Tag: warning letters

U.S. FDA Issues First Warning Letter for Vapor Hardware
Sigelei Humvee 80 coil
The U.S. Food and Drug Administration has issued hundreds of warning letters for vaping products, typically illegal e-liquids. On Tuesday, however, the regulatory agency posted its first warning letter for vaping hardware products. The letter was issued on Feb. 14 to China-based Sigelei Vapor for two coil brands.
“Our review of the website http://sigelei.com revealed that you manufacture and offer for sale or distribution to customers in the United States ENDS [electronic nicotine-delivery system] products without a marketing authorization order including: Sigelei Humvee 80 and Sigelei 213 Fog Coil,” the warning letter states.
The letter also states that Sigelei received a “refuse to accept” letter from the FDA on February 5, 2021 in response to the company’s premarket tobacco product applications (PMTAs) for six Sigelei products. “New tobacco products that do not have the required FDA marketing authorization order in effect, including your ENDS products covered by PMTA STN PM0001221 that resulted in a Refuse to Accept determination, are adulterated and misbranded,” the agency wrote.
The move signals a shift in the FDA’s typical regulatory action against companies selling illegal vaping products. The agency has traditionally only issued letters for e-liquids, but now hardware manufacturers have been put on notice. One manufacturer, who asked to remain anonymous to avoid FDA scrutiny, said the recent action is worrisome.
“The hardware segment has been operating almost at a near-normal, the same as before PMTAs were due. It hasn’t really hit home yet that FDA has the full intention to start enforcing hardware regulations too,” the manufacturer said. “This is going to hurt several companies and we are going to start to see smaller businesses end their marketing in the U.S.”
The letter also suggests that the warning is for all Sigelei products and not just the rejected PMTA products. “The violations discussed in this letter do not necessarily constitute an exhaustive list,” the letter states. “You should address any violations that are referenced above, as well as violations that are the same as or similar to those stated above, and promptly take any necessary actions to bring your tobacco products into compliance with the FD&C [Food, Drug & Cosmetics] Act.”
February 23, 2022
FDA Issues Warning Letters to Four ‘Wellness’ Vape Firms
The U.S. Food and Drug Administration has issued warning letters to four companies marketing “wellness” vaping products. The FDA says the vaping devices contain vitamins and/or essential oils and the companies are making unproven health claims about them. Currently, no vaping products are approved by the FDA to prevent or treat any health conditions or diseases. The devices in question do not contain nicotine. The FDA calls the products “unapproved new drugs” sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act.
Credit: FDA
“The FDA issued warning letters to companies for illegally selling these vaping products with unproven health claims. The letters provide the companies notice and request that they take prompt action to address any violations of the law,” according to an FDA press release. “If companies refuse to comply, the FDA may take enforcement actions to prevent the products from reaching consumers.”
The FDA stated that it had received complaints concerning several “wellness” products being advertised and sold to minors. “Online advertising, especially social media posts, often make false claims and cite the latest ‘scientific study,’ or do not include important details that may apply to you or allow you to make an informed decision,” the release states. “Other red flags include claims like “miracle cure” or “guaranteed results.” Remember, if a company really made a breakthrough, revolutionary health-related discovery, the news, researchers, and the government would discuss it in depth.” The letters were issued through the FDA’s Center for Drug Evaluation and Research (CDER).
The letters to Vitastick, Vitacig, NV Nutrition (NVN) and Vitamin Vape were issued on Dec. 1. Some of the unproven health or wellness claims include improving mental clarity or treating tumors or asthma. Some examples of the fraudulent product claims are:

“Fight off tumors and alleviate symptoms of chemotherapy!”

“It’s been used as a [sic] organic asthma remedy, ADHD remedy, and dementia treatment.”

“Helps prevent a type of anemia called megaloblastic anemia that makes people tired and weak.”

