Category: PMTA

  • FDA Issues 103rd PMTA Warning to Custom Vapes

    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.

  • FDA: 102 Warnings for Illegal E-liquid Sales so Far in 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.

  • FDA Hands Down 4 More Letters for Illegal E-liquids

    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.

  • Beard Management Says PMTA has Advanced to Filing Stage

    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.”

  • Artisan Vapor & CBD PMTA Accepted by FDA

    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.

  • 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.

  • FDA Issues 6 More Warnings for Vapor Marketing Violations

    FDA Issues 6 More Warnings for Vapor Marketing Violations

    The U.S. Food and Drug Administration (FDA) has issued 6 more warning letters to vapor companies for failing to submit a premarket tobacco product application. Oregon Vapor, Northwest Vapors, Legend Vapor, Flavor Concepts, Hi Lyfe Vapors and LJ’s E-Smokes all received letters and April 9 and the FDA posted the letters on its website on April 13.

    Today’s postings bring the total number of warning letters issued by the FDA to vapor companies for violating marketing rules to 90 this year. Oregon Vapor has 100 products listed with the FDA, Northwest Vapor has 4,400 and Legend Vapor has 2,500, according to the FDA. Flavor Concepts has 300 products listed, Hi Lyfe Vapors has 100 and LJ’s E-Smokes has 280 products registered with the regulatory agency.

    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.

    Vapor Voice and TMA have created a PMTA tracking tool to help find legal vaping products.

  • 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.

  • Vapor Products Total 46% of All 2021 FDA Warning Letters

    Vapor Products Total 46% of All 2021 FDA Warning Letters

    In the first quarter of 2021, from Jan. 1 to March 31, the U.S. Food and Drug Administration (FDA) issued and posted a total of 166 warning letters. Compared to the same time period in 2020, only 97 total warning letters were issued. In 2020, the 139 letters issued by the Center for Tobacco Products comprised 22 percent of all warning letters issued by the FDA.

    Credit: FDA

    In the first quarter of this year, 80 of the 166 letters [that number is now 82], or 46 percent of warning letters, were related to tobacco products. The vast majority of products at issue were e-cigarette or e-liquid products that violated the FDA’s requirements for premarket approval before sale in the U.S.

    In virtually every warning letter for a tobacco product issued during the period under consideration, the FDA cited the manufacturer because their e-liquid products were considered new tobacco products, and had not submitted a premarket tobacco product application (PMTA), and were not subject to an exemption from the rule, according to Katie Insogna, an analyst with law360.com.

    As a result, the products were considered adulterated under Section 902(6)(A) of the Food, Drug and Cosmetics Act (FDCA). The agency also flagged many of these products for being misbranded under Section 903(a)(6) of the FDCA, because a notice or other information respecting these products were not provided as required by Section 905(j) of the FDCA.

    Manufacturers are responsible for ensuring their tobacco products and all related labeling and/or advertising — including on websites, social media and search engines — comply with each applicable provision of the FDCA and the FDA’s implementing regulations. In many of the recent warning letters, the agency acknowledges that the recipient is a registered manufacturer with thousands of products already listed with the FDA.

    As is customary in the case of most FDA warning letters, the agency has typically provided 15 working days for companies respond. Failure to address any violations may lead to regulatory action — including, but not limited to, civil money penalties, seizure and/or injunction. Because many of these companies already maintain authorizations for other tobacco products, they run the risk of additional regulatory scrutiny and negative action when they are flagged for selling unauthorized products, writes Insogna.

    Many of the FDA’s warning letters centered on Covid-19-related products making false claims. Like Covid-19-related products, tobacco products — especially vaping products — are receiving exceptional regulatory scrutiny. Companies marketing products in both of these categories should be particularly cautious of applicable federal regulations, to avoid negative action.

  • 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.