Category: Regulation

  • Montana Senate Bill Aims to Ban Local Vape Laws

    Montana Senate Bill Aims to Ban Local Vape Laws

    Lawmaker’s bill to stop Montana communities from enacting local ordinances or resolutions to prohibit the sale of any vaping products or alternative nicotine products saw support last week from vape shop owners and opposition from public heath advocates and educators.

    Senate Bill 398 is carried by Republican Sen. Jason Ellsworth. He told the Senate Business, Labor, and Economic Affairs Committee vaping products are legal and should not be banned, according to the Independent Record. “The one thing they cannot do is ban it in totality. It’s a legal product. It should not be banned, but of course they can put sideboards on it,” Ellsworth said.

    Under the bill, a local government could enact a “reasonable” ordinance or resolution related to the sale of vaping products. 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.

    Rep. Ron Marshall, a Republican from Hamilton, spoke in support of the bill. Marshall is co-owner of a vaping store. Earlier this session he 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.

    Reports for the period that include when Ellsworth’s bill was introduced aren’t due yet. At the state level, the Montana Department of Public Health and Human Services proposed to ban flavored vaping products in 2020 over concern that flavors targeted children. Ellsworth was a leader in a push from GOP lawmakers to oppose the ban, which the department eventually dropped.

    After passing the House in February, Marshall’s bill was voted down in the Senate Business, Labor, and Economic Affairs Committee in mid-March. Marshall told the same committee Tuesday in support of Ellsworth’s bill that bans on things like flavored vaping products would hurt businesses like his. He also said local governments shouldn’t have power to create ordinances on vaping products.

  • Alabama House Passes Bill to Raise Age to Vape to 21

    Alabama House Passes Bill to Raise Age to Vape to 21

    A proposal to raise the legal age to buy cigarettes and certain vaping devices is being considered by the Alabama Senate after lawmakers in the Alabama House of Representatives passed the resolution by a vote of 74 to 18.

    Credit: David Mark

    State representatives returned to work Tuesday after taking a vacation last week. The bill to raise the legal age to buy products with nicotine from 19 to 21 was one of the first bills on the agenda in the state House. It’s sponsored by Representatives Barbara Drummond [D], Napoleon Bracy [D], Merika Coleman-Evans [D], David Faulkner [R], Ralph Howard [D] and Debbie Wood [R].

    House Bill 273’s text says “Under existing law, an individual under the age of 19 may not purchase, possess, or transport tobacco products, electronic nicotine delivery systems, or alternative nicotine products.”

  • FDA Issues 3 More Warning Letters for Illegal E-liquids

    FDA Issues 3 More Warning Letters for Illegal E-liquids

    The total is now 73 in 2021. The U.S. Food and Drug Administration (FDA) issued four more warning letters for marketing illegal vapor products. Morin Enterprises Inc. d/b/a Ecig Crib, Nicoticket LLC, Bouji Moj Oyeeb, Inc. d/b/a MasterMix E-Liquid all received letters on on March 26 and those letters were posted to the FDA’s website today, March 30.

    keep out
    Credit: Sandy Millar

    The FDA states that a review of the ecigcrib.com website revealed that the company “manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order “including: E Cig Crib – Planet of the Grapes E Liquid and E Cig Crib – Cotton Candy E Liquid.” Nicoticket’s letter states the website “nicoticket.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order including: Nicoticket Wakonda and Nicoticket The Virus.” Bouji’s letter states that a review of “mastermixeliquid.com revealed that you manufacture and offer for sale or distribution to customers in the United States e-liquid products without a marketing authorization order including: MasterMix E-Liquid – Mango and MasterMix E-Liquid – Maraschino Cherry.”

    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.

    Bouji has over 31,500 products listed with FDA. Nicoticket is a registered manufacturer with over 6,800 products listed with FDA and E-cig Crib is a registered manufacturer with over 4,700 products listed with FDA.

    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.

  • No. 70: The FDA Issues Vintage Vapors PMTA Warning Letter

    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.

