Export to the United States | FDA Industry Guide Update Answer the three major compliance concerns
background
2024 year 12 month,US Food and Drug Administration (FDA) Updated industry guidelines Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and ProductsThis guide aims to assist businesses in complying with 2022Modernization Management Law for Cosmetics MoCRA ,Simplify the process of registering cosmetics factories and listing products.
Key updates
The revised guidelines have finally been finalized2023year12Monthly Version AppendixBIn the middle19A common question FAQ ,And introduced three new onesFAQ
1.Responsibilities of American agents Clearly state that the US agent isMoCRAThe role and obligation of.
2.Multiple construction factoriesFEIcode Factory identification number for managing multiple production or processing construction factories FEI The Guide.
3.List of products with free samples How to handle the specific details of registering promotional cosmetics.
1.Companies located outside the United States can become person liable Is that okay A.according to Federal Food Drug and Cosmetic Act The604(4)Definition of Article, person liable It refers to the manufacturer whose name appears on the cosmetic label Packaging supplier or distributor,accord with Federal Food Drug and Cosmetic Act The609(a)Article or Fair Packaging and Labeling Act The4(a)The provisions of the article.therefore,Companies located outside the United States can also become person liable ,As long as they meet the above definition.however,We have noticed that according to Federal Food Drug and Cosmetic Act The609(a)strip,Every cosmetic should come with a label,This includes domestic addresses Domestic phone number or electronic contact information,So that the responsible person can receive adverse event reports about cosmetics through this information.
We suggest that companies choose electronic contact information when selecting Such as email address or website,Whether abroad or domestically When,Consider how to most effectively facilitate the reception and response of these reports,And meet Federal Food Drug and Cosmetic Act The605Maintenance of regulations Inspection and reporting requirements.for example,Due to possible access restrictions on consumers,Fax numbers or QR codes may not facilitate the reception of reports.
2. My company owns two buildings,There are two addresses,One of the buildings is only used for storage.Do we need to register the building that is only used for warehousing
A. no need.Only engaged in cosmetics storage hold The business organization does not need to be based on Federal Food Drug and Cosmetic Act The607Register the item.
3. Very close apart apart3mile about4.83km within Can multiple buildings be combined with oneFEINumber associated,I still need twoFEInumber
A. Cosmetics production factories can include multiple buildings belonging to the same enterprise.In some cases,OneFEIThe number can be associated with multiple buildings that produce or process cosmetics.If multiple buildings are located three miles apart from each other(about4.83km)within,And its activities are closely related to the same enterprise,Supervised by the same local management department,And it can be inspected in one goFDAConduct an inspection,These buildings are usually regarded as having aFEIFactory with serial number.The cosmetics production factory registration and listing system only allows one cosmetics factory to register with oneFEINumber associated.Can be the same asFEIMultiple buildings related to the number are submitted for registration as cosmetic production factories,And the physical address listed together with the registration of the cosmetics production factory needs to be consistent withFEIListed in the search portal Physical address agreement.
be careful FEIRegistration and cosmetics production factory registration are two independent registration processes.Before submitting the registration of a cosmetics production factory,Must be completedFEIRegistration and acquisition of numbers.
Common Problems with Exporting to the United States
1.Is the brand name the same as the product name
A.inequality,The brand name and product name are not the same.The US Food and Drug Administration FDA Believe that brand name and product name are two different concepts.The product name is usually regarded as an identity statement,This is21CFR701.11Required.The product name provides information about the type or variety of cosmetics in the packaging,To help consumers understand the functional purpose of the product.A brand name is a unique name used by a company to identify commercial products on product labels.The brand name may be proprietary,and/Or already registered as a trademark.
2. Do laboratories that only test cosmetics for research and development purposes need to be registered
A. unwanted.If the cosmetics tested in the laboratory are only used for research purposes Develop or evaluate,And it is not intended for retail sales,No registration is required,Because this doesn't belong to Federal Deposit and Consumer Credit Act The604(3)(B)(vii)Defined in the section factory .
3.My cosmetics do not comply with the appendixAAny product category provided in.that,What product category and code should be used
A. We suggest that you choose the appendixAThe most matching product category and code in,If other categories and codes seem inappropriate,Then use other Category and code.please remember,Products intended for use around the eyes should enter the category of eye products.
FDAPlan to regularly update product categories and codes.We plan to publish any proposed updates to product categories and codes in the form of guidance drafts on our website,And in federal register Post a notice,Announce that the draft guidance document is available for review.After providing an opportunity for public comments on the draft guidance,FDAtake
A Review any comments received,And prepare the final version of the guidance document that includes suggested modifications when appropriate
B stay federal register Publish a notice,Announce that the guidance document is available for retrieval
C Publish the guidance document online,And provide paper copies also
D Execution guidance document.
4. The registration of cosmetics institutions needs to be updated every two years.Does this mean that updates must be made every two years from the initial registration date
A. yes,Cosmetics production factories need to update their registration every two years from the date of initial registration.
5. What are the responsibilities of American agents
A. The liability of American agents is limited,Usually includes
Assist the US Food and Drug Administration FDA Communicate with foreign institutions
Responding to questions about products from foreign institutions,These products are imported or prepared to be imported into the United States
Assist the US Food and Drug Administration in arranging inspections of foreign institutions
When the US Food and Drug Administration FDA When unable to directly or quickly contact foreign institutions,Representing foreign institutions to receive fromFDAInformation or documents related to.FDAProviding such information or documents to a US agent will be deemed as providing the same information or documents to a foreign institution.
We also noticed that,The US Food and Drug Administration FDA Do not recommend or endorse any specific American agents.
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◆ Local agent in the United States (if required)
◆ Cosmetics classification
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