Author: Staff Writer

Simply Perfect

Numerous small changes come together in possibly the most reliable and consistent pod system ever created.
By Mike Huml
The FEELM Air pod system from Smoore boasts a plethora of groundbreaking innovations. From safety to performance, the FEELM Air comes with a laundry list of improvements over past iterations of pod systems. As the largest vapor manufacturer in the world, Smoore has poured resources into refinement of its technologies to produce a near-perfect pod system.
The FEELM Air is a closed pod system, so each 2 mL pod is disposable. The pods are held in the battery section with strong magnets, and there truly isn’t much more to speak of concerning operation. The simplicity is a huge benefit for those who are seeking a no-hassle vape experience. There is no airflow adjustment, no power adjustments and no buttons whatsoever. The FEELM Air is activated by airflow to more closely replicate the sensation of smoking.
Further, Smoore has incorporated the “world’s smallest linear motor,” which not only provides haptic feedback when a pod is connected or disconnected but also vibrates throughout each drag. This acts as confirmation that the pod is firing since there is no button to press but also gives a more turbulent feel to each drag that anyone accustomed to smoking will be familiar with. Dubbed “shockwave mode,” the vibration feature only consumes power equivalent to two puffs throughout a single battery charge cycle. While shockwave mode may be convenient for some, the vibration is sure to turn some people off, and as such, it would have been prudent for Smoore to incorporate an inconspicuous touch-sensitive button to toggle shockwave mode on and off.
Aside from the inability to disable shockwave mode, the FEELM Air has no other issues and offers quite a bit in the way of innovation and refinement. At 7.8 mm, it’s the thinnest pod system available, making it great for taking out and about. It fits in pockets and pocketbooks easily, and it never leaks thanks to further improvements in the pod structure. Smoore uses “puzzle leakage-proof technology” and an absorption layer within the heating element to eliminate leaking.
The juice flow channels are narrow enough that surface tension keeps condensation from backing up, and the absorption layer re-wicks the liquid back into the ceramic heating element. It works extremely well as the FEELM Air doesn’t leak when stored or stowed, doesn’t cause spitback even when multiple drags are taken in rapid succession and never produces dry hits due to slow wicking. By Smoore’s estimation, this design reduces leaking of any kind by 237 percent.
The battery life of the FEELM Air is good and lasts through approximately half of a single 2 mL pod. By only firing at or around 6 watts, a smaller, thinner battery is adequate. The device is charged with an included USB-C cable that is capable of fully charging the battery in about 15 minutes. Additionally, the FEELM Air can be used while it’s charging, reducing the already low downtime to near zero. A constant power output of 6 watts may seem a bit weak, but thanks to the design of the heating element, it produces vapor equivalent to other pod systems that fire between 12 watts and 15 watts.
Each heating element comprises seven different layers, each for a different purpose. In short, the heating element in each pod improves flavor, efficiency, safety, consistency and leakiness. Lower power, a more efficient heating element and a more uniform heating surface reduce exposure to heavy metals, ketones and aldehydes by 80 percent. A separate layer uses Smoore’s “flavor-lock” technology to increase flavor release by 33 percent. The smaller vapor particles produced by the ceramic heating element are also conducive to more efficient nicotine absorption, so each pod lasts a bit longer.
It’s clear that Smoore has put significant resources toward improving the vaping experience provided by its pod systems, but how does it affect the end user? After all, heavily marketed features don’t always translate to better products. In the case of the FEELM Air, there is definitely a marked improvement in consistency over many other pod systems, but given the nature of innovation and refinement, don’t expect mind-blowing improvements to the established order. The improvements are subtle but effective, and the FEELM Air may be the most user-friendly device currently available, particularly for those with absolutely no knowledge of vaping.
Case in point: There is a lot of literature pertaining to the “three innovations” and “seven breakthroughs” implemented in the design and creation of the FEELM Air. A new film designed for the heating element is 40 times thinner than that of the previous generation. The new ceramic coil is also 30 percent thinner. Seven layers of composite heating film are made from medical-grade materials and are created using a nanoscale vacuumed film-forming technique to produce a microporous bionic structure.
