Drugdu.com expert's response:

The import alert system of the FDA (Food and Drug Administration) is a crucial means for it to ensure the safety of imported products, particularly foods, drugs, cosmetics, medical devices, and more. Among them, the red list, yellow list, and green list are ways used by the FDA to indicate the compliance status of different categories of products. Below are their specific meanings in English:

Ⅰ. Red List

Definition: The red list represents the strictest warning, indicating that the product or manufacturer has serious compliance issues, often due to the product failing FDA inspections or tests.

Characteristics: Once a product is placed on the red list, it will face automatic detention until the manufacturer, shipper, grower, or importer proves to the FDA that the violations have been corrected. This detention occurs without the need for FDA to inspect, examine, or sample the product, also known as "Detention Without Physical Examination" or "DWPE".

Impact: Products listed on the red list cannot be imported into the United States, which may lead to business interruptions and financial losses, as well as damage to the company's market reputation.

Ⅱ. Yellow List

Definition: The yellow list indicates that the product has certain compliance issues, but these issues do not warrant a complete ban on imports.

Characteristics: Products on the yellow list usually do not face automatic detention but will undergo more rigorous FDA import inspections, examinations, and tests. The FDA may use the yellow list to enhance scrutiny of products to ensure they do not belong on the red list or to gather evidence for eventually issuing a nationwide or regional import alert.

Impact: Although products on the yellow list are not automatically detained, stricter inspections can increase the cost and time required for product importation. Therefore, companies need to strengthen internal controls to ensure product quality and compliance to avoid being placed on the red list.

Ⅲ. Green List

Definition: Products on the green list meet the requirements of the FDA and can pass inspections smoothly to enter the US market.

Characteristics: The green list represents the most ideal status, meaning that the product meets FDA safety standards and requires no additional inspections. When a company provides compelling evidence and arguments to prove that the import alert should not apply to them, and if the FDA agrees, the company will be placed on the "green list" of the import alert, allowing them to import into the United States without facing automatic detention.

Impact: Products from companies on the green list can clear customs quickly, reducing the risk of automatic detention when importing into the United States.

In summary, the FDA's import alert system and the classification into red, yellow, and green lists are designed to ensure the safety and compliance of imported products. For exporters, understanding the meaning and impact of these lists is crucial to take appropriate measures to ensure products meet FDA regulations and successfully enter the US market.