Notifications
Back
mobile background

FDA Regulation


Import Alert Response : First in Korea to lift Import Alert 66-40 for OTC GMP violations

FDA Regulation


The U.S. Congress grants the FDA strong regulatory authority over imported products—authority that can be even stricter than what it exercises over domestic U.S. companies. If a product “appears” to violate U.S. law, the FDA can refuse entry.


This is known as the “appearance” standard, meaning the FDA only needs to show that the product “appears” to violate the law—without having to prove an actual legal breach. Because of this relatively low threshold, imported products are often subject to more stringent regulations than domestically produced items.

FDA Regulation



The U.S. Congress grants the FDA strong regulatory authority over imported products—authority that can be even stricter than what it exercises over domestic U.S. companies. If a product “appears” to violate U.S. law, the FDA can refuse entry.


This is known as the “appearance” standard, meaning the FDA only needs to show that the product “appears” to violate the law—without having to prove an actual legal breach. Because of this relatively low threshold, imported products are often subject to more stringent regulations than domestically produced items.

Basic Structure of an Import Alert


An Import Alert generally targets companies that have previously violated U.S. law, under the assumption that they may continue to do so in the future.


Once a company is placed on an Import Alert, its products can be automatically detained or refused entry without inspection.


Every time you attempt to import, you must prove the product’s compliance with U.S. law to the FDA. Unless you submit a formal petition to be removed from the alert list, you remain under the alert indefinitely.

Basic Structure of an Import Alert

An Import Alert generally targets companies that have previously violated U.S. law, under the assumption that they may continue to do so in the future.



Once a company is placed on an Import Alert, its products can be automatically detained or refused entry without inspection.



Every time you attempt to import, you must prove the product’s compliance with U.S. law to the FDA. Unless you submit a formal petition to be removed from the alert list, you remain under the alert indefinitely.

Warning Letter


An FDA Warning Letter is considered public information. It is posted on the FDA’s website, revealing the company’s name and the nature of the violation.

If a product is found noncompliant—for example, using drug-only claims on a cosmetic label or failing to properly register an OTC product—an FDA Warning Letter may be issued even if no official FDA inspection has occurred. This letter obligates the company to rectify any Good Manufacturing Practice (GMP) violations and revise any exaggerated claims on packaging, advertising, or websites. Continued noncompliance can lead to further FDA enforcement actions.

Products manufactured at facilities that receive an FDA Warning Letter may face import delays or outright refusals at U.S. ports.

Drawing on long-standing experience in the U.S. market, Resource of K.Beauty promises top-quality services to help you meet FDA regulatory requirements.

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr

Resource Of K-Beauty Co.,Ltd.

Address: 7-3, Gwanggyo Jungang-ro 248beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of Korea

Contact : support@rokbeauty.co.kr