US authorises Juul to market vaping products
Juul won the new marketing granting orders (MGO) after submitting more than 110 scientific studies to the agency, the company said in a statement.
The decision means Juul can continue to sell products that have been on the US market but in regulatory limbo following earlier actions by the FDA.
"Following rigorous evaluation of the data, FDA decided that an MGO for the Juul System was 'appropriate for the protection of public health' –- the standard required by statute for authorisation," Juul said.
Juul has argued that its vaping products provide a public health benefit by shifting smokers away from combustible tobacco products closely linked to deadly illnesses.
But the company has been criticised for its marketing practices, agreeing to pay $438.5-million in a 2022 settlement with 34 US states to resolve accusations of marketing to underage smokers.
The FDA's move allows Juul to sell five products in all: the Juul device and capsules for the "Virginia Tobacco" and menthol flavour, each in versions with three or five percent nicotine concentration, said a spokesperson for the US Department of Health and Human Services.
The products needed to meet the standard set under a 2009 smoking prevention law showing that the benefits of switching to a potentially less harmful product is "sufficient to outweigh the risks of the product," including to anyone not using tobacco products, the spokesperson said.
The applicant submitted data "demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavoured Juul products."
But the agency's determination "does not mean these tobacco products are safe, nor are they 'FDA approved,'" said the spokesperson, who added that the agency will continue to monitor Juul's compliance with youth marketing restrictions.
Juul survived a difficult stretch after the FDA ordered it to halt sales in June 2022 because of health questions, although the decision was administratively suspended by the same agency shortly thereafter.
In June 2024, the FDA formally rescinded its June 2022 order, shifting the matter back into "pending" status while a substantive review continued.
The FDA's action on Thursday "confirms that these products are now authorised to remain on the market," said a Juul spokesman.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Star
23-07-2025
- The Star
WHO announces lenacapavir as a groundbreaking HIV prevention method
Tracy-Lynn Ruiters | Published 1 week ago The World Health Organization (WHO) announced a landmark policy at the 13th International AIDS Society Conference (IAS 2025) on HIV Science in Kigali, Rwanda, releasing new guidelines that recommend injectable lenacapavir (LEN) as a twice-yearly pre-exposure prophylaxis (PrEP) option for HIV prevention. This development has the potential to significantly reshape the global HIV response. LEN is the first twice-yearly injectable PrEP product, offering a highly effective, long-acting alternative to daily oral pills and shorter-acting prevention methods. With just two doses a year, LEN marks a transformative step in HIV prevention, particularly for individuals who face challenges with daily adherence, stigma, or limited access to health care. 'While an HIV vaccine remains elusive, lenacapavir is the next best thing: a long-acting antiretroviral shown in trials to prevent almost all HIV infections among those at risk," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. 'The launch of WHO's new guidelines, alongside the FDA's recent approval, marks a critical step forward in expanding access to this powerful tool. WHO is committed to working with countries and partners to ensure this innovation reaches communities as quickly and safely as possible.' The new guidelines come at a pivotal time, as global HIV prevention efforts have stalled, with 1.3 million new infections recorded in 2024. Key and priority populations — including sex workers, men who have sex with men, transgender individuals, people who inject drugs, those in prisons, as well as children and adolescents — continue to be disproportionately affected. WHO's endorsement of LEN marks a significant step toward broadening and diversifying HIV prevention strategies, empowering people with more choices to protect their health in ways that align with their needs and circumstances. WHO has recommended a simpler, more accessible approach to HIV testing using rapid tests to support the rollout of long-acting injectable PrEP like LEN and CAB-LA. This change removes a major barrier by cutting out complex, expensive procedures and allowing delivery through local clinics, pharmacies, and tele-health. LEN now joins other WHO-approved HIV prevention options — including daily oral PrEP, injectable cabotegravir, and the dapivirine vaginal ring. Although access to LEN outside clinical trials is still limited, WHO is calling on governments and health partners to begin implementing it within national HIV prevention programmes while gathering data on its real-world use and impact. For the first time, WHO now recommends long-acting injectable cabotegravir and rilpivirine (CAB/RPV) as an option for adults and adolescents who are already virally suppressed on oral antiretroviral therapy (ART) and don't have hepatitis B. This is especially helpful for people who struggle with daily pill-taking. WHO also updated its guidance on inte grating HIV care with other health services, such as treating high blood pressure, diabetes, mental health conditions (like depression, anxiety, and alcohol use disorders), and improving ART adherence. The organisation now recommends STI screening (gonorrhoea and chlamydia) for key and priority populations, even when no symptoms are present. For people living with HIV who have or are at risk of mpox (formerly monkeypox), WHO strongly recommends starting ART quickly, especially if they've never started treatment or have had long interruptions. HIV and syphilis testing is also advised for anyone with suspected or confirmed mpox. Given funding challenges facing global HIV programmes, WHO released new guidance to help countries maintain essential HIV services. This includes advice on how to prioritise services, manage risks, and keep health systems resilient. Dr Meg Doherty, WHO's HIV programme director, emphasised the urgency of acting on these guidelines: 'We have the tools and the knowledge to end AIDS as a public health problem. What we need now is bold implementation of these recommendations, grounded in equity and powered by communities.' HIV continues to be a major public health issue, with an estimated 40.8 million people living with the virus globally by the end of 2024. While treatment access is growing — 31.6 million people are now on ART — new infections and deaths remain high, particularly in the WHO African Region. With these updated guidelines, WHO said it is offering countries practical tools to make HIV responses more efficient, equitable, and sustainable. The focus now shifts to putting these strategies into action. [email protected] Weekend Argus
