U.S. FDA Issues 'Import Alert' to 30 Vape Companies

The US Food and Drug Administration (FDA) recently issued Import Alert 98-06, which targets the sale of unauthorized vaping products. 

Import Alerts are issued by the US Food and Drug Administration (FDA) to protect public health. They provide guidance to FDA field personnel on manufacturers and/or products that may pose a risk to consumers. Import Alert 98-06 is an alert issued by the FDA in May 2023, which allows for the detention of new tobacco products without physical examination if they lack required marketing authorization from the FDA.

The scope of Import Alert 98-06 applies to all new tobacco products, including e-cigarettes, vape pens, and other electronic nicotine delivery systems (ENDS). The alert was triggered due to concerns about these products being imported into the US without proper authorization or quality control measures in place. The alert also applies to companies that transport, distribute, or sell these products without proper authorization.

In order to avoid triggering Import Alert 98-06, companies should ensure that their products have been properly authorized by the FDA before importing them into the US. Companies should also take steps to ensure that their products meet all applicable standards for quality control and documentation. Additionally, companies should be aware of any changes in regulations or requirements for importing new tobacco products into the US and adjust their import procedures accordingly.

Violating Import Alert 98-06 can result in serious legal and financial penalties for companies found in violation of the alert. This includes fines, product seizures, and even criminal prosecution in some cases. In addition to these penalties, violating Import Alert 98-06 can also damage a company's reputation and ability to do business in the US market.

The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as ELFBAR, EB DESIGN, Eonsmoke, Esco Bar and Stik that are on the agency’s “Red List.”

The alert covers China, South Korea and the United States. See the list below

Country	Company
China	GUANGSONG QISITECH CO., LTD.
	HAIQIANG LOGISTICS INTERNATIONALCO., LTD
	HEAVEN GIFTS INTERNATIONAL LIMITED
	HEAVEN GIFTS INTERNATIONAL LTD
	IMIRACLE SHENZHEN TECHNOLOGY COLTD
	SCHENZEH INNOKIN TECHNOLOGY CO LTD
	SHENZHEN FIRST UNION TECHNOLOGYCO LTD
	SHENZHEN FUNYIN ELETRONIC TECHNOLOGY CO LTD
	SHENZHEN FUNYIN INTELLIGENT MANUFACTURING CO., LTD
	SHENZHEN PINGRAY TECHNOLOGY
South Korea	WOOJIN ELECTRONICS INC
United States	AFFILIATED IMPORTS LLC
	COBEN YUME INTERNATIONAL INC
	FAST RUNNING INTERNATIONAL INC
	FRESH FARMS
	HAPPY FISHING CO LTD
	JOCOR ENTERPRISED LLC
	JR FAST TRADING INC
	KTM, LLC
	PASTEL CARTEL LLC
	Savage Enterprises

 

 

In order to remove a firm’s product from the Red List, companies must provide information to the FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation.

“The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, ‘Detention without Physical Examination (DWPE),'” the alert states.

The FDA states that the import alert is to prevent the sale of potentially illegal goods in America; release agency resources to inspect other goods; provide uniform coverage across the country; shift the blame back to the importer​​ to ensure that products imported into the United States comply with FDA laws and regulations, according to the agency.

At Ruthless Vapor Corporation, we take pride in providing our customers with high quality vaping products that are safe and reliable. We understand that the FDA’s decision to issue Import Alert 98-06 was made with the intention of protecting consumers from potentially dangerous vaping products. We are committed to upholding these standards and ensuring that all of our products meet or exceed all safety requirements set forth by the FDA.

We believe that it is important for consumers to be aware of what they are buying when it comes to vaping products. That is why we make sure that all of our products are clearly labeled with all relevant information, including ingredients, warnings, and usage instructions. We also provide detailed information about each product on our website so that customers can make an informed decision before purchasing any of our products.

At Ruthless Vapor Corporation, we strive to provide consumers with a safe and enjoyable experience when using our products. We are proud to continuing to provide high quality vaping products for years to come.