31 May Understanding MoCRA: A Guide to the Modernized Cosmetics Regulation Act of 2022
In the ever-evolving world of cosmetics, ensuring consumer safety and regulatory compliance is of paramount importance. Recognizing the need for modernization, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in significant changes to the regulatory landscape governing cosmetic products in the United States. Aimed at enhancing safety, transparency, and oversight, MoCRA replaces outdated regulations from 1938 and introduces a range of new requirements that impact manufacturers and importers alike. In this blog, we will delve into the key updates brought about by MoCRA, providing valuable insights to beauty manufacturers and importers regarding compliance and industry best practices.
Under MoCRA, cosmetic facilities must register with the US Food and Drug Administration (FDA) and renew their registrations every two years. The registration requirement applies to establishments involved in manufacturing or processing cosmetic products distributed in the United States. Existing facilities have until December 29, 2023, to complete their registrations, while new facilities must register within 60 days of commencing manufacturing operations. It is crucial for facilities to initiate the registration process early to account for any unforeseen issues or potential delays from the FDA.
The FDA holds the authority to suspend a facility’s registration if it determines that a product manufactured or processed by the facility poses a reasonable probability of causing severe adverse health consequences or death. Moreover, if the agency believes that other products in the facility may be similarly affected due to an inability to isolate the failure or a pervasive failure concern, registration suspension is also applicable. In such cases, the facility is prohibited from selling or distributing cosmetics products in the United States.
Additionally, responsible persons, such as manufacturers, distributors, or packers whose names appear on the label, are required to list each cosmetic product with the FDA. This step promotes transparency and facilitates efficient monitoring of products in the market.
The Voluntary Cosmetic Regulations Program (VRCP), which allowed voluntary submission of product information to the FDA, is no longer accepting submissions. MoCRA mandates a more extensive volume of submissions, necessitating the development of a new program by the FDA to handle facility registrations and product listings. This change enables the FDA to manage regulatory oversight effectively, ensuring greater transparency and safety within the industry.
MoCRA places a strong emphasis on consumer safety by mandating cosmetic manufacturers to submit safety information about their products to the FDA. This includes reporting any adverse reactions experienced by consumers and disclosing information regarding potentially harmful ingredients used in the products. The FDA utilizes this data to evaluate product safety and take appropriate actions to protect consumers.
Furthermore, manufacturers must adhere to Good Manufacturing Practices (GMPs), which encompass guidelines ensuring the quality and safety of cosmetic products. Compliance with GMPs involves using clean equipment, proper handling and storage of ingredients, and implementing robust quality control measures.
Another crucial aspect of MoCRA is the requirement for cosmetic manufacturers to disclose the full list of ingredients used in their products on the product label. This shift from previous regulations, which allowed vague terms like “fragrance,” provides consumers with enhanced transparency, enabling them to make informed decisions about the products they use.
Under MoCRA, certain exemptions are granted to cosmetic/drug and cosmetic/device combination products, relieving them from specific requirements including compliance with Good Manufacturing Practices (GMPs), adverse event reporting, registration and listing obligations, safety substantiation, and recordkeeping. These exemptions do not extend to facilities involved in the manufacturing of both combination products and cosmetics.
Small businesses are exempt from GMP and registration and listing requirements. A small business is defined as having average gross annual sales in the U.S. for the previous three-year period of less than $1,000,000, adjusted for inflation. It is important to note that the small business exemption does not apply if the business manufactures products that come into contact with the eyes, are injected, are intended for internal use, or alter appearance for more than twenty-four hours.
The Modernization of Cosmetics Regulation Act (MoCRA) represents a crucial leap forward in the regulation of cosmetics in the United States. With its emphasis on safety, transparency, and compliance, MoCRA ensures that the beauty industry aligns with evolving consumer expectations. Manufacturers and importers must familiarize themselves with the updated requirements to ensure they meet the standards set forth by MoCRA.
At Future Forwarding, our expertise in supply chain management and deep understanding of regulatory compliance can help you stay on top of these complex requirements. By leveraging our industry knowledge and network, we ensure that you can effectively navigate the regulatory landscape, maintain compliance, and streamline your operations. With our reliable support, shippers can focus on core business while confidently meeting the obligations imposed by MoCRA. To find out more, reach out to Future Forwarding today.