Cosmetic Facility Registration, Labeling, and Ingredients
You may have heard (or been told by a service provider) that cosmetic manufacturers are required to register their manufacturing facilities or products with FDA. That is not true.
As long as your cosmetic product is not also a drug (for instance, cosmetics sold with sun block labeling or making claims that cause the product to be a drug) the manufacturer is not required to register. Rather, the owner or operator of a cosmetic product establishment which is not exempt under the regulations and which engages in the manufacture or packaging of a cosmetic product is requested by the Food and Drug Administration to register each such establishment with FDA, whether or not the product enters interstate commerce. This request extends to any foreign cosmetic product establishment whose products are exported for sale in any state. 21 C.F.R. § 710.1.
If you wish to voluntarily register your establishment, then Tthe owner or operator of the an establishment entering into the manufacturing or packaging of a cosmetic product should register the establishment within 30 days after the operation begins. 21 C.F.R. § 710.2.
Caution: Registration of a cosmetic product establishment or assignment of a registration number does not mean FDA in any way denote has approvedal of the firm or its products. So you may not make any representation on product by the Food and Drug Administration. Any representation in labeling or advertising that creates an impression of official approval because of registration or possession of a registration number. This kind of labeling may be will be considered “misleading” resulting in the cosmetic being “misbranding” and subject to refusal of admission at importation. 21 C.F.R. § 710.8.
FDA also says that registering your cosmetic facility or product with FDA will not make it easier to import your product into the U.S. Although that is technically true, FDAImports.com has occasionally been able to reduce delays of imported cosmetics simply because the manufacturer registered its facility and product with FDA – voluntarily. So sometimes we can make good use of a cosmetic registration.
You may wonder why we at FDAImports.com are telling you this, rather than just selling you a registration process. The answer is that we do not want to charge you for performing unnecessary services. We certainly do not you to be misled into believing that you must pay for certain services, which are not necessary. Rather, we want to you help you understand and comply with the actual requirements of law in the U.S. so you may successfully export your cosmetic products here and build an impressive brand and business. Registration is to be made on Form FDA 2511 (Registration of Cosmetic Product Establishment), which may be obtained online from the FDA. 21 C.F.R. § 710.3.
The completed form should be mailed to Cosmetic Product Establishment Registration, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. 21 C.F.R. § 710.3.
Form FDA 2511 requests information on the name and address of the cosmetic product establishment, including zip code, all business trading names used by the establishment, and the type of business, whether a manufacturer or a packer or both. 21 C.F.R. § 710.4.
The information requested should be given separately for each establishment, [ 21 C.F.R. § 710.4.] an establishment being a place of business where cosmetic products are manufactured or packaged. 21 C.F.R. § 700.3(j).
A copy of the Form FDA 2511 filed by the registrant will be available for inspection at Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. 21 C.F.R. § 710.7.
Within 30 days after a change in any of the information contained on a submitted Form FDA 2511, a new Form FDA 2511 should be submitted to amend the registration. This amendment is also necessary when a registration is to be canceled because an establishment has changed its name and no longer conducts business under the original name. 21 C.F.R. § 710.5.
The Commissioner of Food and Drugs will provide the registrant with a validated copy of Form FDA 2511 as evidence of registration. This validated copy will be sent only to the location shown for the registering establishment. A permanent registration number will be assigned to each cosmetic product establishment registered in accordance with the regulations. 21 C.F.R. § 710.6.
Should you wish to register your Cosmetic Product Establishment, contact FDAImports.com: The Way Through today.
Cosmetic Labeling and Ingredients Reviews Imported cosmetics are often reviewed by FDA for labeling and ingredients compliance. It is important that your cosmetics are properly labeled and contain ingredients permitted by FDA (because they are safe or they are pre-approved color additives). The easiest import refusal to make is one based upon labeling, because FDA does not have to test the product to find the violation. Therefore, FDA looks for labeling violations on cosmetic packages all the time – and frequently finds them FDAImports.com conducts cosmetic label and ingredients reviews for foreign and domestic clients to ensure the products comply with FDA requirements. If you want to find The Way Through for your cosmetic products, call FDAImports.com today.