The seven-layer heating element includes a nanoscale protection layer, a microporous flavor lock layer, a nano silver electro layer, a superabsorbent lock layer, a precise composite heating layer, a temperature control layer and a porous thermal resistance layer. These layers in tandem with the upgraded capillary structure incorporated into the pod itself contribute to the aforementioned reduced leakage and improved consistency. What does all of this actually mean?—It vapes good.
However, even given the above information and more, there are still a few unknowns. What is the battery capacity? What is the nicotine strength of the e-liquid? Even with a lot of marketing, some basic information is omitted—but this is information only an experienced vaper would value. A new user probably wouldn’t care that the FEELM Air has a 100 mAh battery while Pod System B uses a 150 mAh battery.
How does one measure “flavor release” to determine that it’s increased by 30 percent? And why would that matter for a pod that can’t be refilled? Will Smoore produce less expensive pods due to not needing as much flavor extract, or will the flavor be stronger than usual due to this flavor increase while the same e-liquid is used? How many of the claims benefit the industry or the user, and how many are just big words to use as filler for a brochure? With all the apparent detail provided, it’s suspicious that basic information was left out—or at least it would be if the FEELM Air was a poor product.
Whatever Smoore is doing, it’s working because the FEELM Air is probably the most consistent pod system currently available. After significant usage, there was no spitback, no misfires, no leaking, no dry hits and no kind of any other issue. Each subsequent drag was identical to the previous one, and the flavor was admittedly good. It wasn’t leaps and bounds beyond other pod systems, but it was consistent, voluminous and flavorful enough.
Operation couldn’t be simpler or more straightforward. Perhaps the reason for the lack of information that vapers are used to having access to (such as battery capacity) isn’t needed. For someone brand new to vaping, the FEELM Air requires virtually no explanation. Insert the pod; start vaping. Plug it in when the battery dies, and replace the pod when it’s empty. There’s no fiddling, no settings, no troubleshooting problems. It’s simple, and it works consistently.
While the marketing for the FEELM Air seems a bit excessive and overly technical, Smoore clearly wants the industry and consumers to know the nature of the work they’ve been doing to improve the vaping experience and safety. Just the peace of mind brought about by knowing that the efficient, 6 watt output and seven-layer heating element are working to further reduce any harm caused by vaping or technical shortcomings may be enough to make the sale. The diminutive size is also a huge positive, but the vibration feature borders on gimmicky rather than useful.
Tactile confirmation of automatic switch activation may provide an extra layer of protection against accidental firing, but that’s largely a solution to a problem that hasn’t existed in any meaningful way since 2010 when automatic switches would fire if music was played too loudly. Still, it’s a small complaint considering that the package as a whole is providing one of the best vape experiences for a pod system on the market.
The FEELM Air from Smoore takes refinement to a new level. A multitude of small changes come together to provide possibly the most reliable and consistent pod system ever created. While everyday use won’t knock anybody’s socks off with massive clouds or tear-jerking flavor, it’s definitely among the best options for new users and smoking converts. As the vapor industry delves deeper into the era of refinement, these sorts of innovations will become commonplace. The average user won’t necessarily care about what each of the seven layers in the heating element actually do, but everyone will benefit from more consistency and, therefore, safety.

May 9, 2022
TMA: Talking With FDA

Mike Ligon, TMA board chair, and Matt Holman, director of the CTP’s Office of Science, discuss regulatory reaction.
By Timothy S. Donahue
The U.S. Food and Drug Administration has been busy. Before it had the chance to finish the first round of premarket tobacco product application (PMTA) reviews, the agency’s Center for Tobacco Products (CTP) was charged with also regulating all synthetic and other nontobacco-derived nicotine products (see “Unnatural Response,” page 28). Manufacturers must submit PMTAs for the newly regulated products by May 14, 2022.
