The U.S. Small Business Administration (SBA) has urged the Food and Drug Administration to allow nicotine products to remain on the market for another year while their premarket reviews are in progress, reports Vaping 360.
In a letter sent to the FDA on June 7, the SBA Office of Advocacy asked the agency to seek a court order extending for an additional year the current freeze on enforcement actions against small vape manufacturers who submitted Premarket Tobacco Applications (PMTAs) before last year’s Sept. 9 deadline.
In the current situation, manufacturers who submitted PMTAs on time may leave those products on the market until Sept. 9, 2021. The SBA advocacy office is asking the FDA to request that U.S. District Court Judge Paul Grimm allow the agency to extend the deadline until September 2022.
Considering the large volume of PMTAs submitted—the FDA says it received more than 6 million applications—It is unlikely that the agency will be able to process all submissions before manufacturers are required to pull their products off the market.
“Small ENDS manufacturers cannot afford to have their products pulled from store shelves while the FDA continues to review the timely submitted PMTAs for millions of ENDS products,” the SBA writes. “Most small ENDS manufacturers do not have the resources to absorb the losses from having their products pulled from the marketplace for several months or more. Once the FDA orders small ENDS manufacturers’ products removed from the market, those small businesses will close permanently.”
The letter also urges the FDA to end its current practice of processing PMTAs in order of manufacturer market share. By doing so, the FDA all but guarantees that small vaping companies will be unable to have their reviews completed in time to remain on the market, according to the SBA.
The SBA is a federal agency represents the views of small business to the various branches of government.
It’s over. After winding it’s way through the court system for nearly two years, the Supreme Court of the United States (SCOTUS) has denied Big Time Vapes a request for a writ of certiorari.
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On August 19, 2019, Big Time Vapes and United States Vaping Association, an e-cigarette manufacturer and an e-cigarette trade association, filed suit in the U.S. District Court for the Southern District of Mississippi challenging the constitutionality of the U.S. Food and Drug Administration’s (FDA) authority over vaping products.
The original complaint was dismissed by the U.S. District Court in December 2019, and failed on appeal in the Fifth Circuit Court of Appeals last year. On June 25th, 2020, the Court of Appeals issued its opinion, finding that Congress’ delegation of authority to the Secretary of Health and Human Services to deem additional products subject to the Tobacco Control Act is not unconstitutional, upholding the district court’s decision.
The nation’s highest court referred the case back to a lower court. Since the court did not accept the petition, the lower court’s decision will stand. SCOTUS accepts 100-150 of the more than 7,000 cases that it is asked to review each year, according to its website. It’s is the first petition for a case involving e-cigarettes to be considered by SCOTUS.
The suit challenges the Tobacco Control Act, claiming that Congress unconstitutionally ceded its legislative authority to the FDA when it gave the agency the power to “deem” products as tobacco products that were not specified in the 2009 legislation.
The FDA argued the Tobacco Control Act is constitutional, however, as “Congress laid out intelligible principles with appropriate boundaries for FDA to apply.” The FDA has also cited the public health issues posed by e-cigarettes, particularly to children, in defending the its authority to regulate the industry.
The additive that has been found as the source of THC vaping-related lung injuries and death would be formally banned in Michigan under legislation passed in the Michigan House this week. House lawmakers on Thursday approved a package of bills aimed at prohibiting the sale of tobacco and marijuana vaping products containing vitamin E acetate or other additives not approved by the Food and Drug Administration (FDA).
A processor or provisioning center found in violation of the ban would face a misdemeanor punishable by a fine of up to $10,000, according to M Live.
House Bills 4249 and 4250 passed the chamber with wide bipartisan support. The package now heads to the Senate for further review. The legislation is similar to bills introduced last session that also passed the House, but were never taken up for a vote in the Senate.
During a March 16 Regulatory Reform Committee hearing, one lawmaker said the harmful effects of vitamin E acetate were discovered in 2019 amid an “emergency when young people were dying after vaping.”
