Tag: New York

  • Group of 31 States Wants FDA to Ban Most E-Liquid Flavors

    Group of 31 States Wants FDA to Ban Most E-Liquid Flavors

    A coalition of 31 U.S. states and territories has penned a letter the U.S. Food and Drug Administration (FDA) to asking the agency to ban all flavors other than tobacco, limit nicotine levels and restrict the marketing of all electronic nicotine delivery system (ENDS) products. The group wants the regulations to also apply to oral nicotine products such as pouches, gum and lozenges.

    Credit: Balint Radu

    Led by New York Attorney General Letitia James, the group’s letter to the FDA argues that the FDA must address the epidemic of youth use of ENDS products by imposing restrictions and age verifications on traditional and digital marketing tactics aimed towards youth, according to a press release. The group claims that e-cigarettes and oral nicotine products have not received marketing authorization from the FDA, as required by federal law.

    “Flavored nicotine products attract kids to dangerous, habit-forming products that only jeopardize their health,” said James. “New York has taken important steps to protect our kids by banning non-tobacco flavored vapor products and limiting the sale of e-cigarettes, but the FDA must also do its part to curb the youth nicotine epidemic. The health and wellbeing of our kids is our top priority and the federal government must act now.”

    The FDA must make a decision by Sept. 9 on whether to allow nicotine products to stay on the market through its premarket tobacco product application (PMTA) pathway for any ENDS product that submitted the application by Sept. 9, 2020. The group’s proposed restrictions would require the FDA to deny approval for most products.

    The coalition argues that banning candy, mint, fruit, and menthol flavors, is essential to eliminating the appeal of the products to youth consumers. Other signatories to the letter are the attorneys general of Idaho, Illinois, Nebraska, North Carolina, and Tennessee. Additional states joining the letter include Alaska, Arkansas, California, Colorado, Connecticut, Delaware, the District of Columbia, Guam, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Utah, Vermont, Washington, and Wisconsin.

    James has a long history of challenging the ENDS industry. In April 2019, she led a coalition of seven states in urging the FDA to take stronger action in addressing “the scourge of e-cigarette use among youths” by taking proposed measures such as strengthening guidance, beginning enforcement earlier and banning online sales of e-cigarettes.

    Later that year, James filed a lawsuit against the electronic cigarette company JUUL Labs for deceptive and misleading marketing of its e-cigarettes, which “contributed to the ongoing youth vaping epidemic in New York state.” In December 2020, James ordered dozens of retailers across New York state to immediately stop selling e-cigarette products to underage customers and to stop selling flavored vaping products in violation of New York state law.

    Several recent studies have found that banning flavored vaping products boosts sales of combustible cigarettes and youth use. If vapor product sales were restricted to tobacco flavors, one-third of U.S. vapers between the ages of 18 and 34 would switch to smoking combustible cigarettes, according to at least three known studies.

  • Plaintiffs Sought in RLX Technology Class-Action Suit

    Plaintiffs Sought in RLX Technology Class-Action Suit

    Wolf Haldenstein Adler Freeman & Herz LLP are now seeking additional plaintiffs for a federal securities class action lawsuit that has been filed in the United States District Court for the Southern District of New York on behalf of investors that purchased RLX Technology Inc. The lawsuit was filed by Glancy Prongay & Murray LLP on behalf of investors.

    The filed complaint alleges that the Registration Statement misrepresented and omitted, among other things, RLX’s exposure to China’s then-existing campaign to establish a national standard for e-cigarettes that would bring them into line with regular cigarette regulations, according to a press release.

    “The truth was revealed when draft regulations were posted by the Ministry of Industry and Information Technology, before the market opened on March 22, 2021, eight weeks after RLX’s IPO, which confirmed e-cigarettes and new tobacco products would be regulated similar to traditional tobacco offerings,” the release states.

    Following the news out of China, the price of RLX’s shares suffered an enormous decline. On March 22, 2021, RLX’s ADR closed at $10.15 per share, down nearly 48 percent from its previous close of $19.46 on March 19, 2021, the previous trading day.

