
Juul gets FDA's OK to keep selling tobacco and menthol e-cigarettes
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The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend.
FDA regulators said Thursday that Juul's studies show its e-cigarettes are less harmful for adult smokers, who can benefit from switching completely to vaping.
The FDA decision applies to both tobacco- and menthol-flavored versions of the reusable product, which works with nicotine-filled cartridges sold in two different strengths. Juul previously discontinued several fruit and candy flavors that helped drive its popularity but were favored by teens.
Juul will be one of only two U.S. companies authorized to sell menthol-flavored vapes, which many adults prefer to tobacco flavor.
'This is an important milestone for the company and I think we made a scientifically sound case for the role that menthol can play in e-vapor,' Juul CEO K.C. Crosthwaite told The Associated Press.
Parents, politicians and anti-tobacco groups are certain to oppose FDA's decision. They have argued for years that Juul products should be permanently banned due to their role in triggering a yearslong spike in underage vaping.
'It is a big step in the wrong direction to authorize sales of the product that was responsible for this public health crisis in the first place,' said Yolonda Richardson, CEO of the Campaign for Tobacco-Free Kids in a statement.
Juul was once valued at over $13 billion and its small, sleek e-cigarettes revolutionized the image and technology of the vaping industry. But the company has since been forced to slash hundreds of jobs and pay billions to settle lawsuits over its role in the rise of youth vaping.
The FDA had ordered the company to remove its products from the market in June 2022. But then the agency abruptly reversed course days later and agreed to reopen its scientific review of Juul's application after the company pushed back in court.
Juul said that regulators had overlooked thousands of pages of scientific data critical to its submission.
Thursday's announcement is not an approval or endorsement, and the FDA reiterated that people who do not smoke should not use Juul or any other e-cigarettes. The FDA determination indicates that smokers who switch completely to Juul can reduce their exposure to deadly carcinogens and other chemicals found in traditional cigarettes.
The FDA decision applies to Juul's original system, which is now roughly a decade old. Crosthwaite said the company hopes to win authorization for its next-generation device and is also considering applying to FDA for more flavors.
'It's critically important that American adults who use tobacco have regulated options,' Crosthwaite said.
In recent years, the FDA has authorized a handful of e-cigarettes to help adult smokers cut back on cigarettes. Juul's main competitors, Vuse and Njoy, each previously received FDA permission to remain on the market. Njoy sells the only other menthol-flavored e-cigarettes authorized by FDA.
To meet FDA requirements, companies must show that their products benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them.
The brainchild of two Stanford University students, Juul launched in 2015 and within two years rocketed to the top of the vaping market.
Juul quickly outpaced older brands with its high-nicotine, fruity-flavored cartridges, sold in mango, mint and creme brulé. The company's small, discrete devices provided a more potent, user-friendly alternative to older, bulkier devices.
But the company's rise was fueled by underage use, and e-cigarettes quickly became ubiquitous in U.S. schools. In 2019, the company was pressured into halting all advertising and eliminating most of its flavors, leaving only tobacco and menthol-flavored options.
By then the company was already the target of multiple investigations and lawsuits by federal, state and local officials as well as class action attorneys.
In 2022, the company paid $1.7 billion to settle thousands of lawsuits brought by families of Juul users, school districts, city governments and Native American tribes. The company separately agreed to pay $1.1 billion to settle lawsuits or investigations from most U.S. states.
Juul is no longer the top-selling e-cigarette brand and now trails Vuse, which is sold by tobacco giant Reynolds American, which also makes Camel and Newport cigarettes.
Teens have shifted away from Juul amid a wider drop in vaping, according to the latest federal figures. The FDA reported last year that teen vaping dropped to a 10-year low, after stepped up enforcement against unauthorized brands imported from China, such as Elf Bar.
Unlike Juul, disposable e-cigarettes like Elf Bar still come in fruit and candy flavors, despite efforts by regulators to block their use.