During the 103rd annual meeting of Vapor Voice’s parent company, TMA, Mike Ligon, TMA board chair, and Matt Holman, director of the FDA CTP’s Office of Science (OS), discussed the regulatory agency’s challenges and lessons learned in regulating electronic nicotine-delivery systems (ENDS) and other novel tobacco products. It was the first time Holman had spoken publicly since Congress granted the FDA the authority to regulate synthetic products, and Ligon emphasized that the audience was eager to hear Holman answer questions.
Holman made clear from the beginning that he heard during the conference that the FDA needs to do a better job with consistency, transparency and predictability. “That’s something I’ve strived to make sure we do as office director, but I’m hearing we’re not doing as good a job as we need to,” said Holman. “That’s something I’m certainly taking back to my colleagues to figure out … I think the point I’ve heard the most along those lines was just the timing and not knowing what the timing would be [for] taking action on applications. We need to do a better job of that.”
Credit: Timothy S. Donahue
After a federal judge ordered the FDA to complete a majority of PMTA reviews by Sept. 9, 2021—one year after the deadline for PMTA submissions—Holman said the review process was still new and that it was a challenge to build the programs necessary to complete reviews on time. He said that staffing the agency, for example, was a giant undertaking.
“Something folks outside the agency don’t think about all that much is staffing levels. When I took over this position, we had something around 325 staff members that were in the office,” Holman explained. “And now, five years later, we have about 575-ish. Any of you who have not been in the federal government and tried to hire—it is a huge-level effort to hire that many people in that period of time; a huge-level effort … half my staff have come on board during the pandemic and have not met colleagues in person.”
Holman said that the big-picture goal for the OS and FDA alike is creating an offramp for smokers to transition to less-harmful products while minimizing any potential on-ramps for youth initiation, adding that youth use has been “decreasing the last couple of years, which is a really positive thing.” He also explained that the agency often hears a lot of criticism, some undeserved, surrounding the misinformation disseminated into the public by “stakeholders” (anti-nicotine organizations, health agencies, tobacco control groups, regulators and industry players).
“We take all the feedback seriously … And we certainly actively encourage all stakeholders to engage with one another. I would hope to be able to sit here and say that I’ve been more successful than I have in that. There’s still a lot of resistance. There’s still a lot of really emotional, heated exchanges and feelings toward stakeholders,” said Holman. “I’m even seeing a shift in some of the stakeholder groups that have been aligned [previously] and now aren’t necessarily aligning.
“I’ve just celebrated 20 years at the FDA in December. That entire 20 years, I’ve spent really actively engaging with all stakeholders, and I think it’s critical as regulators that we hear from and we talk with and we communicate—and we’re trying to be as transparent as possible—with all stakeholders. Unfortunately, I don’t control all the stakeholders. And I keep carrying this message forward. It doesn’t always get heard so well. And so, it’s still very much a work in progress.”
Ultimately, Holman said the FDA is trying its best to base its decisions on the “good” science and not a specific source of data. “I don’t even care who the author is. I mean, the science is science,” he said. “Unfortunately, we have a lot of stakeholders that don’t look [at] it that way, and a lot that think they know what the policies shouldn’t be, and they want to come up with the science to demonstrate that. But we’re very aware of that. We’re very much looking out for that type of thing.”
Being approachable
Holman said he understands the frustration of trying to combat misinformation. On the FDA’s side, he wanted to clarify at least some of the misunderstandings and misperceptions he commonly hears when stakeholders discuss the FDA. For example, he had recently heard a stakeholder saying that the FDA only had one economist on staff. “FDA has more than one economist,” he said. “The CTP has more than one economist. I want to be clear about that … You can agree or disagree with where economists land on their analysis. That’s fine. But just to say that we only have one economist—this concern is just a major misrepresentation of the situation.”
There are also the rumors that the regulatory agency doesn’t read all the docket submissions (everything submitted to the agency, whether a comment on rulemaking or a PMTA). Holman said the quality of the submissions vary greatly, but the agency is required by law to look at every single one. “To suggest that the FDA’s regulators don’t carefully consider the data when we’re weighing options … at the end of the day, we have a public health mission where we’re here to serve,” said Holman. “We’re not here to oppose anyone. I look at data from all sources. I don’t care who it comes from … to suggest anything otherwise, at least for the FDA, honestly, it’s a bit insulting … you can criticize all you want about where we come out on decisions and rulemaking, but at the end of the day, we are very much a science-based organization.”