  • Connecticut Could Ban Flavored Vapes by October

    Connecticut Could Ban Flavored Vapes by October

    A bill winding its way through the Connecticut General Assembly would ban the sale of flavored e-cigarettes and tobacco products in the state. Lawmakers who sponsored the bill say the bill is needed to reduce nicotine addiction, which disproportionately affects young adults and people of color.

    Credit: Ethan Parsa

    The ban would target vape products with fruit and dessert flavors, while allowing for tobacco flavored vapes. The bill would also prevent the sale of all menthol flavored products. “For many years I have watched my community suffer from the long-standing results of having this habit of smoking that they can’t seem to break; and we watch them suffer and lose their lives,” NAACP Bridgeport Chapter President Rev. D. Stanley Lord said during a press conference, as reported by wshu.com. “Families lose loved one’s because they have targeted the Black and Brown community.”

    Critics say that the ban would drive former smokers back to combustible cigarettes. Traditional tobacco use is a major contributor to heart disease, cancer and strokes, which are the three leading causes of death among African Americans, according to the U.S. Centers for Disease Control and Prevention.

    The bill advanced from the state’s public health committee to the full Legislature on March 5. Senate Committee Chair Mary Daugherty Abrams said during the press conference that she thinks that there is a “strong” chance that the bill passes through the legislature. If the bill is enacted, the ban would go into effect in October.

    “I don’t think we here at the state of Connecticut can wait indefinitely for the federal government to take action,” Steinberg said. “So we’re following through, on what we promised we would do, which would be to end flavors which we view as an unfortunate temptation into the world of addiction.”

  • Jarvis Vaping Supply Receives PMTA Acceptance Letter

    Jarvis Vaping Supply Receives PMTA Acceptance Letter

    Jarvis Vaping Supply (JVS), parent to four of 21 Ohio-based Vapor Station vape shops, announced that its premarket tobacco product application (PMTA) has been accepted by the U.S. Food and Drug Administration (FDA). James Jarvis, co-owner of JVS with his wife Gerri, announced the receipt of the acceptance letter on his Facebook page. The acceptance includes all 998 SKUs submitted to the FDA for authorization, James confirmed in a text.

    “I’m so proud of my wife … she spent so many late nights, so many hours, frustration, stress and a lot of patience went into this,” James wrote. “She helped many others once she finished ours on top of this.”

    JVS is a wholesale vaping supply store. Alongside the four Vapor Station retail stores in and around Columbus, Ohio, James also serves as president of the Ohio Vapor Trade Association, and both Gerri and James are avid advocates of the vapor industry.

    Gerri and James Jarvis

    While James continued to run the business, Gerri worked day and night over six months to fill out PMTAs for 998 products (SKUs). In the end, she dumped roughly 3 million pages off at the FDA. With just the help of a Facebook group called PMTA Sharing, Gerri was able to climb the PMTA mountain without any help from firms experienced in submitting PMTAs. The Jarvis’ were among 1,600 vapor company representatives who joined this and other private groups to help them navigate the PMTA process.

    “With Covid-19 hitting right in the thick of the PMTA process, money was so tight that we needed to be careful with spending. Thanks to the help of the Facebook group, we were confident that we could turn something in to the FDA,” Gerri said in a recent interview with Vapor Voice.

    After submitting JVS PMTAs, Gerri then went on to help her friend Jason Gang of Westside Vapor as well as several other small companies negotiate the PMTA process, including Dripology, Vapor Generation, KL Labs and E Cig Cafe. Gerri said Westside Vapor’s PMTAs for its 1,800 products totaled over 6 million pages. Westside Vapor also received an acceptance letter according to James, but that has not yet been verified.

  • China Vows to Regulate Vapor, RLX Stock Tumbles

    China Vows to Regulate Vapor, RLX Stock Tumbles

    China’s Ministry of Industry and Information Technology (MIIT) and the State Tobacco Monopoly Administration announced today the Chinese government’s intent to overhaul rules governing the vapor and electronic nicotine-delivery systems (ENDS) market. The news started a swift downfall of shares of RLX Technology, parent to RELX, China’s largest e-cigarette brand, on the New York Stock Exchange. At 2:45pm today, RLX was down nearly 45 percent to $10.69 per share after recent high of $19.46 per share on March 19.