  • FDA Issues 3 Warning Letters for PMTA Violations

    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.

  • New York Latest State to Ban Delta-8 Products

    New York Latest State to Ban Delta-8 Products

    New York state has joined a growing number of U.S. states that have expressly prohibited delta-8 THC and other THC isomers derived from hemp. However, lawmakers in the Empire State did make several small concessions to hemp producers, including a modification to limits on smokable hemp and removing a requirement that all cannabinoids over 0.05 percent THC be listed on product labels.

    The delta-8 THC ban is part of the state’s revised regulations for hemp products. The new rules state that hemp cannabinoid products may “not contain synthetic cannabinoids, or cannabinoids created through isomerization, including [delta] 8-tetrahydrocannabinol and [delta] 10-tetrahydrocannabinol.”

    New York has also placed a ban on hemp prerolls, cigarettes and any “flower product labeled or advertised for the purpose of smoking.” But the state health department says it will allow the sale of hemp flower, so long as the flower is not branded as an item for smoking, according to Hemp Industry Daily.

    Hemp vapes are legal for customers over 21 and must carry “a warning stating that smoking or vaporizing is hazardous to your health.”

    At least six states have considered or are currently updating their laws to specifically govern delta-8 THC, joining at least 11 that already have laws on the books addressing the minor cannabinoid, which can produce psychoactive effects in some people, although they are considered to be less potent than the delta 9-THC common in marijuana.

    The labeling requirement remains in place for CBD and THC amounts in a product, just not for all cannabinoids in a product. The New York updates come six weeks after Gov. Andrew Cuomo signed a law making a first-in-the-nation attempt to regulate hemp operators working with flower and cannabinoid products the same way the state oversees marijuana operators, designating a new category for “cannabinoid hemp” that will be governed by a new Office of Cannabis Management.

    New York’s health department told hemp and marijuana operators that it won’t require track-and-trace systems for hemp products, as some marijuana operators have requested. “Unlike medical marijuana and adult–use cannabis markets, cannabinoid hemp products can enter interstate commerce and it would be impractical to impose a state level seed–to–sale requirement on an industry not limited to intrastate,” regulators wrote. The state legalized recreational marijuana earlier this year.

    Michelle Bodian, a cannabis attorney with the Vicente Sederberg firm in New York City, said that the state has the “potential to set a model for the rest of the country in regulating consumable hemp products.” But she added that the U.S. Food and Drug Administration needs to implement a single set of health-and-safety regulations. “Until there are national standards from FDA concerning cannabinoid hemp products, it continues to be very difficult and impractical for businesses to comply with these very specific state testing and labeling requirements, let alone all the other unique requirements.”

  • New York Attorney General Cracks Down on Vape Shops

    New York Attorney General Cracks Down on Vape Shops

    New York Attorney General Letitia James ordered dozens of retailers across the state to immediately stop selling flavored e-cigarette and vaping products and to end underage sales. New York banned flavored vaping products statewide as of May 2020.

    Letitia James
    New York Attorney General Letitia James

    James’ office issued cease and desist letters to 47 retailers that were illegally selling tobacco products throughout New York. The shops were located in the cities and counties of Albany, Buffalo, Elmira, Hamilton, Nassau, Rochester, Saratoga County, Syracuse, Warren County, Watertown, and the New York City area, according to a press release.

    “New York banned flavored vaping products and raised the age to buy tobacco products because teens were getting addicted to the dangerous habit of smoking,” said James. “These businesses skirted the law, jeopardizing the health of young New Yorkers. We will remain vigilant in holding anyone accountable who endanger our children by circumventing our laws.”

    The release states that investigators discovered retailers selling nicotine products to underage customers and selling flavored nicotine vaping products. Some shops were also selling nicotine-free flavored liquid alongside vaping products for customers to create their own flavored vaping products.

    The illicit products were sold both in the open and secretly from behind the counter, according to the release.

