With Illegal E-Cigs Dominating 90% Market, Can American Democrats and Republicans Jointly 'End' the Gray Zone？

Recently, the Oversight and Government Reform Committee of the U.S. House of Representatives held a hearing with the theme "Restoring Trust in FDA: Rooting Out Illicit Products".

The meeting aims to thoroughly review the performance of the U.S. FDA in safeguarding the supply of food and drugs, cracking down on illegal e-cigarettes, and counterfeit products. Members present generally believe that illegal e-cigarettes have already taken over the U.S. market, and the audit standards set by the FDA's tobacco management department have been criticized as opaque and stringent. The goal of reformers is to expedite and make the approval process of the FDA more transparent, in order to establish a regulated and legal market where compliant businesses can sell authorized, safer alternative products.

The witnesses who testified included:

• Richard Williams, senior affiliated scholar at the Mercatus Center
• Guy Bentley, director of consumer freedom at the Reason Foundation
• Jonathan Miller, general counsel for the Marijuana Roundtable
• Shabbir Safdar, legal advisor for the Safe Medicines Partnership
• David Kessler, former commissioner of the Food and Drug Administration

The FDA is facing challenges due to significant partisan divides.

The focus of the hearing is mainly on the efficiency and credibility of the FDA, as well as the challenges of cracking down on illegal e-cigarettes and counterfeit products. Republicans and Democrats have presented starkly different attributions for the root causes of the current predicament facing the FDA.

James Comer, the Chairman of the Oversight and Government Reform Committee, along with several Republican lawmakers, are primarily targeting the failures of the FDA during the "Biden administration." They criticize the FDA during this period for being bogged down in red tape, stifling innovation. They argue that the FDA failed to effectively prevent illegal products from China (especially e-cigarettes, counterfeit drugs, and unsafe food) from entering the US market. They commend the current "Trump administration" for taking actions to address these issues, including restarting approvals for tobacco alternatives deemed to be safer.

Republican lawmakers are calling for reforms to the FDA, with a focus on prioritizing innovation, utilizing technologies such as artificial intelligence (AI) to expedite the approval process, supporting domestic production, establishing a regulatory framework for cannabidiol (CBD), and enhancing accountability within the agency.

Democratic Congressman Suhas Subramanyam and several other Democratic lawmakers harshly criticized the current "Trump administration" and its appointed Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. They believe that this administration has carried out a large-scale "personnel purge" at the FDA, firing thousands of experienced senior staff members, which has "destroyed the FDA's operational capacity" and seriously endangered public health safety.

Former FDA Commissioner Dr. David Kessler agrees with the Democratic Party's concerns about mass layoffs, calling the actions "devastating, arbitrary, ill-considered, and chaotic," severely weakening the core functions of the FDA. He warns that the United States may fall behind other countries in the fields of science and regulation as a result. On the other hand, Dr. Richard Williams criticizes some of the FDA's past regulatory actions, arguing that they were more about market control than clear public health benefits.

Illegal e-cigarettes have become a major problem area, with delays in approvals fueling the growth of the black market.

One key focus of the hearing is on how to effectively combat the widespread presence of illegal and counterfeit products in the market, with a particular emphasis on the illegal e-cigarette market.

There is a widely held belief that the U.S. market is flooded with a large number of unauthorized illegal e-cigarette products, especially disposable flavored e-cigarettes from China. Congressman Byron Donalds showcased a "Lost Mary" ginger beer flavor e-cigarette on site, and witness Guy Bentley estimated that close to 90% of e-cigarette products sold on the market may be illegal.

Bentley believes that the slow, cumbersome, and overly strict Pre-market Tobacco Product Application (PMTA) process by the FDA is a major factor contributing to the proliferation of the black market. This process is seen as stifling the opportunity for legal, American-made and potentially safer e-cigarette products to enter the market, thus creating a huge market void for unregulated, illegal Chinese products. For example, the law mandates that PMTAs should receive initial feedback within a 180-day review period, but in reality, the average processing time is up to 3 years.

The approval standards set by the FDA, especially the interpretation of "beneficial to public health," have been criticized for being opaque and stringent, resulting in only a very small number of e-cigarette products being authorized (mainly tobacco and mint flavors), in sharp contrast to the higher authorization rate for combustible cigarettes during the same period (e-cigarettes accounting for only 0.2% of all tobacco product authorizations, while cigarettes account for 22%). This makes it easier to introduce new cigarettes than to introduce safer e-cigarette products designed to help smokers quit, contradicting public health goals.

Interdepartmental task force fails to address underlying issue.

Despite the FDA's establishment of a cross-agency task force with the Department of Justice (DOJ) and Customs and Border Protection (CBP) in an effort to combat the illegal market, critics including Bentley argue that this is merely a stopgap measure that fails to address the underlying issue (i.e. the approval process) and shifts the burden onto the resource-strapped DOJ and CBP. The FDA's primary enforcement tool - issuing warning letters - is seen as lacking in deterrent effect and ineffective in preventing illegal sales. The lack of routine product seizures and harsher penalties (such as civil fines) also demonstrate ineffective enforcement.

Bentley believes that flavored e-cigarette options, other than tobacco and mint, are crucial for attracting adult smokers looking to quit smoking and switch to a safer alternative (reportedly favored by 18 million adult users). The FDA's restrictions on such flavors are seen as depriving adults of their right to choose.

Democratic lawmaker Raja Krishnamoorthi believes that flavorings, especially those targeting children such as candy and dessert flavors, are the main reason teenagers start using e-cigarettes, and presented multiple products as evidence.

Even illegal e-cigarettes are much less harmful than traditional cigarettes.

According to data, there are still 28 million adult smokers in the United States, and smoking leads to hundreds of thousands of deaths each year. Providing more authorized and safer alternatives can help reduce this number.

Bentley stated that even illegal e-cigarettes pose far less harm than combustible cigarettes and may have potential public health benefits, despite their unknown ingredients. He also expressed concern that the public commonly mistakenly believes that e-cigarettes are as harmful or even worse than cigarettes, and the FDA has not effectively corrected this misconception.

Cuomo mentioned that the user fees collected by the FDA's Center for Tobacco Products have significantly increased, but it does not seem to have correspondingly improved regulatory efficiency. Additionally, key personnel responsible for regulating e-cigarettes and preventing youth marketing have been laid off in this round of layoffs, weakening the FDA's regulatory capabilities in this area.

Supporters of reform aim to streamline the FDA approval process to make it faster and more transparent, in order to establish a regulated legal market where compliant companies can sell authorized, safer alternatives, ultimately replacing the deadly cigarette and dangerous illegal e-cigarette markets.