Category: Regulation

  • SHEER Opinion on Novel Products Due Friday

    SHEER Opinion on Novel Products Due Friday

    Photo: andriano_cz

    The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is due to present its opinion on novel tobacco products Friday.

    The opinion is part of an assessment of the EU Tobacco Product Directive (TPD), which will determine whether e-cigarettes will be treated the same way as traditional cigarettes.

    SHEER’s preliminary opinion published in September 2020 drew strong criticism of several stakeholders who accused the EU of being selective in its findings when it comes to their health implications.

    “Research in recent years, after the adoption of TDP in 2014, has become increasingly positive about e-cigarettes, always as a substitute for smoking,” Konstantinos Farsalinos of the University of Patras told Eurarchiv. “Compared to 2014, one would expect a more positive attitude. On the contrary, EU policymakers remain scientifically unsubstantiated with the risk of sabotaging the efforts to replace smoking with e-cigarettes,” he said.

    Pietro Fiocchi, a member of the European Parliament from the European Conservatives and Reformists Group, expressed concern about increased smoking if the EU Commission decides to equate novel tobacco products with traditional ones.

    “My impression is that the Commission is against a differentiation between traditional tobacco and reduced-risk products, and it will plan to apply the same limitations, through heavy regulations and fiscal impositions,” he said.

    “We all agree that not smoking at all is the best solution, but it would be detrimental if SCHEER will ignore plenty of scientific studies that show much smaller health impact of reduced-risk products is versus traditional tobacco,” said Fiocchi.

  • Alabama Passes Vape Bill With Heavy Restrictions

    Alabama Passes Vape Bill With Heavy Restrictions

    The Alabama House of Representatives passed a vaping bill that will prevent vape manufactures and retailers from using advertising techniques designed to appeal to young people, such as incorporating characters from comic books in ad campaigns. It would also prevent makers of vape pods and cartridges from claiming the taste of their product resembled “candies, cakes, or other sugary treats.”

    Credit: David Mark

    The legislation, HB 273, also changes Alabama’s law to mirror the federally established age to purchase vaping products, 21. The bill would require the Alabama Department of Revenue to build and maintain a directory of businesses that sell and manufacture vape cartridges, e-liquids and any alternative nicotine product in Alabama. Furthermore, it would require the relevant businesses to pay for certification in the directory.

    Selling vape cartridges and e-cigarettes in vending machines would be banned under HB 273. Manufacturers and retailers of nicotine products like vapes and e-cigarettes will also be required to post notices about the dangers of their usage, such as exposure to toxic metals. All locations selling vapes and any nicotine delivery system would be required to post a prominent sign near where customers check out that displays 21 as the legal age to buy nicotine products.

    The bill is sponsored by Rep. Barbara Drummond (D-Mobile). Two Republican members, Reps. Debbie Wood (R-Valley) and David Faulkner (R-Mountain Brook), are among the cosponsors of the legislation. It passed the House on a bipartisan vote of 74-18 with two abstentions. They say the bill is designed to reduce the use of e-cigarettes and vaporizers among young people.

    “My issue has always been to safeguard the welfare of young people,” Drummond said on the floor about her proposed law, according to the Yellow Hammer News.

    Each business entity that deals with vaping would have to pay the state an initial $2,000 certification fee, and each subsequent year would have to pay a $500 renewal for continued certification. Funds from the fees would go to implementing and maintaining the directory.

    “There are some bad actors out there selling this stuff illegally right now,” noted Drummond about the need for a registry, further explaining that the registry makes the job of law enforcement easier.

  • 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.

  • South Carolina Bill Banning Local Vapor Rules Advancing

    South Carolina Bill Banning Local Vapor Rules Advancing

    A bill that would ban South Carolina cities and counties from limiting sales of vaping products and traditional tobacco products is advancing in the state’s House of Representatives.

    A 15-7 vote April 6 by the House Judiciary Committee sent the bill to the House floor for debate. Advocates said they don’t want local governments to create a mishmash of fees and rules across the state that hamper businesses and cut into state tax collections, according to an article in The Post & Courier.

    State taxes on cigarettes, cigars and “other tobacco products” (which includes vapor) tallied nearly $146 million last fiscal year, according to the state Revenue and Fiscal Affairs Office. Opponents include more than a dozen public health groups which have urged legislators to reject the proposal co-sponsored by both the chamber’s Republican and Democratic leaders.

    As amended, the measure grandfathers in any local ordinances enacted before Dec. 31, 2020. That would allow Myrtle Beach to keep in place its ban on sales of tobacco, hemp oil and vaping products within a 10-block section along Ocean Boulevard, if it survives a court challenge. It’s unclear how many other local rules exist. Advocacy groups that represent local governments did not immediately know.

    “The idea is we establish a statewide standard and don’t have a hodgepodge of rules related to these products,” said state Rep. Micah Caskey, R-West Columbia. “This is an attempt to get ahead on this issue so we don’t end up with more.” The bill does not affect local governments’ ability to use zoning laws to regulate where tobacco businesses can locate within their borders.

    Update: On April 7, the South Carolina House of Representatives passed the law by a vote of 80-23. The bill will now move to the South Carolina Senate.

  • Bill to Ban Local Vapor Rules Dies in Montana Senate

    Bill to Ban Local Vapor Rules Dies in Montana Senate

    An attempt by the Montana legislature to stop local governments from enacting ordinances to ban the sale of flavored vaping products was shot down by the state’s Senate on Tuesday. Senate Bill 398, from Sen. Jason Ellsworth was voted down on a second reading by a 21-29 margin. It was then indefinitely postponed on a 31-18 vote.

    In opposition to the bill, Sen. Carlie Boland, D-Great Falls, said the state is dealing with a vaping epidemic and that companies make flavors to target children. Boland said taking away the ability to enact regulations to counter vaping among children was harmful, according to an article in the Montana Standard.

    “It has to be a community working together to achieve this. We need to address this problem and it should start at our homes and at the local level,” Boland said. Ellsworth argued vaping products are legal and their sale should not be restricted. He also said owners of vape shops testified that local ordinances dramatically hurt their businesses and that shops aren’t allowed to sell to underage minors.

    “We should not be enacting laws on a local level. Just think about that for a second. We’ve seen that happen. We’ve seen how that has had repercussions and we’ve had to come back here as a body to rein in these local governments trying to restrict our freedoms,” Ellsworth said

    Earlier this session, Rep. Ron Marshall, R-Hamilton, brought a bill that would have barred a local government or the state Department of Public Health and Human Services from creating or continuing a regulation, ordinance or restriction related to vaping products. That bill passed the House in February but later was voted down in the Senate Business, Labor and Economic Affairs Committee. Marshall is a co-owner of a vaping shop.

    At the state level, the Montana Department of Public Health and Human Services proposed to ban flavored vaping products in 2020 over concern that flavors targeted children. Ellsworth was a leader in a push from GOP lawmakers to oppose the ban, which the department eventually dropped. Missoula had passed a ban on flavored vaping products, but delayed enforcement until May after it was sued.

    Ellsworth’s bill would have said local governments could not enact ordinances that prohibited the sale of vaping products or alternative nicotine products. It did allow the enactment of “reasonable” ordinances or resolutions related to the sale of vaping products, but did not define reasonable.

  • 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.