The JD Nova Group submitted premarket tobacco product applications (PMTAs) for an estimated 4.5 million products, approximately two-thirds of the total number of PMTA submissions. Today, the U.S. Food and Drug Administration issued a Refuse to File (RTF) letter to the company. The letter notified JD Nova that the majority of their PMTAs did not meet the filing requirements for a new tobacco product seeking a marketing order.
Credit: Tashatuvango
“This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020 deadline are still moving through the review process,” the FDA stated in a press release. “As a result of this RTF action, the company must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.”
During the filing stages of application review, the FDA reviews for basic information to ensure applications contain the required material for scientific review, according to the release. If required contents for filing are missing, the FDA refuses to file the application.
“JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate Environmental Assessment (EA),” the release states. “Under FDA’s regulations implementing the National Environmental Policy Act (NEPA), an EA must be prepared for each proposed authorization, and an EA adequate for filing addresses the relevant environmental issues.”
JD Nova was one of more than 360 companies included on a recent list of products that had submitted a timely PMTA to the FDA and was allowed to market products for up to one year, until Sept. 9 2021, or until the FDA makes a regulatory decision such as refusing to file a PMTA.
From January through July 2021, the FDA has issued more than 135 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. One company, Visible Vapors, had more than 15 million products registered with the FDA. On FDA’s Warning Letters page, you can find these warning letters by searching “Center for Tobacco Products” under “Issuing Office.” The regulatory agency has issued at least two warning letters in August so far.
The U.S. Food and Drug Administration has issued a warning letter to Visible Vapors. The regulatory agency advised the company that marketing its electronic nicotine-delivery system (ENDS) products, which lack a premarket tobacco product authorization (PMTA), is illegal, and therefore they cannot be sold or distributed in the U.S. The FDA states that the company did not submit PMTAs by the Sept. 9, 2020 deadline.
While the warning letter issued cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanut Butter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement, according to the letter. Visible Vapors has the largest number of products registered with the FDA to have received a warning letter to date.
From January through July 2021, the FDA has issued more than 135 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. On FDA’s Warning Letters page, you can find these warning letters by searching “Center for Tobacco Products” under “Issuing Office.”
The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
The U.S. Food and Drug Administration’s process for premarket tobacco product applications (PMTAs) has not been perfect. The regulatory agency has been accused of falsely issuing warning letters, leaving companies off of its list of accepted PMTAs and of having issues with its PMTA filing software.
As of July 9, the FDA has issued 130 warning letters for the marketing of illegal vaping products. The majority of those letters centered on e-liquids produced and sold online by small-sized vape shops. As the FDA continues its blitz, however, there is some confusion as some companies who have submitted PMTAs by the Sept. 9, 2020 deadline have received warning letters.
According to Facebook posts from the American Vaping Manufacturers Association (AVM), at least two companies have received warning letters for products that submitted timely PMTAs. Posts acknowledged that the FDA corrected its mistake in a follow-up letter after receiving complaints from the companies. While the number may be small, it does show that the regulatory agency is overwhelmed by the number of submissions it is reviewing.
The FDA also had recently started listing closeout letters for companies that had responded to warning letters. Recently, however, the agency removed those letters from its website. The FDA offered no explanation for the removal of the closeout letters.
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. A court order requires the FDA to complete review of all submitted PMTAs by Sept. 9, 2021.
If a negative action is taken by the FDA on a PMTA application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
There are other issues with the FDA PMTA process, as well. The FDA released its list of products that are legal for sale in the U.S. A total of 360 companies (on the original list) filed PMTAs. However, at least five companies that filed PMTAs were erroneously left off the list, according to posts by Amanda Wheeler of the AVM.
In its own investigation, Vapor Voice found that Humble Juice Co. submitted a timely PMTA, received an acceptance letter and was subsequently misidentified on FDA’s list of approved products. The FDA has corrected the error for Humble. The AVM did not name what companies were left off the list or had falsely received warning letters.
The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on the current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed. It is possible companies were left off the list because they did not respond to the FDA before publication of the list.
Other issues with PMTAs include errors in submitting them electronically. Several companies have complained that the FDA’s software that manufacturers must download in order to submit PMTA data has randomly left out some of files that the companies are uploading. At least two companies that have helped prepare more than 500 PMTAs have acknowledged the issue and have presented the problem to the FDA.