“This chemical is actually inserted in the vaping process and the manufacturing process, and there it was discovered that it was extremely dangerous to be inhaled,” they said at the time
The Marijuana Regulatory Agency in November 2019 created testing requirements banning the presence of vitamin E acetate in all marijuana vaping products and halted marijuana vaping sales until they could be tested for the presence of vitamin E acetate. In December 2019, the state recalled thousands of marijuana vaping products that tested positive for the additive.
Vitamin E acetate is safely consumed in food and applied to the skin in cosmetic products. When it comes to vaping, Vitamin E acetate can be used as a filler added to THC vaping cartridges – it’s a cheaper substance that dilutes potency.
The Centers for Disease Control and Prevention pointed to vitamin E acetate as a factor in many of the vaping-related deaths around the country, noting it “may interfere with normal lung functioning” when inhaled through a vaping product.
The U.S. Food and Drug Administration (FDA) has issued a statement that it has updated the language used in its deficiency letters. The new language is intended to clarify the purpose of the letters that are related to its premarket tobacco product application (PMTA) process. In an email on June 3, the FDA explained that such letters are only meant to communicate information gaps identified during review. The letter offers the applicant an opportunity to provide further information.
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“The language further clarifies that the letter is not intended to convey a list of concerns about the product, and a complete response to the deficiency letter does not guarantee that the applicant will receive a positive marketing order,” the agency states. “Importantly, a final decision regarding marketing of the product(s) will be made at the end of FDA’s scientific review. FDA will base the final decision on the applicable public health standard in the Federal Food, Drug, and Cosmetic Act after reviewing the totality of all the information included in the original submission and amendments.”
Following last year’s Sept. 9 PMTA deadline for most deemed new tobacco products, including vapor and e-cigarette products, that are currently on the market, the FDA’s job is to process, review, and take action on as many applications as possible before September 9, 2021, according to the agency. The substantive review process is the longest and most thorough phase of FDA’s review. Substantive review includes the evaluation of the scientific information and data in an application and often includes identification of follow-up questions for the applicant.
Before a final decision is made based on substantive review, the FDA generally sends a deficiency letter, which allows one opportunity for applicants to provide any additional information that the FDA needs to continue its scientific review. The agency typically allows 90 days for an applicant to respond to a deficiency letter.
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.
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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.
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.
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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.
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.
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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.
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.
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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.
The list has arrived. The U.S. Food and Drug Administration (FDA) published its list of electronic nicotine-delivery system (ENDS) products that can be legally marketed in the U.S. Due to the sheer volume of the list, Vapor Voice has not yet been able to break down the full contents of the list. However, if each of the 15 files the agency published contains 430,000 cells that’s over 6 million individual products.
The publication of the list likely signals the start of enforcement crack-downs. The FDA has already issued 111 warning letters to vapor companies in 2021.
One item that stands out immediately is that one company, JD Nova Group, parent to Vapolocity and De-Ja Juice among others, has filed the majority (an estimated 4 million) of the PMTA submissions.
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.
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“Please note that FDA has not independently verified the information provided by applicants about the marketing status of their products. In addition, the list does not include entries of products from companies that did not provide information on current marketing status of their products to FDA so that the Agency could determine whether the existence of the application could be disclosed,” the FDA states. “It is important to note that the lists are not comprehensive lists intended to cover all currently marketed deemed tobacco products that a company generally might manufacture, distribute, or sell without risking FDA enforcement.”
The FDA had stated in September of 2020 that it would publish a list of vapor companies that had submitted PMTA’s by the Sept. 9, 2020 deadline. The news came just one week after several retail groups submitted a letter to the agency asking for a published list of applicants. Nearly eight months later the list has been published on the FDA’s website.
Companies that submitted their application by the Sept. 9, 2020, deadline can keep their products on the market for one year pending FDA review.
If a negative action is taken by the FDA on the application prior to Sept. 9, 2021, the product must be removed from the market or risk FDA enforcement. If a positive order is issued by the FDA on a product in the lists, the product will be listed on the positive marketing orders page and may continue to be marketed according to the terms specified in the order letter.
The list consists of 361 companies that filed PMTAs. The company’s on the list are as follows:
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.
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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.
