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Cosmetics US FDA clearance
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one. FDA Cosmetics Definition
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Cosmetics sold in the United States, whether locally or imported, must comply with the Federal Food, Drug and Cosmetic Act, the Fair Packaging and Labeling Act, and the regulations issued by the management committee of these laws.
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The Federal Food, Drug and Cosmetic Act defines cosmetics as articles that are specifically designed for use in the body to achieve cleanliness, beautification, enhance attractiveness, or change the appearance of the human body without affecting the structure or function of the human body. Products that fall within this definition include skin cream, lotion, perfume, lipstick, nail polish, eye creams and creams, shampoos, permanent curlers, hair dyes, toothpaste, deodorants and any ingredients used as part of a cosmetic product. Soap is mainly composed of alkali salts of fatty acids, and the label only on the body of the cleaning force to make a statement, so the bill that soap is not cosmetics.
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two. Management of cosmetics laws
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FDA regulates the legal basis of cosmetics primarily in the Food, Drug and Cosmetic Act (FDCA), the Good Packaging and Labeling Act (FPLA) and other applicable regulations.
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three. Cosmetics US customs clearance procedures:
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Within 5 working days from the date of arrival of the goods, the importer or organization needs to submit the immigration document to the US Customs Service. FDCA Section 801 authorizes the US Food and Drug Administration (FDA) to inspect cosmetics that enter the United States through US Customs. The inspection may be carried out either prior to entry or after arriving at importers and brokers. The importer / brokers submit a copy of the customs declaration document to the US Customs, together with the invoice for each shipment, to the FDA. US Customs and FDA classify customs filings to identify procedures that require FDA to enforce laws and regulations. After receiving the declaration documents, the initial inspection of imported products is a record review.
FDA through the review of cosmetics, will make one of the following three decisions:
1. The release of this batch;
2. This batch of automatic seizure;
3. Verification by terminal inspection or sampling.
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When the FDA receives an entry notification, it reviews the importer's customs declaration unit to determine whether a physical inspection (terminal inspection, sampling test) should be carried out. If it is decided not to take samples, the FDA sends to the US Customs and the case and the importer (which may be renewed). At this point, the goods in the FDA to be released.
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Note that "may be continued without inspection" does not mean that the product meets the requirements. It only means that the FDA will not be tested at the time of product entry. If the product is found to be in violation of laws and regulations in the future, the corresponding legal measures (such as forfeiture) will be initiated depending on the nature of the offense.
Wharf inspection
For cosmetics, the terminal inspection basically includes a label test for mandatory labeling requirements to determine whether the label on the cosmetic is included or listed as follows: ingredient label, disqualified ingredient, English label, non-permitted use of pigment, regulatory requirements Warning instructions, the product needs to meet the requirements of 21CFR700.25 anti-jamming packaging.
Other mandatory labeling information (such as the name and address of the manufacturer's factory, the name and address of the manufacturer or distributor, the publication of the net content of the contents, etc.)
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Sampling inspection
If the decision to sample the FDA, respectively, to the US Customs and the case and the importer to send a "sampling notice" the goods must remain as pending further notice, FDA will extract samples from the shipment.
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The decision to collect samples is based on:
The nature of the product;
FDA focus on issues;
The history of the product.
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The FDA obtained a physical sample and sent it to the FDA Regional Laboratory for analysis
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If the FDA finds that the sample meets the requirements, send a "Notice of Release" to US Customs and Importer, respectively.
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If the FDA determines that the sample "has violated the performance of the FDCA and other relevant laws", the "Notice of Seizure and Hearing" is sent to the US Customs and the case and the importer, respectively. The notice specifies the offense and the nature and gives the case and the importer 10 working days to provide evidence of the permit.
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Detained imports must be trimmed, returned or destroyed under the supervision of the FDA or the US Customs
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The hearing is the only opportunity for the importer to defend the goods or provide evidence to enable the goods to be trimmed and suitable for entry. If the case and the underwriter, shipper, importer or a designated representative does not reply to the notice, the FDA sends a "refusal notice" to the US Customs and the case and the importer. And then the product of the product returned or destroyed.
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If the case and the underwriter, shipper, importer or a designated representative have responded to the "Notice of Seizure and Hearing", the FDA has seized the product when the importer has provided evidence that the product "meets the requirements" or submits the application for the trimmed product Hold a hearing.
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If the firm provides evidence that the product meets the requirements, the FDA will collect subsequent samples. After analysis, the product is either released or refused entry.
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The FDA reviews the proposed dressing procedure for the importer, subject to approval or disapproval. Once approved, the FDA will conduct subsequent inspection / sample collection to determine its eligibility. If the sample is qualified, send a "Notice of Release" to US Customs and Importer. Fruit samples failed, issued a "refusal notice". Section 8 (C) of the FDCA requires the applicant to pay the full cost, in addition to updating the label or other charges for the seizure of goods in compliance with the relevant measures in the application (FDA-766 form), including the travel of the FDA officer or employee, Daily and wages. By submitting the FDA-766 form, the applicant agrees to pay the full regulatory fee in accordance with the current regulations.


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