“We did 15 PMTAs for various clients and just all of a sudden had somebody come up and they got a deficiency letter asking for information that was included in their submission. We started looking through it and it’s missing. We then spent a bunch of time going through every single one and found several others that were missing one or two files,” one of the companies that discovered errors told Vapor Voice. “We reached out the FDA, got a basic response … we’re aware of this, we’ll get back to you type of thing. We believe it’s a bug in the agency’s eSubmitter program.”
Because of these issues, some companies are offering free PMTA deficiency reviews for companies that submitted them to the FDA. Delphinus Consulting and Blackbriar Regulatory Services have said they have programs to help companies find faults in their PMTA submissions.
Warning letters are expected to continue to be issued for illegal vapor products as the deadline for FDA action moves closer. The FDA has not said if it intends to ask for an extension on the deadline, however, the U.S. Small Business Administration recently sent a letter to the FDA asking the regulatory agency to request an extension.
The FDA often only lists a few products that a company is selling as illegal in a warning letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA.
Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.
A more in-depth analysis of these issues will be in the next issue of Vapor Voice.
A coalition of 23 organizations have written a letter to the U.S. Food and Drug Administration (FDA) to follow the common-sense recommendations of the Small Business Administration (SBA). The SBA had recommended companies seek a court order to allow vaping manufacturers to keep products on the market while their premarket tobacco product application (PMTA) submissions are being reviewed.
Credit: Tanasin
Due to the large volume of PMTAs submitted—the FDA says it received more than 6 million applications— the FDA has stated publicly that it is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market. All products must be removed from market on Sept. 9, 2022 without FDA approval, according to a court order.
The coalition letter, organized by the Americans for Tax Reform (ATR) acknowledged that FDA promised to exercise discretion in enforcement, stating that “this does not provide the degree of certainty necessary for businesses who have complied with all relevant regulations and have not received authorization due to processing delays by FDA. If an extension is not granted, there could be devastating consequences for businesses, particularly small businesses. Furthermore, any potential reduction in the supply of safe alternatives to tobacco could have a negative impact on public health across the United States and lead to an increase in tobacco-related mortality.”
The letter also argues that there “millions of consumers who depend on ENDS products for their health and thousands of businesses who depend on these products for their livelihood are threatened by this needless bureaucratic uncertainty.” The coalition states that the only way to avert a disastrous outcome for businesses and consumers is for the FDA to obtain a court order allowing it to extend the existing moratorium on enforcement by another year.
“The vaping industry, unlike many others, was created by small businesses, and these same small businesses continue to drive innovation in the market,” the coalition letter states. “Without these entrepreneurs, the vape industry will be consolidated into a few large corporations, causing prices to rise and consumer choice to decrease.”
The full letter and list of signatories can be read here.
The premarket tobacco product application (PMTA) process has been a struggle for vapor industry companies that took on the time, effort and expense to keep their products on the market. During the Tobacco Plus Expo (TPE), Vapor Voice sat down with Blackbriar Regulatory Services (BRS), a firm specializing in helping small-sized to mid-sized companies navigate the regulatory landscape to bring their FDA-regulated product concepts to market, to discuss the lessons it learned while filing 365 PMTAs for its clients. BRS has helped several clients garner acceptance and filing letters from the FDA.
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BRS did not exhibit at the TPE. Don Hashagen, VP of business development, and Kristina Rogers, director of marketing and brand management, attended the show to support its partners that were exhibiting. Some of these partners include the Charlie’s Chalk Dust, The Beard and Humble brands. The pair was also testing the waters for how secure other companies felt about their PMTA submissions.
“If they wait until they get a deficiency letter, that’s too late. That’s 90 days,” said Hashagen. “We want to support the industry whether they have worked with us on their PMTA or not. The more people that make it through PMTA, the better it is for everybody in the industry.”
BRS is offering any company that submitted a PMTA a free gap analysis of their submission. Hashagen said that many companies that submitted PMTAs have yet to complete clinical trials, for example, and the FDA has been clear that it’s a requirement for approval. It’s also time-consuming and expensive.
“The other one is perception and behaviors. We’ve got about 45 people that specialize in PMTAs. Now that we’ve seen enough deficiency letters coming through, we have an understanding of how to respond to those letters,” he said. “Our team can read a PMTA and very quickly say, ‘All right, here’s some major issues you’re going to need to attack. Now, you don’t want to wait too long to get started on a deficiency letter. It’s going to take you more than 90 days to remediate.”
