FDA Imposes Import Alert on Global E-Cigarette Industry

On May 17th, the US Food and Drug Administration (FDA) issued an "import alert" on its official website. The document, known as import alert 98-06, imposes "Detention Without Physical Examination" (DWPE) on multiple global e-cigarette companies, including manufacturers, transporters, and distributors from China, the US, South Korea, and other countries. This action allows FDA to seize products without inspection.

Import Alert" | Image source: FDA official website

Entities that are penalized by DWPE, according to the official definition of FDA, will be listed by FDA onto the Red List. Translated: Entities that are punished by DWPE (Detention Without Physical Examination), according to the FDA's official definition, will be included on the Red List maintained by the FDA.

Import Alert" is not the first occurrence.

In response to this, 2FIRSTS interviewed PMTA expert Zheng Zhi, who has previously overseen PMTA certification projects for a reputable electronic cigarette company in China. Zheng later founded Consult Source Technology and has since focused on researching PMTA regulations.

He told 2FIRSTS that this is not the first time that the FDA has issued an "import alert" against e-cigarette manufacturers.

Upon conducting a check on the FDA website, it has been discovered that prior to this current incident, there were "import alerts" for electronic companies in May 2022 and March of this year.

Three Import Warnings for E-cigarettes" | Image source: FDA website.

However, most of the companies that received the "import alerts" are from China. Zheng Zhi stated that "in January 2022, we already know of six Chinese e-cigarette companies that have received import warnings.

Import ban" is a more serious measure than an "import warning".

Before the recent "Import Alert" issued by the FDA, the agency had previously issued an "Import Refusal" order to a group of e-cigarette manufacturers in April of this year.

According to Zheng Zhi, if the FDA does not receive a response from a company (that has been issued an "import alert") within a designated time period or if the company's response is unsatisfactory, an import refusal order will be issued. If a company or its product is found by the FDA to be engaging in serious misconduct, such as selling counterfeit products or using false trademarks, a direct import refusal order may be issued.

Similarly, most of the "import refusal orders" have been issued to Chinese companies. According to statistics from Zhiyuan Technology, founded by Zheng Zhi, a total of 58 Chinese electronic cigarette manufacturers/exporters had 96 batches of electronic cigarette products refused for import as of November 2021. The main reasons for refusal were counterfeit products without market approval, false trademarks, and lack of branding information. The earliest import refusal order issued to Chinese electronic cigarette companies can be traced back to February 2, 2017.

According to information obtained from the FDA, 2FIRSTS...

Import Refusal" is the final decision made by the FDA to detain goods that violate FDA laws and regulations. Any goods that are refused must be destroyed or exported under the supervision of the FDA and Customs and Border Protection (CBP) within 90 days of receiving the FDA's action notice (refusal notice).

Comparing solely the severity of the two commands, "import rejection order" is a more severe punishment than "import warning." According to Zheng Zhi, companies that receive an "import warning" still have the opportunity to appeal.

Manufacturers who have received a warning can communicate with the FDA's Division of Import Operations directly and appeal for the warning to be lifted.

However, he also added that the reason for the enterprise being warned is due to the lack of product market approval, specifically the PMTA application. The solution is therefore to prove to the FDA that a PMTA application has been submitted.

There is uncertainty surrounding the FDA's PMTA application process and waiting period. According to a statement released by the FDA in March of this year, they have received millions of applications but have only approved 23 new electronic cigarette products and devices to date.

At the time of writing, the FDA has only approved three products as of 2023. Image source: FDA News Center.

The FDA's Hidden struggle.

In fact, the FDA has delayed the final review of PMTA multiple times. The agency has provided a timeline only for "covered applications" - meaning new tobacco products on the market as of August 8th, 2016, and submitted for PMTA by September 9th, 2020.

As of March 31, 2023, 52% of the total number of "covered applications" have been reviewed and action has been taken. This number is expected to increase to 53% by June 30 and to 55% by September 30. By December 31, 2023, all applications are expected to be reviewed and action taken.

FDA publishes progress report on PMTA | Image source: FDA News Center.

After September 9, 2020, the FDA received over 18 million product applications. This large volume of applications put pressure on the internal processing of the FDA. Zheng Zhi previously discussed the pressure and challenges faced by the FDA's Center for Tobacco Products (CTP) in an article titled "Expert Explanation of FDA Regulations: Probability of Approval for Multi-Flavored Electronic Cigarette Products is High".

