Category: Regulation

  • FDA’s Flavor Ban on Closed-Pod Systems Starts at 12:01 am Thursday

    FDA’s Flavor Ban on Closed-Pod Systems Starts at 12:01 am Thursday

    The Trump administration’s partial ban on flavored e-cigarettes will go into effect at a minute after midnight Thursday.

    The partial vape ban will impact most vapor products that use pre-filled pods, often called closed systems. Sales of fruit-, dessert- and mint- flavored pods will be banned; menthol and tobacco flavors will escape prohibition, according to an article in the Washington Post. The closed-pod products products, which were popularized by Juul Labs, have been widely available in convenience stores and in some vape shops.

    The goal of the restrictions is to reduce youth vaping, which health officials say has reached epidemic levels, according to the story. The White House initially indicated it would ban even more products, but backed off amid objections from the vaping industry.

  • U.S. FDA Chief Vows Action if Necessary to Combat Youth Uptake

    U.S. FDA Chief Vows Action if Necessary to Combat Youth Uptake

    Stephen Hahn, the new U.S. Food and Drug Administration (FDA) commissioner, defended the Trump administration’s partial e-cigarette ban but said he would take more actions to stop teen vaping if necessary.

    The vaping ban will take effect on Feb. 6 and will ban the sale of most flavored cartridge-based vapor products, with the exception of menthol and tobacco flavors and single-use disposable products. Critics of the ban say it is too weak and fear youth will simply switch to the nonbanned products.

    In his first interview with a national media outlet since his confirmation in December, Hahn told the Washington Post that the sales restrictions will target the products most popular with youth but that the FDA will closely monitor the situation, and if minors do switch to menthol-flavored products, the agency will take further action to curb vaping.

    “The good thing about this policy is we have the ability without jumping through a lot of hoops to change our enforcement prioritization based on the data we are getting in,” Hahn said.

    Advocates on both sides expressed skepticism at the FDA’s ability to quickly assess and respond to changing patterns in youth vaping. “There is zero percent chance the FDA can quickly respond to what they view as the risks associated with vaping because in three years, they have failed to implement sensible regulations,” said Paul Blair, director of strategic initiatives for Americans for Tax Reform.

    “The agency’s record of monitoring the marketplace in real time is troubling,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. “There have been enormous changes with no evidence of their knowing it.”

  • NJoy Removes Non-Tobacco Flavors From the U.S. Market

    NJoy Removes Non-Tobacco Flavors From the U.S. Market

    NJOY Holdings voluntarily ended sales of its fruit-flavored products in the U.S. market. The announcement came as lawmakers and anti-vaping advocates voice concerns that young users might migrate to the disposable devices.

    The Food and Drug Administration’s (FDA) new electronic delivery system (ENDS) rules will remove all sweet and fruit-flavored products from the U.S. market. The agency also announced it wouldn’t restrict sales of “completely self-contained, disposable products.”

    The flavor takes effect on Feb. 6.

  • New Jersey Governor Signs Vapor Flavor Ban, Takes Effect on April 20

    New Jersey Governor Signs Vapor Flavor Ban, Takes Effect on April 20

    Flavored vaping products, which critics say attract teens and get them hooked on nicotine, will soon be banned in New Jersey, according to an article on nj.com.

    Gov. Phil Murphy on Tuesday signed a bill into law prohibiting flavors in e-cigarettes in the Garden State, just months after he called for state lawmakers to send him a measure barring the products as a national health crisis associated with vaping unfolded.

    The law is the nation’s first permanent flavor ban, according to the governor’s office. Several others issued emergency bans last year as the vaping crisis began, the story states.

    “As governor, I am first and foremost charged with protecting the health and safety of our people,” Murphy, a Democrat, said in a statement. “Research shows that flavored electronic smoking devices and products, such as mint, candy, fruit, and chocolate, are extremely appealing, especially to children.”

    The flavor ban will take effect in 90 days, or on April 20. The small vape shop owners say that leaves them with a short time to clear their shelves and pivot their business models, according to the article.

    Many have said the flavor will take away their main source of revenue and force them into bankruptcy, while the law will do nothing to address the black market. Some former cigarette smokers say switching to vaping helped them to quit and has improved their health.

    But others hope the ban will keep kids from picking up the habit after smoking significantly declined among young people, the article states.

    A former version of the bill included a ban on menthol cigarettes, but state Senate President Stephen Sweeney said lawmakers put that on hold, planning to bring it up again during budget discussions later this year.

