Category: Regulation

South African Researcher Urges Vapor Regulation

Photo: Hazem Mohamed | Dreamstime
Health researchers have called on the South African government to revive legislation intended to regulate e-cigarettes, saying the products don’t help people quit smoking as advertised, reports Business Day.
The Control of Tobacco Products and Electronic Delivery Systems Bill was released for public comment in 2018, but the legislation has yet to be submitted to Parliament. As a result, e-cigarettes and other nicotine-delivery devices remain unregulated in South Africa.
Presenting recent research on e-cigarette use in South Africa, Lekan Ayo-Yusuf, director of the Africa Centre for Tobacco Industry Monitoring and Policy Research at the Sefako Makgatho Health Sciences University, said that more than 95 percent of e-cigarette users continued to smoke and few of them managed to stop smoking for more than six months.
Compared to people who had never used e-cigarettes, the likelihood of kicking the smoking habit for six months to 12 months was 77 percent lower among regular e-cigarette users.
“While the tobacco and e-cigarette industry likes to position e-cigarettes as cessation aids, the limited effectiveness of these products for long-term quitting, the health harms associated with usage and the industry’s clear and targeted marketing to youth are facts which are conveniently omitted from their narrative,” said Ayo-Yusuf.
According to one of the prevalence studies, 2.71 percent of adults, or 1.09-million people, used e-cigarettes daily or occasionally during 2018. Almost all these people (97.5 percent) were regularly smoking cigarettes as well. A separate study found vape shops were clustered in the wealthier parts of urban centers, and two-thirds were within a 20 km radius of a university or college campus.
E-cigarettes have been available in South Africa for more than 10 years but remain untaxed. Recently, the treasury department said it plans to release a discussion paper on tax proposals for electronic nicotine devices.
The recent research has not been published in a peer-reviewed journal.
March 2, 2021
U.S. FDA Sends Another Round of Warning Letters
The U.S. Food and Drug Administration (FDA) issued warning letters to 18 manufacturers selling unauthorized e-liquids. The companies did not submit premarket tobacco product applications (PMTAs) by the Sept. 9, 2020, deadline. It’s the second time in February 2021 that the agency has sent warning letters for illegal e-liquids.
Peanut Butter Crunch Time from California Vaping Co.
The companies that received warning letters include Square Vape Labs, The Vapor Emporium, Tally Ho Vapor Tonic, The Vape Corner., Dripco d/b/a Dripco Vape Co., VaporIce, Vapor Maven E-Juice, Vapor City Plus, Vapor Invasion, Vaporatory, Chuckin’ Clouds Vape Shop, Black Dog Reserve, California Vaping Company, The Chubby Baker, Smooth, Bulldog Vapor, Adore eLiquid and E-Cig Outlet.
While each warning letter issued cites specific products as examples, collectively these companies have listed a combined total of more than 234,000 products with the FDA.
Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to the FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, the FDA generally intends to continue to defer enforcement for up to one year pending review unless there is a negative action taken by the FDA on the application.
The FDA recently published an update on its progress on the processing and review of the applications received by Sept. 9, including a list of companies that submitted timely applications.
March 1, 2021
Bidi Vapor PMTA Moves to Substantive Review Phase
Kaival Brands Innovations Group, the global distributor of all Bidi Vapor products, announced its premarket tobacco product application (PMTA) has moved the substantive review phase of the regulatory process. Bidi’s disposable e-cigarettes, Bidi Stick, comes in 11 flavor varieties, according to a press release.
Substantive Review is where the scientific review of the U.S. FDA’s regulatory process is undertaken. The company received its acceptance letter, the first step, on Feb. 9. The FDA will determine if Bidi products meet the criteria for “appropriate for the protection of the public health” established in the Tobacco Control Act. The agency issues marketing orders that authorize the continued marketing and sale of products meeting the criteria.
“Seeking an order for the continued marketing of Bidi Sticks in the United States is a long process. But it was always our goal to provide a premium vaping experience and an option to traditional, combustible tobacco that meets the needs of every adult smoker,” said Niraj Patel, the president and CEO of Kaival Brands. “This substantive review phase is where months of extensive information collection and hard work gathering together 285,000 pages of science-based evidence will pay off, as we continually put consumer health and the environment first.”
