Category: Regulation

The Smoker’s Alternative Receives FDA Warning No. 104
The agency isn’t slowing down. In the U.S. Food and Drug Administration’s (FDA) quest to relieve the market of illegal vapor products, the regulatory agency has issued 104 warning letters since Jan. 1, 2021. The latest recipient is Texas-based The Smoker’s Alternative. The letters were sent today May, 11, and posted the FDA’s website the same day.
The FDA states that The Smoker’s Alternative did “manufacture, sell, and/or distribute to customers in the United States The Smoker’s Alternative Vanilla Custard 60 ml 3mg e-liquid product without a marketing authorization order.” In order to legally sell vaping products, a company must have submitted a premarket tobacco product authorization (PMTA) to the FDA’s Center for Tobacco Products by Sept. 9, 2020.
The FDA often only lists a product or two that a company is selling as illegal. 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.
:Your firm is a registered manufacturer with over 1,800 products listed with FDA,” the FDA letter to The Smoker’s Alternative states. “It is your responsibility to ensure that your tobacco products comply with each applicable provision of the FD&C Act and FDA’s implementing regulations. Failure to adequately address this matter may lead to regulatory action, including, but not limited to, civil money penalties, seizure, and/or injunction.”
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.
May 11, 2021
Governor Inks Bill to Regulate Vapor Products in Florida
Florida lawmakers have overwhelmingly passed a bill signed by Governor Ron DeSantis Friday that will create a state regulatory framework for the sale of electronic cigarettes. The bill (SB 1080) will take effect Oct. 1. Among other things, the bill will raise the state’s legal age to vape and smoke tobacco to 21, a threshold already established in federal law.
Credit: Giban
It also would create a state regulatory framework for the sale of vapor products. The bill would ban vaping or smoking tobacco within 1,000 feet of a school and makes it illegal for local communities to create any regulations impacting the “marketing, sale, or delivery of, tobacco products.” It would also require retailers to obtain a “tobacco” permit.
House sponsor Jackie Toledo, R-Tampa, said before the bill passed that it is aimed at preventing minors from using electronic cigarettes. “This bill is necessary to stop youth vaping,” Toledo said.

May 8, 2021
FDA Issues 103rd PMTA Warning to Custom Vapes
Since Jan. 1, 2021, the U.S. Food and Drug Administration (FDA) has issued a total of 103 warning letters to firms selling or distributing over 904,000 unauthorized vaping products and who did not submit premarket tobacco product applications (PMTAs) by the Sept. 9 deadline.
Credit: Marcus Krauss
In April alone, the regulatory agency issued a total of 24 warning letters to companies that manufacture and sell unauthorized e-liquids, advising them that selling products which lack premarket authorization is illegal and therefore they cannot be sold or distributed in the U.S. While each of these 24 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively these firms have listed a combined total of more than 154,000 products with the FDA, according to an FDA statement.
The 103rd warning letter was issued on March 6 and posted to the FDA’s website on the same day. The 103rd letter was received Mississippi-based Custom Vapes. The FDA states that the company did “manufacture, sell, and/or distribute to customers in the United States Custom Vapes Amaretto 3MG 3ML 70VG/30PG e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 2,300 products listed with the regulatory agency.
Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products.
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.
May 7, 2021
FDA: 102 Warnings for Illegal E-liquid Sales so Far in 2021
It is now at 102 in 2021. Posting on its website on April 30 that it has issued six more warning letters to companies for marketing illegal e-liquids, the U.S. Food and Drug Administration (FDA) continues its blitz to pull any vaping products from the U.S. market that haven’t submitted a premarket tobacco product application (PMTA) to the FDA’s Center for Tobacco Products.
Credit: Yuri Hoyda
Unfortunately, the FDA often only lists a product or two that a company is selling as illegal. 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 companies receiving the letters on April 9, the products they were cited for and the number of products each has registered with the FDA include:

Smoking Fire Vapor: e-liquid products without a marketing authorization order including: Smokin’ Fire Vapor Captain Custard and Smokin’ Fire Vapor Wrecking Ball; registered manufacturer with over 180 products listed with FDA.

Simply E-Juice: e-liquid without a marketing authorization order including: Simply Bodacious Blueberry and Simply Glorious Grape; registered manufacturer with over 200 products listed with FDA.

Smokecignals: e-liquid products without a marketing authorization order including: Blue Puppet and Black Frost; registered manufacturer with over 100 products listed with FDA.

Rocky Top Vapor: e-liquid products without a marketing authorization order including: RTV LTD Berry Shake and RTV LTD Pink Lemonade; registered manufacturer with over 470 products listed with FDA.

