US Agent is a mandatory requirement when registering cosmetic FDA. So who are US agents and what is their role? Click for more information.
In addition to registering the cosmetic FDA, you need to list the product with the FDA. See more information about cosmetic listings or contact us now.
Set aside the exceptions where certain cosmetics are not required to register, FDA has implemented new rules, turning cosmetics registration from voluntary to obligatory for all applicants.
Hundreds of questions will surely arise during your self-registering in FDA system. To our team, they are daily tasks and bring no difficulties to the application. Call our office today for a re-check on your submission.
Product manufacturers and processors are the applicants. In addition, if you are responsible for the product and your name is on the label, you need to list the product with the FDA.
Remember to renew your application every two years between October 1-December 31 of even-numbered years; otherwise, the FDA will revoke registration and you will have to start over.
As the Cosmetic Modernization Regulations Act (MoCRA) officially takes effect in 2022, our FDA experts begin calling on exporters from outside the United States to register cosmetic products. their products. The reason is, previously registration was an optional task, now it is a mandatory step that you need to do directly.
But MoCRA is not only about the obligatory registration. There is more.
MoCRA creates a complete regulatory framework for companies who want to import cosmetics into US and put them on the shelves of US’s supermarkets and malls. You can see it as an upgraded version of the cosmetics sections in the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938.
With MoCRA, cosmetics industry is raised to the same level of FDA governance as other industries, including food, drugs and medical devices. Besides registration, MoCRA requires different procedures like product listing, labeling requirements, record keeping, adverse event reporting, safety demonstration, good manufacturing practices (GMP) and recalls for cosmetics that are adulterated, mislabeled or contain ingredients harmful to human health. If you are cosmetic manufacturers, packagers or distributors, make yourself familiar with this new Act to ensure your products’ compliance.
Along with FDA registration, FDA regulates that exporting establishments from outside the U.S must appoint a representative in the U.S (U.S Agent) to register with the FDA. U.S Agent is both regular and emergency communication channel between FDA and the facility.
As you know, FDA stipulates that the US Agent can be an individual, company, or organization with a permanent address in the US. However, FDA does not accept a contact email address or automatic answering phone, and maintaining communication seamlessly with FDA 24/7 is a must. Therefore, the idea of declaring an American friend’s home address is not so favorable.
Even if you have an unoccupied friend to contact continuously with FDA 24/7, what will they repond to FDA? Remember that U.S agent represents the image of your busines and requires both high knowledge and responsibility. We are sure that you do not want your US representative to appear needy, or to behave unprofessionally or late. Therefore, a professional US representative who understands FDA law will certainly best take on this role.
We have cooperated with law firms and FDA experts in the U.S to provide U.S Agent services, earning high trust and satisfaction from clients. The U.S representative provided by us will always respond as quickly as possible to information and requests from FDA, especially issues related to resolving goods incidents such as when being warned or detained by FDA, rejected or requested to re-export…, as well as advising businesses to quickly take appropriate actions in each specific situation.
Let us present your best image to the FDA.
In FDA law, the person responsible for cosmetic products consumed in the US must list them with FDA before distributing. Listed cosmetic products shall meet labeling requirements, ingredients allowed for use in the US and several other related requirements.
A responsible person will do. This includes the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such product. The procedure is required to be done every year.
Listing is flexible for you when your cosmetic products share identical formulations or exhibit variances limited to packing size, color additives, fragrances, or flavors. You can file a unified submission then.
Our American lawyers will help you eliminate unwanted risks, don’t hesitate to contact us when you need advice and support.
Labeling products in compliance with the law is an important step before placing a product on the market. For Cosmetic labeling, it is governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These laws are intended to protect consumers from health hazards and misleading information.
Which labeling regulation you follow depends on the classification of the cosmetic product. Is it a simple cosmetic, over the counter drug, or soap? Connect to our FDA expert if your product is hard to be identified.
FDA does not require your cosmetic labels approved before they board the U.S. However, FDA still have the right to supervise the labeling of cosmetic products. When seeing violations of labeling, especially in cases of dishonest, deceptive, or misleading labeling, FDA has the right to warn you over your products and recommend product recalls.
We will be your go-to team of experts, ready to help you with any issue.
We will contact you for consultation as soon as possible.