  • Avail Vapor Divides Into 3 Separate Entities to Better Serve Its Clients

    Avail Vapor Divides Into 3 Separate Entities to Better Serve Its Clients

    Avail Vapor has announced that as of January 1, 2020 the company has divided its operations into three separate businesses. Each entity has its own dedicated management team that will all be headquartered in Richmond, Virginia.

    “Evolving our corporate structure supports our continuing growth across the multiple segments of our portfolio from vaping, manufacturing, distribution, regulatory services to future markets,” said James Xu, former CEO of AVAIL who now serves as chairman of the three entities. “Due to the increasing importance of our regulatory consulting division at a time when U.S. Food and Drug Administration (FDA) compliance is paramount, we want to drive even greater focus to that area, and also support the individual needs of our customers and clients.”

    The three companies are: Avail Vapor (the retail arm with stores in 12 states and online; Blackbriar Regulatory Services, a contract manufacturing, FDA compliance consulting and laboratory services; Blackship Technologies, a research and development services company.

    Blackbriar Regulatory Services (BRS) has also announced it has entered into agreements with Charlie’s Chalk Dust, a major international e-liquid brand and a subsidiary of Charlies Holdings, to manufacture a range of its nicotine products and take the lead in submitting a number of those products for the FDA’s premarket tobacco product application (PMTA) process by the agency’s May 2020 deadline.

    “We are honored that Charlie’s Chalk Dust has added its name to the growing list of companies that trust us to help them move forward in a maturing industry,” said Russ Rogers, CEO of BRS. “Under Avail, we partnered with Charlie’s for several years to help the company deliver the highest quality products to this market, and we are very happy to see that they remain so strongly committed to continuing their success working with Blackbriar as vape-industry leaders start to add regulatory compliance to their list of critical strategies.”

    All e-liquid and device manufacturers have until May 2020 to submit PMTAs for electronic nicotine delivery systems (ENDS) under section 910 of the Federal Food, Drug, and Cosmetic Act. This includes liquids, devices and any affiliated products related to ENDS products. The FDA than has 12 months to review applications.

    “The PMTA process is rigorous and complex,” said Ryan Stump, COO of Charlie’s Holdings. “We are fortunate to have a strong relationship with the leadership team at Blackbriar, a result of prior manufacturing agreements with Avail Vapor, the sister company. We are confident that guidance from BRS will further ensure Charlie’s continued compliance with the regulations put forth by FDA, further supporting Charlie’s leadership in the nicotine e-liquid vape space.”

  • Vape Shop Owners Fighting Back Against New Hampshire Flavor Ban

    Vape Shop Owners Fighting Back Against New Hampshire Flavor Ban

    Vape shop owners in New Hampshire came out in force Wednesday in opposition to a proposed flavor ban on vapor products. They argue the ban would shutter shops and force former smokers back to deadly combustible cigarettes.

    Rep. Jerry Knirk, Freedom, wants New Hampshire to ban the sale of all flavored vaping products, except tobacco flavors. A recent Trump administration ban removed all but tobacco flavors from closed systems.

    “We need to place children’s health and public health over the profits of the vaping industry,” he told the House Commerce Committee, an article on ap.com states.

    After several speakers who support the ban, vape shop owners who followed rebutted those arguments stating that adult vapers like flavors too.

    “I’m 34 years old. Cap’n Crunchberries and pineapple grapefruit, these two things are keeping me off cigarettes,” said Steve Kaltsis, who said he smoked a pack of cigarettes a day for 10 years before taking up vaping five years ago. He opened a vape shop in Pelham in November after sales dropped from $1,800 to $150 per day at his store in Dracut, Massachusetts, where the governor announced a four-month moratorium on the sale of vaping products in September, according to the article.

    “Anything that is opposing adults getting their hands on these flavors that help them quit would be a tragedy for the state of New Hampshire,” he said. “Just look what it did to Massachusetts. Look what it did to me.”

  • Bill to Ban Flavors in Vapor Products in New Jersey Sitting on Governor’s Desk

    Bill to Ban Flavors in Vapor Products in New Jersey Sitting on Governor’s Desk

    New Jersey lawmakers voted on Monday to ban flavored vapor products in an effort to reduce youth tobacco use. The bill now awaits approval from Governor Phil Murray.

    The legislation also prohibits the use of coupons or discounts to purchase tobacco or vapor products, and it would bar menthol-flavored products, as well as fruit and candy flavors, but would allow tobacco flavors.