VaporBombCOM: e-liquid products without a marketing authorization order including VaporBomb.com: Cafe Mocha and Cinnamon Danish Swirl; a registered manufacturer with over 2,200 listed with FDA.

B-X Vapor: e-liquid products without a marketing authorization order including: B-X Vapor Dad’s Milk and B-X Vapor Watermelon Crack; registered manufacturer with over 1,100 products listed with FDA.
The regulatory agency has now issued warning letters to 102 companies in 2021 for violating PMTA rules. 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.
In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.
May 3, 2021
First City in Taiwan Drafts Rules to Ban Vapor Products
The New Taipei City Council on Thursday approved an ordinance to ban the sale of e-cigarettes. If approved by the Executive Yuan, the legislation would make New Taipei the first of the nation’s six special municipalities to impose such a ban if it is approved.
Credit: Busara
The draft regulation prohibits manufacturing, importation, sale, display and advertising of vaping devices, and heated tobacco products and components without an individual drug or medical device license issued by the city government, according to the Taipei Times. Violators of the ban would be fined NT$10,000 to NT$100,000, and sales licenses of repeat offenders would be suspended, the draft regulation states.
It also prohibits people under the age of 18 to use smoking devices banned from sale in the city and violators of the rule must attend smoking cessation classes, and those who fail to attend the classes would be fined NT$2,000 to NT$10,000. New Taipei City Department of Health Director Chen Ran-chou said that the ordinance seeks to protect people from the health risks of e-cigarettes and safeguard public health.
The draft regulation was sent to the Executive Yuan and would take effect three months after it is approved, she said. The Taipei City Council is also reviewing a similar draft regulation, which is expected to clear the council next week.
On the national level, the Ministry of Health and Welfare has proposed an amendment to the Tobacco Hazards Prevention Act, seeking to raise the legal age for smoking from 18 to 20 and regulating e-cigarettes and related products. That amendment would move to the legislature for approval if approved by the Executive Yuan.
April 30, 2021
Florida Bill Banning Local Vape Laws Goes to Governor
The governor of Florida is expected to sign a bill that would ban local communities from enacting laws regulating e-cigarettes. The Florida House on Wednesday gave its final approval with a 103-13 and sent the bill (SB 1080) to Governor Rick DeSantis for a signature. The bill passed the Senate on Monday.
Credit: Aleksandr Kondratov
House sponsor Jackie Toledo told the Tallahassee Democrat that the bill is aimed at preventing minors from using electronic cigarettes. “This bill is necessary to stop youth vaping,” Toledo said.
The bill would raises the state’s legal age to smoke and vape to 21, a threshold already established in federal law. It also would create a state regulatory framework for the sale of vapor products. The bill would ban vaping or smoking tobacco within 1,000 feet of a school and makes it illegal for local communities to create any regulations impacting the “marketing, sale, or delivery of, tobacco products.” It would also require retailers to obtain a “tobacco” permit.
“Years of continued inaction by the state to regulate tobacco products, including e-cigarettes, demands strong, local laws that truly protect our children from a lifetime of addiction,” the American Cancer Society Cancer Action Network said in a statement this week. “Florida kids deserve effective protections, not to be left even more vulnerable to the industry and its predatory practices. And our localities have the right, freedom and responsibility to protect them, especially when the state won’t.”
Backers of the proposals, however, have said they would help with enforcement of tobacco and vaping laws and that preemption of local regulations is needed because retailers could have multiple stores in different areas, which would make it hard to follow varying regulations and do business.
April 29, 2021
Montana Passes Bill to Stop Local Flavored Vapor Bans
The Montana legislature on Monday passed a bill that would block local governments from banning the sale of flavored vaping products. The legislation has been sent to the governor’s desk. Senate Bill 398 was carried by Sen. Jason Ellsworth, a Republican from Hamilton. It cleared a final vote in the House, 59-40.
Credit: Katherine Welles
The bill says local governments may not adopt or enforce any ordinances or resolution that prohibit the sale of vaping products. Under the bill, a local government could enact a “reasonable” ordinance or resolution related to the sale of vaping products, according to helenaire.com. While the bill does not define “reasonable,” Ellsworth said to his thinking that could mean something like keeping products out of reach of children in stores or not allowing vaping in restaurants.
Carrying the bill in the House on Monday, Missoula Republican Rep. Mike Hopkins said local governments shouldn’t have the authority to ban the sale of a legal product. “What they seek to do is make illegal what is a completely legal (product) and in the process of doing so smash the economic and financial lives of Montanans who are running businesses,” Hopkins said.
