Exporting to USA
FDA and State Regulations
Cosmetic products in the US are regulated by the FDA through the FD&C Act and FPLA, as well as state and local laws. The primary reason for FDA sanctions is label mistakes. To sell their products in the US, companies typically prioritize compliance with FDA regulations, particularly with respect to labeling and product information.
The process for selling cosmetics in the United States:
- Check and review the product ingredients in accordance with the restricted drugs list.
- Review and ensure the label conforms with the FDA requirement.
- Adapt the claims of the product to stay within the definition of designs, claims related to medicines or over-the-counter products should be avoided.
- Advisable to register the company and the products in the Voluntary Cosmetic Product Registration (VCRP) (link to FDA)
At Influentive, our experts help you to obtain 100% FDA compliance products and enter the US Market successfully!
Modernization of Cosmetics Regulation Act of 2022 (MoCRA) SERVICES
By the end of 2023, the Modernization of Cosmetics Regulation Act (MoCRA) will become effective and it will introduce some of the most significant and transformative cosmetic regulations by the FDA.
Background Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
The Modernization of Cosmetics Regulation Act of 2022 (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 USA MoCRA:
- 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.
The USA Responsible Person responsibilities including:
- 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.
- 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.
- Cosmetovigilance Dossier: Manufacturers are required to maintain an updated cosmetovigilance dossier, which contains relevant information regarding the safety of their products.
- Fragrance Component Consultation: Manufacturers must allow authorities to access the components of the fragrance used in their products if requested.
- Product Notification: Manufacturers must notify the FDA about their products and ensure that the notification is kept up to date.
- Allergen Labeling: Manufacturers need to correctly label allergens on the packaging of their products.
- Market Recall Management: Manufacturers should organize a product recall when necessary or as requested by the FD
- Implications on cosmetic ingredients and finished products
The upcoming publication of an official method for detecting asbestos in talc-containing products and the evaluation of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products are key impacts of the USA cosmetics reform. Additionally, the reform introduces the requirement to comply with Good Manufacturing Practices (GMPs), with specific GMP requirements to be published by the FDA within three years. 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 Cosmetic Registration
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 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 implementation of both systems will occur simultaneously.
- 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. 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.
- Suspension of Facility Registration: The FDA can suspend a facility’s registration if its products pose a risk of serious harm. It becomes prohibited to distribute or sell products from a suspended facility.
- Cosmetics 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.
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.