Tag: Shop Talk

FDA Continues Warning Letter Blitz for PMTA Offenses
The U.S. Food and Drug Administration (FDA) continues to be adamant about removing illegal e-liquids from the market. On Tuesday, the regulatory agency issued two more warning letters for companies selling e-liquids without having filed a premarket tobacco product application (PMTA). The total now stands at 115 companies that have received notice since Jan.1 of this year.
Credit: Hurricane Hank
Adirondack Juice d/b/a Adirondack Vapor & Co. and Blue Eyed Vapor (BEV) received the letters from the FDA on May 14, however the agency didn’t post the letters to its website until May 25. Adirondack and BEV both were accused of selling or marketing multiple e-liquid flavors. The companies have 5,800 and 20 products registered with the FDA, respectively.
Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. 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 current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
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.
May 27, 2021
VPZ Announces Record Sales, Quit Clinics Launch
A major vaping retailer in the UK is launching a new vape clinic service with a goal of helping to increase numbers of smokers quit. The move comes as VPZ vape shops announced a 165 percent increase in “New to Vaping” kit sales in the first week of re-opening following the relaxation of Lockdown measures.
Credit: VPZ
The uptake and demand for stop smoking services underlines and re-affirms VPZ’s recent calls for vaping stores to be classed as an essential retailer during the Pandemic, according to VPZ director Doug Mutter. “We are investing to help smokers quit and to support the country in its ambition to be a tobacco free nation by 2030.”
Following over a year of having no NHS stop smoking services available, the company has been inundated with smokers looking to quit since reopening its full estate of stores on 26 April, according to Mutter. The retailer has seen a huge demand for New to Vaping (NTV) kits since it reopened its 150+ UK stores, with an unprecedented demand for NTV kits in the first week.
“With access to local stop smoking services and vaping retailers massively reduced during lockdown, thousands of smokers have been left without any services to help them quit,” a press release states. “Since re-opening its stores to bring customers a Covid-secure retail experience, VPZ has faced record demand from smokers looking for expert advice and personalized support to help them make the switch.”
The quit clinic investment and recruitment drive are part of VPZ’s commitment to play its part in helping the UK achieve its ambitions to be a tobacco-free nation by 2030, set out by the Government in 2017. “VPZ is the UK’s leading vaping specialist and we are spearheading the fight against the nation’s number one killer – smoking,” said Mutter. “We are excited to be launching the Vape Clinic concept following strong demand and recognizing the need for an enhanced level of service since reopening our doors. The huge reduction in NHS stop-smoking services, through COVID-19 and local authority cuts have been devastating in the country’s efforts to reduce smoking rates.”
May 17, 2021
USPS Publish ENDS Guidance, CBD Exemption Update
The United States Postal Service (USPS) has published its guidance for mailing vaping products on the Federal Register. The notice provides some clarity on USPS policy and outlined potential exceptions, which could include legal hemp and its derivatives. Until the final rule is issued, ENDS are not subject to the Prevent All Cigarette Trafficking (PACT) Act. The USPS also says that it will not review any exemption applications before the rule is finalized. The agency did, however, state that it has attempted to streamline the application process.
The USPS makes reference to possibly exempting cannabis products. Other exceptions include intrastate shipping within Alaska and Hawaii, shipment 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.
Credit: Bruce Emmerling
When filing for exemption status for mailings related to possibly exempt situations such as legal hemp and CBD products, business-to-business and research, the USPS guidance suggests that applicants create a spreadsheet that contains the following data elements with respect to each sender and recipient address that they intend to identify in their exemption application:

Business or governmental entity name.

Address.

The Postal Service retail or business mail acceptance office(s) where each intended sender would tender shipments.

The Postal Service retail office(s) where each intended recipient would retrieve shipments.

A description of the business or governmental entity (e.g., battery manufacturer, retail store, wholesale distributor, testing laboratory).

For each permit or license, the issuing jurisdiction; the permit or license number; the expiration date (if any); and the activity covered by each current permit or license (e.g., general business operations; sale or manufacture of tobacco products or ENDS).

For each sender or addressee engaged in testing, investigation, or research, the entities authorizing the conduct of such activities; the expiration date (if any) of such authorization; and a brief statement of the subject of each authorization (e.g., health effects of flavor substances, medical effects of cannabidiol (“CBD”), battery safety testing).

The brand name and a description of each product intended to be shipped by each sender or to each addressee.

Whether any identified products or other intended shipments from each sender or to each addressee contain lithium batteries, nicotine, CBD, or tetrahydrocannabinol (“THC”).

For products containing nicotine or THC, the intended quantity of the product per shipment and the concentration of nicotine or THC.