  • Judge Orders New York State to Pay Vapor Group’s Attorney Fees

    Judge Orders New York State to Pay Vapor Group’s Attorney Fees

    Credit: Bill Oxford

    A judge says the state of New York state will now have to reimburse the Vapor Technology Association’s (VTA) attorney fees after the state attempted to ban flavored vaping products last year.

    Acting state Supreme Court Justice Catherine Cholakis said wednesday that she agreed that state officials overreached their authority and thus should cover the legal costs associated with fighting the ban.

    Several vape shops and the VTA are seeking about $381,000 in attorneys’ fees and costs from the state. Cholakis noted an evidentiary hearing will be set to determine if the amount is accurate, court records show, according to The Journal News.

    In the order, Cholakis noted the state Attorney General’s Office lawyers representing New York made a compelling case that the emergency ban “was in response to the serious problems of underage vaping and pulmonary illnesses traced to vaping.”

    But in explaining why the state must cover the group’s attorneys fees, she added: “There can be no denying the seriousness of the health issues surrounding vaping. Concern for those issues, however, cannot excuse clearly unconstitutional action.”

    Cholakis, however, questioned the amount of money sought by the vaping groups.

    New York state’s lawyers “bristle, though, at the amount of costs and fees sought by (the vaping group),” she wrote.

  • New York Lawmaker Wants 25 as Age to Purchase Vapor

    New York Lawmaker Wants 25 as Age to Purchase Vapor

    A legislator in Long Island legislator introduced a bill that would raise the age for vaping and smoking cigarettes from 21 to 25 in in Suffolk County.

    The legal age to smoke statewide is 21. But localities have the option to raise it higher. New York City’s smoking age is 21, according to a story in the New York Post.

    The author of the proposed law, Suffolk County Legislator Sam Gonzalez, said boosting the age to 25 will save thousands of lives by discouraging and preventing young people from smoking. Smoking will be less alluring to a more mature 25-year-old, said Gonzalez, who kicked the habit 27 years ago, around the time his daughter was born.

    “I was a two-pack-a-day smoker,” Gonzalez, 59, said. “The raise-the-age law will stop the younger kids from smoking. There is a big difference between the age of 21 and 25.”

    He said having an age 25 smoking law will “absolutely” make Suffolk a more attractive place to live.

    “God willing. Everyone should follow us,” Gonzalez said.

    But he also pointed to scientific studies that show that the “rational part” of the human brain is not fully developed until the age of 25.

    “The smoking age should be increased in order to protect Suffolk County’s young people from making such a significant decision until such time as their brains are fully developed,” he said. “I’m expecting pushback. I’m hearing whispers of, ‘Are you crazy?’ ”

  • New York Vape Shop Owners Seeing Sharp Declines

    New York Vape Shop Owners Seeing Sharp Declines

    Just three months after the state of New York banned flavored vaping products, vape shop owners say there has been a steep drop in customers. The ban, aimed at reducing youth vaping, came after several cases of lung disease caused by illicit marijuana products.

    The number of those illnesses surged in August and September 2019 and had killed 68 people by Feb. 18, when the U.S. Centers for Disease Control and Prevention stopped collecting state health data on the illnesses because of the decline in cases, according to an article on Newsday.com.

    The CDC concluded that vitamin E acetate, which was sometimes added to vape products containing THC was “the primary cause” of the illnesses, Brain King, a deputy director in the CDC’s Office on Smoking and Health, told Newsday in an email.

    New York’s ban, which went into effect May 18, allows the sale only of vape liquids that are flavorless or taste like tobacco. A ban on all online vape sales started July 1. Some vape shops have shut down since the flavor ban, and others “are just barely hanging on,” said Cheryl Richter, executive director of the New York State Vapor Association.

    Tammy Mink, owner of Shore Vapes in Glen Cove, said the ban, and a Nassau County ban on all flavors except menthol and mint that went into effect Jan. 1, “killed our business.” About 90% of pre-ban sales of vape liquids were of flavored products, she said.

