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Tag: regulation

  • Juul Labs Exploring Options, Including Financing

    Juul Labs Exploring Options, Including Financing

    Juul Labs on Friday said it is in the early stages of exploring several options including financing alternatives, as the company deals with lawsuits and a potential ban on sales of its e-cigarettes by U.S. health regulators.

    Bloomberg News earlier reported, citing sources, that Juul’s bankers at Centerview Partners are sounding out investors for a possible $400 million first-lien term loan due August 2023.

    The proceeds would help refinance an existing term loan, which has around $394 million outstanding and matures on the same date, the report added.

    A spokesperson for Juul told Reuters that the company is looking at options to protect its business and to address the “impact of the FDA’s now stayed order so we can continue offering our products to adult consumers who have or are looking to transition away from traditional cigarettes.”

    Bloomberg News in its report said Juul was also considering a new $150 million second-lien term loan, which may have an August 2024 maturity, to help pay down some of the first-lien term loan and to increase liquidity, the report said.

    Financing proposals for either loan are due July 21, according to the report.

    Last month, the Food and Drug Administration (FDA) blocked sales of Juul e-cigarettes and said the applications “lacked sufficient evidence” to show that sale of the products would be appropriate for public health.

    However, Juul appealed the agency’s order and earlier this month FDA put on hold its ban saying it would do an additional review of the company’s marketing application.

  • Juul: FDA ‘Overlooked’ Aerosol Data

    Juul: FDA ‘Overlooked’ Aerosol Data

    The U.S. Food and Drug Administration overlooked a key part of Juul’s premarket tobacco product application (PMTA) when the agency ordered Juul Labs’ products off the U.S. market, according to court documents.

    In court filings Tuesday, Juul said the agency overlooked more than 6,000 pages of data that the company had submitted to the FDA on the aerosols that users inhale, according to the Wall Street Journal.

    Juul also said the agency failed to consider the totality of Juul’s evidence, which the company said established that the public-health benefits of Juul products significantly outweighed the potential risks.

    “FDA’s order acknowledged that ‘exposure to carcinogens and other toxicants present in cigarette smoke were greatly reduced with exclusive use’ of Juul products compared with combustible cigarettes,” Juul Labs stated in court documents.

    A federal appeals court last week granted Juul Labs a temporary stay of the FDA’s marketing denial order that requires the vaping company to pull its e-cigarettes off the U.S. market.

    “The purpose of this administrative stay is to give the court sufficient opportunity to consider petitioner’s forthcoming emergency motion for stay pending court review and should not be construed in any way as a ruling on the merits of that motion,” the court wrote.

    The FDA has until July 7 to respond to Juul’s motion and Juul Labs has until July 12 to reply to the FDA response if submitted.

  • Philippine Vaping Bill Heads to President’s Desk

    Philippine Vaping Bill Heads to President’s Desk

    Photo: Oleksii

    The Philippine House of Representatives and Senate have ratified a vaping bill that critics describe as too industry-friendly. The legislation will now be forwarded to President Rodrigo Duterte for his signature.

    Among other provisions, the bill transfers regulatory powers from the Food and Drug Administration to the Department of Trade and Industry (DTI) and lowers the legal purchase and consumption age for vapor products from 21 to 18. The DTI is also in charge of setting technical standards for the safety, consistency and quality of these smoking alternatives.

    Philippine College of Physicians (COP) President Maricar Blanco-Limpin said he was particularly concerned about the lower vaping age. “We have been telling all the legislators that making these more available at a younger age is making these e-cigarettes and heated-tobacco products more available to all, including the nonsmokers,” she told CNN Philippines.

    Blanco-Limpin said vape products could lead to health concerns and the “mandate to protect the health of the country falls under the FDA, not the DTI.”

    If the president signs the measure, Blanco-Limpin said the COP would consider all actions, including bringing the issue to the Supreme Court.

  • Broad Support for Philippine Vape Bill

    Broad Support for Philippine Vape Bill

    Photo: Rawpixel.com

    Nine out of 10 smokers in the Philippines support the country’s proposed vaping bill, according to a study, reports the Manila Times. A majority of respondents said the government should enact policies to encourage adult smokers to switch to less harmful alternatives while also ensuring these products are not used by minors.

    In 2021, the Senate and House of Representatives approved their respective versions of the measure. The bills must be reconciled by a bicameral conference committee and ratified by the two chambers. If President Rodrigo Duterte then signs the bill into law, the Vaporized Nicotine Products Bill will regulate e-cigarettes, heated-tobacco products and other vaporized nicotine products while ensuring that they contribute to government revenues.

    The study was conducted by Acorn Marketing and Research Consultants and commissioned by consumer advocacy group Vapers PH in August 2021. The survey sampled 2,000 legal-age smokers.