Tag: FDA

  • FDA Issues 2 More Warning Letters for Lack of PMTAs

    FDA Issues 2 More Warning Letters for Lack of PMTAs

    The U.S. Food and Drug Administration (FDA) issued warning letters to two more e-liquid manufacturers for violating the agency’s marketing rules. Nice Guys Distributing and Lucky’s Vape Lounge received the letters and posted them to the FDA website on Thursday and Friday, respectively. The regulatory agency has issued 92 warning letters for illegal e-liquids in 2021, so far.

    Credit: Bitcoin ATM Map

     

    Nice Guys was warned for its “Mr. Nice Guy’s E-Juice Etc. 2 Pussy Cat e-liquid,” according to the FDA and has more than 600 products listed with the FDA. Lucky’s Vape :Lounge was cited for selling “Lucky’s VapeWaterpop 6 e-liquid product” and has more than 16,000 products with the FDA. It is impossible to know if more than the mentioned products that received the warning letters violate the FDA’s premarket tobacco product application (PMTA) rules.

    The FDA states that the companies failed to submit PMTAs 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.

    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.

    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.

  • Str8Vape and Xtreme Vapour Receive FDA Warning Letters

    Str8Vape and Xtreme Vapour Receive FDA Warning Letters

    The U.S. Food and Drug Administration (FDA) handed down two more warning letters for vapor companies violating marketing rules for tobacco products on Thursday. Str8Vape and Extreme Vapour received letters for selling products without submitting a premarket tobacco product applications (PMTA) to the regulatory agency by the Sept. 9, 2020 deadline.

    The total number of warning letters for the illegal sale of vapor products now stands at 84 in 2021. The letters were posted on the FDA’s website on April 8, the same day the businesses received the warnings.

    The FDA states that is had determined that Extreme Vapour did “manufacture, sell, and/or distribute to customers in the United States the following Xtreme Vapour Babylon Vape Juice Pineapple 30ml e-liquid product without a marketing authorization order.” The company manufacturers over 80 products registered with FDA.

    The FDA states that is has determined Str8Vape did “manufacture, sell, and/or distribute to customers in the United States the following STR8VAPE AMERICAN BLEND 3mg 70VG/30PG 30ML e-liquid product without a marketing authorization order.” The company is a registered manufacturer with over 27,400 products listed with FDA.

    The FDA states that the companies failed to submit PMTAs 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.

    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.

    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.

  • Driftwood Vapor and Super Vape’z Get FDA Warning Letters

    Driftwood Vapor and Super Vape’z Get FDA Warning Letters

    The U.S. Food and Drug Administration (FDA) is intent on removing vaping products from the market that have not submitted a premarket tobacco product authorization (PMTA). The latest companies to receive warning letters are Van Howling Enterprise LLC d/b/a Driftwood Vapor and Super Vape’z, bringing the total number of warning letters for the illegal sale of vapor products to 82 in 2021. The letters were posted on the FDA’s website on April 5, the same day the businesses received the warnings.

    Credit: Vapers Map

    Driftwood received the warning for selling its Driftwood Vapor Watermelon 3mg e-liquid without a marketing authorization order and has over 3,600 products registered with the FDA. Super Vape’z received a warning for its Premium E-liquid Apple Mango 60ml 12mg e-liquid and has over 700 products listed with the FDA. Many of the FDA’s letters so far have gone to local vape shops that manufacturer their own e-liquid in the store, as is the case with Driftwood Vapor, for example.

    The FDA states that the companies failed to submit PMTAs 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.

    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.

    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.

  • FDA Cleaning House With 80 Vapor Warning Letters in 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.

  • 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.

  • U.S. Senate Confirms Vivek Murthy as Surgeon General

    U.S. Senate Confirms Vivek Murthy as Surgeon General

    Photo: forcal35 from Pixabay
    Vivek H. Murthy

    The U.S. Senate on March 23 confirmed Vivek H. Murthy as United States surgeon general, reports The Washington Post.

    The surgeon general, also known as the “nation’s doctor,” typically serves as a prominent spokesperson on public health issues but has a limited role in policymaking. President Joe Biden wants him to be a key public voice on the Covid response to restore public trust in medicine.

    The surgeon general also oversees the U.S. Public Health Service Commissioned Corps, a uniformed service of about 6,000 public health workers who have helped staff the coronavirus response and administer vaccines but struggled earlier this year to get vaccinations of their own.

    Murthy first served as surgeon general during the Obama administration, working on public health issues such as the opioid crisis. He also pursued his own work combating loneliness and the stigma of mental illness. He was the nation’s first Senate-confirmed Asian American surgeon general.

    His original 2013 nomination was stalled in the Senate for more than a year, in part because gun rights organizations faulted Murthy for saying gun violence was a public health problem—a stance Murthy has continued to espouse.

    Murthy is an advocate of e-cigarette regulation. In 2016, he released “E-Cigarette Use Among Youth and Young Adults,” calling for action to reduce the use of vapor products among young people.

    Michael Siegel, a professor at the Boston University School of Public Health, at the time described the report as scientifically dishonest.

    Siegel said the report essentially lied about the single most important fact that the public needed to understand about electronic cigarettes and vaping products: that they do not contain tobacco and therefore vaping is not a form of tobacco use.

  • 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.”

  • 43 Lawmakers Pen Letter to FDA Supporting Flavor Ban

    43 Lawmakers Pen Letter to FDA Supporting Flavor Ban

    Lawmakers in the US House of representatives have sent a letter to the head of the US Food and Drug Administration (FDA) urging the agency to pull all flavored e-cigarettes and other vaping products from the market. The 43 House Democrats sent the letter to Acting FDA Commissioner Janet Woodcock as the agency continues to review thousands of premarket tobacco product applications (PMTAs).

    Credit: Office of Debbie Wasserman Schultz

    “Flavored e-cigarettes are putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use,” states the letter drafted by Reps. Debbie Wasserman Schultz (D-Fla.) and Diana DeGette (D-Colo.), according to The Hill.

    The lawmakers want the FDA to ban all flavored e-cigarettes upon further review and nix the exemption the FDA has for menthol and disposable products.

    Along with a ban on flavored e-cigarettes, lawmakers want a ban on premarket tobacco applications and the marketing of e-cigarettes that target minors. “Today, e-cigarette use by youth remains at what FDA calls ‘epidemic proportions’ and e-cigarettes have been the most commonly used tobacco products among youth since 2014 – and flavors are a key reason why,” the letter states.

    The FDA has already put a ban on fruity e-cigarettes, however, brands such as Puff Bar are sidestepping the ban by selling fruit-flavored disposable vaporizers that use synthetic (tobacco-free) nicotine. “We strongly recommend that FDA’s premarket review process require manufacturers to provide convincing evidence that their products do not increase youth use of nicotine and tobacco in ways that increase the risk of abuse and addiction among youth,” the lawmakers stated.

  • 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.