufacturing practices (GMP) for facilities;
• Fragrance allergens to be labelled when they exceed determined concentration limits;
• Standardized testing methods for detecting and identifying asbestos in cosmetic products containing talc.

It must also assess the use and safety of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products and publish a report by December 29, 2025.