Rep. Mark Thane, a Missoula Democrat, said flavored vaping products are meant to entice youth to take up vaping and that local ordinances are essential to public health. “We have a choice with this bill. We can side with Montana communities and allow them to retain a tool which they can use to help tackle this epidemic or we can prohibit local communities from taking that initiative,” Thane said.
The 2019 Montana Youth Risk Behavior Survey shows that 58.3% of students had vaped in the 30 days prior to the survey. At one point, Ellsworth’s bill was voted down in the Senate before being revived.
Earlier this session, Rep. Ron Marshall, R-Hamilton, brought a bill that would have barred a local government or the state Department of Public Health and Human Services from creating or continuing a regulation, ordinance or restriction related to vaping products. That bill passed the House in February but later was voted down in the Senate Business, Labor and Economic Affairs Committee. Marshall is a co-owner of a vaping shop.
April 28, 2021
FDA Hands Down 4 More Letters for Illegal E-liquids
Four more companies have received warning letters for violating marketing orders for the sale of e-liquids. The U.S. Food and Drug Administration (FDA) says the companies failed to submit a premarket tobacco product applications (PMTA) by the Sept. 9, 2020 deadline. The regulatory agency posted the letters to RP Vapor, DIY Vapor Supply, Electric Freedom (Crown7) and KV Liquids were received on April 23 and posted to the FDA website on April 27.
RP Vapor has over 4,600 products listed with the FDA. DIY Vapor Supply is the registered manufacturer for over 73,300 products listed with FDA. Electric Freedom has over 80 products listed with the FDA, while KV Liquids has more than 300. The FDA states that “the violations discussed in this letter do not necessarily constitute an exhaustive list” and companies should quickly address any products that violate the same rules as the product mentioned in the letter. This means that the company may or may not have submitted a PMTA for some of its registered products.
The regulatory agency has now issued warning letters to 96 companies in 2021 for violating PMTA rules. 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.
In February, the director of the FDA’s Center for Tobacco Products, Mitch Zeller, said that there were over 400 million vaping-related products that required a PMTA in order to remain on the market. “These warning letters are the result of continued surveillance and internet monitoring for violations of tobacco laws and regulations. We want to make clear to all tobacco product manufacturers and retailers that the FDA is keeping a close watch on the marketplace and will hold companies accountable for breaking the law,” said Zeller.
April 28, 2021
Beard Management Says PMTA has Advanced to Filing Stage
Beard Management announced that its premarket tobacco product application (PMTA) has advanced to the filing stage of the regulatory review process. Beard submitted 45 of its nicotine-based e-liquids to the U.S. Food and Drug Administration (FDA), including its The One and Beard Vape Co. brands. Blackbriar Regulatory Services (BRS), the company’s manufacturing partner and FDA agent of record, will be responsible for assisting Beard throughout the next steps of the FDA regulatory process.
“We are pleased to see our application moving through the PMTA process in order to scientifically demonstrate our products are appropriate for the protection of public health,” said Casey Bates, CFO at Beard, stated in a press release. “Partnering with BRS as our manufacturer gives us much broader access to a multitude of regulatory and scientific data that is critical to our ongoing PMTA work.”
BRS is providing Beard with cost-effective, turnkey solutions for manufacturing and regulatory needs, using a science-driven approach to testing for harmful and potentially harmful constituents, demonstrating good manufacturing practices, as well as providing additional analytical lab testing critical to the PMTA process, according to the release.
“We are very happy to be managing Beard’s PMTAs,” said Russ Rogers, CEO at BRS. “We have strong respect for the quality and brand marketing of their products, and we are confident that we can help Beard to achieve a marketing order from the FDA.”
April 28, 2021
Artisan Vapor & CBD PMTA Accepted by FDA
The Artisan Vapor & CBD company announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). The company submitted 39 e-liquid products, seven of which are nicotine salt blends, according to its website.
Credit: Artisan Vapor & CBD
The company announced in a press release that its research included in the submission offered “detailed scientific research demonstrating that their products are appropriate for adult use.” No specific date was given for when Artisan received its acceptance letter, only that the letter was received in April.
Founded in Texas in 2013, Artisan Vapor & CBD has grown to become one of the largest vapor retailers in the world, with more than 70 stores operating across three continents, according to its website. The company now waits for a filing letter from the FDA. Artisan’s application would then move on to the Substantive Review phase where the scientific data is analyzed.
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
April 28, 2021