Congressional lawmakers who have called for a ban by the U.S. Food and Drug Administration (FDA) on imported flavored disposable e-cigarettes from China and other countries hope they’re getting closer to having their request met.
There’s been recent activity at the FDA, which has issued dozens of warning letters to retailers that are manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, many that appeal to youth — the very demographic that lawmakers and the government want to protect.
“The goal is to keep dangerous Chinese-manufactured flavored disposable vapes out of the hands of our children,” U.S. Rep. Sheila Cherfilus-McCormick (D-FL) told Homeland Preparedness News. “The FDA should do everything in its power to accomplish that goal without hesitation. Children all across our country are falling victim to the manufacturers of flavored disposable vapes and are becoming addicted to nicotine. That must stop, and the FDA is the agency that can make that happen.”
The e-cigarette firms that received warning letters late last month make, distribute, or import tobacco products that lack authorization from the FDA, which is a prohibited act under the Federal Food, Drug, and Cosmetic Act.
The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. A majority of recipients of warning letters correct the stated violation. However, failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.
“We will continue to use the full scope of tools in our regulatory toolbox to make sure that those who make, distribute, or sell illegal e-cigarette products are held accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP).
For instance, on May 31, the CTP issued warning letters to 30 retailers, including one distributor, for illegally selling unauthorized tobacco products known as various types of Puff and Hyde brand disposable e-cigarettes, which were two of the most commonly reported brands used by youth e-cigarette users in 2022. The Puff products, which include Puff Bar, and the Hyde products are manufactured in China.
The FDA on May 25 also issued warning letters to firms responsible for two popular flavored, disposable e-cigarette products — Shenzhen Innokin Technology Co. Ltd., which makes Esco Bars products, and Breeze Smoke LLC, which imports and distributes Breeze products. These firms have been manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, CTP says.
Jobe Dickinson, the president of the Border Security Alliance and a retired law enforcement officer, says that hundreds of millions of disposable nicotine vapes with kid-friendly flavors like Kiwi Passionfruit Guava Elf Bar and Jungle Juice Hyde Bar are manufactured in China and are shipped across America’s borders with little to no oversight.
“These products are cheap, disposable and marketed to our children. Websites like Made-In-China.com have over 400,000 disposable nicotine flavored vapors available for sale from unlawful Chinese manufacturers,” Dickinson wrote in a May 1 opinion piece for the Deseret News. “This is not just a public health issue — it’s a national security issue.”
According to King, the CTP’s actions underscore the agency’s “unwavering commitment” to addressing the role retailers and distributors of unauthorized tobacco products play in what has become a concerning public health issue facing America’s youth.
“Since becoming director of CTP, I’ve been crystal clear that FDA will not stand by while retailers and distributors seek to profit off illegally selling products that are well-known to appeal to youth,” King said last week.
Rep. Cherfilus-McCormick and several other members of Congress say that’s good news, but it may not be enough.
“The Biden-Harris administration should be applauded for taking action on this issue, and I encourage them to finish the job by ridding our store shelves of Chinese-manufactured flavored disposable vapes,” the congresswoman wrote in an email. “If we fail to clamp down on this epidemic, over five million American children may lose their lives from a smoking-related illness. The health and safety of our children depend on swift and bold action.”
U.S. Reps. Raja Krishnamoorthi (D-IL) and Chris Stewart (R-UT) recently partnered with U.S. Sen. Dick Durbin (D-IL) to relaunch the bipartisan Congressional Caucus to End the Youth Vaping Epidemic, founded in 2019 to educate Congress, public servants, and community stakeholders on the history of tobacco policy and regulation — particularly as it pertains to e-cigarettes.
“Since the industry emerged, our children and adolescents have been targeted for vaping and nicotine addiction by e-cigarette makers seeking to profit off the health of America’s youth,” said Rep. Raja Krishnamoorthi, who called the caucus “the premiere forum in Congress for members of both parties to work together to protect our young people from the dangers and health risks of vaping and e-cigarettes.”
Rep. Stewart pointed out that young people across the country are using vaping products at an alarming rate. “Simply put, our children deserve better protection from the dangers of nicotine addiction,” he said. “This caucus is committed to finding real-world, bipartisan solutions that will combat the growing epidemic and create a healthier America for future generations.”