Credit: Timothy S. Donahue
The agency also tries to consider the unintended consequences of regulatory action, according to Holman.
However, he explained that determining these factors, such as the growth of a black market, is complicated because there’s often not a lot of data.
“It’s very much [speculating] what’s going to happen to the black market or the gray market when we take an action. We don’t often have data on that. So it’s really modeling or predicting,” he said. “We absolutely consider that because, at the end of the day … as I like to say to my staff, we’re trying to tackle this with a scalpel not a machete. Because I think that’s how you sort of leave this fine line that we’re all trying to leave here.”
Ligon asked Holman whether the FDA’s approach to regulating next-generation tobacco products was a workable standard. Ligon wanted to know if the FDA still recognizes that tobacco products exist on a continuum of risk, with combustible cigarettes being the most harmful (the “continuum of risk” is the scientific concept that not all tobacco and nicotine-delivering products are equally harmful). Holman said that while the FDA doesn’t know precisely what the relative risks are of the different products on the spectrum, the agency still believes in the continuum of risk.
“The challenge is having strong, rigorous data that we can stand behind and say, ‘Yes, we know this product is lower in risk than that product.’ That’s one of the biggest challenges still, I think, figuring out how to collect that data, what are the right types of studies, what’s the sort of full body of data that we need to be comfortable saying, ‘Yes, this product is down the continuum from that product,’” he said. “I think the other big challenge in this is … communicating with the consumers because if they don’t understand—and we know there’s a lack of understanding—a lot of misperceptions and misunderstandings [begin to grow].”
Workable solution
Communication is key. Holman said that to better understand the process and the challenges that stakeholders are suffering, the agency needs to better communicate its thought processes and goals. Before the Covid-19 pandemic limited stakeholder interaction, the agency would hold workshops to hear directly from stakeholders about their concerns. Holman wants to bring back that level of communication.
“We need to do workshops. It’s been almost a year since we’ve done the last workshop, and a whole heck of a lot of things have happened in that time period. We’re definitely going to take that back with our staff and talk about how to put some workshops together because the feedback we’ve gotten to date on the workshops we have done [previously] have been very positive,” said Holman. “Folks really appreciate the discussion. Not only to hear what we have to say, but just talks among attendees and some shared ideas and thoughts.”
Matt Holman / FDA
When asked if there were any suggestions from TMA attendees for workshop concepts, several stakeholders offered ideas. One stakeholder wanted to discuss with the FDA how PMTA data is managed and submitted to the FDA. The participant said that his company had received a deficiency letter; however, the additional data requested was already included in the company’s PMTA. Holman said that type of seminar would be a “win-win” for both the agency and the stakeholders.
Another attendee suggested that the agency bring in consumers to allow the FDA to hear from them directly and to understand the consumers’ thoughts, behaviors and attitudes as well as the impact of potential regulations on possible future consumer behavior. “I just feel like there’s a gap,” the attendee said. “I really think that would do a lot in being able to bring all of us together to promote the science.”
Other attendees wanted to have a better understanding of how the FDA comes to its decisions and what some of the common errors were in PMTAs that had received marketing denial letters. “I’m suggesting a little bit [of a] deeper dive by product category into the top 10 reasons you’re finding that something succeeds and [the] top 10 reasons you’re finding that something fails,” the attendee said. “I’m talking more about … here are the reasons why these fail … here’s why this doesn’t work.”
Holman said the fundamental goal of the FDA is moving people down the continuum of risk. He said that the consumer is the most important part of the equation and that all stakeholders need to be better at getting less-harmful tobacco products into the hands of adult combustible smokers. He said that he would hope that five years from now the tobacco product marketplace looks very different. Holman suggested that manufacturers with the ENDS products that exist now, alongside the “products we’re not even talking about that I know are in the pipeline” at various companies, should also consider using the agency’s modified-risk tobacco product (MRTP) pipeline moving forward.