Bidi Vapor also announced they have discontinued their online direct-to-consumer (DTC) sales through its website as of February 22, 2021. The company will allow sales through gopuff.com. “With a long history of distribution of alcoholic beverages, goPuff has pioneered a very stringent and dynamic compliance program and age-gating process,” the release states.
“We are extremely excited to partner with one of the fastest growing and most secure online delivery services in the country,” stated Kaival Brands’ Chief Executive Officer, Niraj Patel. “More importantly, goPuff’s commitment to protecting minors and stringent procedural implementations will allow Kaival Brands to focus on our rapidly developing additional wholesaler distribution agreements.”
While Kaival Brands will continue its business-to-business (B2B) online sales to retailers, it believes its decision to halt online DTC sales specifically through www.bidivapor.com will set an example for the industry and help reduce the larger problem of underage access to vaping devices. “The decision also bolsters its commitment to brick-and-mortar retail, which Kaival Brands believes to be a stronger age-verification distribution model than online sales,” the release states.
February 24, 2021
FDA ‘Public List’ of Products has Critical Flaws
By Bryan Haynes, Troutman Pepper
On February 16, 2021, the Food and Drug Administration (FDA) published the long-awaited “public list” of “deemed” tobacco products that: (1) were on the US market on August 8, 2016, (2) are currently on the US market, and (3) were the subject of a request for marketing authorization submitted to FDA by September 9, 2020.
The stated intent of the “public list” is to advise stakeholders of “deemed” tobacco products that can be legally sold in the United States. However, FDA’s approach to the list leaves critical gaps that, in many cases, fails to apprise stakeholders of unlawfully marketed products and, in other cases, fails to identify products that are lawfully marketed.
The initial version of the list includes cigar, pipe tobacco and waterpipe tobacco products that were the subject of substantial equivalence (SE) or exemption from substantial equivalence (EXSE) applications filed by September 9, 2020. However, the list expressly does not include any submissions for electronic nicotine delivery systems (ENDS), apparently because FDA has not yet completed its intake review of the thousands of Premarket Tobacco Applications (PMTAs) submitted for ENDS products.
This omission is striking, given what appears to be the plethora of ENDS products that are currently on the market and for which no PMTA was submitted by the manufacturer or importer. Although FDA has issued a few warning letters to sellers of these unauthorized products, it appears that these warning letters have only scratched the surface of unauthorized products.
The “public list” is also underinclusive in that it does not contain “deemed” products that are grandfathered from the premarket review process. Under the Family Smoking Prevention and Tobacco Control Act, products sold in the US as of February 15, 2007 (and unchanged since then) are not subject to premarket review. There are thousands of grandfathered deemed products that are not subject to premarket review.
Although FDA has published a separate database of products that have received standalone grandfather determinations, industry stakeholders are rightly concerned that distributors and retailers may conclude a product is not legally marketed if it does not appear on the “public list.” Distributors and retailers would need to separately consult the grandfather database, which is itself underinclusive because there are many grandfathered products that have not received formal FDA determinations.
The “public list” is also underinclusive in that it does not contain “deemed” products that have actually received FDA marketing authorization. For that, stakeholders would need to consult separate databases of products that have received either SE, EXSE or PMTA marketing orders. However, those databases are not current. Indeed, to our knowledge, there are scores of deemed products that obtained FDA marketing authorization months ago, and those products have not been identified in any of FDA’s databases.
The “public list” was ostensibly designed to be a tool for stakeholders to understand products that can, and cannot, be legally marketed in the United States. In order to better advise the public as to which products can legally be sold, FDA will need to expedite the inclusion of ENDS products on the list, as well as consider better ways to advise the public of products that are exempt from premarket review or that have obtained marketing authorization.
The above opinion may not be the same as Vapor Voice or it’s staff. Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
This article first appeared on tobaccolawblog.com.