“Neroli oil… has long been used as a treatment against anxiety and depression, to calm the mind and soothe away tension.”
The FDA, Centers for Disease Control and Prevention, state and local health departments, and other clinical and public health partners are continuing to monitor and research vaping-associated lung injury. The FDA warns consumers to not be misled by vaping products claiming to contain “vitamins” and other “natural” ingredients or being advertised for “wellness” purposes.
December 8, 2021
First Warnings After PMTA ‘Refuse to Accept’ Notices
In August, the U.S. Food and Drug Administration issued 29 warning letters to firms it says were manufacturing and selling unauthorized electronic nicotine delivery system (ENDS) products. The agency advised the companies that selling products which lack a marketing authorization is “illegal and therefore they cannot be sold or distributed in the U.S.” The companies did not submit a premarket tobacco product application (PMTA) by the Sept. 9, 2020 deadline.
Credit: Андрей Яланский
While each of these 29 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 268,000 products, according to the FDA.
In a first for ENDS products, two of the warning letters went to companies for selling after their PMTAs were not accepted. “Both Vapor Boss, LLC, and Kaleidoscope Custom Vapor Lounge, LLC have continued to sell ENDS products after receiving “Refuse to Accept” (RTA) determinations from the agency following submission of their premarket tobacco applications,” the FDA stated. “These are the first warning letters issued for an application that was submitted by the Sept. 9, 2020 deadline that subsequently received a RTA determination.”
Companies who receive an RTA determination must remove any products currently on the market or risk enforcement action by FDA, according to the agency. Companies may resubmit a complete application for these products at any time, however the products may not be marketed unless they receive a marketing granted order.
FDA also issued the first warning letter to a company that submitted premarket applications for some, but not all, of its products. The company (Maduro Distributors d/b/a The Loon) submitted a premarket application covering 18 products, but it manufactures and sells additional products not covered by the premarket application and thus lacking premarket authorization.
From January through August 2021, FDA has issued a total of 169 warning letters to firms selling or distributing more than 17 million unauthorized electronic nicotine delivery system (ENDS) products and that did not submit premarket applications by the Sept. 9 deadline, according to the agency.
On FDA’s Warning Letters page, you can find all of these warning letters by entering “Center for Tobacco Products” in the “Issuing Office” box in the “Filter by” section of the search tool.
September 5, 2021
FDA: ‘Refuse to File’ Letter for JD Nova, 4.5 Million PMTAs
The JD Nova Group submitted premarket tobacco product applications (PMTAs) for an estimated 4.5 million products, approximately two-thirds of the total number of PMTA submissions. Today, the U.S. Food and Drug Administration issued a Refuse to File (RTF) letter to the company. The letter notified JD Nova that the majority of their PMTAs did not meet the filing requirements for a new tobacco product seeking a marketing order.
Credit: Tashatuvango
“This RTF does not apply to all product applications submitted by JD Nova. The remaining product applications the company submitted by the Sept. 9, 2020 deadline are still moving through the review process,” the FDA stated in a press release. “As a result of this RTF action, the company must remove approximately 4.5 million products from the market or risk enforcement action by FDA. The company may resubmit a complete application for these products at any time. However, the products may not be marketed unless they receive a marketing granted order.”
During the filing stages of application review, the FDA reviews for basic information to ensure applications contain the required material for scientific review, according to the release. If required contents for filing are missing, the FDA refuses to file the application.
“JD Nova was issued the RTF letter because the company’s applications for these products lacked an adequate Environmental Assessment (EA),” the release states. “Under FDA’s regulations implementing the National Environmental Policy Act (NEPA), an EA must be prepared for each proposed authorization, and an EA adequate for filing addresses the relevant environmental issues.”
JD Nova was one of more than 360 companies included on a recent list of products that had submitted a timely PMTA to the FDA and was allowed to market products for up to one year, until Sept. 9 2021, or until the FDA makes a regulatory decision such as refusing to file a PMTA.
From January through July 2021, the FDA has issued more than 135 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. One company, Visible Vapors, had more than 15 million products registered with the FDA. On FDA’s Warning Letters page, you can find these warning letters by searching “Center for Tobacco Products” under “Issuing Office.” The regulatory agency has issued at least two warning letters in August so far.
August 9, 2021
Firm With 15 Million Products Registered With FDA Warned
The U.S. Food and Drug Administration has issued a warning letter to Visible Vapors. The regulatory agency advised the company that marketing its electronic nicotine-delivery system (ENDS) products, which lack a premarket tobacco product authorization (PMTA), is illegal, and therefore they cannot be sold or distributed in the U.S. The FDA states that the company did not submit PMTAs by the Sept. 9, 2020 deadline.
While the warning letter issued cites specific products as examples, including Visible Vapors Irish Potato 100mL and Visible Vapors Peanut Butter Banana Bacon Maple (The King) 100mL, the company has more than 15 million products listed with FDA, and must ensure all of its products comply with federal rules and regulations, which include the premarket review requirement, according to the letter. Visible Vapors has the largest number of products registered with the FDA to have received a warning letter to date.
From January through July 2021, the FDA has issued more than 135 warning letters to firms selling or distributing more than 1,470,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline. On FDA’s Warning Letters page, you can find these warning letters by searching “Center for Tobacco Products” under “Issuing Office.”
The FDA often only lists a few products that a company is selling as illegal in the letter. 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 agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
