Category: U.S. 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.

  • 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.

  • 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.

  • 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.

  • 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.