February 23, 2021
Utah Lawmakers Want Control of Nicotine Limits
The a new bill in the U.S. state of Utah seeks to un-do some vaping restrictions in the state. S.B. 134 would raise the standard of 24 mg/ml to 65 mg/ml if passed. Senator Curtis Bramble, the lawmaker behind the bill, says that the current standard bars 70 to 80 percent of all vape products on the market.
Credit: Tyler Moore
“We’ve done everything prudent to limit access of these products to youth; the question is if these are legal products in the US, should it be by administrative rule that they are prohibited or should it by an affirmative vote of the legislature that we limit the market?” Senator Bramble asked during a senate committee.
Over the last few years, Utah’s state legislature has given the Utah Department of Health (UDH) the power to limit nicotine sales and quantities in Utah. Beginning in 2020, UDH set a standard of 24 mg/mL of nicotine in vaping products sold in the state.
Beyond raising the nicotine standards, the law would also strip UDH of the ability to create these kinds of limits. Opponents to S.B. 134 say the more limits to nicotine the better, no matter where those limits are coming from.
“We have a youth addiction problem with nicotine; we have 30,000 youth in Utah vaping. Why on earth would the legislature want to increase the amount of nicotine?” asked Walter Plumb, the president of Drug Safe Utah, said, according to a story on abc4.com.
The bill has passed in a Senate committee and is waiting for a vote by the full Senate.
February 22, 2021
U.S. FDA has Processed PMTAs for 4.8 Million Products
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.
Mitch Zeller speaking at a TMA annual meeting. Photo: Taco Tuinstra
FDA Center for Tobacco Products (CTP) director Mitch Zeller stated as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies. “We have accepted applications for about 84,000 products and refused to accept applications for about 3,100 products submitted through the PMTA pathway,” wrote Zeller. “As of mid-January 2021, of the applications submitted by Sept. 9, we have filed applications for about 29,000 products and refused to file applications for about 1,650 products submitted through the PMTA pathway.”
He also stated that several factors have slowed the agency’s progress in getting application’s into the system. Companies submitted PMTAs differently, for example some applicants provided information on one product per submission while other applicants provided information for all of the company’s products within one submission.
“One firm submitted information on more than 4 million tobacco products within a single submission,” Zeller wrote. “The amount of content in each submission also greatly varied, with some applications including up to 2,000,000 files where each file contains multiple pages of content for FDA to review.” The letter is part of a pledge Zeller made that the agency would keep interested stakeholders updated on the agency’s progress.
FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency did not receive a product application. To date, the FDA has sent warning letters to 30 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, which lack premarket authorization, according to the letter.
The agency also stated that the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low. Because of the sheer number of applications, the agency has set aside the products with the greatest market share and will push those products through the process more quickly. “[We will] focus resources on products where scientific review will have the greatest public health impact, based on their market share, while also committing to providing an opportunity for review to all companies,” Zeller wrote. This could prove positive or negative as a quick denial would force the product off the market.
The agency can still not confirm when it would release a list of products that are approved to be on the market. Zeller wrote that the agency continues to work on processing submissions and verifying the dates of initial marketing and current marketing status of products that submitted a timely PMTA.
“We have already verified this information for around 86,000 products received through the PMTA pathway,” he wrote. “Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time.”

February 16, 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
New Jersey Wants to Ban Vape Sales in Pharmacies
New Jersey is one step closer to banning pharmacies in the state from selling any deemed tobacco products, including e-cigarettes.
The Senate Health, Human Services and Senior Citizens Committee approved legislation the legislation sponsored by Senator Joe Vitale, S-1144, would prohibit the sale of all tobacco products and electronic smoking devices at pharmacies, however, department stores and food retailers licensed to operate a pharmacy on its premises or lease space to a third party to run a pharmacy would not be subject to the prohibition.
Credit: CVS
“Pharmacies have the important responsibility of making and dispensing medicine to patients in the community and providing them with health advice to help them get well,” said Senator Vitale (D-Middlesex), who is chairman of the Senate’s health committee. “With tobacco as the leading cause of preventable death and disease in the nation, it’s antithetical that pharmacies sell tobacco products and smoking devices.”