    RELX vaporizer
    Credit: RLX Technology

    Draft regulations posted online by MIIT suggest it will seek to regulate these products similarly to ordinary cigarettes. The ministry is seeking public comments on the draft regulations until April 22. The implications of the draft regulations could be wide-ranging as, with an estimated 300 million smokers, China is considered the world’s largest market for tobacco product.

    “In order to implement the decision-making and deployment of the CPC Central Committee and the State Council, further strengthen the supervision of new tobacco products such as e-cigarettes, and safeguard the legitimate rights and interests of consumers, we have drafted the Decision on Amending the Regulations on the Implementation of the Tobacco Monopoly Law of the People’s Republic of China,” the rule states. “The amendment is mainly to implement the requirements of the CPC Central Committee and the State Council on promoting the rule of law in the supervision of e-cigarettes , to clarify the legal basis for the supervision of new tobacco products such as e-cigarettes , and to do a good job in connecting with laws and regulations such as the Law of the People’s Republic of China on the Protection of Minors, so as to play an important role in strengthening the rule of law , stabilizing expectations and promoting the long-term.”

    RLX Technology raised $1.4 billion during its initial public offering (IPO) in January this year. It sold 116.5 million shares with a target price of between US$8 and US$10 a share. Its successful market debut turned its 39-year-old founder, Wang Ying, into a billionaire overnight with an estimated net worth of $24.8 billion.

    In its prospectus, RLX stated that vaping products only have a 1.2 percent penetration rate in China, compared with 32.4 percent in the U.S. According to the China-based Electronic Cigarette Industry Committee, China’s 2020 e-cigarette sales were an estimated 14.5 billion RMB yuan ($2.2 billion), an increase of 30 percent from 2019 (11.2 billion RMB yuan). According to Grandview Research, the US e-cigarette market in 2019 and was valued at $5.34 billion and is expected to reach $6.50 billion in 2020.

    RELX recently announced its partnership with 110 authorized distributors to supply its products to over 5,000 RELX-branded partner stores, and over 100,000 other retail outlets nationwide, covering over 250 cities in China, according to its prospectus. Revenue for the company nearly doubled in the nine months ended September 30, 2020 to $324 million, with a net income of $16 million, the latest figures available at the time of this writing.

    But tobacco companies are increasingly facing scrutiny from regulators in China. Currently, the only regulatory actions taken by Chinese authorities are in 2018, the country made it a crime to sell a vapor product to anyone under 18 years of age and then, in November 2019, an online sales ban was implemented in order to further prevent youth initiation. In 2020, the country passed the Law of the People’s Republic of China on the Protection of Minors. That law is aimed at preventing parents or other guardians from “indulging or instigating minors” to smoke or vape.

    CNTC is a source of major funding for the Chinese government. Its contribution accounted for an estimated 5.45 percent of the country’s tax revenue in 2018. That amounts to 10.8 trillion yuan ($1.5 trillion), according to media reports. If CNTC were to enter the vapor market, the monopoly’s existing 5 million domestic retail outlets could present a major challenge for private vape shop owners.

    Wang told Reuters in a recent news article that she’s “not worried” about the government’s impact on the sector. The products will continue to remain available, she said, “as long as there’s proof that this is a good solution for smokers.”

  • FDA Issues its 69th Vapor PMTA Warning Letter This Year

    FDA Issues its 69th Vapor PMTA Warning Letter This Year

    The US Food and Drug Administration (FDA) issued three more warning letters to vapor industry companies on March 19. The latest announcement total brings the count to 69 letters this year for companies selling vapor products without gaining regulatory approval through the agency’s premarket tobacco product application (PMTA) process, according to the agency’s website.