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Percent weight reduction: -7.5% (-7.8 kg; 17.2 lbs; 6 mg), -8.4% (-8.6 kg; 19.0 lbs; 12 mg), -11.2% (-11.3 kg; 25.0 lbs; 36 mg), -2.1% (-2.4 kg; 5.3 lbs; placebo) Percentage of participants achieving body weight reductions of ≥10%: 33.3% (6 mg), 40.0% (12 mg), 54.6% (36 mg), 12.9% (placebo) Percentage of participants achieving body weight reductions of ≥15%: 15.1% (6 mg), 20.3% (12 mg), 36.0% (36 mg), 5.9% (placebo) The overall safety profile of orforglipron in ATTAIN-1 was consistent with the established GLP-1 receptor agonist class. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity. The most common adverse events for participants treated with orforglipron (6 mg, 12 mg and 36 mg, respectively) were nausea (28.9%, 35.9% and 33.7%) vs. 10.4% with placebo, constipation (21.7%, 29.8% and 25.4%) vs. 9.3% with placebo, diarrhea (21.0%, 22.8% and 23.1%) vs. 9.6% with placebo, vomiting (13.0%, 21.4% and 24.0%) vs. 3.5% with placebo, and dyspepsia (13.0%, 16.2% and 14.1%) vs. 5.0% with placebo. Treatment discontinuation rates due to adverse events were 5.1% (6 mg), 7.7% (12 mg) and 10.3% (36 mg) for orforglipron vs. 2.6% with placebo. The overall treatment discontinuation rates were 21.9% (6 mg), 22.5% (12 mg) and 24.4% (36 mg) for orforglipron vs. 29.9% with placebo. No hepatic safety signal was observed. The detailed ATTAIN-1 results will be presented next month at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025 and published in a peer-reviewed journal. More results from the ATTAIN Phase 3 clinical trial program will be shared later this year, along with findings from the ACHIEVE Phase 3 clinical trial program evaluating orforglipron for adults with type 2 diabetes. About orforglipron Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.3 Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.4 Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea (OSA) and hypertension in adults with obesity. About ATTAIN-1 and ATTAIN clinical trial program ATTAIN-1 (NCT05869903) is a Phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron 6 mg, 12 mg and 36 mg as monotherapy to placebo in adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, OSA or cardiovascular disease, who did not have diabetes. The trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan in 3:3:3:4 ratio to receive either 6 mg, 12 mg or 36 mg orforglipron or placebo. The primary objective of the study was to demonstrate that orforglipron (6 mg, 12 mg, 36 mg) is superior to placebo in body weight reduction from baseline after 72 weeks in people with a BMI ≥30.0 kg/m² or a BMI ≥27.0 kg/m² with at least one weight-related comorbidity and a history of at least one self-reported unsuccessful dietary effort to lose body weight. All participants in the orforglipron treatment arms started the study at a dose of orforglipron 1 mg once-daily and then increased the dose in a step-wise approach at four-week intervals to their final randomized maintenance dose of 6 mg (via steps at 1 mg and 3 mg), 12 mg (via steps at 1 mg, 3 mg and 6 mg) or 36 mg (via steps at 1 mg, 3 mg, 6 mg, 12 mg and 24 mg). Dose reduction was only allowed for GI tolerability if other mitigations failed. The ATTAIN Phase 3 global clinical development program for orforglipron has enrolled more than 4,500 people with obesity or overweight across two global registration trials. The program began in 2023 with additional results anticipated this year. About LillyLilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram and LinkedIn. P-LLY Endnotes and References: The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments. The treatment-regimen estimand represents the estimated average treatment effect regardless of adherence to study intervention or initiation of prohibited weight management treatments. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152. T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, (2020). Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about orforglipron as a potential treatment for adults with obesity or overweight, Lilly's ability to supply orforglipron, if approved, and the timeline for future readouts, presentations, and other milestones relating to orforglipron and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that orforglipron will prove to be a safe and effective treatment for obesity or overweight, that orforglipron will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Brooke Frost; 317-432-9145 (Media)Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Sign in to access your portfolio