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Amazon US Station Cosmetics FDA Certification

07/29/2022
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Amazon US Station Cosmetics FDA Certification

one. FDA Cosmetics Definition

All cosmetic products sold in the United States, whether locally manufactured or imported from abroad, must comply with the regulations promulgated by the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the governing boards of these laws.

The Federal Food, Drug, and Cosmetic Act defines cosmetics as articles that are used exclusively on the human body for the purpose of cleaning, beautifying, enhancing attractiveness, or altering the appearance of the human body without affecting the structure or function of the human body. Products that fall under this definition are skin creams, lotions, perfumes, lipsticks, nail polishes, eye and face creams, shampoos, permanent curlers, hair dyes, toothpastes, deodorants and any ingredient used as part of a cosmetic product. Soaps are mainly composed of alkali salts of fatty acids, and the label only needs to make a statement about the cleansing power of the human body, so the bill does not consider soaps to be cosmetic.

two.laws governing cosmetics

The FDA's legal basis for regulating cosmetics is mainly the Food, Drug and Cosmetic Act (FDCA), the Good Packaging and Labeling Act (FPLA) and other applicable regulations.

three. US Customs Clearance Procedures for Cosmetics:

Within 5 working days from the date of the arrival of the goods at the port of entry, the importer or agency needs to fill in the entry documents to the US Customs Service. Section 801 of the FDCA authorizes the U.S. Food and Drug Administration (FDA) to inspect cosmetic products entering the United States through U.S. Customs. Inspection can be carried out either before entry or after arrival at importers and brokers.

The importer/intermediary submits a copy of the U.S. Customs declaration to FDA, along with an invoice for each declared item. U.S. Customs and FDA classify customs filings to identify procedures that require FDA to enforce laws and regulations. After receiving the customs declaration documents, the initial inspection of imported products is a record review.

FDA will make one of the following three decisions by conducting a record review of the cosmetic product:

1. This batch is released;

2. This batch is automatically seized;

3. Pass terminal inspection or sampling for inspection.

When FDA receives an entry notification, it reviews the importer's customs declaration unit to determine whether physical inspection (dock inspection, sampling inspection) should be carried out. If it decides not to take a sample, FDA sends (renewable notices) to U.S. Customs and the importer, respectively. At this point, the shipment was released at the FDA.

Note that "continued without inspection" does not imply that the product complies with the requirements. It just means that FDA does not inspect the product when it enters the country. If the product is found to violate laws and regulations in the future, corresponding legal measures (such as confiscation, etc.) will be initiated depending on the nature of the violation.

Dock Inspection

For cosmetics, terminal inspection basically includes label inspection for mandatory labeling requirements to determine whether the label of the cosmetic contains or lists the following: ingredient labels, prohibited ingredients, English labels, disallowed pigments, regulatory requirements Precautionary Statements, Products must be packaged in anti-jamming packaging that meets the requirements of Section 21CFR700.25.
Other mandatory label information (such as the name and address of the manufacturer's factory, the name and address of the packager or distributor business, the product name, the publication of the net content of the contents, etc.)

Sampling inspection

If it decides to sample and inspect FDA to send a "Sampling Notice" to U.S. Customs and the importer, respectively, the shipment must be kept as it is until further notice, and FDA will take samples from the shipment.

The decision to collect a sample is based on:

the nature of the product;

Issues that the FDA is focusing on;

The past history of the product.

FDA takes a physical sample and sends it to an FDA regional laboratory for analysis. If FDA finds that the sample meets the requirements, it sends a "Notice of Release" to U.S. Customs and the importer, respectively.

If FDA concludes that the sample "shows violations of the FDCA and other relevant laws," it will send a "Notice of Seizure and Hearing" to U.S. Customs and the importer, respectively.

The notice details the violation and its nature and gives the case and the importer 10 working days to provide evidence that the consignment is allowable.

Impounded imports must be reconditioned under the supervision of FDA or U.S. Customs, and a reshipment or destruction hearing is the importer's only opportunity to defend the imported item or provide evidence that the consignment can be reconditioned and fit for entry. If the applicant and underwriter, consignor, importer, or a designated representative does not respond to the notification, FDA sends a "Notice of Denial of Entry" to U.S. Customs and the applicant and importer. The product in question is then returned or destroyed.

If the case and the underwriter, consignor, importer, or a designated representative responds to the Notice of Seizure and Hearing , FDA will not be liable for the seized product when the importer provides evidence that the product "complies with the requirements" or submits an application to modify the product. Hold a hearing.

If the firm provides evidence that the product complies with the requirements, FDA will collect follow-up samples. After analysis, it is decided that the product is either released or refused entry.

FDA reviews the importer's proposed modification procedures and approves or disapproves as appropriate. Once approved, FDA will conduct follow-up testing/sample collection to determine eligibility.

If the sample is acceptable, send a "Notice of Release" to U.S. Customs and the importer. If the sample is unqualified, a "Notice of Rejection" will be issued. Section 8(C) of the FDCA requires applicants to pay the full cost, in addition to the cost of updating labels or otherwise bringing the seized merchandise into compliance with the provisions of the application (FDA-766), travel, travel of FDA officials or employees, daily necessities and wages. By submitting Form FDA-766, the applicant agrees to pay the full regulatory fee under current regulations.

For details, please consult Jinda Testing Li Gong: l8938040l50

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