Several manufacturers have received filing letters for their PMTA submissions. This is the stage that the FDA will ask a company to respond to questions the FDA has as well as receive deficiency letters. Because the PMTA is a “living process,” BRS can help a company potentially address a known or found deficiency often before a deficiency letter is even issued.
“Submitting your PMTA is really the first step in a very long, lengthy process. You have multiple audits afterwards with people looking into your manufacturing, into registration, into your PMTA, into post-market surveillance … even after you are authorized for marketing authorization,” explains Rogers. “It’s a long year-to-year process. This is just the beginning of something that’s going to last the length of your product lifetime.”
Having an organization like BRS managing a company’s PMTA allows the client to have access to experts that know what’s coming, says Rogers. BRS knows what’s needed to help take a brand and make it successful in the market while complying with regulatory requirements.
“You spend all this money, you get a market authorization, you’re doing well. But four months later, you trip over your own shoelaces because you did something that could hurt your brand from a marketing standpoint … how you positioned it. Maybe your brand is suddenly considered youth-friendly as FDA guidelines change,” said Rogers. “You can be taken off market almost instantly. As this evolves, you want somebody who’s talking to the [FDA] frequently. We’ve built a working relationship with the agency.” Hashagen says the main reason BRS is offering the free gap analysis is because they really want the industry to not just survive but thrive. “We really want to help people,” he said. “This industry is about helping adult smokers quit combustible tobacco for good. That’s really, really important to us.”
Harm reduction advocates worry about the effects on vapers when the USPS implements PACT Act requirements for ENDS.
By Vapor Voice staff
The United States Postal Service (USPS) has delayed the implementation of a requirement to place electronic nicotine-delivery systems (ENDS) under the same shipping rules as combustible cigarettes. As of this writing, the USPS has not published its final rule for mailing ENDS products in the Federal Register. The USPS has stated that the rules will take effect immediately when the final rule is published.
The rule has been delayed because the USPS is still determining how it will handle the broad definition of ENDS set by the U.S. Congress and how the USPS will process and determine eligibility for companies seeking an exception to the Prevent All Cigarette Trafficking (PACT) Act rules. For example, CBD vaping devices fall under the ENDS definition, but it is believed that it was not the intent of Congress to ban the mailing of hemp products. No date has been announced for when the USPS intends to publish the final rule.
Emily Burns, of counsel for the Green Light Law Group, noted that while the USPS could have banned vaping products altogether as part of the new rule, the USPS is now taking time to revisit the implications of an all-encompassing prohibition on shipments of vaping products. She wrote in the firm’s blog that the USPS must not exceed its own legal authority under the PACT Act by regulating vaping products that fall outside the definition of tobacco product as such a rule could be subject to challenge by various industry groups.
Credit: Aleksandr Yu
“If lawmakers intended to truly change the way the federal government defines ENDS to include nontobacco and non-nicotine products, it is rational to assume that Congress would have also amended the [Tobacco Control Act] to allow the FDA to regulate these other substances. The strategy moving forward should be to encourage USPS to specifically focus on the ENDS market … anything done in relation to cannabis or hemp should be seriously challenged by the industry.”
The USPS confirms Burns’ concerns and has stated that the process is turning out to be more complicated than just ending all vape mail of vapor products. On April 19, the USPS issued guidance for exemptions to the requirements for mailing all vapor products, including cannabis. The USPS was inundated with exemption applications, none of which will be addressed until the final rule is published, according to the USPS.
The USPS refers to possibly exempting cannabis products in its guidance. Other exceptions include intrastate shipping within Alaska and Hawaii, shipments between businesses engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation or research, shipments by individuals for noncommercial purposes (including return of goods to manufacturer), limited shipments by manufacturers to adult smokers for consumer testing, and limited shipments by federal agencies for public health purposes.
For cannabis-based product exemptions, the guidance states that “mailers must retain, and prepare to make available upon request, records establishing compliance with all applicable federal, state and local laws pertaining to hemp production, processing, distribution and sales, including the [2014 Farm Bill] and [2018 Farm Bill].” The guidance says such records may include “laboratory test results, licenses and compliance reports.”
