Cosmetics

The U.S. FDA regulates cosmetics sold in the Americas to protect consumers in the Americas, but the regulations are strict, so if you export cosmetics without sufficient understanding, problems may arise. For this reason, companies that export cosmetics to the Americas must fully understand and apply the relevant information before exporting their products When a cosmetic is classified as a drug, a company must register a manufacturer with the FDA and pass the approval process for the drug. If it is classified as a general cosmetic, the product can be sold through self-registration rather than FDA approval.
Companies can register company information, products, and ingredients in relation to their products under the FDA's Cosmetic Self-Registration Program. This registration program is The Voluntary Cosmetic Registration Program (VCRP) and is a reporting system to the FDA by companies that manufacture, package, and distribute cosmetics that are commercially distributed in the United States. The VCRP is divided into two items, and you can participate in two or one item of

Key Requirements of MoCRA

Facility Registration : All facilities that manufacture or process cosmetic products distributed in the U.S. market must register with the FDA, and such registrations must be renewed every two years.

Product Listing : Cosmetic products marketed in the United States must be registered with the FDA, including ingredient information and product details.

Safety Substantiation : Companies must maintain adequate evidence to substantiate the safety of their products, such as test data, research results, or expert evaluations.

Adverse Event Reporting : Serious adverse events experienced by consumers must be reported to the FDA, and proper records must be maintained.

Cosmetic GMP Requirements : The FDA plans to apply quality management and Good Manufacturing Practices (GMP) requirements to cosmetic manufacturing facilities, and compliance with these regulations is required.

· Registration of cosmetics manufacturing and/or packaging facilities

Cosmetic facility refers to the place where cosmetics are manufactured and/or packaged, and does not apply to places where only business operations are conducted. Only the owner or operator of a cosmetic manufacturing or packaging facility can register the facility using the form for the location of each facility, and distributors cannot register the facility. Companies located outside the United States may voluntarily register their facilities after exporting cosmetics for sale to the United States. FDA will assign a registration number to each facility location.

· Preparation of Cosmetic Product Ingredient Statement (CPIS)

Cosmetics manufacturers, packers, or distributors may submit a statement for each product that the company has initiated commercial distribution in the United States. A separate form must be used for each lineage. FDA will assign a CPIS number for each line submitted to the VCRP.

· Modification or disruption of the product line

CPIS may be amended or discontinued in a complete form and a continuous form. Changes to the brand name or ingredient must be submitted within 60 days of the product entering commercial distribution. CPIS must cease distribution within 180 days of becoming aware of the discontinuation of distribution of commercial distribution.