{"id":5974,"date":"2024-09-11T19:21:46","date_gmt":"2024-09-11T19:21:46","guid":{"rendered":"https:\/\/blogs.luc.edu\/compliance\/?p=5974"},"modified":"2024-09-11T19:21:46","modified_gmt":"2024-09-11T19:21:46","slug":"fda-approves-flavored-vape-products-for-the-first-time-ever","status":"publish","type":"post","link":"https:\/\/blogs.luc.edu\/compliance\/?p=5974","title":{"rendered":"FDA Approves Flavored Vape Products for the First Time Ever"},"content":{"rendered":"

Anne Bredemann<\/em><\/p>\n

Associate Editor <\/em><\/p>\n

Loyola University Chicago School of Law, 2026<\/em><\/p>\n

The popularity of vaping in the United States peaked<\/a> in 2018 when the company Juul Labs attracted young customers with its variety of flavors and an easily concealable nicotine delivery device. At that time, the FDA had not approved Juul products<\/a> for use in the United States but had not banned the products either. Instead, the FDA issued a few limitations regarding the sale of Juul products \u2013in 2018, the FDA limited what flavor Juul pods could be sold, and in 2019 required that customers in all states be at least 21 years of age<\/a>. This marks the beginning of the FDA\u2019s struggle to regulate the availability of flavored nicotine products, which continues today.<\/p>\n

<\/p>\n

It was not until 2022 that the FDA completed their review of Juul\u2019s market application and determined that the toxicological profile of the vape products was insufficiently appropriate for public use.<\/a> The FDA was concerned that Juul provided insufficient and conflicting data in their studies \u201cregarding [the] genotoxicity and potentially harmful chemicals leaching from the company\u2019s proprietary e-liquid pods<\/a>,\u201d and acknowledged that these products \u201chave played a disproportionate role in the rise of youth vaping<\/a>.\u201d The acting director of the FDA\u2019s Center for Tobacco products commented that while the FDA is tasked with ensuring that a product meets legal standards, the responsibility to show that those standards are met ultimately falls on companies<\/a>. Because the FDA found that Juul failed to demonstrate that their e-cigarette products sufficiently met those standards, the FDA issued<\/a> a sweeping ban of all Juul sales on June 23, 2022.<\/p>\n

In response, Juul Labs filed a lawsuit against the FDA in federal court, claiming that a fuller review of its data would show that the tobacco products are safe for the public. Subsequently, the FDA reversed its ban and instead began conducting further review on Juul e-cigarettes. The present result of this lifted order is that Juul products remain legal to sell in the United States, available in menthol and tobacco flavors for customers aged 21 and above. The Campaign for Tobacco-Free Kids criticized the move<\/a>, arguing that Juul\u2019s history shows that the products are highly appealing to the youth and that the FDA must expedite review and again deny all of Juul\u2019s marketing applications. Juul Labs has continued to face over 5,000 lawsuits<\/a> alleging the company engaged in deceptive marketing or failed to warn about the risks of its products.<\/p>\n

Who is Altria and what do they have to do with Juul?<\/strong><\/p>\n

Altria Group, Inc. was previously Philip Morris, the company that makes Marlboro cigarettes. Today, they continue to operate<\/a> as a holding company which manufactures and sells cigarettes and e-cigarettes to wholesalers and distributors. In 2018, Altria purchased<\/a> a 35% stake in Juul Labs for $12.8 billion. As more FDA regulations, antitrust issues, and lawsuits unfolded for Juul, Altria stepped back and exchanged<\/a> its minority share for the intellectual property rights of Juul\u2019s vape products. In an attempt to revive the market and make up for their losses, Altria announced their decision in March 2023 to purchase startup NJOY<\/a>, a company whose unflavored vape products have already been approved by the FDA. NJOY and Altria are positioning themselves as healthier, smokeless alternatives to traditional cigarette products; however, most health professionals, including the CDC, recognize that no nicotine product is healthy and all should be avoided<\/a>.<\/p>\n

June 2024 Update<\/strong><\/p>\n

In a surprising shift in June this year, the FDA officially approved, for the first time ever, NJOY’s flavored<\/a> pod-based vape products. Matthew Farrelly, Director of the Office of Science in the FDA\u2019s Center for Tobacco Products, said in a press release<\/a>, \u201cBased upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth.” His comments, along with the FDA\u2019s issued decision, are receiving a great deal of pushback; some think no nicotine products should be available on the market given the detrimental health risks they pose to users, some argue that perhaps they should only be available as prescribed quitting-aids for smokers, while others think the percentage of nicotine each pod could be limited from 5% down to 3%, as it is in Europe.<\/p>\n

The decision certainly raises questions about where the nicotine market will go, and how these regulations, or lack thereof, might affect younger generations in the future. The FDA should take note of states, organizations, and individuals who are continuing to pursue legal action against Juul for the harm their products cause. The safety of the public must be the primary concern of the FDA, and as such flavored Juul products should not be approved and available for consumption.<\/p>\n","protected":false},"excerpt":{"rendered":"

The popularity of vaping in the United States peaked in 2018 when the company Juul Labs attracted young customers with its variety of flavors and an easily concealable nicotine delivery device. At that time, the FDA had not approved Juul products for use in the United States but had not banned the products either. Instead, the FDA issued a few limitations regarding the sale of Juul products \u2013in 2018, the FDA limited what flavor Juul pods could be sold, and in 2019 required that customers in all states be at least 21 years of age. This marks the beginning of the FDA\u2019s struggle to regulate the availability of flavored nicotine products, which continues today.<\/p>\n","protected":false},"author":157,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[24],"tags":[810],"class_list":["post-5974","post","type-post","status-publish","format-standard","hentry","category-fda","tag-fda"],"_links":{"self":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/5974","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/users\/157"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5974"}],"version-history":[{"count":5,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/5974\/revisions"}],"predecessor-version":[{"id":5980,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=\/wp\/v2\/posts\/5974\/revisions\/5980"}],"wp:attachment":[{"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5974"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5974"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.luc.edu\/compliance\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5974"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}