Burns stated that the USPS guidance also indicates that cannabis products with greater than 0.03 percent THC would be nonmailable if they are deemed to be drug paraphernalia for purposes outlined under the Controlled Substances Act (CSA), which includes a federal ban on mailing drug paraphernalia that already exists outside of the PACT Act. However, the CSA prohibition on drug paraphernalia does not apply to “any person authorized by local, state or federal law to manufacture, possess or distribute” such items.
“In the case of medical and recreational cannabis states that have removed criminal statutes penalizing drug paraphernalia used to consume cannabis, anyone who is shipping from one legalized state to another would technically fall under the paraphernalia definition exception, thus providing a legal basis for exception from the PACT Act requirements,” Burns states.
The move to place ENDS under the PACT Act has been heavily scrutinized. Several harm reduction advocates say the new rule will bring unintended and deadly consequences. During a seminar sponsored by Hall Analytical in mid-May titled “PMTA and Beyond: A Global Outlook on ENDS Regulatory Requirements,” David Lawson, CEO of Inter Scientific, said that placing vaping products under the PACT Act only serves to benefit large tobacco companies and could push former smokers who shop for vaping products online back to combustible cigarettes.
“If you’re a large tobacco company in the U.S., you most likely sell directly to the likes of Walgreens and these kinds of stores. They then sell them to consumers. Many of the independent vaping companies and manufacturers, they sell online. The PACT Act doesn’t really impact store sales. It only impacts online sales,” explains Lawson. “So a company who relies entirely on online sales may have gone through the [submitting a premarket tobacco product application (PMTA) to the U.S Food and Drug Administration] process. They’re now risking the potential for not being able to ship to their clients at all. I think from that perspective, it’s quite negative and damaging.”
Lawson said that what lawmakers failed to realize when moving ENDS under the PACT Act is that online retail has the advantage of being able to do more thorough ID checks than a local mom-and-pop shop. A credit card is needed for an online purchase, for example, along with a photo ID. At a brick-and-mortar store, a youth simply needs a fake ID and cash. “It’s much easier to do detailed checks on people online than it is to do them in store,” he said. “It is a growing concern for the U.S., the ability of youth to get access to ENDS, but I think, from the experience I’ve had, from what I’ve seen from our clients in the U.S., the kids aren’t getting the products online.”
Credit: Michael Vi
Another consequence of the PACT Act is that when adult consumers who purchase vaping products online can’t get their products anymore, they may go back to smoking combustible cigarettes, which are more readily available in local stores, according to Lawson.
“In the U.S., if you’re buying a specific product online, certainly it’s not going to be available anymore. You have the option there to try and find an alternative brand or risk going back to cigarettes. I think there’s a huge risk impact that will result in adult smokers who are currently vaping going back to smoking again, which is, obviously, not good for public health,” said Lawson. “I don’t personally see the value of the PACT Act. I think it’s kind of a step backwards. It does risk impacting public health negatively.”
While the industry continues to wait for the USPS to publish its finalized rule and what a PACT Act exemption might entail, Burns recommends that concerned business owners “reach out to a regulatory attorney about the compliance process ahead of time in preparation of the forthcoming regulatory changes.”
Coupled with the requirement to submit premarket tobacco product applications to the FDA, the PACT Act and flavor bans, ENDS regulations have become overly stringent, and the complex rules can turn smokers away from the idea of switching to ENDS products, said Lawson, especially when that regulation doesn’t allow for clarification of the science behind vaping products.
“The issue here really is around all this information from the perspective of science, perhaps. When ENDS first entered the market back in 2006 … there was a lot of bad science and bad data generated. When you generate a bad set of data and it becomes publicly available, people don’t necessarily question and interpret how the information has been generated or the validity of that data,” said Lawson. “I think there’s a huge risk with the media and with the interpretation of science that it can certainly switch people away from using ENDS.”
There are other regulatory challenges coming too. The Tobacco Tax Equity Act Of 2021, a bill that would establish the first federal e-cigarette tax, increase the traditional tobacco tax rate and close tax loopholes, is currently making its way through the U.S. Senate. The rule would follow the lead of 21 states, and Washington, D.C., that have set their own state taxes on vapor products by setting a federal tax on ENDS products.
Senator Dick Durbin, who sponsored the bill, said tobacco-related disease accounts for one out of every five deaths in America. He did not mention that there has never been a reported death associated with vaping of legal nicotine products.
“Data shows that the most effective strategy to prevent children from starting this deadly habit is to price it out of their range. This bill would help reduce tobacco and e-cigarette use by ending loopholes that the industry has exploited to target our children,” he said in a statement. “If America can kick its nicotine addiction, it would go a long way to improving our public health for generations to come.”