eNCA
18-07-2025
- eNCA
US may revise hormone replacement therapy warnings
WASHINGTON - US Food and Drug Administration Commissioner Marty Makary signalled that he is open to revising strict warning labels on Hormone Replacement Therapy, following testimony from experts who said the treatment's risks have long been exaggerated. HRT is taken to replace estrogen, the body stops producing after menopause -- when periods end permanently -- and helps relieve symptoms such as hot flashes, vaginal discomfort, and pain during sex. But its use has plummeted in recent years amid concerns, including a possible link to invasive breast cancer. Food and Drug Administration (FDA) chief Marty Makary, who convened Thursday's meeting of outside experts, told AFP: "We have to revisit these topics." He argued that the framework that led to so-called "black box warnings" -- the strongest warning the FDA can require for prescription drugs -- "came from a different era." "Not only is there no clinical trial showing an increase in breast cancer mortality, but there are also other tremendous long-term health benefits," Makary added. The 12 experts convened by the agency said HRT's benefits go beyond easing menopausal symptoms. They cited evidence for reduced fracture risk, improved cardiovascular and cognitive health, and fewer urinary tract infections. "Estrogen is the only well-established intervention to reduce the frequency of osteoporotic fracture in postmenopausal women, to the tune of 30 to 50 percent," said Vonda Wright, an orthopaedic surgeon at the University of Central Florida. Roberta Diaz Brinton, director of the Center for Innovation in Brain Science, said her research suggests the reason two-thirds of people globally with Alzheimer's are women is not because they live slightly longer than men, but because the disease begins during the menopausal transition. "Depending upon when hormone therapy is introduced... there's a significant reduction in risk of developing Alzheimer's disease," she said. The University of Arizona researcher linked menopause to a drop in the brain's ability to metabolise glucose and a rise in protein plaque deposits. Panellists blamed the collapse in HRT use on the Women's Health Initiative (WHI), a landmark clinical trial halted in 2002 after flagging a possible increased breast cancer risk -- findings they say were misinterpreted. "Prescriptions for hormone replacement therapy plummeted in the United States, women flushed their pills down the toilet," Makary said in his opening remarks, mentioning his own mother's experience of multiple bone fractures in old age. Critics of the WHI argue it included participants well past menopause -- when risks are higher and benefits lower -- and used outdated formulations no longer common today. - Label changes - Still, the issue remains divisive within the medical community. HRT can be administered through various means and is given either as estrogen alone or with progesterone. The FDA's own warning label for it cites risks including endometrial cancer, breast cancer, and life-threatening blood clots. Adriane Fugh-Berman, who directs a project that promotes rational prescribing at Georgetown University, attended as an observer and criticized the lack of dissenting voices. "This was a very one-sided panel of people who are all proponents of hormone therapy and who seem to have a very poor understanding of the evidence," she told AFP. "While hormones can be a useful treatment for severe menopausal symptoms, they should not be used for chronic disease prevention," she added, noting that no randomised clinical trial -- the gold standard of evidence -- has found HRT beneficial for cognition or dementia prevention. She also said that after the WHI findings were released, hormone use fell globally -- and breast cancer rates dropped across registries tracking them. Several of the panellists had ties to companies offering menopause treatments or are affiliated with the advocacy group "Let's Talk Menopause," which receives pharmaceutical funding and campaigns to revise FDA warning labels.
eNCA
18-07-2025
- eNCA
US authorises Juul to market vaping products
WASHINGTON - Juul Labs said that the US Food and Drug Administration had officially authorised the e-cigarette maker to market its vaping system and refill capsules in the United States. Juul won the new marketing granting orders (MGO) after submitting more than 110 scientific studies to the agency, the company said in a statement. The decision means Juul can continue to sell products that have been on the US market but in regulatory limbo following earlier actions by the FDA. "Following rigorous evaluation of the data, FDA decided that an MGO for the Juul System was 'appropriate for the protection of public health' –- the standard required by statute for authorisation," Juul said. Juul has argued that its vaping products provide a public health benefit by shifting smokers away from combustible tobacco products closely linked to deadly illnesses. But the company has been criticised for its marketing practices, agreeing to pay $438.5-million in a 2022 settlement with 34 US states to resolve accusations of marketing to underage smokers. The FDA's move allows Juul to sell five products in all: the Juul device and capsules for the "Virginia Tobacco" and menthol flavour, each in versions with three or five percent nicotine concentration, said a spokesperson for the US Department of Health and Human Services. The products needed to meet the standard set under a 2009 smoking prevention law showing that the benefits of switching to a potentially less harmful product is "sufficient to outweigh the risks of the product," including to anyone not using tobacco products, the spokesperson said. The applicant submitted data "demonstrating high rates of adults completely switching from cigarettes to either the tobacco- or menthol-flavoured Juul products." But the agency's determination "does not mean these tobacco products are safe, nor are they 'FDA approved,'" said the spokesperson, who added that the agency will continue to monitor Juul's compliance with youth marketing restrictions. Juul survived a difficult stretch after the FDA ordered it to halt sales in June 2022 because of health questions, although the decision was administratively suspended by the same agency shortly thereafter. In June 2024, the FDA formally rescinded its June 2022 order, shifting the matter back into "pending" status while a substantive review continued. The FDA's action on Thursday "confirms that these products are now authorised to remain on the market," said a Juul spokesman.
