On January 24th, 2FIRSTS received an email reply from a spokesperson of the U.S. Food and Drug Administration (FDA), regarding the sales ban imposed on 22 SMOK brand e-cigarette products by Shenzhen IVPS Technology Co., Ltd.
The following is a summary of the key points from FDA's response, providing a condensed translation of the original content.
2FIRSTS: We understand that the FDA issued marketing denial orders (MDOs) to Shenzhen IVPS Technology Co., Ltd for 22 SMOK brand e-cigarette products on Jan 16. To the best of our knowledge, the cartridge and atomizer that received an MDO do not contain e-liquid/juice. What is the legal basis of the enforcement?
FDA: The FDA does not comment on possible, pending or ongoing litigation.
2FIRSTS: As the first batch of MDOs that targeted open-system vape, is it a sign that open-system vape is seen as a kind of medical device? To what extent does the FDA plan to expand its involvement in vaporization devices in the future?
FDA: When Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009, it gave FDA broad authority to regulate tobacco products. A “tobacco product” is a product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product. In 2016, the FDA finalized a rule extending its authority to all products that meet the statutory definition of “tobacco product” in the Federal Food, Drug, and Cosmetic Act, except accessories of deemed tobacco products. As such, the products subject to the denials are tobacco products, not medical devices, and the FDA did not evaluate these products as medical devices. Firms can view this webpage to help identify if their product is a medical device, including if the product “is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”
The FDA evaluates each premarket tobacco product application (PMTA) on a case-by-case basis based on a public health standard that considers the risks and benefits of the product to the population as a whole.
2FIRSTS: Gregory Conley, Director of Leg & Ext Affairs, comments on the recent MDOs that FDA is now “attempting to ban open system vape products on the basis that they *may* be used with flavored e-liquids”, what is FDA ‘s response to that?
FDA: The FDA makes product-by-product determinations to ensure any new tobacco product, including an open or closed system, meets the standards set forth by the Federal Food, Drug, and Cosmetic Act (FD&C Act). Each application is reviewed individually and independently at each phase of the premarket application process, and the agency will make a decision based on the evidence provided within that application. Under the PMTA pathway, manufacturers must demonstrate that marketing of the new tobacco product would be appropriate for the protection of the public health. That standard requires the agency to consider the risks and benefits to the population as a whole—as laid out by Congress in the FD&C Act—including users and non-users of tobacco products. The burden is on the applicant to provide the necessary information to show that the appropriate public health standard has been met. Specifically, in the context of e-cigarettes, the data in their application must show the benefits, including those to adult smokers, outweigh the risks, including those to youth, resulting in a net benefit to the public health. The agency’s evaluation includes, for example, reviewing a tobacco product’s components, ingredients, additives and health risks, as well as how the product is manufactured, packaged and labeled. We also consider the impact of marketing restrictions and other mitigation efforts that aim to reduce the risk of youth initiation and tobacco use, such as advertising and sales restrictions, and device access restrictions.
(Note: Shenzhen IVPS Technology Co., Ltd. announced on January 18 that it has filed an appeal with the United States Fifth Circuit Court of Appeals opposing the Marketing Denial Order (MDO) imposed by the U.S. Food and Drug Administration (FDA) on the SMOK brand's open system kits and related accessories.)
2FIRSTS will continue to monitor the further developments in this matter.
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