“PMTA certification already reduces or eliminates the smell, so it may not be necessary to go that long. Thousands of companies have submitted six to seven million applications, but so far, only 23 have been approved. As far as I know, there are several The companies themselves submitted more than a million applications. The irony is: everyone approved is a big tobacco company, and they represent only a small portion of the overall e-cigarette market.”
The second irony beyond this is that those so-called approved products are the ones that no one wants.
What is PMTA?
PMTA, the full name is Premarket Tobacco Application, that is, tobacco pre-market application. This is a market access license issued by the U.S. Food and Drug Administration (FDA) for new tobacco products.
As the U.S. federal government gradually upgrades and tightens its regulatory measures on e-cigarette products, PMTA (Premarket Tobacco Application) will be an unavoidable threshold for domestic e-cigarette companies to enter the U.S. market. They must either follow the trend or retreat and give up.
PMTA requires that the legal promotion of any new tobacco product needs to be reviewed and approved by the FDA. The FDA needs to comprehensively consider whether the product is beneficial to public health (smokers and non-smokers are considered as a whole). Once qualified, the FDA will Issue “Certificate of Conformity (Premarket Tobacco Product Marketing Orders)” to related products.
The United States passed the Family Smoking Prevention and Tobacco Control Act (Family Smoking Prevention and Tobacco Control Act), giving the FDA (U.S. Food and Drug Administration) the power to manage traditional tobacco for the first time, but the scope of supervision is limited to regulating cigarettes, cigarette tobacco, and smokeless tobacco. and homemade cigarettes.
The FDA approved the first premarket tobacco application PMTA, granting Swedish Match North America’s snus to market a smokeless tobacco product.
On May 10, 2016, the FDA issued new rules for the Deeming Tobacco Products Regulation to regulate all tobacco products, including e-cigarettes, cigars, hookahs and pipe tobacco, which took effect on August 8, 2016. The new regulations officially include e-cigarettes among the regulated tobacco products, which means that e-cigarettes are fully included in the PMTA. PMTA’s terms on e-cigarettes require that any ENDS (Electronic nicotine delivery system) produced after August 8, 2016 must first obtain a PMTA before it can be sold in the U.S. market, and all e-cigarette brands and manufacturers must be in Submit your application before August 2022. If the product was launched before August 8, 2016, it must obtain PMTA certification before August 8, 2020 before it can continue to be sold.
Since then, the FDA can legally supervise the manufacturing, import, packaging, labelling, advertising, promotion, sales and distribution of ENDS (Electronic Nicotine Delivery Systems). For example:
Manufacturers in the United States are required to register each tobacco production site in the factory with the FDA and report any harmful and potentially harmful substances. (Companies outside the United States do not need to register for the time being, but they will also be required to register in the near future)
1.U.S. manufacturers are required to submit lists of manufactured tobacco products to the FDA.
2.ENDS manufacturers are required to submit a list of ingredients for each product to the FDA (Translator’s Note: This applies to Chinese manufacturers).
3.Danger modifiers such as light, low, mild cannot be used to describe tobacco products.
4.Free samples of tobacco products (such as e-cigarettes, etc.) are not allowed to be sold (except B2B), etc.
In July 2017, the FDA announced a comprehensive plan for tobacco and nicotine regulation and extended the PMTA application submission deadline for ENDS (e-cigarettes) to August 8, 2022.
On March 14, 2019, the FDA announced that it would recommend revisions to the current ENDS (e-cigarette) compliance policy (July 2017 policy). The revised draft specifically targets flavored e-cigarettes, including: 1. Some flavored e-cigarette products will no longer be sold. 2. The PMTA deadline for flavored e-cigarettes will be advanced one year to August 8, 2021. 3. Flavored cigars will no longer be sold. 4. It is recommended that e-cigarettes cannot be promoted through social media like traditional cigarettes.
On June 11, 2019, the FDA finalized the “Premarket Application for Tobacco Products for Electronic Cigarette Devices (ENDS)” guidance, further clarifying the premarket tobacco product application (PMTA) process for manufacturers of e-cigarettes and related tobacco products. This guidance is intended to assist persons submitting premarket tobacco product applications (PMTAs) for e-cigarettes (ENDS) under Section 910 of the FD&C Act (21 USC 387j). The guidance explains what products and when the PMTA process is required, as well as the general process for tobacco product premarket applications (ENDS); including what information is required to be submitted in a PMTA under the FD&C (Federal Food, Drug, and Cosmetic) Act; and FDA recommends that information be submitted that a product could be beneficial to public health.