    If approved, New Jersey would follow Massachusetts as the only other state with a statewide ban on flavors, though other states have enacted emergency regulations on the sales of flavored products.

    Murray has not indicated whether he will sign the legislation into law.

  • Closed Pod Flavor Ban to Take Effect on Feb. 6, Tobacco and Menthol Exempt

    The U.S. Food and Drug Administration (FDA) filed its notice in the Federal Register for its new regulatory restrictions that would ban all flavors except menthol and tobacco in closed-pod systems.

    The filing started the 30-day countdown for manufacturers of closed-pod systems, such as Juul, Vuse and Blu products, to stop making, distributing and selling the “unauthorized flavorings,” or risk enforcement actions.

    Retailers must also stop selling the products by Feb. 6.

    “[Health and Human Services] HHS is taking a comprehensive, aggressive approach to enforcing the law passed by Congress, under which no e-cigarettes are currently on the market legally,” HHS Secretary Alex Azar said on Jan. 2.

    FDA Commissioner Stephen Hahn said federal regulators will regularly review the use of tobacco and menthol flavorings by youth and will be prepared “to take additional restrictive actions.”

    The FDA also reminded producers of nicotine e-liquids that they are considered as manufacturers, thus subject to a court-ordered May 12 deadline for submitting a premarket tobacco product application (PMTA) to the FDA.

    The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and nonusers, particularly compared with traditional cigarettes.

    E-liquids for use with open systems will remain available in tobacco and vape shops — primarily because the FDA and other Trump administration officials stated that those products don’t appeal to people under 21 and that those shops are more responsible about age verification than traditional retail outlets.

  • Claim That E-cigarettes 95 Percent Safer Than Traditional Cigarettes Disputed

    Claim That E-cigarettes 95 Percent Safer Than Traditional Cigarettes Disputed

    An article published on Jan. 8 in the American Journal of Public Health (AJPH) dismisses the claim that e-cigarettes are 95 percent safer than combustible cigarettes as a “factoid”—unreliable information repeated so often that it becomes accepted as fact.

    The 95 percent claim stems from a 2013 study rating the relative harm of 12 nicotine products using 14 criteria. The authors of the 2013 study concluded that electronic cigarettes were substantially less harmful than combustible cigarettes. Their claim was characterized in the popular media as e-cigarettes being “95 percent less risky” than tobacco cigarettes.

    Although the researchers of the original study acknowledged the shortcomings of their work—i.e., a lack of hard evidence for the harms of most products on most criteria—Public Health England and the Royal College of Physicians endorsed the claim, lending it credibility.

    The authors of the AJPH article point out that today’s vapor products are very different from those available in 2013. The devices are now more powerful, create more aerosol and expose users to more toxicants.

    The proliferation of e-liquids with nicotine salts, meanwhile, allow users to inhale significantly higher levels of nicotine. In addition, more research has emerged about the toxicants in e-cigarettes and their potential respiratory and cardiovascular effects, according to the AJPH article.

    “Even if the 2013 estimate was valid then it can no longer apply today,” the authors of the AJPH article wrote.

    “Public health practitioners, scientists and physicians should expose the fragile status of the 95 percent less risky claim by highlighting its unreliable provenance and lack of validity today,” they added.

  • Public Hearing Coming for Proposed Flavor Ban in U.S. State of Rhode Island

    Public Hearing Coming for Proposed Flavor Ban in U.S. State of Rhode Island

    In the US state of Rhode Island, public health officials have announced a public hearing on proposed regulations to permanently ban the sale of flavored vaping products in the state.

    The state Department of Health said the hearing is scheduled for Tuesday in Providence, according to an article on apnews.com.

    The department is considering making the temporary ban currently in effect in Rhode Island permanent.

    Democratic Gov. Gina Raimondo signed an executive order in September banning the sale of flavored vaping products. In response, the Health Department issued emergency regulations Oct. 4 to implement a four-month ban, with an optional two-month extension, according to the article.

    The department has said it’s acting now to permanently ban flavored vaping products because the temporary ban will soon lapse, and it wants to prevent teenagers and adolescents from vaping, given the health concerns.

    Raimondo supports a permanent ban, according to the article.

    Federal health officials say there have been 55 vaping-related deaths across the country, including one in Rhode Island, and more than 2,500 vaping-related hospitalizations nationwide, the article states.

    The state Health Department is accepting public comment until Jan. 26.