Earlier this year, Senate Majority Whip Durbin also rebuked the FDA for what he called an unacceptable failure to protect children from the dangers of vaping after the agency failed to meet a court-ordered deadline of Sept. 9, 2021, to review e-cigarettes.
The FDA in January issued notice that it needed another six-months before completing its premarket review process for the most popular vapes used by children. That process, the FDA says, will now take until Dec. 31.
And in that amount of lost time, Durbin says that roughly one million more children could be at risk of vaping.
“The decade-long delay of the Food and Drug Administration to properly regulate e-cigarettes is in a league of its own,” the senator said. “Under the law known as premarket review, no tobacco product… is permitted on store shelves unless the manufacturer proves to the Food and Drug Administration in advance… that it is ‘appropriate for the protection of public health.’
“For years, the Food and Drug Administration, despite this charge under the law, has ignored it,” he said. “Instead, they sat back as millions of e-cigarettes in fruit, mint, and candy flavors were illegally flooding the market and addicting America’s children.”
Chinese firms still on the loose
Last October, China initiated a ban on the sale of flavored e-cigarettes and ruled that vapes with flavorings other than tobacco (like fruity or sweet tasting flavors) cannot be sold on the domestic market.
But they can still be manufactured in China and shipped around the world.
“These products have not been approved for sale by the FDA and should not be entering our borders,” said Rep. Cherfilus-McCormick. “Beyond the addictive nature of the nicotine in the vapes, there could well be other harmful chemicals and drugs in the devices. We just don’t know what the true dangers of these devices are.
“We simply don’t know whether the products contain the level of nicotine it says on the packaging,” the congresswoman added. “We do not know if they have been contaminated with deadly drugs such as fentanyl. We do not know whether they contain synthetic nicotine. These products should not be allowed in the country.”
That’s why Cherfilus-McCormick said it’s so important that the Biden-Harris administration has empowered inspectors to detain shipments of the products.
“Now, we must ensure they do not enter the country through alternative avenues. To that end, the FDA should be working closely with CBP and other federal agencies to prevent the entry of these deadly Chinese-manufactured flavored disposable vapes,” she said.
U.S. Senate Majority Leader Chuck Schumer (D-NY) agrees and in April issued a statement again calling on the FDA to investigate the Chinese-made e-cigarette known as Elf Bar, which he says is side-stepping American advertising laws by appealing directly to kids and teenagers via social media.
The e-cigarette is wrapped in colorful packaging to attract youth, said Schumer, and targets them with friendly, fun flavors like rainbow candy, cotton candy, peach mango, and vanilla ice cream.
“While the FDA has done much to snuff out the worst kinds of e-cigs that can hook kids, like Juul, there are clear workarounds and illegal methods being used by unscrupulous actors like Elf Bar,” Sen. Schumer said.
During the month of May, the FDA’s CTP heeded such calls and started issuing warnings to dozens of companies.
“Firms receiving a warning letter have 15 days to respond to FDA outlining how they will address the violation,” King said. “If a firm doesn’t adequately address the violation, we have a bevy of enforcement actions at our disposal that potentially await them.”
The FDA on May 17 also issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border. The alert covers China, South Korea and the United States, and impacts all importers, manufacturers and transporters of vaping product brands, such as Elf Bar, EBDESIGN, Eonsmoke, Esco Bar and Stik that are on the agency’s “Red List.”
“Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the CTP,” according to the alert. “CTP concurrence is required to add a product to the Red List.”
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 created “the appearance of the violation.”
The FDA states that the import alert is to prevent the sale of potentially illegal goods in America; releases agency resources to inspect other goods; provides uniform coverage across the country; and shifts the blame back to the importer to ensure that products imported into the U.S. comply with FDA laws and regulations.
“The Biden-Harris administration understands the importance of this issue and the dangers that Chinese-manufactured flavored disposable vapes pose to our children. The effectiveness of the alert will come down to enforcement on the ground,” said Rep. Cherfilus-McCormick. “My office will monitor the FDA’s progress. If the FDA requires more resources or authority to crack down on dangerous Chinese-manufactured disposable vapes, I stand ready to advocate for the agency in Congress.”