    The latest letters were issued to Arizona-based Vapor Outlet, Vapor Tech Hawaii and the Vaporium in Illinois. In its letter to Vaporium, the FDA stated that the company continues to “manufacture, sell, and/or distribute to customers in the United States The Vaporium 6mg Red White and Blue 70/30 30 ML e-liquid product” without a marketing authorization order.

    “Your firm is a registered manufacturer with 19,860 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. “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.

    Many of the FDA’s letters so far have gone to local vape shops that manufacturer their own e-liquid in the store. For example, Vapor Tech Hawaii’s letter states that the FDA has determined that it “manufacture, sell, and/or distribute to customers its Vapor Tech Hawaii Waikikiwi 100ML 3mg e-liquid product” without a marketing authorization order. On March 16, the company issued three letters to stores owned by the Louisiana-based Little Town Vaping for selling house brand e-liquids.

  • Cambodia Cracks Down on Heated-Tobacco Products

    Cambodia Cracks Down on Heated-Tobacco Products

    Photo: IRIS AO from Pixabay

    Cambodia’s National Authority for Combating Drugs (NACD) has instructed all relevant ministries and institutions to take immediate action to stop the use and commercialization of heated tobacco products (HTPs), reports The Phnom Penh Post.

    “All forms of trafficking, trading and importation of HTPs must be stopped and information on import restrictions must be disseminated to all vendors and the public,” the NACD stated in a directive.

    Citing the World Health Organization, the NACD said the use of cigars, electronic nicotine delivery devices (ENDS) and HTPs can lead to serious lung disease and even death. The announcement further said that using these products is also a motivating factor for people to use other illegal drugs.

    Cambodia has restricted ENDS since February 2014, but its guidelines did not cover newer HTPs.

    Deputy National Police chief Mak Chito said that in the past the authorities had confiscated many of these products. He said that although some other countries consider the use of these products legal, Cambodia does not allow it.

     “In Cambodia, there are also bad people who are cheating by using methamphetamines or marijuana [with these devices],” he said.

  • Philippine House Committees Endorse Vapor Rules

    Philippine House Committees Endorse Vapor Rules

    In the Philippines, three committees of the House of Representatives have endorsed to the plenary the approval of a measure that will regulate all vapor products, whether they contain nicotine or not. The rule will also apply to heated tobacco products (HTPs).

    House Committees on Trade and Industry, on Health and on Appropriations has submitted Committee Report 873 for the proposed Non-Combustible Nicotine Delivery Systems Regulation Act (House Bill 9007), according to politics.com.ph. The rule applies to electronic nicotine- and non-nicotine-delivery systems (ENDS/ENNDS).

    The measure provides that the allowable minimum wage to purchase, sale and use ENDS/ENNDS or HTPs shall be 18 years old, although there is debate to raise that age to 21 or even 25. The seller would also be required to verify the age of the buyer by requiring any valid government-issued identification card bearing the picture, age or date of birth.

    “It shall not be a defense for the person selling or distributing that oneself did not know or was not aware of the real age of the purchaser. Neither shall it be a defense that oneself did not know nor had any reason to believe that the product was for the consumption of a person below 18 years old,” the committee report read.

    The use of ENDS/ENNDs or HTPs will be banned in all enclosed public places except in designated vaping areas if passed, and the use of product will be prohibited in schools, hospitals, government offices and facilities intended particularly for minors. The bill prohibits the sale or distribution of ENDS/ENNDS or HTPs within 100 meters from a school, playground or other facility frequented by minors.

    It also prohibits manufacturers of ENDS/ENNDS or HTPs from sponsoring any sport, concert, cultural or art event, as well as individual and team athletes or performers where such sponsorship shall require or involve the advertisement or promotion of the products.

    Violators of the proposed law will be fined P500,000 for the first offense and P750,000 for the second offense. On the third offense, a fine of P1 million and/or imprisonment of not more than six years. The business permit and licenses of the company will also be revoked or cancelled.

    If the offender is a foreign national, they will be deported only after serving their sentence.