    Mink said most of her customers started vaping to stop smoking — as she did — and some have now returned to smoking. Mink said she would have welcomed a crackdown on sales of vape products to people under 21. Instead, the ban “opened up a black market,” she said. “It will not stop the kids from getting it.”

    Several stores on the Shinnecock reservation — which asserts it is exempt from the ban because of its legal sovereignty — still sell flavored vape products, said Taobi Silva, a former tribal trustee who co-owns a vape store and manages a smoke shop that sells vape products and traditional cigarettes.

    Silva saw increased sales after the ban went into effect “but not as significant as we were expecting.” That’s largely because gas stations and bodegas outside the reservation, as well as people operating from their car trunks, illegally sell the flavored products, he said.

    The current ban was passed by the State Legislature and signed by Gov. Andrew M. Cuomo. A state health council approved a ban in September, but a state appeals court blocked enforcement after a lawsuit filed by the Washington, D.C.-based Vapor Technology Association. Association president Tony Abboud said in a statement Thursday that the group “does not have any plans to litigate” the new flavor ban.

  • Three Entities Ordered to End New York Online Vape Sales

    Three Entities Ordered to End New York Online Vape Sales

    Credit: Mike Valdivia

    The New York Attorney General’s office has ordered three online vaping companies to end the online sale of vaping products to consumers in New York. 

    Cloud X Vapes, HQD Tech USA, and PodVapes, have been ordered to cease and desist illegally selling vaping products. All three companies were found selling products to minors, offering flavored nicotine vaping products, including cotton candy, pineapple mist, and green apple, according to an article on informnny.com.

    “Candy and fruit flavored vaping products exist to reel teens into the dangerous habit of smoking, which is why New York banned them,” said Attorney General Lititia James. “It is shameful that these companies attempted to skirt the law through sneaky, illegal online sales. We will not hesitate to hold those who put our children at risk accountable for their unlawful actions.” 

    Recent legislation in New York prohibits the sale of any nicotine product to anyone under 21, the sale of flavored nicotine product as of May 18, and the sale of vaping products online and through mail order to New York consumers as of July 1 2020.

  • Last Day: New York State Vapor Ban Starts July 1

    Last Day: New York State Vapor Ban Starts July 1

    A Billion Lives
    Credit: A Billion Lives

    Tomorrow, July 1st, a ban on the sale of flavored vapor products, other than tobacco and menthol, goes into effect for the State of New York. Pharmacies will also no longer be permitted to sell any tobacco or nicotine product that isn’t an approved smoking cessation therapy.

    Online sales of any e-liquids–regardless of flavor–are banned (vapor products are folded into the same provision that bans shipment of cigarettes to consumers). This does not include components or devices. The penalty for selling or shipping a vapor product to a consumer in NY is a Class A misdemeanor and carries a fine of $5000 or $100 per vapor product, according to the Consumer Advocates for Smoke-free Alternatives Association (CASAA), a non-profit, grassroots organization.

    A person other than a common or contract carrier can still transport vapor products, but there is now a limit of 500 milliliters or 3 grams of nicotine. Additionally, coupons or “price reduction instruments” for tobacco products are banned.

    “Vapor manufacturers must post a detailed ingredient list including a disclosure of ‘the nature and extent of investigations and research performed by or for the manufacturer concerning the effects on human health of such product or its ingredients.’” writes Casaa. “Manufacturers are also required to list ‘each byproduct that may be introduced into vapor produced during the normal use of such e-cigarette.’ (this requirement does not apply to any other tobacco product).”

    In April, New York became the fourth state in the U.S. to restrict the sale of flavored vaping products. The New York Assembly reluctantly passed S. 7506-B, a budget bill, which banned the sale of vapor products in flavors other than tobacco. The budget bill was heavily criticized because it debated and passed under cover of darkness, according to CASAA. “There were no opportunities for the public to weigh in on the bill unless you diligently followed the constantly changing bill numbers and language,” the organization wrote at the time.