Tag: American Vapor Manufacturers Association

  • AVM Urges Investigation of Dick Durbin

    AVM Urges Investigation of Dick Durbin

    Dick Durbin and Center for Tobacco Products Director Brian King (Photo: The office of Senator Dick Durbin)

    The American Vapor Manufacturers Association (AVM) has requested that the Senate Ethics Committee investigate Illinois Senator Dick Durbin for allegedly violating Senate rules by attempting to improperly influence U.S. Food and Drug Administration scientific decisions about vaping products, according to Vaping360.

    On Oct. 14, the AVM delivered a letter to the chair and vice chair of the Senate Select Committee on Ethics that alleged Durbin pressured the FDA to ban all vaping products despite the agency’s premarket tobacco product application (PMTA) review process.

    Citing Durbin’s track record (urging the FDA to ban vapor products via letters, Senate floor speeches, press releases and private meetings) the AVM says it believes Durbin attempted “to interfere with and influence the outcome of an ongoing executive branch agency review process in violation of Senate Ethics rules.”

    “Senator Durbin’s arrogant bullying has now become a grave threat to public health.”

    Amanda Wheeler, president, AVM

    “Senator Durbin’s arrogant bullying has now become a grave threat to public health,” AVM President Amanda Wheeler said in a press release. “At a time when trust in public health authorities is already shaky, Durbin’s shameful campaign to hijack federal policy on this crucial health issue should come to an immediate end.”

    The letter to the Senate committee marks the second time this year that the AVM has asked a government body to investigate corruption of the FDA PMTA review process.

    According to Vaping360, the ethics committee is unlikely to seriously investigate Durbin or cite him for misconduct; Durbin is Senate Majority Whip, making him the second-highest ranking Democrat in the Democratic-led body.

  • ‘FDA Downplays PMTA Acceptance Numbers’

    ‘FDA Downplays PMTA Acceptance Numbers’

    Amanda Wheeler (Photo: AVM)

    The U.S. Food and Drug Administration is understating the number of nontobacco nicotine (NTN)-related premarket tobacco product applications (PMTAs) it has accepted for review in order to avoid criticism from tobacco control groups that seek prohibition of all vaping products, reports Vaping360, citing American Vapor Manufacturers Association (AVM) President Amanda Wheeler.

    On Sept. 8, the FDA announced it has accepted over 350 PMTAs (out of nearly 1 million applications) for NTN products. Wheeler insists that AVM member companies alone have received acceptance letters for 4,700 PMTA submissions.

    “Once again, the FDA and its Center for Tobacco Products are misleading the public and press on crucial data and methods in its approval process for vaping products,” Wheeler said in a statement. “The figures stated in its press release today on synthetic nicotine applications are demonstrably inconsistent with FDA letters to our own members indicating many thousands more applications successfully filed than FDA now claims.”

    An acceptance letter indicates that the application has met the basic requirements to move forward in the review process. It does not authorize the applicant to market the product.

    The AVM also says the FDA altered required PMTA forms close to the submission deadline to disqualify already-submitted applications. According to Wheeler, the application forms were “abruptly altered” without public notice, “apparently as a means to disqualify wide swaths of already-filed applications.”

    In March, U.S. President Joe Biden signed legislation authorizing the FDA to regulate synthetic nicotine products. Manufacturers had until May 14 to submit PMTAs and were given two additional months to continue selling products with pending PMTAs. When the grace period ended July 13, all synthetic nicotine-based products became subject to FDA enforcement.

  • Vaping Advocate Greg Conley Joins the AVM

    Vaping Advocate Greg Conley Joins the AVM

    Greg Conley

    Longtime vaping industry advocate Gregory Conley is joining the American Vapor Manufacturers Association (AVM) as director of legislative and external affairs.

    Under the direction of AVM President Amanda Wheeler, Conley will focus on government and media relations, while helping advance public policy supporting the American vaping product industry in its fight for survival.

    “Over the last decade-plus, myself and millions of American adults have given up cigarettes because of vaping,” said Conley. “During that time, I have been proud to advocate for vaping from the perspective of a consumer and harm reductionist. In this new role at AVM, I will continue to push for appropriate regulations to ensure that American businesses are not replaced with a multibillion-dollar illicit market.”

    “Gregory is a critical voice for vaping and understands adult smokers and ex-smokers face dire circumstances because of the FDA,” said Wheeler. “One billionaire is pumping hundreds of millions of dollars into campaigns designed to end the vaping industry. The stakes have never been greater and I am thrilled to have him aboard to work towards a unified industry.”

    Conley has a long history of advocacy for vaping products and tobacco harm reduction, dating back to 2010. While receiving a la and business degree from Rutgers University, Conley served as the pro bono legislative director for the Consumer Advocates for Smoke-Free Alternatives Association.

    Conley then founded the American Vaping Association (AVA), and during his time there he testified before dozens of state legislative bodies, appeared on numerous news networks, and participated in a White House listening session with then-President Donald Trump.

    Conley plans to continue working with AVA as it charts a new path forward focusing on voter education and outreach.

  • Association Calls For Investigation Of MDO’s

    Association Calls For Investigation Of MDO’s

    Photo: Andrey Popov

    The American Vapor Manufacturers Association (AVMA) has asked the U.S. Department of Health and Human Services’ (HHS) Inspector General to investigate whether the Food and Drug Administration’s marketing denial orders for vaping products are driven by political pressure.

    The AVMA says it wants the inspector general to help the public learn about FDA Commissioner Robert Califf’s coordination with elected officials, allied activists and reporters as his agency continues its review of premarket tobacco product applications (PMTA).

    Amanda Wheeler

    In a letter sent to HHS Inspector General Christi A. Grimm, AVMA President Amanda Wheeler contends that interference has corrupted FDA’s statutory obligation to properly implement its PMTA review process based solely on scientific, empirically based judgment.

    “Manufacturers are routinely meeting the PMTA requirements to scientifically demonstrate how their products are appropriate for the protection of public health,” Wheeler wrote. “Despite compliance, the agency isn’t approving the vape products sought by adults who want to quit smoking. The Office of Inspector General should open the door and hold the FDA accountable to its standards.”