Tag: breaking

  • U.S. FDA Files First Civil Money Penalties for Illicit Sales

    U.S. FDA Files First Civil Money Penalties for Illicit Sales

    Credit: VetKit

    Some manufacturers of e-liquids could soon be paying nearly $20,000 per violation for selling vaping products without approval. Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.

    This marks the first time the regulatory agency has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket tobacco product application (PMTA) process.

    The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s PMTA requirements and that failure to correct these violations could lead to enforcement action, such as a CMP, according to a press release.

    Despite the agency’s warning, the companies continue to make and sell their unauthorized e-liquids to consumers.

    “Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.”

    As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:

    • BAM Group LLC doing business as VapEscape
    • Great American Vapes LLC doing business as Great American Vapes
    • The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
    • 13 Vapor Co. LLC doing business as 13 Vapor

    Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.

    The companies the FDA has filed CMP complaints against can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.

    “These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”    

    Manufacturers that continue to violate the law risk subsequent enforcement, according to the FDA. In addition to CMPs, the agency also has the authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.

  • Juul Labs to Exit South Korea, 5 EU Markets

    Juul Labs to Exit South Korea, 5 EU Markets

    Juul Labs said today it would end operations in South Korea, a year after it entered the market. The company states the cause was its inability to gain market share amid government health warnings.

    In a statement, Juul Labs stated that since the beginning of the year it was working through a restructuring process aimed a re-establishing a viable business in South Korea by significantly reducing costs and making changes to its products.

    “However, these innovations will not be available as anticipated,” the statement said. “As a result, we intend to cease our operations in South Korea.”

    In October last year, South Korea’s health ministry advised people to stop vaping because of growing health concerns, especially after a case of pneumonia was reported in a 30-year-old e-cigarette user that month, according to Reuters news article.

    The announcement prompted convenience store chains and duty free shops to suspend the sale of flavored liquid e-cigarettes, including those made by Juul Labs.

    In December, South Korean health authorities said they had found vitamin E acetate, which may be linked to lung illnesses, in some liquid e-cigarette products made by Juul Labs, but the company denied using the material, according to Reuters.

    Juul Labs launched a product portfolio that was specifically developed for the Korean market in May 2019, but “our performance has not met expectations in terms of meeting the needs of our Korean adult smokers to successfully transition from combustible cigarettes,” according to the statement. “We have learned through this process and are focused on innovating our product portfolio.”

    Juul Labs is also reportedly ready to withdraw from a handful of EU markets as well, claiming the regulatory environment has become overly hostile to the device.

    According to BuzzFeed News, Juul will soon remove its products from shelves in Austria, Belgium, Portugal, France, and Spain.

    The news outlet reports the European Union’s strict requirement that e-cigs contain no more than 20 milligrams of nicotine makes it difficult for Juul to do business there.

    Austria, Belgium, and Portugal are very small markets for Juul, but the leading e-cig manufacturer generates significant sales from France and Spain. It will exit France by the end of the year, but withdraw from the other countries in July, paring its presence in global markets to a narrow selection that includes Germany, Italy, Russia, and the U.K.

  • Foundation Debates Covid-19 Crisis’ Impact on Harm Reduction

    Foundation Debates Covid-19 Crisis’ Impact on Harm Reduction

    Sally Satel during the 2019 GTNF in Washington DC | Photo David Parker

    The Reason Foundation will host a webinar on May 19, 2020, at 12:30 p.m. Eastern time to discuss how Covid-19 is affecting tobacco harm reduction and policymaking.

    Guy Bentley, director of consumer freedom research for the Reason Foundation, will host the webinar. Other speakers will include Sally Satel, resident scholar at the American Enterprise Institute, Michelle Minton, senior fellow at the Competitive Enterprise Institute, and Tim Andrews, executive director for the Taxpayers Protection Alliance.

    The webinar is open to the public.