According to the FDA, PMTA applications are relatively complex and require submission of a lot of information, including ingredients, product design, possible health risks, etc., and cost hundreds of thousands of dollars. So far, only IQOS and a Swedish company have passed PMTA.
PMTA’s review items include nine aspects:
Application qualifications
Basic Information
descriptive information
product sample
product label
scientific research results
Product attributes and production process
In vivo toxicology studies
HPHCS (Hazardous and Potentially Harmful Constituents)
The cost of the PMTA takes approximately two years from inception to approval, and the total project cost is estimated to be US$117,000 to US$466,000.
U.S. e-cigarette policy in recent years
Restrictions on sales to minors
As of March 31, 2023, all 50 states, the District of Columbia, Guam, the Northern Mariana Islands, Palau, Puerto Rico, and the U.S. Virgin Islands have passed legislation prohibiting the sale of e-cigarettes to minors.
American Samoa and the Marshall Islands do not have any legislation prohibiting the sale of e-cigarettes to people under a certain age.
E-cigarette retail license
As of March 31, 2023, 34 states (Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Indiana, Iowa, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Utah, Vermont, and Washington), the District of Columbia, the Northern Mariana Islands, Palau, and the U.S. Virgin Islands Legislation has been passed requiring a retail license to sell e-cigarettes over the counter.
Smoke-free indoor air laws, including e-cigarettes
As of March 31, 2023, 17 states (California, Colorado, Connecticut, Delaware, Hawaii, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Dakota, Ohio , Oregon, Rhode Island, South Dakota, Utah, and Vermont), the District of Columbia, and Puerto Rico have passed comprehensive smoke-free indoor air laws that include e-cigarettes. These laws prohibit smoking and vaping in indoor areas of private workplaces, restaurants and bars.
As of October 1, 2018, Alaska implemented new legislation prohibiting smoking and e-cigarette use in indoor areas of private workplaces, restaurants, and bars. The legislation also includes the ability for municipalities to opt out of the regulations through a voter referendum. Because Alaska municipalities are able to exempt from this legislation, it is not considered a comprehensive smoke-free indoor air policy that includes e-cigarettes.
E-cigarette tax
As of March 31, 2023, there are 30 states (California, Colorado, Connecticut, Delaware, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, New Hampshire) York, North Carolina, Ohio, Oregon, Pennsylvania, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin and Wyoming) , the District of Columbia, Puerto Rico and the U.S. Virgin Islands have passed legislation requiring taxes on e-cigarettes. Twelve states (Connecticut, Delaware, Kansas, Louisiana, New Jersey, North Carolina, Ohio, Utah, Virginia, Washington, West Virginia, and Wisconsin) have or tax on e-cigarettes that consume materials. Fifteen states (California,Colorado, Illinois, Indiana, Maine, Maryland, Massachusetts, Minnesota, Nevada, New York, Oregon, Pennsylvania, Utah, Vermont, and Wyoming), the District of Columbia, and the United States The Virgin Islands taxes e-cigarettes as a percentage of a specific cost. Georgia, Kentucky, New Hampshire and New Mexico tax closed e-cigarette systems (prefilled cartridges) and open e-cigarette systems (refillable cartridges) as a percentage of the specified cost per milliliter of liquid. Puerto Rico taxes the vaping device itself (if disposable) as well as the nicotine cartridge per milliliter of consumable liquid.
Norm Bour: Current status of the e-cigarette industry
“The more things change, the more they stay the same” is a saying that has been around for nearly two centuries and illustrates the fact that the small picture of life may change, but the bigger picture does not. . The vaping industry and all the challenges and changes that have occurred over the past decade are the exact opposite of this quote.
10 years ago, the vaping industry was a Wild West epidemic, with vape shops on every corner and everyone making e-liquid in their bathtubs at home. Regulation and competition changed all that, bringing some degree of “order” to the market, but with state and federal regulations bombarding the industry, and the FDA creating onerous and difficult-to-implement guidelines, the e-cigarette space has really become The way to survive.
E-cigarette event in Phoenix brings together dozens of top manufacturers, distributors and buyers
Why is business declining?
