US FDA Cosmetics Registration India MoCRA

MoCRA stands for Modernization of Cosmetics Regulation Act of 2022. It aims to strengthen the regulatory oversight for cosmetic products, facilities, and companies

The MoCRA responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The duties of the MoCRA responsible person are cosmetic product listing, adverse event reporting, safety substantiation, correct product labelling, and facility registration.

As per MoCRA guidelines, each marketed cosmetic product, including its ingredients, has to be listed with the US FDA within 1 year of MoCRA’s enactment. Furthermore, for products marketed after MoCRA’s enactment, a complete listing has to be submitted to the FDA within 120 days of marketing. Additionally, the responsible person must annually update the product listing information.

As per MoCRA guidelines, for cosmetics facility registration, companies are required to register their facilities with the FDA. Additionally, they must renew their facility registration every two years. As per MoCRA guidelines, for cosmetics product listing, the responsible person must list each marketed cosmetic product with the FDA. Additionally, the listing has to be updated annually.

MoCRA has the option for flexible listings using a flexible submission form for cosmetics products with minor variations. In case of flexible listings, a single listing for cosmetic products with identical formulations or formulations with slight variations can be submitted. The products can differ only with respect to fragrances, flavours, quantity of contents, or colours.

MoCRA has bestowed the FDA with legal authority to order a mandatory recall for products that they consider adulterated or misbranded. If the authorities feel exposure to a cosmetics product may cause serious adverse health effects, they may demand a recall. Once a mandatory recall is issued, the responsible person will be obliged to recall the products.

Small businesses whose average gross annual cosmetic products sale for the previous 3 years is less than USD 1 Million are exempt from MoCRA requirements. They are exempt from MoCRA requirements, such as facility registration, GMP, and product listing requirements. To be eligible for the exemption, the business should not be involved in manufacturing/processing cosmetic products that can be injected. Additionally, the products should not alter appearance for more than 24 hours without consumer removal. Furthermore, they should not be intended for internal use. Moreover, they should not come into contact with the eye’s mucus membrane.

MoCRA guidelines mandate cosmetics facilities to adhere to cosmetics good manufacturing practices (GMP). This will align the cosmetics manufacturing process with international standards. Hence, high-quality and safe cosmetics products will be consistently manufactured. Therefore, adulterated and substandard products will not enter the US cosmetics market, thereby protecting consumer health.

MoCRA guidelines have introduced certain new mandatory labelling requirements for cosmetics products. Firstly, the domestic address, domestic phone number, or electronic contact information of the person responsible for receiving adverse event reports has to be included. Additionally, fragrance allergens present in the product have to appropriately flagged. Furthermore, cosmetics intended for use by professionals should be properly labelled as “professional use” products.