FDA Orders Detention of Elf Bar and Esco Bar

Time： 2023-05-19

The U.S. FDA has ordered its import inspectors to detain Elf Bar and Esco Bar disposable e-cigarettes that are being shipped to U.S. ports from manufacturers an...

The U.S. FDA has ordered its import inspectors to detain Elf Bar and Esco Bar disposable e-cigarettes that are being shipped to U.S. ports from manufacturers and exporters in China and South Korea. These products have been placed on the Import Red List, allowing them to be detained at U.S. ports of entry without a medical examination.

Packages identified as containing Elf Bar or Esco Bar products from red list shippers may be detained as unauthorized tobacco products. The shipper or manufacturer needs to prove that the product is legal before it can be removed from the red list and continue shipping to a U.S. destination. Import Alerts represent current guidance to FDA field personnel.

"Detention without inspection"

The alert lists Elf Bar under its ELFBAR and EBDESIGN names and names six Chinese shippers who can detain its products, in addition to one from the Republic of Korea and one address in the United States. The document lists six Chinese shippers and one U.S. address for Esco Bar.

In the Notes section of each Elf Bar shipper, FDA indicates that its Center for Tobacco Products (CTP) has determined that this company may be importing/manufacturing/shipping a new tobacco product (Elf Bar/Elfbar or EBDESIGN) without Marketing Authorization. Tobacco products that lack premarket authorization requirements are considered adulterated. For each Esco Bar shipper, use the same language. Each Red List entry has a date of May 15 or May 17.

The alert was issued by FDA's Office of Import Operations within the Office of Regulatory Affairs (ORA). But the impetus to crack down on imports comes from CTP.

"Tobacco products identified on this Import Alert Red List may be detained without a medical examination," the FDA alert said. “If the Department is unsure whether a tobacco product is the same product identified on the Red List, the Department should consult with the Center for Tobacco Products (CTP). Adding a product to the Red List requires CTP consent.”

Withholding Products with Pending PMTAs is New

The alert was based on the fact that the products in question were sold without FDA authorization, which technically makes them illegal (adulterated and misbranded) - yet the FDA has so far allowed products with pending premarket tobacco applications (PMTAs) to remain on the market unaffected. interference. The question is whether FDA's enforcement discretion allows the agency to pick two brands (out of thousands) with pending PMTAs to enforce.

Vaping360 was informed by a major Elf Bar distributor that last year both the Elf Bar and the Esco Bar submitted PMTAs within a short period of time, and the FDA accepted the PMTA for products containing synthetic nicotine. The distributor said the FDA could face lawsuits challenging the import ban.

“Unless the Supreme Court or Congress steps in, the FDA will simply double and triple its current whack-a-mole enforcement strategy,” Gregory Conley, Director of Legislative and External Affairs for the American Steam Manufacturers Association, told Vaping360. "Arbitrarily selecting products to be specifically banned is something federal agencies do when they don't have an effective long-term vision or plan."

In 2009, the FDA Office of Drugs seized shipments of e-cigarettes from China, sparking a court battle that NJOY’s owners won. The FDA gained regulatory authority over tobacco products shortly after those seizures were challenged, and then in 2016, the agency granted itself regulatory authority over vaping products by designating them as tobacco.

FDA under pressure to enforce disposables

The FDA is under pressure from anti-vaping groups like the Campaign for Tobacco-Free Kids to crack down on disposable e-cigarettes (and all flavored and synthetic nicotine vaping products). But the pressure is also coming from Congress — and from a big tobacco company that also sells vaping products.

RJ Reynolds -- maker of Vuse e-cigarettes, including the hugely popular Vuse Alto -- filed a citizen petition with the FDA in February asking the agency to prioritize enforcement of illegally sold disposable electronic nicotine delivery systems ('ENDS ') products in order to better protect public health. Shortly after Reynolds' petition, a bill was introduced in the House of Representatives that would make the FDA prioritize enforcement on disposables.

Many also believed that Reynolds was the funder of a bizarre anti-sex movement started by a so-called consumer group called Consumer Action for a Strong Economy. The campaign included social media posts and a signature truck driving around the FDA's Washington, D.C., office. The truck was laden with messages condemning the FDA's inaction on flavored disposables aimed at minors.

Disposable e-cigarettes like the Elf Bar and Esco Bar exploded in popularity after early 2020, when the FDA announced a priority crackdown on pod- and pod-based vaping products sold in flavors other than tobacco and menthol. In the two years since the FDA changed its enforcement focus, disposables accounted for 33% of the convenience store segment of the e-cigarette market.

Prev : Chinese e-cigarette companies are warned by the US FDA

Next : South Africa will impose a tax on e-cigarettes from June 1

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Email:sales@mlifevapor.com

WhatsApp:+86 13871529372

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen

Language：简体中文 | >

Tel：+86 13871529372

Add：6 / F, block B, building 2, Fuyong Tongtai times center, Bao'an District, Shenzhen Website