“I would hope that our MRTP program sees a lot more action and that we see a lot more modified-risk statements on products … And again, I think the lack of dialogue amongst stakeholders, and the lack of sort of any level of agreement, really thwarts communication because the information the consumers are receiving, it’s all over the place, right?” Holman suggested. “There’s a lot of misinformation out there that certain stakeholders convey that just doesn’t reflect the science. Just flat out doesn’t … if we could just get stakeholders to agree on some basic key communication points that we would all collectively share with consumers, I think we could really drive this forward. But right now, consumers are just confused.”

May 9, 2022
Dragbar 600S Launches, Offers a ‘More Balanced Taste’
The latest in disposable vaping, the ZOVOO Dragbar 600S, was unveiled and officially entered the market on May, 9. In a press release sent to Vapor Voice, the company states that the new device is equipped with an upgraded design of five flower-shaped air inlets, which allows for a more evenly distributed airflow. This creates a more comfortable and balanced taste experience.
“Without sacrificing user experience or changing external dimensions, it optimizes the internal space structure of the atomizing rod and enlarges the battery capacity to 500 mAh for durability. This new product delivers enormous value in addition to excellent daily experience,” according to the release.
The first offerings of the Dragbar 600s includes 10 mouthwatering flavors, including strawberry ice, peach ice and O.M.G. In addition, 10 new flavors will be available at a future date.
“Quality and taste are the core to impress consumers and the soul of electronic atomizers. ZOVOO always adheres to the concept of ‘user-focus’ and constantly develops new disposable vapes to meet the ultimate needs of users all over the world,” according to the release.
May 9, 2022
Orinda, California Passes First Reading of Flavor Ban Bill
Credit: Rezona
Another California city is considering a flavor ban for vaping products. The Orinda City Council introduced and unanimously passed the first reading of an ordinance during its meeting last week, that would ban the sale of all flavored vaping and other tobacco products within the city beginning in just a few weeks.
The ban would prohibit the sale or any other former of distribution of flavored tobacco products, which would include products with menthol, to Patrick Lagreid of Halfwheel. There are no exemptions for premium cigars or other products.
The ordinance will return for a second vote on May 17; if approved it will go into effect 30 days later, though there will be a 120 day grace period before enforcement begins.
May 9, 2022
Jamaica Set to Consider Passing Tobacco, Vaping Rules
Credit: Zabanski
Jamaica is set to consider comprehensive legislation in the House of Representatives that would address the devastating effects of tobacco and e-cigarette consumption in Jamaica, Minister of Health and Wellness, Christopher Tufton said.
The Tobacco Control 2020 Bill will, among other things, impose restrictions on the marketing of vaping and other tobacco products as well as prohibit sales to children, according to Tufton.
Tufton said the legislation is now at the committee stage “and I am happy to report that we are well advanced in that process,” according to Caribbean National Weekly.
“I expect over the next month, six weeks maybe, to table the comprehensive Bill, and I urge my colleagues to quickly pass this bill for the protection of the Jamaican people and to reduce the cost of treatment,” he said.
Outlining some of the provisions of the Bill, Tufton informed that in addition to curtailing the marketing of tobacco products and prohibiting sales to children, it will also prohibit the use of electronic nicotine delivery systems such as e-cigarettes in public spaces.
More Jamaicans are embracing vaping to help quit combustible products, according to vape shop owners on the island.

May 7, 2022
Connecticut Flavor Ban Bill Fails for 3rd Year in a Row
Credit: Sharaf Maksumov
For the third year in a row, an effort to ban flavored vaping products in Connecticut couldn’t muster enough support.
“We’re incredibly frustrated that the legislature can’t seem to get their priorities in order in a way that would protect kids, the way all of Connecticut’s neighbors already have,” said Kevin O’Flaherty, northeast advocacy director for the Campaign for Tobacco Free Kids. They “continue to support industry and industry profits instead of protecting kids.”
The flavor ban had early momentum in the General Assembly. The Public Health Committee approved the measure in March after hearing hours of testimony, according to CT Mirror.
Connecticut is one of few states in the region that has not adopted a prohibition on flavored e-cigarettes. New York, New Jersey and Rhode Island have barred the sale of flavored vaping products. Massachusetts banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods.
