Export Services
Opening a company in the USA
ExportUSA opens US incorporated companies in all of the United States. We can open both LLCs and corporations
https://www.exportusa.eu/opening-a-company-exportusa.php
(+1) 718-5225575
(+1) 718-5225575
With the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA certification of cosmetic products intended for the American market puts a new emphasis on the safety factor.
For example, there is a requirement to report serious adverse events and the FDA has the authority to request a mandatory recall if a cosmetic poses a serious risk to public health.
This new regulatory direction also impacts FDA certification and the review of cosmetic product labels. The manufacturer and American importer must adopt a proactive attitude that fits into this new regulatory framework. It is always advisable, for example, to indicate the expiration date on the label of cosmetic products intended for the American market, even if it is not always a mandatory requirement for labels. The manufacturer must then have data demonstrating the safety of the cosmetic product to be exported to America throughout its lifecycle.
In America, cosmetic products are subject to FDA labeling requirements. It is necessary to ensure that the product labels comply with the FDA
Once FDA registration is complete, the next step to exporting cosmetics to the United States is label review. Exporters will need to ensure that the labels are appropriate to import the products and avoid them being blocked at customs. The rules concerning labels are very precise and often technical, generally requiring the following elements:
On the Principal Display Panel
On the information panel of the label
The correct preparation of the label is crucial for selling on the American market and given the level of expertise required, the FDA itself recommends consulting an expert for cosmetic compliance: ExportUSA New York Corp. offers this type of service to companies wishing to export cosmetic products to the United States.
| Field | FDA Regulation | Cosmetic Product Compliance Notes |
|---|---|---|
| Basic Regulation | Cosmetics are governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FP&L Act). | Verify that the product falls under the definition of cosmetic and not "drug" (or a combination of both), as FDA requirements for labeling and compliance vary. |
| Principal Display Panel (PDP) | The main panel must display the product name, its nature/use (statement of identity), and the declaration of the net quantity of contents. | Ensure the translation of the name and use of the cosmetic product into English; express the quantity in imperial units (oz, fl oz) and metric (g, mL). |
| Information Panel | The other panel of the package must indicate the name and address of the manufacturer, packer, or distributor, any warnings, usage instructions, and other required information. | If the subject on the label is the USA distributor, use the English phrase "Distributed by" or "Manufactured for". |
| Ingredient List | Ingredients must be listed in descending order of predominance, generally with the INCI nomenclature. For products with cosmetic and pharmaceutical uses, Active Ingredient(s) follow OTC drug rules. | Check the conformity of INCI names and align the ingredient list with the formula actually exported to the United States. |
| Mandatory Warnings | Certain categories of cosmetics require specific warnings (e.g., for aerosol products, hair dyes, etc.). Absence of warnings can render the product "misbranded". | Identify mandatory warnings by product type and include them in English in a clear and readable manner. |
| Language and Readability | The information required by the FDA must be in English, with easily readable characters and appropriate contrasts. Other languages are allowed as a supplement. | Maintain Italian possibly as an accessory language, but ensure that English is complete and prioritized for all mandatory information according to FDA standards |
| Country of Origin | If the product is imported, the label must indicate the country of origin in English (e.g., "Made in Italy"). | Insert the mention "Made in Italy" in a clear position consistent with USA customs and origin labeling practices. |
| "Cosmetic + Drug" Products | Products making therapeutic claims or affecting the structure/functions of the body are also regulated as "drugs" (e.g., SPF, anti-acne, anti-dandruff). The label must comply with the "Drug Facts" format. | Carefully evaluate marketing claims: if they extend into therapeutic claims, the label must be configured as an OTC drug in addition to cosmetic. |
| MoCRA – Facility Registration | The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires the registration of facilities that manufacture, bottle, or process cosmetics intended for the USA market. | Coordinate with the importer/"responsible person" to ensure that the Italian facility and any USA facility are registered according to MoCRA terms. |
| MoCRA – Product Listing | MoCRA requires submission to the FDA of a list (cosmetic product listing) of marketed cosmetic products, with periodic updates. | Align the label with the information communicated in the list (product name, category, ingredients). |
| Serious Adverse Events | The "responsible person" must report serious adverse events to the FDA within 15 business days and maintain documentation. The contact information on the label must allow the consumer to easily contact the company. | Ensure that the label and packaging bear clear contacts (address, phone, website or email) to facilitate the collection of complaints and adverse events. |
| GMP, Allergens, Talc (MoCRA developments) | MoCRA sets forth Good Manufacturing Practice (GMP) standards for cosmetics, possible future obligations on fragrance allergen labeling, and specific requirements for products containing talc (asbestos testing). | Monitor FDA implementing regulations and prepare safety files, technical sheets, and data on potential fragrance/allergen components now. |
| Safety Documentation | The manufacturer must be able to demonstrate that the cosmetic is safe under the intended conditions of use for the entire indicated or reasonably expected shelf life. | Prepare an internal safety dossier (stability, challenge testing if relevant, toxicological assessment) consistent with the label and usage indications. |
ATTENTION:
The export of cosmetic products to America is now subject to new regulations that will take effect on December 29, 2023: MOCRA - Modernization of Cosmetics Regulation Act
ExportUSA opens US incorporated companies in all of the United States. We can open both LLCs and corporations
https://www.exportusa.eu/opening-a-company-exportusa.php
ExportUSA takes care of ensuring that your products adhere to FDA standards. We make sure that all food products, cosmetics, medical devices, and dietary supplements comply with FDA regulations.
https://www.exportusa.eu/fda-compliance-exportusa.php
Branding Services for the American Market: ExportUSA adapts, or {re}adapts your product and prepares it for the American market
https://www.exportusa.eu/re-branding-exportusa.php