For products containing CBD with a THC concentration not exceeding 0.3 percent, whether the CBD derives from hemp.
“If any of the relevant exceptions are ultimately made available for [electronic nicotine delivery systems (ENDS)], then, given the highly decentralized nature of the ENDS industry relative to the industries historically covered by the PACT Act, the Postal Service anticipates receiving ENDS-related exception applications at a rate several orders of magnitude above the historic norm,” the guidance reads. “The Postal Service has not yet determined whether and to what extent those exceptions will be extended to ENDS. Early acceptance of applications would pose significant administrative challenges for the very Postal Service personnel who are developing the final rule amid substantial public comment under a tight timeframe.
Credit: blr60
“The Postal Service understands that those concerns are heightened by Congress’s decision to make ENDS nonmailable immediately upon publication of the final rule, rather than applying the 30-day notice period that typically follows a final rule under the Administrative Procedure Act. Therefore, this document is intended to clarify the state of the exception application process in advance of the final rule and to provide guidance to mailers interested in availing themselves of any exceptions that may ultimately be made available.”
Creating spreadsheets listing every address is an arduous task, according to many vaping industry businesses, however it’s just one of the requirements placed on business owners when the federal government placed electronic nicotine-delivery system (ENDS) products under the PACT Act rules. Among other requirements, the PACT Act also stipulates that manufacturers register with the Bureau of Alcohol, Tobacco, Firearm and Explosives (ATF), as well as file monthly reports with state tobacco tax administrators.
Effective March 28th, 2021, recipients of all vaping product(s) purchased online are required, by law, to present ID and sign for their delivery. Many states are expecting businesses to start filing monthly reports on May 10 and the USPS is expecting to post the final rule and officially end the mailing of ENDS products to consumers on April 27. The rules are also having an impact internationally. The U.K. Vaping Industry Association (UKVIA), for example, has expressed “deep concern” about the measures, saying that U.K. business are affected.
April 21, 2021
Avail Vapor to Carry Bantam Vape E-liquids in Stores
Bantam Vape announced that its e-liquid products are now available for purchase through Avail Vapor’s specialized brick-and-mortar locations, as well as on its e-commerce website, www.availvapor.com. Avail will offer a wide selection of Bantam’s products including Sour Strawberry and Kiwi Berry, according to a press release.
“Bantam is known for our artisanal flavors that are built from scratch using only high-quality ingredients, as well as our commitment to compliance and transparency,” said Bantam director of sales Michelle Gottlich. “Joining with an established leader in the vaping category like Avail poses an exciting opportunity as we continue to expand our retail and online presence; and most importantly, gives our consumers greater access to our products.”
All of Bantam’s flavors are backed by science, manufactured in certified clean rooms and undergo rigid testing and analysis, “resulting in smooth, clean-tasting e-liquids, making Bantam Vape your coil’s best friend,” the release states. Additionally, the brand’s premarket tobacco product application (PMTA) submission to the U.S. Food and Drug Administration (FDA) is queued for formal scientific review.
“We recognize that Bantam, like Avail, is dedicated to providing consumers with products that echo our principals of exceptional quality and flavors,” said Justin Murphy, Avail’s vice president of retail operations and marketing. “We are excited to stock the variety of flavors, nicotine level options and reliable quality of merchandise that the Bantam brand offers.”
April 20, 2021
FDA Cleaning House With 80 Vapor Warning Letters in 2021
The total number of warning letters issued by the U.S. Food and Drug Administration (FDA) to e-liquid manufacturers for illegally marketing vapor products now stands at 80 in 2021. The FDA issued four more warning letters for marketing illegal vapor products. Kidney Puncher, Vapor Gold, Violet Vapor and Voltage Vapor all received letters on March 26 and those letters were posted to the FDA’s website on April 1.
The FDA states that the company’s failed to submit premarket tobacco product applications (PMTA) by the required Sept. 9, 2020 deadline. The FDA also 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.
Kidney Puncher has more than 1,000 products registered with the FDA; Vapors Gold has more than 500; Voltage Vapor has more than 1,500 products registered; and Violet Vapor has more than 4,900 products listed with the regulatory agency.
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.
April 4, 2021
No. 70: The FDA Issues Vintage Vapors PMTA Warning Letter
The U.S. Food and Drug Administration (FDA) issued its 70th warning letter this year to a company the regulatory agency says is violating marketing rules. Vintage Vapors received the letter on March 22 and the FDA posted the information on its website on March 25.
The FDA states that it determined the company did “manufacture, sell, and/or distribute to customers in the United States Vintage Vapors Unflavored Tobacco 03MG 30/70 e-liquid product without a marketing authorization order.” Premarket tobacco product applications (PMTA) were due to be submitted to the FDA by Sept. 9, 2020.
The FDA also 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. “Your firm is a registered manufacturer with 1,433 products listed with FDA. 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,” the letter states.
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.
March 28, 2021
FDA Received Over 15,000 PMTAs in FY2020
Update: 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, according to a press release.
More than 15,000 premarket tobacco product applications (PMTA) were submitted to the U.S. Food and Drug Administration (FDA) during fiscal year 2020, according to data provided on the regulatory agency’s website.
In August 2020, the FDA received 10,184 applications and in September 2020 it received 4,567. Prior to August, the FDA had only received 686 applications. The FDA does not distinguish how many of those products are electronic nicotine-delivery system (ENDS) devices.
Of the 15,437 applications turned in during fiscal year 2020 (October 2019 to September 2020), 767 PMTAs were closed, according to FDA data. An application is considered closed after the FDA issues an order letter, a refuse-to-accept letter or the PMTA is withdrawn by the applicant.
Companies that submitted a PMTA by the Sept. 9, 2020 deadline and were previously on the market before Aug. 8, 2016, can remain on the market for up to one year while the FDA reviews the PMTA. The FDA said it will release a list of the deemed new tobacco products that were subject to the Sept. 9 PMTA deadline, however, no date has set for the list’s release.
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February 16, 2021
Indiana Introduces Annual Bill to Boost Vapor Tax
The Indiana state legislature has begun to debate raising taxes on vaping products … again. The annual introduction centers on a proposed tax rate of $1.56 on a two-pod pack, the equal nicotine content to a pack of combustible cigarettes.
Credit: Davis Mark
Indiana’s traditional cigarette tax of just under a dollar a pack is the 13th lowest in the nation. Legislators are considering a bill to double it, and tax e-cigarettes for the first time, according to an article on wibc.com. Marion County health director Virginia Caine says it’s critical to include e-liquids in the bill.
She says vaping among teenagers has doubled in the last two years, wiping out any progress the state has made in reducing teenage smoking. Recent U.S. CDC reports say that teen smoking rates declined in 2020. Mason Odle, owner of Just Vapors in Fishers, says he fully supports raising the cigarette tax, but argues e-liquids shouldn’t be included.
He contends e-cigarettes are a more popular and effective means of quitting smoking than FDA-approved products like nicotine gum or patches. That brought a fierce pushback from health officials, who point out the FDA has specifically banned vape manufacturers from marketing their product as a stop-smoking aid until they produce more evidence that it works. And Caine says there are serious concerns about lung damage from vaping.
Former Libertarian candidate for governor Don Rainwater argues increasing cigarette taxes would punish store owners at a time when they’re already reeling from the coronavirus pandemic. But the main objection from House Public Health Committee members centered on the lack of a specific plan for the proceeds from the tax. A vote has been put off till next week to add language earmarking the money for health programs.
Governor Holcomb and House and Senate leaders have all said a cigarette tax hike isn’t on their agenda, without flatly ruling out the possibility. The House approved an increase in 2016 and 2017, and a vape tax in 2019. All three times, the proposals died in the Senate.
February 3, 2021
New York Attorney General Cracks Down on Vape Shops
New York Attorney General Letitia James ordered dozens of retailers across the state to immediately stop selling flavored e-cigarette and vaping products and to end underage sales. New York banned flavored vaping products statewide as of May 2020.
New York Attorney General Letitia James
James’ office issued cease and desist letters to 47 retailers that were illegally selling tobacco products throughout New York. The shops were located in the cities and counties of Albany, Buffalo, Elmira, Hamilton, Nassau, Rochester, Saratoga County, Syracuse, Warren County, Watertown, and the New York City area, according to a press release.
“New York banned flavored vaping products and raised the age to buy tobacco products because teens were getting addicted to the dangerous habit of smoking,” said James. “These businesses skirted the law, jeopardizing the health of young New Yorkers. We will remain vigilant in holding anyone accountable who endanger our children by circumventing our laws.”
The release states that investigators discovered retailers selling nicotine products to underage customers and selling flavored nicotine vaping products. Some shops were also selling nicotine-free flavored liquid alongside vaping products for customers to create their own flavored vaping products.
The illicit products were sold both in the open and secretly from behind the counter, according to the release.
December 5, 2020
Bantam E-Liquids Garners Acceptance Letter for PMTA