The state has attempted a ban twice before. The proposal was raised in 2020 as part of Gov. Ned Lamont’s budget but was unsuccessful. Lamont had recommended banning flavored vaping products and increasing the tax on all e-cigarette liquids.
Last year, a bill barring the sale of flavored cigarettes, tobacco products and e-cigarettes was watered down and then shelved. A version of the plan was also added to the state budget implementer but was scrapped.
This year’s version only targeted the sale of flavored vaping products (not flavored cigarettes or cigars). But it still ran into opposition. E-cigarette makers, store owners and people who say that vaping is an important alternative for those who are quitting smoking testified against the bill.
May 7, 2022
Malaysia Vape Industry Players Want Regulations to Begin
Credit: Krzysztof Wiktor
In order to avoid a total ban vaping products, some Malaysian vaping industry players are urging the government to implement long-delayed regulations for the industry.
The Malaysia Retail Electronic Cigarette Association (MRECA) president Datuk Adzwan Ab Manas, in a statement, said a taxation framework for e-liquids with nicotine was supposed to be implemented from Jan. 1 this year, but has been delayed for four months because the Ministry of Health (MoH) still has not implemented regulations for the industry.
The delay has not only left the industry in limbo but has resulted in the government listing more than RM750 million ($172 million) a year in tax revenue, according to the Malay Mail.
“Furthermore, the MoH’s proposal to ban the sale of vape along with cigarettes, although the two products are different, is akin to declaring war on the local vape industry especially for the 3,000 local entrepreneurs and 15,000 employees in the industry,” Ab Manas said.
The president of the Malaysian Vape Industry Advocacy (MIVA), Rizani Zakaria, agrees with Adzwan. Zakaria said the ban is unfair as vape and cigarettes are two very different products.
Rizani was reported saying international studies show vaping is less harmful and can be used to help cigarette smokers quit smoking.
May 6, 2022
Colorado Flavor Ban Heads to Senate After House Win
Credit Renan
After months of debates and amending, Colorado’s House passed a ban on flavored vaping and other tobacco products this week. The bill passed 35-27 on Wednesday after the appropriations committee approved it earlier in the day on a 7-4 vote.
That ban will not apply to the sale of premium cigars after they were given an exemption during the debate process, as was pipe tobacco and hookah products.
The bill now goes to the state Senate. Even with the session end looming, one of its co-sponsors, state Sen. Rhonda Fields said she was optimistic, according to Colorado Public Radio.
“You know, it looks great. It’s on its way to the Senate, and then we’ll make sure it goes through all the appropriate committees and I’m looking forward to debating it,” said Fields.
Opponents say a ban would hurt convenience stores and vape shops and have argued the issue is one of personal choice.
For Fields, she said it’s about the toll tobacco consumption, driven by attractive flavors like menthol, has taken on the community.
“It started back in the ’60s, (the brand) Kool Cigarettes, all these menthol flavors,” she said. “The industry has now put flavors into vaping, into cigarettes to make it more attractive for young people to start smoking early.”
The measure, HB22-1064, bans retailers of cigarettes, tobacco or nicotine products from selling or marketing any flavored product. Those are defined as products “imparting a taste or smell other than the taste or smell of tobacco.”

May 6, 2022
Hawaii to Ban Flavored Vapes if Governor Signs Bill
Credit: Timothy S. Donahue
Having survived a rollercoaster legislative session that saw the bill near death on multiple occasions, Hawaii’s ban on flavored e-cigarettes now land’s on the governor’s desk. Many industry experts say he may veto the controversial legislation.
The ban, which takes effect after the new year, outlaws the sale of nearly all flavored tobacco products in Hawaii stores, including menthol cigarettes and flavored cigars, according to Civil Beat. The primary target of the measure, however, are flavored e-cigarettes most popular with middle and high school students.
After a contentious debate Tuesday, House Bill 1570 passed its final reading in the state House of Representatives with 36 voting in favor and 15 in opposition, reflecting division among public health advocates and other supporters who turned their backs on the measure they helped write.
