Personal and Home Care Products
CIRS Group
Medical Devices
C&K Testing
Carbon Neutrality
United States
FDA Direct is a U.S. Food and Drug Administration's web-based and free structured product labeling (SPL) authoring tool. Previously CDER Direct, FDA Direct now includes CDER Direct and Cosmetics Direct. Users can create separate accounts, depending on drugs or cosmetics submissions, or a single account that includes both CDER Direct submissions as well as Cosmetics Direct submissions.
According to FDA regulations, if a product is intended to be applied to a person’s body to make the person more attractive, it’s a cosmetic under the law, for instance perfumes, colognes and aftershave should all be regulated as cosmetics. However, some products add fragrances for therapeutic purposes, such as aromatherapy products that could relieve muscle pain or headaches, and fragrance products that help sleep. These kind of fragrance products are generally regulated as pharmaceuticals. Other products that may contain fragrance ingredients, but are not applied to the body, including detergent, fabric softener and carpet freshenerare, are under the administration of the Consumer Product Safety Commission.
The US Food and Drug Administration has published a Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetic product facility registrations and product listings are now included within the SPL framework. The Implementation Guide can be used to develop SPL authoring tools. In the future, once FDA begins accepting data, users may transmit SPL-formatted submissions through FDA’s Electronic Submissions Gateway (ESG), or SPL authoring software including Xforms, for cosmetic product facility registrations and product listings, mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
The US FEI Portal allows a user to look up an FDA Establishment Identifier (FEI) based on a firm name and address, or validate the address of an FEI.
On August 7, 2023, the US Food and Drug Administration (FDA) published draft guidance on cosmetic product facility registrations and product listings, as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). When finalized, the draft guidance will assist stakeholders with cosmetic product facility registration and product listing submissions to FDA, by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, and when to submit, as well as certain exemptions to the registration and listing requirements.
In December 2022, Hochul, governor of New York State, signed an amendment to the Environmental Protection Act (A8630A) to prohibit the use of 1,4-dioxane or mercury in cosmetics and personal care products. The bill will come into effect on June 1, 2023. From the effective date, cosmetics or personal care products containing 1,4-dioxane or mercury must not be sold in New York State.
On December 29, 2022, US President Biden signed into law the Food and Drug Omnibus Reform Act (FDORA Act), which included the Modernization of Cosmetics Regulation Act of 2022 (MOCRA Act). This is the first significant amendment to American cosmetics regulations since 1938. Compared with the current Federal Food, Drug and Cosmetic Act (FDC Act), MOCRA Act forces cosmetic enterprises to register their facilities and maintain records for their products.
There is a diverse range of cosmetic packaging materials, such as glass, metal, plastic, and soft paper packaging. As the last process in the modern cosmetics industry, packaging is necessary to keep the contents clean and safe. However, it is also important to make sure the packaging itself does not pollute the cosmetics or add any unsafe factors to the contents. In addition, consumers’ understanding and judgment of cosmetics products often relies on the information provided on the products and by the sellers, the display of such information, to a large extent, determines consumers’ purchasing decisions and use methods for products.
On 29 Jul. 2019, ICMAD and PCPC jointly held a panel discussion regarding the hot topics of China, US and Canada cosmetics regulations in Cosmoprof North America. The top concerns include but not limited to animal testing ban, environmental impact of sunscreen ingredients, ingredients disclosure, etc. During the panel discussion, CIRS shared the latest info of China cosmetics regulations including the filing status of imported non-special use cosmetics at different local MPA
On February 24-27th, 2019, the annual meeting of the Personal Care Products Council (PCPC) was held in West Palm Beach, Florida. April Guo, General Manager of Personal Care Division of CIRS, was invited as the guest speaker. The PCPC is the leading national trade association representing cosmetic and personal care products companies that has more than 600 member companies represent more than 90 percent of the U.S. beauty industry. The PCPC annual meeting is the largest gathe