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Compiled by Bidi Vapor, LLC

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WASHINGTON—As the U.S. Food and Drug Administration (FDA) further defines its policies on electronic nicotine-delivery systems (ENDS), state and local lawmakers, industry stakeholders and consumers alike will closely monitor its decisions on pivotal issues, including flavors, the needs of adult smokers vs. concerns over underage vaping and the related challenges of illicit markets and counterfeit products. With the FDA’s Sept. 9, 2020, deadline for submitting Premarket Tobacco Product Applications (PMTAs) now passed, the agency will begin reviewing countless pages of research and supporting documentation for ENDS and other tobacco products (OTP) falling under its authority. All relevant issues will undoubtedly come up.

In the meantime, state and local lawmakers have continued to make their own decisions concerning ENDS. Most recently, California Gov. Gavin Newsom signed a bill this past August, banning the sale of most flavored tobacco and nicotine products in the state, while in September, Florida Gov. Ron DeSantis vetoed a similar flavor ban that lawmakers passed earlier this year. With the controversy over ENDS intensifying, the FDA will have to contend with competing data points, as well as weighing the public health benefits and consequences of these products both intended and unforeseen. What follows are five of the more significant conflicts they will have to resolve:

The 2020 National Youth Tobacco Survey (NYTS) reported 1.8 million fewer U.S. youth said they used vaping devices than 2019 compared to the previous year, but 3.6 million minors still did, with eight out of 10 saying they used flavored products. At the same time, flavors are also playing a pivotal role in meeting the needs of adult (21+) smokers. After the FDA issued its January 2020 guidance that took non-tobacco and non-menthol flavored e-cigarette cartridges (pods) off the market, it appears that a high percentage of older, former smokers who had switched to vaping went back to smoking combustible tobacco products. With data making compelling arguments on both sides, the determining factor may lie in why youth under the age of 21 may choose to vape.
While flavors are a part of the larger issue of youth and underage vaping, it comes with a myriad of other issues—just as important if not more so—including teens wanting to look “cool,” issues of availability and access to the devices and simple curiosity.
ENDS devices on the market vary widely, from products designed to meet all accepted manufacturing guidelines regarding safety and quality to those that are counterfeit, subpar or sold without regard to established manufacturing standards, marketing guidelines or compliance with any local, state or federal regulation.
Often, manufacturers of products receiving scrutiny are the very ones trying to comply with all the current guidelines and marketing best practices, while other less scrupulous suppliers bring lower-quality products to the public without concern over basic safety or acceptable marketing practices.

When states or local municipalities decide to ban flavors or any type of in-demand product, the concern of illicit markets arises. As the supply chain moves away from a regulated environment, criminal elements tend to fill the gap. In the case of age-restricted products, this shift tends to circumvent any system of age verification or adherence to product standards, regulation or taxation. The choices the FDA makes in the coming months will affect what adult consumers of tobacco and nicotine products will have for many years to come, with everyone from public health officials to industry stakeholders and the general public living with the ramifications. “Bidi Vapor fully supports proper regulation of the category so that all ENDS products meet the highest manufacturing, safety and marketing standards for adult smokers, with the ultimate  goal of improving the public health,” said Niraj Patel, president and CEO of Bidi Vapor, which submitted its PMTA on Sept. 8, 2020. “We look forward to working with the FDA as it constructs its regulatory policy based on science and facts.” Based in Melbourne, Fla., Bidi Vapor, manufacturers and markets the premium vape pen called BIDI™ Stick, and is committed to the highest standards in manufacturing, marketing to adults age 21 and over and age-verification practices both for online and at brick-and-mortar retail.