The repercussions of the USPS vapor mail ban on the vaping industry will not be realized for some time. While the PACT Act requirements have forced many businesses to close, the vapor industry is used to dealing with a great amount of uncertainty. With numerous regulatory hurdles on the horizon, it does not seem like that is going to change any time soon.
The acting US Food and Drug Administration Commissioner Dr. Janet Woodcock on Wednesday was pushed by members of the U.S. Congress to ban all flavored e-cigarettes, saying the sweet and fruity flavors are attracting too many children and teens.
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However, Woodcock would not assure lawmakers on whether the agency plans to ban or otherwise limit the sale of flavored vapes later this year. The agency has until September 9 to decide. When pressed multiple times over the course of the hearing, Woodcock would not commit to denying premarket tobacco product applications (PMTAs) for flavored vaping products at this time, according to CNN.
“While I can’t predict the future, I think that might be likely. We also would have to, regardless, limit advertising and sales in targeting children and other practices,” Woodcock said, adding that the FDA will look at the scientific evidence. “As I have said already, I can’t prejudge the scientific,” she said, before being cut off.
During the House Oversight and Reform Committee hearing, Rep. Katie Porter asked if the FDA banned all flavored e-cigarettes, would less kids continue to vape, among those who have started. “If kids have the choices of any tasty flavor, they’re going to go for it, and I’m speaking to you from experience here as a mom of three school-aged kids,” Porter said. “If there were no watermelon snow cones, my kids are happy with blue raspberry. No blue raspberry? They’ll take mango. No mango? They’ll take strawberry. But if their only choice was a brown, tobacco-flavored snow cone, they are going to walk away.”
Rep. Raja Krishnamoorthi (D-IL), chairman of the Oversight Subcommittee on Economic and Consumer Policy, said after the hearing he felt Woodcock would do as Democratic members of Congress wished. “I am more optimistic than ever that Commissioner Woodcock will do the right thing and deny the premarket tobacco product applications (PMTA) for all flavored vaping products, and all high-nicotine vaping products,” Krishnamoorthi said in a statement.
Woodcock also suggested at the hearing that e-cigarette manufacturer Juul Labs Inc. played a significant role in creating a youth vaping epidemic. When asked if Juul was “the e-cigarette company most responsible for creating this epidemic.” Woodcock replied that it does “appear” to be the case.
Woodcock would also not commit to removing menthol-flavored e-cigarette products from the US market, even though she said she believes menthol flavoring could heighten the effects of nicotine.
“I was so pleased that you banned menthol combustible cigarettes, which was the right thing to do,” Krishnamoorthi said during the hearing. “Will you pledge to clear the market of menthol e-cigarettes?”
U.S Senate Majority Whip Dick Durbin yesterday testified at a House Oversight and Government Reform Subcommittee on Economic and Consumer Policy hearing that focused on youth vaping and the role of the Food and Drug Administration (FDA) in regulating e-cigarette products.
During his testimony, Durbin blasted the shortcomings of the FDA’s tobacco oversight over the last several years and urged the agency to rectify its missteps and put public health and the safety of children at the forefront of its mission, according to a press release.
“Flavored e-cigarette products have exploded in popularity among our kids—nearly four million now vaping, a 361 percent increase in just eight years when only 800,000 kids were vaping,” Durbin said. “Who is the cop on the beat to whom we entrust our children? It’s the Food and Drug Administration. And this agency has been timid and reluctant for way too long.”
All e-cigarette manufacturers were required to submit Premarket Tobacco Product Applications (PMTAs) to FDA by September 9, 2020, in order to legally stay on the market. FDA is now evaluating those applications based upon a public health framework and is required to complete review by September 9, 2021. FDA’s decisions on the PMTA applications will determine the course of the youth vaping epidemic.
In his testimony, Durbin urged the FDA to finally apply the public health standard that Congress passed in 2009 under the Tobacco Control Act and evaluate whether a product can stay on the market if it is, “appropriate for the protection of public health.” Durbin said he feared the FDA will over-value the unproven potential benefit of cessation for adult smokers, while under-valuing the clear evidence and experience we’ve had over the past several years on how flavored products hook kids.