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.
July 29, 2021
FDA Issues 3 Warning Letters for PMTA Violations
The U.S. Food and Drug Administration (FDA) has issued three more warning letters for illegal e-liquids. The regulatory agency issued the letters on May 28 and June 3 and posted them to its website on the same days. Companies that received the latest round of letters have a combined 750 products registered with the FDA. The agency has now issued 123 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.
Credit: Chris Titze Imaging
North Carolina-based Asheville Vapor received letter on May 28 (50 registered products), while Kansas-based Tiger Vapes (100) and New York-based The Vapor Shop received the letters on Thursday, June 3.
In May, the FDA issued a total of 19 warning letters to firms who 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 19 warning letters cites specific products as examples of tobacco products that lack the required premarket authorization, collectively those firms have listed a combined total of more than 378,000 products with the FDA, according to an email from the agency.
Since January 2021, FDA has issued a total of 123 warning letters to firms selling or distributing more than 1,280,000 unauthorized ENDS and that did not submit premarket applications by the Sept. 9 deadline.
The FDA recently released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. 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 agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
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.
June 4, 2021
5 More FDA Warning Letters for Illegal E-liquids
Five more vapor companies have received warning letters from the U.S. Food and Drug Administration (FDA) for illegal e-liquids. The regulatory agency issued the letters on May 21 and posted them to its website on May 27. Companies that received the latest round of letters have a combined 96,960 products registered with the FDA. The agency has now issued 120 letters to vapor companies for marketing vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.
Credit: Jon
Nicfixed d/b/a Good Karma Vapor-received letter on May 27 – (1,400 registered products), Soul Vapor (2,100), Nelson Endeavors d/b/a Liberty Vape Co. (60), Premium eJuice USA d/b/a Vapor Lab (92,000) and Capitol Hill Vapor Co. (400) all received letters for illegal e-liquids.
Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. 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 agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
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.
May 28, 2021
FDA Continues Warning Letter Blitz for PMTA Offenses
The U.S. Food and Drug Administration (FDA) continues to be adamant about removing illegal e-liquids from the market. On Tuesday, the regulatory agency issued two more warning letters for companies selling e-liquids without having filed a premarket tobacco product application (PMTA). The total now stands at 115 companies that have received notice since Jan.1 of this year.
Credit: Hurricane Hank
Adirondack Juice d/b/a Adirondack Vapor & Co. and Blue Eyed Vapor (BEV) received the letters from the FDA on May 14, however the agency didn’t post the letters to its website until May 25. Adirondack and BEV both were accused of selling or marketing multiple e-liquid flavors. The companies have 5,800 and 20 products registered with the FDA, respectively.
Last week, the FDA released its list of products that are legal for sale in the U.S. A total of 360 companies filed more than 6 million PMTAs. The FDA stressed it has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list excludes entries of products from companies that did not provide information on current marketing status of their products to the FDA so that the agency could determine whether the existence of the application could be disclosed.
The FDA often only lists a few products that a company is selling as illegal in the letter. 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 agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
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.
May 27, 2021
FDA Issues Warning 112, 113 in 2021 for Illegal E-Liquid
On the same day it released its much anticipated list of legal electronic nicotine-delivery system (ENDS) products, the U.S. Food and Drug Administration (FDA) issued its 112 warning letter to a company for selling products without a marketing order. Companies must have submitted a Premarket tobacco product application to the FDA by Sept. 9, 2020 in order to legally sell vaping products. The following day the agency issued No. 113.
Credit: Postmodern Studio
Louisiana-based Big Chief Vapor received the letter for selling its Zulu Pride 6mg nicotine e-liquid product without a marketing authorization order, according to the FDA. The letter was posted to the regulatory agency’s website on May 20. Big Chief Vapor has over 4,400 products registered with the FDA.
On May 21, the FDA posted on its website that it had issued also a letter to Mississippi-based Vape Lizard Co. for selling Vape Lizard Strawmelon 3mg without a marketing order. The company has over 400 products registered with the FDA.
The FDA often only lists a few products that a company is selling as illegal in the letter. 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 agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
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.
May 21, 2021
FDA Drops 7 More Warning Letters, Total Now 111
The U.S. Food and Drug Administration (FDA) issued seven more warning letters to vapor companies for selling illegal products. The total now stands at 111 for the number of warning letters the regulatory agency has issued to vapor companies in 2021. The FDA accuses the companies of selling vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.
Credit: Trend Objects
The companies all received their letters on May 7, however the FDA didn’t post the letters on its website until May 18. The companies receiving letters include:

Nicotine Nirvana, which has over 50 products registered with the FDA;

FF Vapors, which has over 257,000 registered products with the FDA;

JP & SN Enterprises Inc. d/b/a eCigs International, which has over 4,500 products listed with the FDA;

The Iron Crow, which has 400 products listed with the FDA;

Sema International, which has over 500 products listed with the FDA;

Central Iowa Electronic Cigarettes, which has over 3,400 products listed with the FDA;

High Voltage Vaporz, which has over 600 products registered with the FDA.
The FDA often only lists a few products that a company is selling as illegal in the letter. 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 agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.
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.
May 19, 2021