Tag: e-cigarettes

#FDA DENIES AUTHORIZATION to Market-Juul Products

Currently Marketed #JUUL Products Must Be Removed from US Market

For Immediate Release:June 23, 2022 Press Release

The U.S. Food and Drug Administration issued marketing denial orders (MDOs) to JUUL Labs Inc. for all of their products currently marketed in the United States. As a result, the company must stop selling and distributing these products. In addition, those currently on the U.S. market must be removed, or risk enforcement action. The products include the JUUL device and four types of JUULpods: Virginia tobacco flavored pods at nicotine concentrations of 5.0% and 3.0% and menthol flavored pods at nicotine concentrations of 5.0% and 3.0%. Retailers should contact JUUL with any questions about products in their inventory.

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” said FDA Commissioner Robert M. Califf, M.D. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

These MDOs only pertain to the commercial distribution, importation and retail sales of these products, and do not restrict individual consumer possession or use—the FDA cannot and will not enforce against individual consumer possession or use of JUUL products or any other tobacco products. 

After reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health. In particular, some of the company’s study findings raised concerns due to insufficient and conflicting data – including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed and precluded the FDA from completing a full toxicological risk assessment of the products named in the company’s applications. 

BACKGROUND

FDA Denies Marketing Applications for About 55,000 Flavored E-Cigarette Products for Failing to Provide Evidence They Appropriately Protect Public Health

https://www.fda.gov/news-events/press-announcements/fda-denies-marketing-applications-about-55000-flavored-e-cigarette-products-failing-provide-evidence

TOBACCO CONTROL ACT AND THE PRESENT-DAY IMPACT ON “OVERLOOKED AND BELATED ISSUES”—ENDS, YOUTH EPIDEMIC, GRAPHIC WARNINGS

Abstract

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3311583

Although smoking has plagued the United States for generations, it was not until the past several years that smoking received more serious scrutiny. Yet, the reality is that as far back as the 1960s, tobacco products posed a serious threat to human health as evidenced by the Surgeon General’s report explaining that smoking causes cancer.  

Fast forward to current times, the Centers for Disease Control (“CDC”) has determined that over 1,300 people in the United States die each day due to smoking and over sixteen million Americans have a disease attributed to smoking. The CDC concluded that in the United States, cigarette smoking is responsible for more than 480,000 deaths annually, and secondhand smoke exposure caused more than 41,000 of these deaths.  

These statistics do not just cover the older generations that many associate with smoking. Over the years, the numbers in teen smoking statistics have escalated since the 1990s. Based on CDC statistics, about 2,000 youth start smoking their initial cigarette, and 300 youth become day-to-day smokers. This means that using current rates of smoking among youth, 5.6 million Americans younger than eighteen years of age are expected to die prematurely from a smoking-related illness. This denotes about 1 in every 13 Americans aged seventeen years or younger who are alive today. The Center for Tobacco Products (“CTP”) within the United States Food and Drug Administration (“FDA”) regulates tobacco products with a mission of diminishing tobacco related deaths and diseases. Since its creation, the CTP has maintained a critical mission on educating youth about the dangers of smoking. Yet, teen use of tobacco related products has increased.  

The Family Smoking Prevention and Tobacco Control Act (FSPTCA or Tobacco Act) became law on June 22, 2009. This legislation conferred authority to the FDA to regulate tobacco products. The FSPTCA amended the Food, Drug, and Cosmetic Act (FDCA) and other federal laws by permitting FDA regulatory authority over of tobacco products. This includes cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Yet, the FSPTCA, when enacted, was silent on issues of e-cigarettes and other electronic nicotine delivery systems (ENDS) and were eventually “deeming” as part of the FSPTCA. 

There are a myriad of matters concerning tobacco products regulation. However, this article highlights critical issues important to the public health in the United States. This article provides an overview of tobacco products regulation, including the FSPTCA. Yet, issues persist such as undue delay in reissuing graphic warnings for cigarettes and lengthy legal battles over the language used in court-ordered corrective statements. Further, the FSPTCA was silent on other tobacco products besides traditional cigarettes such as cigars, pipe tobacco and ENDS including e-cigarettes. To overcome the lack of inclusion in the FSPTCA, deeming regulations were enacted. Despite the deeming regulations, the use of tobacco products, including vaping and e-cigarettes, has escalated. Finally, this article discusses the FDA’s accomplishments along with further recommendations to stem the rise in youth use of e-delivery products. 

Keywords: Tobacco Regulation, E-Cigarettes, Family Smoking Prevention and Tobacco Control Act, Food and Drug Administration, Electronic Nicotine Delivery Systems, Youth Smoking