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

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  Subject to VCRP registration

  VCRP applies only to cosmetics sold to consumers in the United States. It does not apply to cosmetics used for professional use, such as products used in beauty salons, spas, or skin clinics. It also does not apply to products other than for sale, such as hotel samples, free gifts, or homemade cosmetics to give to friends.
  
  In addition, products for which cosmetics are used for therapeutic or preventive purposes are considered both cosmetics as well as pharmaceuticals, so the relevant drug provisions must be applied to comply with legal requirements.

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  Advantages of VCRP registration

  VCRP assists FDA in its responsibility to regulate cosmetics marketed in the US Product submission and facility registration are not required, but through voluntary submission, we provide data so that FDA can obtain useful information about cosmetics and ingredients, frequency of use, and business related to manufacturing and distribution. This can in turn help promote the export activities of companies.
  
  Information from the VCRP database is also used for Cosmetic Ingredient Review (CIR). Independent Industry Supported Expert Panel the CIR Expert Panel is being used to help prioritize ingredient safety assessments as part of the ingredient safety review.

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  Precautions on VCRP registration

  • Cosmetics are not FDA pre-market approval.
  • VCRP cannot be a cosmetic approval program or a marketing promotion tool.
  • Cosmetic registration, registration numbering, cosmetic filing, or CPIS numbering does not mean that the FDA has approved the company or product.
  • VCRP is not a prior notification system for imported cosmetics, and importing companies in the United States are not required to register with the FDA.

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  How to register

  1. 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.

  2. 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.

  3. 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.

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  IGC’s Competency

  • IGC, in cooperation with PATS Corp. located in the United States, assists in registering cosmetics sold in the US and provides overall guidelines.
  • PATS Corp. (Pan America Technical Service, Corp.) is located in LA, USA, and provides fast and competitive support services to domestic and foreign companies in compliance with US FDA regulations and cGMP