On one hand, in December 2022, the Reagan-Udall evaluation committee stated that the Center for Tobacco Products (CTP) was "slow to react, overburdened," and had low employee morale, making it difficult to regulate both traditional tobacco products and the rapidly growing market of electronic cigarettes.

On the other hand, the FDA appears to be seeking to regulate all nicotine products through a bill that would establish guidelines for chewing tobacco, cigarettes, cigars, hookahs, e-cigarettes, and heated tobacco products. However, they are faced with the dilemma of varying product standards within each category.

The above represents only the internal factors that the FDA must face, and external factors cannot be ignored as well.

On February 6, 2023, tobacco company Reynolds American, the parent company of e-cigarette brand Vuse, submitted a citizen petition requesting that the FDA establish mandatory regulations addressing the issue of illicit sales of disposable e-cigarette products.

Renowned tobacco company, Reynolds Tobacco, has requested that the FDA prioritize enforcement in the following areas:

Any disposable electronic cigarette containing nicotine derived from sources other than tobacco but not authorized for sale prior to market approval.

Any disposable e-cigarette containing nicotine from tobacco that was not on the market by August 8, 2016, or whose manufacturer did not submit an application to the FDA by September 9, 2020, or had its PMTA application rejected and not challenged in court before the deadline, is currently not allowed.

In addition, the United States Congress is pushing for the FDA to take action against disposable e-cigarettes. The bill (HR 901) requires disposable e-cigarettes to be listed as a high priority for FDA enforcement. Senate Majority Leader Chuck Schumer has called on the FDA to investigate disposable e-cigarettes made in China and to "prepare to ban them from the market".

Details of HR 901 Bill: Image source - Official website of the US Congress.

Senate Majority Leader Chuck Schumer, as seen in a photo from the New York Post.

As an example in this case, if businesses that have received an "import alert" fail to apply for PMTA within the set timeframe, the FDA will issue an "import refusal order" to them.

Zheng Zhi expressed:

Manufacturers who have not performed PMTA can expect to receive import refusal orders if they receive warnings without market approval.

Who will receive the next "warning"?

It is worth noting that the FDA has issued a "import alert" to disposable e-cigarette companies, and subsequently released two Marketing Denial Orders (MDO) on its news center.

On May 12, the FDA issued an MDO (Marketing Denial Order) to approximately 6,500 different flavored electronic cigarette oils and products from 10 companies. Then, on May 18, the FDA issued another MDO to Mothers Milk WTA, a company that produces more than 250 flavors of tobacco and flavored electronic cigarette oils.

The FDA has issued marketing denial orders (MDOs) to around 6,500 varieties of e-cigarette liquids and e-cigarette products from 10 companies. This decision was announced by the FDA News Center.

The FDA has issued an MDO to Mothers Milk WTA for over 250 flavors of electronic cigarette e-liquids that contain tobacco flavors.

Within less than a week, the FDA has released a series of regulations related to electronic cigarettes, signaling its determination to regulate the American e-cigarette market.

Especially on May 17th, the main focus was on the top two brands in the disposable e-cigarette category. Regarding this matter, Zhengzhi stated:

The purpose is clear: the FDA is working to expedite its collaboration with customs to regulate the electronic cigarette market. E-cigarette companies that have not applied for PMTA and are hoping to speculate in the US market are finding their chances increasingly slim.

This "import warning" is neither the first nor the last.

The Chinese electronic cigarette industry may face increasing pressures in the US market, which may not necessarily stem from competitors within the industry. Rather, with new regulatory standards being set by the government, the industry may struggle to cope with the consequences of such changes.

We attempted to contact some of the businesses that received the "import warning", but as of the time of publication, no businesses have responded to our inquiry.

Cover image source: FDA.

Reference:

The US Food and Drug Administration (FDA) has issued an "Import Alert 98-06.

Industry tobacco products have been issued an import alert.

The U.S. Food and Drug Administration (FDA) has rejected the sale and advertising of over 250 varieties of flavored and tobacco-flavored e-liquids.

The FDA has assessed over 99% of the 26 million tobacco products for which applications were submitted.

Five incidents of import refusals have been reported.

6. Senator Schumer warns that the brightly-colored, Chinese-made Elf Bar e-cigarette is marketed using influencers to attract young people. 7. FDA's actions in the post-PMTA era discussed in the context of the "red list".

The Disposable Electronic Nicotine Delivery Systems (ENDS) Product Enforcement Act of 2023, also known as H.R.901, is a piece of legislation that has been proposed for implementation.