“Only four percent of adults use e-cigarettes [compared] to 20 percent of high-school students. Kids who never would have picked up a tobacco product are vaping. It’s simple: any product with a history of increasing youth use must be rejected by FDA—especially flavored products that we know hooks the kids. This is the Super Bowl for the FDA’s tobacco effort and I’m afraid they aren’t ready for primetime. I hope they prove me wrong,” Durbin said.
Durbin went on to describe how despite promises from the Trump Administration to crack down on kid-friendly e-cigarette flavors, the FDA still left loopholes that have been exploited by the vaping industry to continue to hook kids onto new and illegal products.
“The result? Kids migrated…to the products that remained unregulated on the market: menthol flavored e-cigarettes and disposable vaping products. The use of disposable e-cigarettes… which were exempted from FDA’s January 2020 action, increased 1,000 percent last year. Make no mistake: kids get it. If we don’t take this seriously they will find those loopholes continue their addiction,” Durbin said. “And because FDA allowed menthol-flavored cartridges from JUUL and others to stay on the market, their use…increased from 11 percent to 62 percent of the [cartridge] market. Another failure by the FDA.”
U.S. Customs and Border Protection (CBP) officers last week seized nearly 20,000 flavored vape pens worth nearly $600,000 in Atlanta. According to the agency, last Wednesday, CBP Atlanta officers found 66 boxes of “Ricky and Morty” branded vape pens and e-cigarettes as they were inspecting a shipment and suspected the items violated copyright and trademark law.
Credit: CBP
The vape pens, which originated in a shipment from China, were to be distributed across Georgia, according to a statement. CBP contacted Warner Bros. Entertainment Inc. and confirmed they hadn’t licensed their copyright of the animated series for vape pens. Officers ultimately seized the 19,800 vape pens with an estimated retail price of over $590,00.
“One of our primary missions is to intercept merchandise that could pose a serious health risk to the consumer, but this shipment of counterfeit vape pens violated Intellectual Property Rights,” said Paula Rivera, Atlanta’s CBP port director. “CBP collaborates with many government agencies to enforce laws to protect the health and safety of the consumer and our communities.”
In January, CBP Chicago seized 50,000 illegal “Rick and Morty” vape pens. CBP says each year, they seize millions of counterfeit goods that could otherwise hurt the U.S. economy, threaten consumers and fund criminal activity. Counterfeit items are often sold in underground outlets or on third-party e-commerce sites, according to CBP. Consumers might think they’re buying a genuine product but are left with a poor-quality item.
Last year, CBP seized nearly $1.3 billion worth of goods that violated intellectual property rights. The FDA announced an increased enforcement priority of electronic nicotine delivery systems, and issued detailed guidance to the industry of these new enforcement priorities that regulate the unauthorized importation of tobacco products.
CBP provides basic import information about admissibility requirements and the clearance process for e-commerce goods and encourages buyers to confirm that their purchases and the importation of those purchases comply with any state and federal import regulations.
CBP conducts operations at ports of entry throughout the United States, and regularly screens arriving international passengers and cargo for narcotics, weapons, and other restricted or prohibited products. CBP strives to serve as the premier law enforcement agency enhancing the Nation’s safety, security, and prosperity through collaboration, innovation, and integration.
Acting FDA Commissioner Janet Woodcock is set to testify before a House subcommittee on Wednesday morning about youth vaping. Rep. Raja Krishnamoorthi, chair of the panel, plans to press Woodcock to do more to stop kids from vaping and becoming addicted to nicotine.
“We still have a youth vaping epidemic, even amidst our pandemic,” said Krishnamoorthi, in a story for Yahoo Finance.
Krishnamoorthi has been an advocate for cracking down on the vaping industry over the past several years. In 2019, amid an outbreak of vaping-related illness linked to black market THC products not nicotine, there was bipartisan support for a crackdown — leading the Trump administration to issue a vaping flavor ban in an effort to curb teenage use.
The ban covered flavors that critics argued targeted children — like fruit, mint and candy flavors — but allowed menthol and tobacco flavors to remain legal. The ban only applied to cartridges or pre-filled pod devices, like the ones sold by Juul, not disposable e-cigarettes. Some critics argued the move wasn’t enough.
“You’ve got to get rid of all the flavors. Secondly, you have to make sure that disposable cigarettes are subject to the same flavor ban that all other products are subject to — and then third, we have to regulate the nicotine content,” said Krishnamoorthi. “These vapes that are currently on the market are so addictive.”