At issue was a Senate amendment that would exempt from the ban certain tobacco products that had received federal Food and Drug Administration approval.
It is a major loss for Hawaii’s legal vaping industry, which has campaigned vigorously against a prohibition on the products that form their livelihood.
“[About] 99.9 percent of everything that our industry sells to adult consumers, legally with age verification, is flavored products,” said Scott Rasak, chief operating officer of Volcano, a vape shop chain with 16 locations across the state. “We’re talking about hundreds of businesses, thousands of jobs.”
Vape shop owners argue that a tobacco ban will force kids onto the black market. Public health activists, however, have long advocated for cutting flavored vapes off at the source.
Hawaii’s vaping industry will challenge the ban’s legality in court, Volcano’s Rasak vowed.
The bill might also receive pushback from Gov. David Ige, who introduced a similar flavor ban to the Senate this year but has yet to reveal his stance on HB 1570 in its current form.
“I think that the governor might veto the bill,” Matayoshi said in an interview after the vote. “It really depends on the census of the (public health) community.”
May 4, 2022
FDA Issues First Warnings for Illegal CBD, Delta-8 Products
The U.S. Food and Drug Administration today issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (THC). The regulatory agency claims that the companies violated the Federal Food, Drug, and Cosmetic (FD&C) Act. It’s the first time the FDA has issued warning letters for products containing delta-8 THC.
“Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers. The FDA has received reports of adverse events experienced by patients who have consumed these products,” the agency stated in a release. “There are no FDA-approved drugs containing delta-8 THC. Any delta-8 THC product claiming to diagnose, cure, mitigate, treat, or prevent diseases is considered an unapproved new drug.”
The states that it has not evaluated whether “these unapproved drug products” are effective for the uses manufacturers claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns, according to the statement.
“Delta-8 THC is one of over 100 cannabinoids produced in the Cannabis sativa L. plant but is not found naturally in significant amounts. Concentrated amounts of delta-8 THC are typically manufactured from hemp-derived cannabidiol (CBD) and have psychoactive and intoxicating effects,” the release states. “Products containing delta-8-THC are available in varying forms, including but not limited to candy, cookies, breakfast cereal, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta-8-THC extract, distillate, tinctures, and infused beverages.”
The warning letters address the illegal marketing of unapproved delta-8 THC products by companies as unapproved treatments for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., the products lack adequate directions for use) and the addition of delta-8 THC in foods, such as gummies, chocolate, caramels, chewing gum and peanut brittle.
“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”
The FDA recently published a consumer update expressing concerns about the potential health effects of delta-8 THC products. The FDA has received adverse event reports involving products containing delta-8 THC from consumers, healthcare practitioners and law enforcement, some of which resulted in the need for hospitalization or emergency room treatment, according to the agency.
The FDA states that it is also aware of an increasing number of exposure cases involving products containing delta-8 THC received by national poison control centers and alerts issued by state poison control centers describing safety concerns and adverse events with products containing delta-8 THC.
In addition to the violations related to FDA-regulated products containing delta-8 THC, several of the warning letters outline additional violations of the FD&C Act, including marketing CBD products claiming to treat medical conditions in humans and animals, promoting CBD products as dietary supplements, and adding CBD to human and animal foods.
“CBD and delta-8 THC are unapproved food additives for use in any human or animal food product, as the FDA is not aware of any basis to conclude that the substances are generally recognized as safe (GRAS) or otherwise exempt from food additive requirements,” the release states. “One of the letters expresses concerns regarding CBD products marketed for food-producing animals, and the potential safety concerns related to human food products (e.g., meat, milk, eggs) from animals that consume CBD, as there is a lack of data on safe CBD residue levels.”
The FDA issued warning letters to:

ATLRx Inc.

BioMD Plus LLC

Delta 8 Hemp

Kingdom Harvest LLC

M Six Labs Inc.
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there were further violations because CBD was added to food products. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, according to the agency.
The FDA has requested written responses from the companies within 15 working days stating how they will address these violations and prevent their recurrence. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
May 4, 2022