Research shows most smokers begin using tobacco products as minors and that pharmacies are an important point of access for young users, Senator Vitale noted in a press release. It also suggests that banning tobacco sales in pharmacies can reduce “tobacco retail outlet density,” which is associated with higher rates of youth usage as well as racial and economic disparities in tobacco use.
The owners of any businesses caught violating the ban would be subject to a civil penalty of not less than $250 for a first violation, $500 for a second violation, and $1,000 for a third or subsequent violation.
The bill exempts food and department stores because previous versions of the bill had stalled in the Senate Budget & Appropriations Committee because they had not included that exemption. CVS has not sold tobacco in its stores nationwide since 2014 while Wegmans stopped selling them in 2008.
February 14, 2021
U.S. FDA Sends 11 Warning Letters for Illegal Products

The U.S. FDA issued warning letters today to 11 firms who manufacture and sell unauthorized e-liquids for premarket tobacco product application (PMTA) violations. The regulatory agency advised the manufacturers that selling products which lack PMTA authorization is illegal, and therefore cannot be sold or distributed in the U.S. The firms did not submit PMTA by the Sept. 9, 2020 deadline.
The firms receiving warning letters are Jojo’s Smokeless World Inc. d/b/a Mod Shield; Sugar Vapor Company; DC Vapor, Inc.; Take Off Corp; The Vapor Spot, LLC; Premium Vapor Technologies LLC; Vaping Xtreme, LLC; Vapes Gone Wild Juice, LLC; Vapeoholic LLC; Vaporescence LLC d/b/a Vape King USA; and Elemental Vapor Bar, LLC.
Credit: Premium Vapor Technologies
While each warning letter issued today cites specific products as examples, collectively these companies have listed a combined total of more than 150,000 products with the FDA, according to a to the FDA’s website.
Following an initial set of such warning letters announced earlier this year, FDA has continued to issue additional warning letters for these types of products. The FDA sent 10 warning letters in mid-January.
“Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016—including e-liquids—were required to be submitted to FDA by Sept. 9, 2020. For companies that submitted applications by that deadline, FDA generally intends to continue to defer enforcement for up to one year pending FDA review, unless there is a negative action taken by FDA on the application,” the agency wrote. “In line with the agency’s stated enforcement priorities, after Sept. 9, 2020, FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency has not received a timely product application.”
February 12, 2021
Bidi Vapor Announces PMTA Acceptance Letter
After submitting its PMTA application to the U.S. FDA on Sept. 8, 2020, Bidi Vapor, the producer of the Bidi Stick closed system, announced yesterday that it had received a PMTA acceptance letter from the regulatory agency.
“It has always been our goal to provide a premium vape experience as an option to traditional, combustible tobacco that meets the needs of every adult smoker, age 21 and older,” said Niraj Patel, the president and CEO of Bidi Vapor and Kaival Brands Innovations Group, global distributor of all Bidi brand products “We couldn’t be more pleased that we are one step further in achieving this goal.”
The company now waits for a filing letter from the FDA. The Bidi Stick PMTAs would then move on to the Substantive Review phase where the scientific data is analyzed. The Bidi Stick, is the fastest-growing closed system vaping product in the U.S., based on Goldman Sachs’ equity research report on the Nielsen data for total nicotine volumes in 2020. Nielsen data showed the Bidi Stick as the second-largest disposable electronic nicotine-delivery system (ENDS) offering based on retail sales for previous 52-week period.
The acceptance letter covers all 11 flavors in the Bidi Stick lineup. “Moving to the filing and, we anticipate, to the substantive review phase of the PMTA process is where our months of extensive data collection, investment and hard work assembling 285,000 pages of science-based evidence will pay off,” Patel said. “Receipt of the acceptance letter is a major step, as we await the FDA’s filing letter and then substantive review of our products.”
The press release also states that the Bidi Stick is also the only adult-focused vape product on the market with an ecologically friendly, mass-recycling program. Kaival Brands also recently launched Bidi Vapor ‘s Bidi Pouch, a tobacco-free nicotine pouch.
February 10, 2021