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Pre-Market Tobacco Products Applications (PMTA) List Impact on the US Vaping Industry

California, USA, The electronic cigarette and vaping industry has grown rapidly in the years starting from 2016. Statistics indicate that what was once a USD 2.98 Billion industry in 2016 grew to USD 15.04 billion in 2020. Prior to the FDA bans, experts estimated that the industry was likely to continue growth at a CAGR of an astounding 21.8% from 2021 to 2028. In the last few years, products have evolved with features like complete customization and a selection of nicotine levels. Consumers can design and build atomizers and experiment with DIY e-liquids and e-juices in different flavors, a factor that has contributed in a big way to the rising popularity.

New Regulations May Impact Market Growth

The rapid growth in the vaping industry attracted several smaller, cheaper players and vendors who imported products from China. Not only are the products sub-standard in quality, they are made with cheap, toxic plastics and sold by unknown manufacturers. In an attempt to control the risks to public health, especially underage consumers aged 12 to 18, the US government instituted the Consolidated Appropriations Act, 2021 on December 27, 2020. This law is an amendment of the Prevent All Cigarette Trafficking (PACT) Act and now encompasses all vaping products, e-cigarettes, and Electronic Nicotine Delivery Systems (ENDS) components.

The FDA Now Has Authority Over Tobacco Products

In response to the new Section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, the FDA required manufacturers and vendors to submit Premarket Tobacco Product Applications (PMTA) for their products. Individual applications were to be submitted for each product for approval for sale to the general public. The submission deadline was fixed on September 9th, 2020. After evaluating over 6 million applications, the FDA has released a 15-part list of Deemed New Tobacco Products.

Some of the products on the list are permitted for sale in the market while the FDA continues to review them. The ENDS (Electronic Nicotine Delivery Systems) Companies list includes 360 vaping brands and products. Manufacturers producing items similar in composition and features to existing products that have approval need not submit fresh applications.

The FDA Has Started Denying Marketing Permissions

On August 26, 2021, the FDA released the first list of Marketing Denial Orders (MDOs) for ENDS products with around 55,000 products being banned. The agency has identified products from three leading companies: JD Nova Group LLC, Great American Vapes, and Vapor Salon. The products lack adequate evidence to prove that they do not pose health risks to adult smokers in the face of alarming reports of these products being used by underage vapers. The primary products deemed unfit for marketing by the FDA include flavors like Cinnamon Toast Cereal, Dr. Cola, and Apple Crumble. Currently, the FDA’s main focus is on flavored vapes that are highly popular among the youth and likely to encourage underage vaping. Menthol-flavored vapes are not targeted.

In the Coming Months, the FDA Will Continue to Review Applications

Given the mind-boggling range of vape products and brands available, the FDA has not been able to assess all the applications. In the coming months, the agency will continue to review product-specific scientific evidence to evaluate the risks faced by the youth, as against the benefits to adult users. Products will be permitted only if they comply with the statutory standards for authorization deemed by the FDA.

Growth Projections Have Become Uncertain

The new regulations and FDA bans have resulted in many smaller manufacturers going out of business overnight. Some have been unable to invest the funding necessary to get their products tested in scientific labs and send out applications for approval. Even reputable vendors and eCommerce stores like Blackout Vapors have been reviewing their buying and stocking strategies to delay stocking until after the release of the final list of deemed products. The primary concern is that all stores, online or offline, don’t want to be stuck with dead inventory that cannot be sold or sent back to the manufacturer.

Until the complete list of deemed products is released by the FDA, conditions in the vaping industry continue to remain uncertain.

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