The legal e-liquid market continues to grow. Bantam Vape announced yesterday that it had received an acceptance letter for its premarket tobacco product application (PMTA) from the U.S. Food and Drug Administration (FDA). The brand’s application now moves to the next step in the PMTA process—a preliminary scientific review to ensure the application contains all required items to permit a substantive review by the FDA.
Bantam submitted its application to the FDA on Sept. 2.
“Bantam has been anticipating and planning for these regulations since entering the e-liquids category,” said Bantam spokesperson Anthony Dillon. “The receipt of this acceptance letter is a significant milestone for Bantam. It reiterates a commitment to providing adult-use consumers with high-quality, science-based and compliant e-liquid products that can be enjoyed for years to come.”
In preparation for its submission, Bantam worked with highly-qualified labs to conduct the in-depth product-specific and non-product specific testing needed for its PMTA, including: storage and stability testing; toxicity testing; and pharmacokinetic and topography studies. Bantam also submitted an extensive review of available literature on electronic nicotine delivery systems (ENDS) products.
“Bantam has always supported the need for science-based regulation for the e-liquids industry. And while the PMTA process is complex and resource intensive, it is necessary to establish much needed standards and oversight across the board,” said Dillon. “Bantam is confident in the content and quality of materials prepared by its hardworking team of experts, and remains committed to working with the FDA throughout the PMTA process.”
October 9, 2020