There are many reasons, including strict regulations that are now even more strictly enforced, but overall the reasons are much simpler. The sharp rebound in COVID-19 in 2020-22 has put more money in consumers’ pockets and more time on their hands. These issues combined have created an artificial bubble that many believe is here to stay. But time has passed. Coupled with inflation driving up food and other living costs, some former necessities are now unaffordable luxuries.
“It’s a balancing act between the addictive nature of some nicotine products and the budget constraints of buyers,” says Jamie Reed of Simple Vape Supply in Orange County, California. “I have been working in this industry for over a decade and this is evolution in its purest form and is based on ‘survival of the fittest’.”
Simple manufactures and distributes more than 100 different varieties of nicotine pods, including disposable pods, which include various versions of CBD, Delta-8 and Kratom.
“It’s fun,” Reed added. “When I was hired, I was told there was an ‘expiration date’ and we all knew this industry probably wouldn’t last and the cream would rise (to the top). We planned to be one of the companies that survived, and we’ve been able to adapt era.”
Her company, and many that still exist, were largely run by rebels, radicals, and envelope pushers. Many people have actually made corresponding changes, but some people have just learned how to “play the game” and appear to be following the rules on the surface, but the actual situation may be different.
“We know COVID-19 is a one-time event. People are at home, they have government money to spend, and no one is checking on them or asking for any urine tests. The boom in Delta Air Lines (8,10) has really exacerbated this trend, per Individuals are jumping on the bandwagon,” she enthuses.
This CBD line is an example of how the industry has conducted and continues to resist. The FDA said you can’t do this, so the industry said, “Screw you, let’s do it.”
As regulations eliminate or reduce product options, nearly every industry will do the same thing: adapt; repurpose or reposition.
Among the dozens of people I spoke to at the event, the numbers (from shop owners and manufacturers) were pretty consistent, with most of them down 20 to 30 percent. Many say purchases are smaller than normal, with a typical $10,000 order now only half the normal size. They’ve seen some stores close, but most are seeing reduced revenue. Meanwhile, on the other side of the equation, e-cigarette liquid manufacturers trying to “play the game” correctly and submit a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration are frustrated with the time required and how to get the job done. Frustrated. A lot of money was thrown into a (seemingly) black hole.
I spoke with one of the owners of a large e-cigarette manufacturing and distribution company in Idaho, and he shared some facts and figures about their process of trying to make their products “legal.” In the FDA’s view, legal issues caused his company to waste more than $5 million over the past few years trying to obtain authorization.
Mike Larsen is a detailed and dedicated vaping expert who has been working in the industry for over a decade and is with Lotus Vaping Technology, founded in 2011. As Partner and Sales Director, he is on the front lines of everything the company does. Staying legal and compliant is a daily roller coaster ride.
“Disposable products are a real game changer,” he said. “They reduce the role of e-cigarette stores where people used to go for education and guidance. Consolidations and closings have also reduced the number of stores by 30 to 40 percent, and there are now larger of conglomerates doing the work of numerous stores.”
We talked about a possible nationwide flavor ban, and he said he doubted it.
“PMTA certification already reduces or eliminates the smell, so it may not be necessary to go that long. Thousands of companies have submitted six to seven million applications, but so far, only 23 have been approved. As far as I know, there are several The companies themselves submitted more than a million applications. The irony is: everyone approved is a big tobacco company, and they represent only a small portion of the overall e-cigarette market.”
The second irony beyond this is that those so-called approved products are the ones that no one wants.
We discussed whether these approvals were fair or the result of favoritism and prejudice, and he laughed because we both knew the answer.
“When you look at the PMTA process and stringent requirements, they are clearly designed to give advantage to the big, established companies, while the ‘small companies’ have little chance in this twisted game. You can’t even argue for Budgeting for things like this,” he continued. “The initial application cost over a million dollars, and I know a few companies that put in another $10 million and were rejected. Who has such deep pockets? In 2016, I could list over 150 companies that were doing well and Liquid companies; I can name about three dozen today.”
That’s why the number of companies manufacturing tobacco and vaping products has been cut in half and is decreasing year by year. The FDA continues to change the rules of the game.
“Something’s happening here, but it’s not clear what it is,” is the opening line of a song about the changes taking place in society. That Buffalo Springfield song may have nothing to do with vaping, but its message says the same thing: There’s something going on here, although it may be clearer than we realize. We all knew this was going to happen; this was predicted ten years ago.
In the world of vaping, the more things change…the more things change.
Norm Bour is the founder of VapeMentors, working with vaping businesses around the world.
